Zepbound® (tirzepatide) Safety Information
Important Safety Information for Zepbound® (tirzepatide) injection
Warning: Risk of Thyroid C-Cell Tumors
In rats, Zepbound® (tirzepatide) caused thyroid tumors, including thyroid cancer. It is not known if Zepbound® (tirzepatide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
Do not use Zepbound® (tirzepatide) if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Zepbound® (tirzepatide)?
Zepbound® (tirzepatide) is used along with a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m^2 or greater (obesity) or
- 27 kg/m^2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, dyslipidemia, type 2 diabetes mellitus, obstructive sleep apnea, or cardiovascular disease).
Limitations of use:
- Zepbound® (tirzepatide) should not be used in combination with other tirzepatide-containing products or any other GLP-1 receptor agonist.
- The safety and efficacy of coadministration with other products for weight management have not been established.
- Zepbound® (tirzepatide) has not been studied in patients with a history of pancreatitis.
Who should not use Zepbound® (tirzepatide)?
Do not use Zepbound® (tirzepatide) if:
- You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have a known allergic reaction to Zepbound® (tirzepatide).
How should I take Zepbound® (tirzepatide)?
You can take Zepbound® with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your He + She provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimven or stop taking Zepbound® (tirzepatide) as prescribed without discussing with your provider first.
What should I tell my He + She provider before using Zepbound® (tirzepatide)?
Zepbound® (tirzepatide) has certain drug interactions.It’s important to tell your He + She provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
Some medications to watch out for include:
- Medications for diabetes:Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Other oral medications: Zepbound® (tirzepatide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
- Hormonal birth control:If you are using an oral hormonal contraceptive (birth control), Zepbound® (tirzepatide) may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Zepbound® (tirzepatide) and for 4 weeks after each dose escalation, until you reach a maintenance dose.
- Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
- Other products for weight loss:Including dietary supplements
- It’s important to share your entire medical history with your provider.In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Gastrointestinal disease
- Pancreatitis
- Kidney disease
- Diabetic retinopathy
- Depression
- Suicidal thoughts or behavior
- Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Zepbound® (tirzepatide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Zepbound® (tirzepatide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female reproductive potential:Zepbound® (tirzepatide) may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
- If you are breastfeeding: It is not known if Zepbound® (tirzepatide) passes into breast milk. Talk to your provider first about the benefits and risks of using Zepbound® (tirzepatide) while breastfeeding.
- Pregnancy registry:There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Zepbound® (tirzepatide) during pregnancy. Pregnant patients exposed to Zepbound® (tirzepatide) and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Zepbound® (tirzepatide)?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with Zepbound® (tirzepatide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors: In rats, Zepbound® (tirzepatide) caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Zepbound® (tirzepatide) causes thyroid C-cell tumors in humans. Zepbound® (tirzepatide) is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Severe Gastrointestinal Disease: Zepbound® (tirzepatide) is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
- Acute Kidney Injury: Gastrointestinal side effects of Zepbound® (tirzepatide) like diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems if dehydration is severe. It is important for you to drink plenty of water to help reduce your chance of dehydration.
- Acute Gallbladder Disease: Zepbound® (tirzepatide), other GLP-1 receptor agonists, and weight loss are associated with an increased chance of acute gallbladder disease. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
- Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
- Allergic Reactions: Stop using Zepbound® (tirzepatide) right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
- Low Blood Sugar (Hypoglycemia): Zepbound® (tirzepatide) lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
- Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Never Share a Pen: Pen-sharing poses a risk of infection.
What are the most common side effects of Zepbound® (tirzepatide)?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Stomach pain
- Indigestion
- Injection site reactions
- Feeling tired
- Allergic reactions
- Belching
- Hair loss
- Gastroesophageal reflux disease (heartburn)
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
Disclaimer: Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. He + She Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of He + She Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordisk or Eli Lilly .
Wegovy® (Semaglutide) Safety Information
Warning: Risk of Thyroid C-Cell Tumors
- In studies with mice and rats, semaglutide (the active ingredient in Wegovy® and Ozempic®) caused thyroid tumors, including thyroid cancer. It is not known if Wegovy® (semaglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people. Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Do not use Wegovy® (semaglutide) if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Wegovy® (semaglutide)?
Wegovy® (semaglutide) is a glucagon-like peptide-1 (GLP-1) receptor agonist for chronic weight management, along with a reduced calorie diet and increased physical activity, for people with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obesity) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (e.g., hypertension, type 2 diabetes mellitus, or dyslipidemia).
Limitations of use:
- Wegovy® (semaglutide) should not be used in combination with other semaglutide-containing products or any other GLP-1 receptor agonist
- The safety and efficacy of coadministration with other products for weight loss have not been established
- Wegovy® (semaglutide) has not been studied in patients with a history of pancreatitis
Who should not use Wegovy® (semaglutide)?
Do not use Wegovy® (semaglutide) if:
- You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have a known allergic reaction to semaglutide (the active ingredient in Wegovy® or Ozempic).
How should Wegovy® (semaglutide) be administered?
You can take Wegovy® (semaglutide) with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. Your He + She provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Wegovy® (semaglutide) as prescribed without discussing with your provider first.
What should I tell my He + She provider before using Wegovy® (semaglutide)?
Wegovy® (semaglutide) has certain drug interactions. It’s important to tell your He + She provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
Some medications to watch out for include:
- Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Wegovy® (semaglutide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
- Other GLP-1 medications, including WeGovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liraglutide), Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Victoza® (liraglutide), Byetta® (exenatide), or Bydureon® (exenatide).
- If you’re using other products for weight loss, including dietary supplements
It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Pancreatitis
- Kidney disease
- Diabetic retinopathy
- Depression
- Suicidal thoughts or behavior
Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Wegovy® (semaglutide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Wegovy® (semaglutide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female or male of reproductive potential:Discontinue Wegovy® (semaglutide) at least 2 months before a planned pregnancy since the drug can stay in the bloodstream for a long time.
- If you are breastfeeding: Wegovy® (semaglutide) was found in the milk of lactating rats. Tell your He + She provider if you are breastfeeding before you start Wegovy® (semaglutide).
Pregnancy registry: There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to semaglutide (the active ingredient in Wegovy® and Ozempic®) during pregnancy. Pregnant women exposed to these products and healthcare providers are encouraged to contact Novo Nordisk at 1-800-727-6500.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Wegovy® (semaglutide)?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects can occur with Wegovy® (semaglutide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors:In mice and rats, semaglutide (the active ingredient in Wegovy® and Ozempic®) caused an increase in thyroid C-cell tumors, including medullary thyroid carcinoma (MTC). It is unknown whether Wegovy® (semaglutide) causes thyroid C-cell tumors in humans. There were cases of MTC reported in patients who took liraglutide (the active ingredient in Victoza® and Saxenda®) after the drug was put on the market. Wegovy® (semaglutide) is contraindicated in patients with a family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Inflammation of Pancreas (Acute Pancreatitis): Monitor for signs of acute pancreatitis, including severe abdominal pain that does not go away, sometimes radiating to the back, with or without vomiting.
- Acute Gallbladder Disease:Wegovy® (semaglutide) may cause gallbladder problems, including gallstones. Some gallbladder problems require surgery. Tell your provider right away if you have pain in your upper stomach, yellowing of skin or eyes (jaundice), fever, or clay-colored stools.
- Low Blood Sugar (hypoglycemia): Wegovy® (semaglutide) lowers blood glucose. It can cause too low blood sugar in patients with type 2 diabetes who also take another glucose control medication. Monitor your blood sugar and watch out for signs of too low blood sugar such as dizziness, blurred vision, mood changes, sweating, or fast heartbeat.
- Acute Kidney Injury: In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration) which may cause kidney problems to get worse. It is important for you to drink plenty of water to help reduce your chance of dehydration.
- Serious Allergic Reactions: Stop using Wegovy® (semaglutide) right away if you experience symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, severe rash or itching, very rapid heartbeat, problems breathing or swallowing, or fainting or feeling dizzy.
- Diabetic Retinopathy Complications in Patients with Type 2 Diabetes: If you have type 2 diabetes, tell your provider right away if you experience changes in vision.
- Increase in Heart Rate: Tell your provider right away if you have a racing heartbeat while at rest.
- Suicidal Behavior and Ideation:You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Never Share a Pen: Pen-sharing poses a risk of infection.
What are the most common side effects of Wegovy® (semaglutide)?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Abdominal pain
- Headache
- Fatigue
- Dyspepsia
- Dizzyness
- Abdominal distension
- Eructation
- Hypoglycemia in patients with type 2 diabetes
- Flatulence
- Gastroenteritis
- Gastroesophageal reflux disease
You are encouraged to report negative side effects of prescription products:
- Contact Novo Nordisk Inc. at 1-833-934-6891
- Contact FDA MedWatch at 1-800-FDA-1088 or visit fda.gov/medwatch
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
Disclaimer: Ozempic®, WeGovy® and Saxenda® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. He + She Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of He + She Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordiskor Eli Lilly .
Mounjaro® (tirzepatide) Safety Information
Important Safety Information for Mounjaro® (tirzepatide) injection
Warning: Risk of Thyroid C-Cell Tumors
Mounjaro® (tirzepatide) injection may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
- Do not use Mounjaro® (tirzepatide) injection if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
- Do not use Mounjaro® (tirzepatide) injection if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Mounjaro® (tirzepatide) injection?
Mounjaro® (tirzepatide) injection (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).
Limitations of use:
It is not known if Mounjaro® (tirzepatide) injection can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro® (tirzepatide) injection is not for use in people with type 1 diabetes. It is not known if Mounjaro® (tirzepatide) injection is safe and effective for use in children under 18 years of age.
Who should not use Mounjaro® (tirzepatide) injection?
Do not use Mounjaro® (tirzepatide) injection if:
- You or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC) or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- You have a known allergic reaction to Mounjaro® (tirzepatide) injection.
How should I take Mounjaro® (tirzepatide) injection?
You can take Mounjaro® (tirzepatide) injection with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. You should change your injection site each week. Do not use the same site for each injection. Your He + She provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Mounjaro® (tirzepatide) injection as prescribed without discussing with your provider first. If you take too much Mounjaro® (tirzepatide) injection, call your healthcare provider or seek medical advice promptly.
What should I discuss with my He + She provider before using Mounjaro®?
- Mounjaro® (tirzepatide) injection has certain drug interactions.It’s important to tell your He + She provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
- Your healthcare provider should show you how to use Mounjaro® (tirzepatide) injection before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and how to manage it.
- If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro® (tirzepatide) injection. Birth control pills may not work as well while using Mounjaro® (tirzepatide) injection. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro® (tirzepatide) injection and for 4 weeks after each increase in your dose of Mounjaro® (tirzepatide) injection.
Some medications to watch out for include:
- Medications for diabetes: Medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Other oral medications: Mounjaro® (tirzepatide) injection causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same ti Your provider can guide you on how to schedule your medications.
- Hormonal birth control:If you are using an oral hormonal contraceptive (birth control), Mounjaro® (tirzepatide) injection may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Mounjaro® (tirzepatide) injection and for 4 weeks after each dose escalation, until you reach a maintenance dose.
- Other GLP-1 medications: Including Zepbound® (tirzepatide) injection, Wegovy® (semaglutide), Ozempic® (semaglutide), Saxenda® (liguratide), Victoza® (liguratide), Byetta® (Exenatide), Bydureon ® (Exenatide), or compounded GLP-1 formularies. These medications should not be taken with Mounjaro® (tirzepatide) injection.
- Other products for weight loss: Including dietary supplements
- It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Gastrointestinal disease
- Pancreatitis
- Kidney disease
- Diabetic retinopathy
- Depression
- Suicidal thoughts or behavior
- Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Mounjaro® (tirzepatide) injection should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Mounjaro® (tirzepatide) injection during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female reproductive potential:Mounjaro® (tirzepatide) injection may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
- If you are breastfeeding:It is not known if Mounjaro® (tirzepatide) injection passes into breast milk. Talk to your provider first about the benefits and risks of using Mounjaro® (tirzepatide) injection while breastfeeding.
- Pregnancy registry:There will be a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to Mounjaro® (tirzepatide) injection during pregnancy. Pregnant patients exposed to Mounjaro® (tirzepatide) injection and healthcare providers are encouraged to contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979).
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Mounjaro® (tirzepatide) injection?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with Mounjaro® (tirzepatide) injection. You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors: In rats, Mounjaro® (tirzepatide) injection caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Mounjaro® causes thyroid C-cell tumors in humans. Mounjaro® (tirzepatide) injection is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Severe Gastrointestinal Disease: Mounjaro® (tirzepatide) injection is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
- Inflammation of the pancreas (pancreatitis). Stop using Mounjaro® (tirzepatide) injection and call your healthcare provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Low blood sugar (hypoglycemia).Your risk for getting low blood sugar may be higher if you use Mounjaro® (tirzepatide) injection with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include dizziness or light-headedness, sweating, confusion or drowsiness, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability, or mood changes, hunger, weakness and feeling jittery.
- Serious allergic reactions.Stop using Mounjaro® (tirzepatide) injection and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue or throat, problems breathing or swallowing, severe rash or itching, fainting or feeling dizzy, and very rapid heartbeat.
- Kidney problems (kidney failure). In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- Severe stomach problems.Stomach problems, sometimes severe, have been reported in people who use Mounjaro® (tirzepatide) injection. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- Changes in vision.Tell your healthcare provider if you have changes in vision during treatment with Mounjaro® (tirzepatide) injection.
- Gallbladder problems.Gallbladder problems have happened in some people who use Mounjaro® (tirzepatide) injection. Tell your healthcare provider right away if you get symptoms of gallbladder problems, which may include pain in your upper stomach (abdomen), fever, yellowing of skin or eyes (jaundice), and clay-colored stools.
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
- Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Never Share a Pen: Pen-sharing poses a risk of infection.
What are the most common side effects of Mounjaro® (tirzepatide) injection?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Stomach pain
- Indigestion
- Injection site reactions
- Feeling tired
- Allergic reactions
- Belching
- Hair loss
- Gastroesophageal reflux disease (heartburn)
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
Disclaimer: Ozempic®, WeGovy® and Saxenda® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. He + She Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of He + She Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordiskor Eli Lilly .
Ozempic® (semaglutide) Safety Information
Important Safety Information for Ozempic® (semaglutide) injection
Warning: Risk of Thyroid C-Cell Tumors
Mounjaro® (tirzepatide) injection may cause tumors in the thyroid, including thyroid cancer. Watch for possible symptoms, such as a lump or swelling in the neck, hoarseness, trouble swallowing, or shortness of breath. If you have any of these symptoms, tell your healthcare provider.
Ozempic® (semaglutide) may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rodents, Ozempic® (semaglutide) and medicines that work like Ozempic® (semaglutide) caused thyroid tumors, including thyroid cancer. It is not known if Ozempic® (semaglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Ozempic® (semaglutide) if you or any of your family have ever had MTC, or if you have an endocrine system condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
What is the FDA-approved use of Ozempic® (semaglutide)?
Ozempic® (semaglutide) injection 0.5 mg, 1 mg, or 2 mg is an injectable prescription medicine used:
- along with diet and exercise to improve blood sugar (glucose) in adults with type 2 diabetes.
- to reduce the risk of major cardiovascular events such as heart attack, stroke, or death in adults with type 2 diabetes with known heart disease.
Limitations of use:
It is not known if Ozempic® (semaglutide) can be used in people who have had pancreatitis. Ozempic® (semaglutide) is not for use in people with type 1 diabetes. It is not known if Ozempic® (semaglutide) is safe and effective for use in children under 18 years of age.
Who should not use Ozempic® (semaglutide)?
Do not use Ozempic® (semaglutide) if:
- you or any of your family have ever had MTC or if you have MEN 2.
- you are allergic to semaglutide or any of the ingredients in Ozempic®. See symptoms of serious allergic reaction in “What are the possible side effects of Ozempic®?”.
How should I take Ozempic® (semaglutide)?
You can take Ozempic® (semaglutide) with or without food. The pre-filled injector pen is self-administered as a subcutaneous injection in the stomach, thigh, or upper arm once a week on the same day every week. You should change your injection site each week. Do not use the same site for each injection. Your He + She provider will guide you on a treatment regimen that may include an increase in dose every four weeks.
You should not change your dosing regimen or stop taking Ozempic® (semaglutide) as prescribed without discussing with your provider first. If you take too much Ozempic® (semaglutide), call your healthcare provider or seek medical advice promptly.
What should I discuss with my He + She provider before using Ozempic® (semaglutide)?
- Mounjaro® (tirzepatide) injection has certain drug interactions.It’s important to tell your He + She provider all of the medications you are currently taking, including prescription, over-the-counter medications, vitamins, and herbal and dietary supplements.
- Your healthcare provider should show you how to use Mounjaro® (tirzepatide) injection before you use it for the first time.
- Talk to your healthcare provider about low blood sugar and how to manage it.
- If you take birth control pills by mouth, talk to your healthcare provider before you use Mounjaro® (tirzepatide) injection. Birth control pills may not work as well while using Mounjaro® (tirzepatide) injection. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro® (tirzepatide) injection and for 4 weeks after each increase in your dose of Mounjaro® (tirzepatide) injection.
Some medications to watch out for include:
- Medications for diabetes: Other medications used to treat type 1 or type 2 diabetes, including insulin or sulfonylureas (such as Amaryl or Glucotrol XL)
- Other oral medications: Ozempic® (semaglutide) causes a delay in gastric emptying, so it has the potential to impact the absorption of medications that are taken by mouth at the same time. Your provider can guide you on how to schedule your medications.
- Hormonal birth control:Other GLP-1 medications have been shown to potentially decrease the efficacy of oral birth control pills. If you are using an oral hormonal contraceptive (birth control), Ozempic® (semaglutide) may decrease its efficacy, especially after the first dose. Switch to a non-oral contraceptive method or use a barrier method of contraception for 4 weeks after starting Ozempic® (semaglutide) and for 4 weeks after each dose escalation, until you reach a maintenance dose.
- Other GLP-1 medications:Including Zepbound® (tirzepatide), Mounjaro® (tirzepatide), Wegovy® (semaglutide), Saxenda® (liraglutide), Victoza® (liraglutide), Byetta® (exenatide), Bydureon® (exenatide), or compound GLP-1 formularies. These medications should not be taken with Ozempic® (semaglutide).
- Other products for weight loss: Including dietary supplements
- It’s important to share your entire medical history with your provider. In particular, tell your provider if you have a past history of:
- Type 1 or type 2 diabetes
- Thyroid cancer
- Gastrointestinal disease
- Pancreatitis
- Kidney disease
- Diabetic retinopathy
- Depression
- Suicidal thoughts or behavior
- Tell your provider if you are pregnant, planning to become pregnant, or breastfeeding.
- If you are pregnant: Ozempic® (semaglutide) should not be used during pregnancy. Based on animal studies, there may be potential risks to an unborn baby from exposure to Ozempic® (semaglutide) during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the unborn baby.
- If you are a female reproductive potential:Ozempic® (semaglutide) may reduce the efficacy of oral hormonal contraceptives. Switch to a non-oral contraceptive method, or add a barrier method of contraception for 4 weeks after starting medication and for 4 weeks after each dose escalation until you reach a maintenance dose.
- If you are breastfeeding: It is not known if Ozempic® (semaglutide) passes into breast milk. Talk to your provider first about the benefits and risks of using Ozempic® (semaglutide) while breastfeeding.
Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm, including, in some cases, death.
What are the most serious side effects that I or a caregiver should monitor for when taking Ozempic® (semaglutide)?
If you are experiencing a medical emergency, call 911 or seek immediate medical attention.
These serious side effects are rare, but can occur with Ozempic® (semaglutide). You or a caregiver should carefully monitor for these side effects, especially in the beginning of treatment and with dose changes.
- Thyroid C-Cell Tumors: In rats, Ozempic® (semaglutide) caused a dose-dependent and treatment-duration-dependent increase in thyroid C-cell tumors. It is unknown whether Ozempic® (semaglutide) causes thyroid C-cell tumors in humans. Ozempic® (semaglutide) is contraindicated in patients with a family history of medullary thyroid cancer (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Tell your provider if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer.
- Severe Gastrointestinal Disease: Ozempic® (semaglutide) is associated with gastrointestinal side effects, such as nausea, diarrhea, vomiting, constipation, and stomach pain, and can sometimes be severe. It hasn’t been studied in patients with severe gastrointestinal disease and isn’t recommended in these patients. The majority of nausea, vomiting, and/or diarrhea events occurred during a dose increase and decreased over time.
- Inflammation of your pancreas (pancreatitis): Stop using Ozempic® (semaglutide) and call your health care provider right away if you have severe pain in your stomach area (abdomen) that will not go away, with or without vomiting. You may feel the pain from your abdomen to your back.
- Low blood sugar (hypoglycemia): Your risk for getting low blood sugar may be higher if you use Ozempic® (semaglutide) with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin. Signs and symptoms of low blood sugar may include: dizziness or lightheadedness, blurred vision, anxiety, irritability or mood changes, sweating, slurred speech, hunger, confusion or drowsiness, shakiness, weakness, headache, fast heartbeat, and feeling jittery.
- Kidney problems (kidney failure): In people who have kidney problems, diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems to get worse. It is important for you to drink fluids to help reduce your chance of dehydration.
- Serious allergic reactions: Stop using Ozempic® (semaglutide) and get medical help right away if you have any symptoms of a serious allergic reaction, including swelling of your face, lips, tongue, or throat; problems breathing or swallowing; severe rash or itching; fainting or feeling dizzy; or very rapid heartbeat.
- Gallbladder problems: Gallbladder problems have happened in some people who take Ozempic® (semaglutide). Tell your health care provider right away if you get symptoms which may include: pain in your upper stomach (abdomen), fever, yellowing of the skin or eyes (jaundice), or clay-colored stools.
- Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Ozempic® (semaglutide). Tell your healthcare provider if you have stomach problems that are severe or will not go away.
- Changes in vision. Tell your healthcare provider if you have changes in vision during treatment with Ozempic® (semaglutide).
- Diabetic Retinopathy Complications in Patients with a History of Diabetic Retinopathy: Rapid improvement of glucose control has been associated with temporary worsening of diabetic retinopathy. Tell your provider right away if you experience changes in vision.
- Suicidal Behavior and Ideation: You should pay attention to any mental health changes, especially sudden changes in your mood, behaviors, thoughts, or feelings. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.
- Never Share a Pen: Pen-sharing poses a risk of infection.
What are the most common side effects of Ozempic® (semaglutide)?
- Nausea
- Diarrhea
- Vomiting
- Constipation
- Stomach pain
- Indigestion
- Injection site reactions
- Feeling tired
- Allergic reactions
- Belching
- Hair loss
- Gastroesophageal reflux disease (heartburn)
You are encouraged to report negative side effects of prescription products to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
This information is not comprehensive. Please see the full Prescribing Information for complete safety information.
Disclaimer: Ozempic®, WeGovy®, Saxenda® and Victoza® are registered trademarks of Novo Nordisk. Zepbound® and Mounjaro® are registered trademarks of Eli Lilly. He + She Health has no affiliation with Novo Nordiskor Eli Lilly . The compounded products available as part of He + She Health’s Weight Loss Program are not made by Novo Nordiskor Eli Lilly or any company affiliated with Novo Nordiskor Eli Lilly .
Saxenda® (liraglutide) Safety Information
Important Safety Information for Saxenda® (liraglutide) injection
Warning: Risk of Thyroid C-Cell Tumors
Saxenda® (liraglutide) may cause serious side effects, including: Possible thyroid tumors, including cancer. Tell your health care professional if you get a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath. These may be symptoms of thyroid cancer. In studies with rats and mice, Saxenda® (liraglutide) and medicines that work like Saxenda® (liraglutide) caused thyroid tumors, including thyroid cancer. It is not known if Saxenda® (liraglutide) will cause thyroid tumors or a type of thyroid cancer called medullary thyroid carcinoma (MTC) in people.
Do not use Saxenda® (liraglutide) if