Important Safety Information

Safety Information

Side effects are typically mild and go away over time.

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What are the most common side effects?

• Nausea
• Vomiting
• Decreased appetite
• Dizziness
• Headache
• Diarrhea
• Gastritis

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Full side effect profile:

• Low dose Naltrexone: nausea/vomiting, decreased appetite. Dizziness, headache, insomnia (can resolve in 2 weeks), vivid dreams, joint pain, muscle cramps, tooth pain, and anxiety which are all more commonly seen at higher doses
• Inositol: nausea, vomiting, diarrhea, abdominal pain/cramps, gastritis, dizziness, high BP, decreases absorption of Iron, Ca, and Zn in bloodstream, hypoglycemia—all usually mild and go away over time. All typically seen at higher doses of 1,000-4,000mg per day.
• L-Carnitine: nausea, vomiting, diarrhea, abdominal pain/cramps, gastritis, body odor—all usually mild and go away over time. All typically seen at higher doses of 1,000-3,000mg per day. At high doses (1,000mg-3000mg) L-Carnitine may affect the efficacy of warfarin or dicumarol.

Safety Information

Do not use if you have been diagnosed with the following:

• Diabetic ketoacidosis
• Type 1 diabetes
• Diabetic retinopathy
• Kidney disease
• Multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Thyroid cancer
• Pancreatitis

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Some side effects may occur that do not require medical attention, as they may lessen as your body adjusts to the medication. You may experience more gastrointestinal (GI) side effects when you increase your dose, however it should be less over time. Reach out to your healthcare provider if you experience any unwanted side effects as there may be ways to prevent or reduce side effects. You may always reach out with any additional questions regarding your medication therapy and side effects.

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More common side effects:

• acid or sour stomach
• belching
• constipation
• diarrhea
• stomach discomfort or upset
• stomach pain
• hypoglycemia (low blood sugar)
• injection-site reactions
• gallbladder disease
• hypersensitivity reactions

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Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of side effects: https://www.mayoclinic.org

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Mounjaro® Safety Information

Mounjaro® (mown-JAHR-OH) is an injectable medicine for adults with type 2 diabetes used along with diet and exercise to improve blood sugar (glucose).

• It is not known if Mounjaro can be used in people who have had inflammation of the pancreas (pancreatitis). Mounjaro is not for use in people with type 1 diabetes. It is not known if Mounjaro is safe and effective for use in children under 18 years of age.

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Warnings

Mounjaro® 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 if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Mounjaro if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Mounjaro if you are allergic to it or any of the ingredients in Mounjaro.

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Mounjaro® may cause serious side effects, including:

• Inflammation of the pancreas (pancreatitis). Stop using Mounjaro and call your healthcare provider right away if you have severe painin 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 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 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 vomitingmay 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. 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.
• Gallbladder problems. Gallbladder problems have happened in some people who use Mounjaro. 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.

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Common side effects

The most common side effects of Mounjaro® include nausea, diarrhea, decreased appetite, vomiting, constipation, indigestion, and stomach (abdominal) pain. These are not all the possible side effects of Mounjaro. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

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Before using Mounjaro®

• Your healthcare provider should show you how to use Mounjaro 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 youuse Mounjaro. Birth control pills may not work as well while using Mounjaro. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Mounjaro and for 4 weeks after each increase in your dose of Mounjaro.

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Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
• Do you take other diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? It is not known if Mounjaro will harm your unborn baby or pass into your breast milk.
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?

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How to take

• Read the Instructions for Use that come with Mounjaro®.
• Use Mounjaro exactly as your healthcare provider says.
• Mounjaro is injected under the skin (subcutaneously) of your stomach (abdomen), thigh, or upper arm.
• Use Mounjaro 1 time each week, at any time of the day.
• Do not mix insulin and Mounjaro together in the same injection.
• You may give an injection of Mounjaro and insulin in the same body area (such as your stomach area), but not right next to each other.
• Change (rotate) your injection site with each weekly injection. Do not use the same site for each injection.
• If you take too much Mounjaro, call your healthcare provider or seek medical advice promptly.

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Learn more

Mounjaro® is a prescription medicine. For more information, call 1-833-807-MJRO (833-807-6576) or go to www.mounjaro.com.

This summary provides basic information about Mounjaro but does not include all information known about this medicine. Read the information that comes with your prescription each time your prescription is filled. This information does not take the place of talking with your healthcare provider. Be sure to talk to your healthcare provider about Mounjaro and how to take it. Your healthcare provider is the best person to help you decide if Mounjaro is right for you.

Click here to visit the manufacturer's support page to make a report.

BLACK BOX WARNING:

GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.

If you experience a medical emergency, call 911 or go to the nearest emergency room.

Tell your healthcare provider about your medical history prior to taking Ozempic®.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Ozempic®, as your diabetes medications may need to be adjusted as you lose weight.

Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Ozempic® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Ozempic® 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.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Ozempic® if suspected and promptly seek medical advice.

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WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

• Severe nausea and/or vomiting resulting in dehydration-  it is important to stay well hydrated and drink plenty of fluids while on this medication
• Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis
• Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
• Pancreatitis: Severe pain in your abdomen or back that will not go away
• Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
• Hepatitis/Elevated liver enzymes/Jaundice
• Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
• Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
• Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (ie sulfonylurea) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
• Increasing heart rate
• Worsening depression, behavior changes, or suicidality
• Never share the Ozempic® pen with other people

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Side Effects

Many people experience no side effects. Some of the most common or potential side effects include:

• Nausea
• Constipation
• Vomiting
• Diarrhea
• Abdominal Pain
• Headache
• Indigestion
• Injection site reactions
• Dizziness
• Back pain
• Increased Lipase or Amylase
• Altered taste
• Nasopharyngitis (common cold)
• Passing Gas
• Bloating
• Belching
• Gastroenteritis
• Decreased appetite
• Fatigue
• Gastroesophageal reflux disease
• Low blood sugar (hypoglycemia) in those with type II diabetes
• Upset stomach

‍

These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. For a complete list of side effects, review the medication packaging inserts.

‍

Drug Interactions

As with other medications, Ozempic® can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Ozempic® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Ozempic®, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on Ozempic®.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

To report suspected adverse reactions to Ozempic® contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go to the nearest emergency room.

BLACK BOX WARNING:

GLP-1s are contraindicated in individuals with a history of medullary thyroid carcinoma, a family history of such, or in patients with multiple endocrine neoplasia syndrome type 2. Do not take them if you have ever had thyroid cancer. In studies with rodents, GLP-1s caused thyroid tumors, including thyroid cancer; it is not known if they will cause thyroid tumors or cancer in humans. Please notify your doctor ASAP if you develop trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath.

If you experience a medical emergency, call 911 or go to the nearest emergency room.

Tell your healthcare provider about your medical history prior to taking Wegovy®.

Avoid alcohol while taking this medication. If you’re taking diabetes medications, please discuss this with your prescribing doctor before starting Wegovy®, as your diabetes medications may need to be adjusted as you lose weight.

Use adequate contraception while taking this medication. Do not take this medication if pregnant, trying to get pregnant or breastfeeding. If you plan to become pregnant, this medication needs to be stopped at least 2 months before trying. This medication may cause fetal harm.

Notify your doctor if you have kidney, liver, or pancreas problems.

Stop using Wegovy® and call your healthcare provider immediately if you have severe stomach or abdomen pain that will not go away, with or without vomiting.

Stop using Wegovy® 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.

Serious hypersensitivity reactions (e.g., anaphylaxis and angioedema) have been reported. Discontinue Wegovy® if suspected and promptly seek medical advice.

‍

WARNING

Please contact your doctor ASAP and seek in-person care immediately if a side effect becomes problematic or you experience:

• Severe nausea and/or vomiting resulting in dehydration-  it is important to stay well hydrated and drink plenty of fluids while on this medication
• Kidney problems/kidney failure - vomiting, nausea, diarrhea can cause dehydration and kidney issues and make kidney problems worse in individuals who have pre-existing kidney conditions; may sometimes lead to the need for hemodialysis
• Thyroid C-Cell Tumor: Trouble swallowing, hoarseness, a lump or swelling in your neck, or shortness of breath (see black box warning below)
• Pancreatitis: Severe pain in your abdomen or back that will not go away
• Acute gallbladder disease - Pain in the middle or right upper stomach, fever, white parts of your eyes turn yellow or skin turns yellow, nausea/vomiting. If gallstones or inflammation of the gallbladder is suspected further studies are needed.
• Hepatitis/Elevated liver enzymes/Jaundice
• -Diabetic retinopathy problems: Changes in vision in those with type II diabetes, particularly vision problems may worsen in those with a history of diabetic retinopathy
• Severe gastrointestinal disease - may cause gastrointestinal disease; do not use if you have a history of severe gastrointestinal disease
• Signs of low blood sugar (for example, dizziness, weakness, shakiness, jitteriness, headache, anxiety/mood changes, rapid heartbeat, confusion, slurred speech, sweating, or lightheadedness). While this is rare with GLP-1s, if it occurs, please seek in-person care immediately. If you have these symptoms, try having liquid or food containing sugar (around 15-20 grams) —drinking juice, having regular soda, or eating some hard candies right away, as this will help raise your blood sugar quickly. If taken with insulin or an insulin secretagogue (ie sulfonylurea) it is best to talk to your healthcare provider about possibly lowering the dose of these medications to lower the risk of hypoglycemia.
• Increasing heart rate
• Worsening depression, behavior changes, or suicidality
• Never share the Wegovy® pen with other people

‍

Side Effects

Many people experience no side effects. Some of the most common or potential side effects include:

• Nausea
• Constipation
• Vomiting
• Diarrhea
• Abdominal Pain
• Headache
• Indigestion
• Injection site reactions
• Dizziness
• Back pain
• Increased Lipase or Amylase
• Altered taste
• Nasopharyngitis (common cold)
• Passing Gas
• Bloating
• Belching
• Gastroenteritis
• Decreased appetite
• Fatigue
• Gastroesophageal reflux disease
• Low blood sugar (hypoglycemia) in those with type II diabetes
• Upset stomach

‍

These symptoms often subside as your body adjusts to the medications. Please notify your provider if side effects persist. For a complete list of side effects, review the medication packaging inserts.

‍

Drug Interactions

As with other medications, Wegovy® can interact with alcohol and certain prescription and non-prescription medications and herbal products. The risk of hypoglycemia is increased when combined with insulin or insulin secretagogues such as sulfonylureas. Wegovy® delays gastric emptying and may impact the absorption of oral medications. If you are on thyroid hormone medication, prior to starting Wegovy®, please review the timing of taking your thyroid hormone medication with the doctor who prescribes it as it may need to be adjusted. The drug levels of medications with narrow therapeutic windows (ie warfarin) should be monitored closely while on Wegovy®.

Please consult the pharmaceutical packaging for a full list of side effects, warnings, interactions and additional information.

To report suspected adverse reactions to Wegovy® contact the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

In case of emergencies, please call 911 or go to the nearest emergency room.

Safety Information

Do not use if you have been diagnosed with the following:

• Diabetic ketoacidosis
• Type 1 diabetes
• Diabetic retinopathy
• Kidney disease
• Multiple endocrine neoplasia syndrome type 2 (MEN 2)
• Thyroid cancer
• Pancreatitis

‍

Some side effects may occur that do not require medical attention, as they may lessen as your body adjusts to the medication. You may experience more gastrointestinal (GI) side effects when you increase your dose, however it should be less over time. Reach out to your healthcare provider if you experience any unwanted side effects as there may be ways to prevent or reduce side effects. You may always reach out with any additional questions regarding your medication therapy and side effects.

‍

More common side effects

• acid or sour stomach
• belching
• constipation
• diarrhea
• stomach discomfort or upset
• stomach pain
• hypoglycemia (low blood sugar)
• injection-site reactions
• gallbladder disease
• hypersensitivity reactions

‍

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of side effects: https://www.mayoclinic.org

‍

Zepbound™ Safety Information:

Zepbound™ (ZEHP-bownd) is an injectable prescription medicine that may help adults with obesity, or with excess weight (overweight) who also have weight-related medical problems, lose weight and keep it off. It should be used with a reduced-calorie diet and increased physical activity.

Zepbound™ contains tirzepatide and should not be used with other tirzepatide-containing products or any GLP-1 receptor agonist medicines. It is not known if Zepbound is safe and effective when taken with other prescription, over-the-counter, or herbal weight loss products. It is not known if Zepbound can be used in people who have had pancreatitis. It is not known if Zepbound is safe and effective for use in children under 18 years of age.

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Warning

Zepbound™ 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 Zepbound if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC).
• Do not use Zepbound if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
• Do not use Zepbound if you have had a serious allergic reaction to tirzepatide or any of the ingredients in Zepbound.

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Zepbound™ may cause serious side effects, including:

• Severe stomach problems. Stomach problems, sometimes severe, have been reported in people who use Zepbound. Tell your healthcare provider if you have stomach problems that are severe or will not go away.
• Kidney problems (kidney failure). Diarrhea, nausea, and vomiting may cause a loss of fluids (dehydration), which may cause kidney problems. It is important for you to drink fluids to help reduce your chance of dehydration.
• Gallbladder problems. Gallbladder problems have happened in some people who use Zepbound. 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), or clay-colored stools.
• Inflammation of the pancreas (pancreatitis). Stop using Zepbound 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.
• Serious allergic reactions. Stop using Zepbound 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.
• Low blood sugar (hypoglycemia). Your risk for getting low blood sugar may be higher if you use Zepbound with medicines 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, mood changes, hunger, weakness or feeling jittery.
• Changes in vision in patients with type 2 diabetes. Tell your healthcare provider if you have changes in vision during treatment with Zepbound.
• Depression or thoughts of suicide. You should pay attention to changes in your mood, behaviors, feelings or thoughts. Call your healthcare provider right away if you have any mental changes that are new, worse, or worry you.

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Common Side Effects

The most common side effects of Zepbound™ include nausea, diarrhea, vomiting, constipation, stomach (abdominal) pain, indigestion, injection site reactions, feeling tired, allergic reactions, belching, hair loss, and heartburn. These are not all the possible side effects of Zepbound. Talk to your healthcare provider about any side effect that bothers you or doesn’t go away.

Tell your healthcare provider if you have any side effects. You can report side effects at 1-800-FDA-1088 or www.fda.gov/medwatch.

‍

Before using Zepbound™

• Your healthcare provider should show you how to use Zepbound before you use it for the first time.
• Tell your healthcare provider if you are taking medicines to treat diabetes including insulin or sulfonylureas which could increase your risk of low blood sugar. Talk to your healthcare provider about low blood sugar levels and how to manage them.
• If you take birth control pills by mouth, talk to your healthcare provider before you use Zepbound. Birth control pills may not work as well while using Zepbound. Your healthcare provider may recommend another type of birth control for 4 weeks after you start Zepbound™ and for 4 weeks after each increase in your dose of Zepbound.

‍

Review these questions with your healthcare provider:

• Do you have other medical conditions, including problems with your pancreas or kidneys, or severe problems with your stomach, such as slowed emptying of your stomach (gastroparesis) or problems digesting food?
• Do you take diabetes medicines, such as insulin or sulfonylureas?
• Do you have a history of diabetic retinopathy?
• Do you take any other prescription medicines or over-the-counter drugs, vitamins, or herbal supplements?
• Are you pregnant, plan to become pregnant, breastfeeding, or plan to breastfeed? Zepbound™ may harm your unborn baby. Tell your healthcare provider if you become pregnant while using Zepbound. It is not known if Zepbound passes into your breast milk. You should talk with your healthcare provider about the best way to feed your baby while using Zepbound.

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Pregnancy Exposure Registry: There will be a pregnancy exposure registry for women who have taken Zepbound™ during pregnancy. The purpose of this registry is to collect information about the health of you and your baby. Talk to your healthcare provider about how you can take part in this registry, or you may contact Lilly at 1-800-LillyRx (1-800-545-5979).

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

For a full list of side effects: https://www.mayoclinic.org