Safety

Important safety information for GLP-1s.

Boxed warnings, who should not take these medicines, what to watch for, and how to report a side effect — for every GLP-1 we dispense.

Awaiting clinical sign-off. The text below summarises the FDA-approved prescribing information for each product. 2 sections covering compounded preparations need the medical director's approval before publication, because no approved labelling exists for a compounded medicine. Re-verify every section against the current label whenever a manufacturer updates it.

Semaglutide

Wegovy® pen · Compounded semaglutide

Warning: Risk of thyroid C-cell tumors

In studies with mice and rats, semaglutide caused thyroid tumors, including thyroid cancer. It is not known if 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 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).

FDA-approved use

Wegovy® is used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or with overweight plus a weight-related condition.

It is also used to reduce the risk of major adverse cardiovascular events — cardiovascular death, non-fatal heart attack, or non-fatal stroke — in adults with known cardiovascular disease and either obesity or overweight.

  • Limitation of use: not to be taken with any other semaglutide-containing product or any other GLP-1 receptor agonist.

Who should not take semaglutide

Do not take semaglutide if any of the following applies to you:

  • You or anyone in your family has ever had medullary thyroid carcinoma (MTC)
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • You have had an allergic reaction to semaglutide or to any ingredient in the product

How it is taken

Wegovy® is a once-weekly injection under the skin of the stomach, thigh, or upper arm, taken on the same day each week, with or without food. Your clinician will set a schedule that usually increases the dose about every four weeks.

Do not change your dose or stop taking it without speaking to your clinician first. Never share a pen with anyone — sharing carries a risk of infection.

What to tell your clinician

Tell your clinician everything you take, including prescription and over-the-counter medicines, vitamins, herbal products and supplements. Some interactions to raise specifically:

  • Insulin or sulfonylureas such as glimepiride or glipizide — taken together, the risk of low blood sugar rises and doses may need to change
  • Any medicine you swallow — semaglutide slows how fast your stomach empties, which can change how other oral medicines are absorbed
  • Any other GLP-1 medicine, including Ozempic®, Saxenda®, Victoza®, Byetta® or Bydureon® — these are not taken together
  • Any other weight-loss product, including dietary supplements

Medical history to share

Tell your clinician if you have now, or have ever had, any of the following:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy

Pregnancy and breastfeeding

Do not use semaglutide during pregnancy. Animal studies suggest potential risk to an unborn baby, and there is no benefit to weight loss during pregnancy.

If you could become pregnant, stop semaglutide at least two months before a planned pregnancy — the medicine stays in your bloodstream for a long time.

Semaglutide was found in the milk of lactating rats. Tell your clinician if you are breastfeeding before you start.

Pregnancy registry: Novo Nordisk monitors pregnancy outcomes in women exposed to semaglutide. Call 1-877-390-2760 or visit wegovypregnancyregistry.com.

Serious side effects to watch for

Watch for these especially when you start and after each dose increase. If you are having a medical emergency, call 911.

  • Thyroid C-cell tumors — a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath
  • Inflammation of the pancreas — severe stomach pain that does not go away, sometimes spreading to your back, with or without vomiting
  • Gallbladder problems, including gallstones — pain in your upper stomach, yellowing of the skin or eyes, fever, or clay-coloured stools
  • Low blood sugar — dizziness, blurred vision, mood changes, sweating, or a fast heartbeat, particularly if you also take insulin or a sulfonylurea
  • Kidney injury — diarrhoea, nausea and vomiting can dehydrate you and worsen existing kidney problems. Drink plenty of water
  • Severe gastrointestinal reactions
  • Serious allergic reaction — swelling of the face, lips, tongue or throat, severe rash or itching, very fast heartbeat, trouble breathing or swallowing, fainting or dizziness. Stop taking it and get help
  • Worsening diabetic retinopathy if you have type 2 diabetes — tell your clinician right away about changes in vision
  • A racing heartbeat while at rest
  • Food or liquid entering the lungs during surgery under sedation. Tell your surgical team you take a GLP-1 before any planned procedure

Common side effects

Most cluster after a dose increase and settle as your body adapts.

  • Nausea
  • Diarrhoea
  • Vomiting
  • Constipation
  • Stomach pain
  • Indigestion
  • Headache
  • Fatigue
  • Dizziness
  • Bloating
  • Belching
  • Flatulence
  • Heartburn
  • Gastroenteritis
  • Unusual skin sensations
  • Hair loss
  • Low blood sugar in people with type 2 diabetes

Compounded semaglutide has no FDA-approved labelling

Compounded semaglutide is prepared for you by a LegitScript-verified 503A pharmacy under physician oversight. It is not FDA-approved, and it is not an FDA-approved generic or equivalent of Wegovy® or Ozempic®.

No approved prescribing information exists for the preparation itself. Everything above describes the molecule, and is drawn from the branded products that were studied — the approved-use statement and the trial results belong to those products, not to a compounded preparation. Your clinician uses the molecule's known profile to prescribe and to set your titration.

Compounded medication is supplied as a vial and syringe rather than a fixed-dose pen, so your clinician's instructions on drawing and measuring your dose are part of the prescription. Ask before you change anything about how you take it.

Needs clinical sign-off — Medical director to confirm the compounded-specific administration guidance.

Reporting a side effect

  • Report negative side effects to Novo Nordisk at 1-833-934-6891.
  • Report to FDA MedWatch at 1-800-FDA-1088 or fda.gov/medwatch.

This page is a summary and is not comprehensive. See Wegovy® prescribing information for complete safety information.

Tirzepatide

Zepbound® pen · Zepbound® vials · Compounded tirzepatide

Warning: Risk of thyroid C-cell tumors

In rats, tirzepatide caused thyroid tumors, including thyroid cancer. It is not known if 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 tirzepatide 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).

FDA-approved use

Zepbound® is used together with a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity, or with overweight plus a weight-related condition.

  • Limitation of use: not to be taken with any other tirzepatide-containing product or any other GLP-1 receptor agonist.

Who should not take tirzepatide

Do not take tirzepatide if any of the following applies to you:

  • You or anyone in your family has ever had medullary thyroid carcinoma (MTC)
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • You have had an allergic reaction to tirzepatide

How it is taken

Zepbound® comes as a single-dose pre-filled pen, as a single-dose vial with a separate syringe and needle, or as a multi-dose KwikPen® with separate needles. All three are injected under the skin of the stomach, thigh, or upper arm once a week, on the same day each week, with or without food.

Your clinician will set a schedule that usually increases the dose about every four weeks. Do not change your dose or stop without speaking to them first. Never share a pen or needle — sharing carries a risk of infection.

What to tell your clinician

Tell your clinician everything you take, including prescription and over-the-counter medicines, vitamins, herbal products and supplements. Some interactions to raise specifically:

  • Insulin or sulfonylureas such as glimepiride or glipizide — taken together, the risk of low blood sugar rises
  • Any medicine you swallow — tirzepatide slows how fast your stomach empties, which can change how other oral medicines are absorbed
  • Oral birth control — tirzepatide can make it less effective, particularly after the first dose. Switch to a non-oral method, or add a barrier method, for four weeks after starting and for four weeks after every dose increase until you reach your maintenance dose
  • Any other GLP-1 medicine, including Mounjaro®, Wegovy®, Ozempic®, Saxenda®, Victoza®, Byetta® or Bydureon® — these are not taken together
  • Any other weight-loss product, including dietary supplements

Medical history to share

Tell your clinician if you have now, or have ever had, any of the following:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Gastrointestinal disease

Pregnancy and breastfeeding

Do not use tirzepatide during pregnancy. Animal studies suggest potential risk to an unborn baby, and there is no benefit to weight loss during pregnancy.

If you could become pregnant, stop tirzepatide at least two months before a planned pregnancy — the medicine stays in your bloodstream for a long time.

It is not known whether tirzepatide passes into breast milk. Talk to your clinician about the benefits and risks before breastfeeding.

Pregnancy registry: Eli Lilly monitors pregnancy outcomes in women exposed to tirzepatide. Call 1-800-LillyRx (1-800-545-5979).

Serious side effects to watch for

Watch for these especially when you start and after each dose increase. If you are having a medical emergency, call 911.

  • Thyroid C-cell tumors — a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath
  • Severe gastrointestinal disease — tirzepatide has not been studied in people with severe gastrointestinal disease and is not recommended for them
  • Kidney injury — diarrhoea, nausea and vomiting can dehydrate you and worsen existing kidney problems. Drink plenty of water
  • Gallbladder problems, including gallstones — pain in your upper stomach, yellowing of the skin or eyes, fever, or clay-coloured stools
  • Inflammation of the pancreas — severe stomach pain that does not go away, sometimes spreading to your back, with or without vomiting
  • Serious allergic reaction — swelling of the face, lips, tongue or throat, severe rash or itching, very fast heartbeat, trouble breathing or swallowing, fainting or dizziness. Stop taking it and get help
  • Low blood sugar — dizziness, blurred vision, mood changes, sweating, or a fast heartbeat, particularly if you have type 2 diabetes and take another glucose-lowering medicine
  • Worsening diabetic retinopathy — rapid improvement in blood sugar can temporarily worsen it. Tell your clinician right away about changes in vision
  • Food or liquid entering the lungs during surgery under sedation. Tell your surgical team you take a GLP-1 before any planned procedure

Common side effects

Most cluster after a dose increase and settle as your body adapts.

  • Nausea
  • Diarrhoea
  • Vomiting
  • Constipation
  • Stomach pain
  • Indigestion
  • Injection-site reactions
  • Fatigue
  • Belching
  • Heartburn
  • Hair loss
  • Allergic reactions

Compounded tirzepatide has no FDA-approved labelling

Compounded tirzepatide is prepared for you by a LegitScript-verified 503A pharmacy under physician oversight. It is not FDA-approved, and it is not an FDA-approved generic or equivalent of Zepbound® or Mounjaro®.

No approved prescribing information exists for the preparation itself. Everything above describes the molecule, and is drawn from the branded products that were studied — the approved-use statement and the trial results belong to those products, not to a compounded preparation. Your clinician uses the molecule's known profile to prescribe and to set your titration.

Compounded medication is supplied as a vial and syringe rather than a fixed-dose pen, so your clinician's instructions on drawing and measuring your dose are part of the prescription. Ask before you change anything about how you take it.

Needs clinical sign-off — Medical director to confirm the compounded-specific administration guidance.

Reporting a side effect

  • Report negative side effects to Eli Lilly at 1-800-LillyRx (1-800-545-5979).
  • Report to FDA MedWatch at 1-800-FDA-1088 or fda.gov/medwatch.

This page is a summary and is not comprehensive. See Zepbound® prescribing information for complete safety information.

Orforglipron

Foundayo™ tablet

Not yet dispensed by Zappy. Published in advance so the safety information is available before the first prescription.

Warning: Risk of thyroid C-cell tumors

In rats and mice, certain GLP-1 medications caused thyroid C-cell tumors. Orforglipron did not produce these tumors in rats and mice. However, it is unknown whether orforglipron causes these tumors 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 orforglipron if you or any of your family have ever had a type of thyroid cancer called medullary thyroid carcinoma (MTC), or if you have a condition called Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).

FDA-approved use

Foundayo™ is used together with a reduced-calorie diet and increased physical activity to reduce and maintain weight in adults with obesity, or with overweight plus a weight-related condition.

  • Limitation of use: not to be taken with any other GLP-1 receptor agonist.

Who should not take orforglipron

Do not take orforglipron if any of the following applies to you:

  • You or anyone in your family has ever had medullary thyroid carcinoma (MTC)
  • You have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)
  • You have had an allergic reaction to orforglipron

How it is taken

One tablet by mouth each day, swallowed whole. Do not cut, crush or chew it. You can take it with or without food, and there are no restrictions on water or other drinks.

Your clinician will set a schedule that usually increases the dose about every four weeks. Do not change your dose or stop without speaking to them first.

What to tell your clinician

Tell your clinician everything you take, including prescription and over-the-counter medicines, vitamins, herbal products and supplements. Some interactions to raise specifically:

  • Simvastatin — do not take more than 20 mg a day while taking orforglipron
  • Insulin or sulfonylureas such as glimepiride or glipizide — taken together, the risk of low blood sugar rises
  • Any medicine you swallow — orforglipron slows how fast your stomach empties, which can change how other oral medicines are absorbed
  • Oral birth control — orforglipron can make it less effective, particularly after the first dose. Switch to a non-oral method, or add a barrier method, for four weeks after starting and for four weeks after every dose increase until you reach your maintenance dose
  • Any other GLP-1 medicine, including Mounjaro®, Zepbound®, Wegovy®, Ozempic® or Saxenda® — these are not taken together
  • Any other weight-loss product, including dietary supplements

Medical history to share

Tell your clinician if you have now, or have ever had, any of the following:

  • Type 1 or type 2 diabetes
  • Thyroid cancer
  • Pancreatitis
  • Kidney disease
  • Diabetic retinopathy
  • Gastrointestinal disease
  • Liver disease

Pregnancy and breastfeeding

Do not use orforglipron during pregnancy. Animal studies suggest potential risk to an unborn baby, and there is no benefit to weight loss during pregnancy.

If you could become pregnant, stop orforglipron at least two months before a planned pregnancy — the medicine stays in your bloodstream for a long time.

Orforglipron is not recommended while breastfeeding. Talk to your clinician about the benefits and risks first.

Pregnancy registry: Eli Lilly monitors pregnancy outcomes in patients exposed to orforglipron. Call 1-800-LillyRx (1-800-545-5979).

Serious side effects to watch for

Watch for these especially when you start and after each dose increase. If you are having a medical emergency, call 911.

  • Thyroid C-cell tumors — a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath
  • Inflammation of the pancreas — severe stomach pain that does not go away, sometimes spreading to your back, with or without vomiting
  • Severe gastrointestinal disease — orforglipron is not recommended if you have severe gastroparesis
  • Kidney injury — diarrhoea, nausea and vomiting can dehydrate you and worsen existing kidney problems. Drink plenty of water
  • Low blood sugar — dizziness, blurred vision, mood changes, sweating, or a fast heartbeat, particularly if you have type 2 diabetes and take another glucose-lowering medicine
  • Serious allergic reaction — swelling of the face, lips, tongue or throat, severe rash or itching, very fast heartbeat, trouble breathing or swallowing, fainting or dizziness. Stop taking it and get help
  • Worsening diabetic retinopathy — rapid improvement in blood sugar can temporarily worsen it. Tell your clinician right away about changes in vision
  • Gallbladder problems — pain in your upper stomach, yellowing of the skin or eyes, fever, or clay-coloured stools
  • Food or liquid entering the lungs during surgery under sedation. Tell your surgical team you take a GLP-1 before any planned procedure

Common side effects

Most cluster after a dose increase and settle as your body adapts.

  • Nausea
  • Constipation
  • Diarrhoea
  • Vomiting
  • Indigestion
  • Stomach pain
  • Headache
  • Bloating
  • Fatigue
  • Belching
  • Heartburn
  • Flatulence
  • Hair loss

Reporting a side effect

  • Report to FDA MedWatch at 1-800-FDA-1088 or fda.gov/medwatch.

Products this applies to

Withholding or providing inaccurate information about your health and medical history in order to obtain treatment may result in harm. This page is a summary, not a substitute for the full prescribing information or for your clinician's advice. If you are having a medical emergency, call 911.