Important Safety Information for GLP-1 and GLP-1/GIP Medicines
This information is intended to support conversations with your CPG Telehealth provider. It does not replace the FDA-approved Prescribing Information or the Medication Guide that comes with your prescription. Always review the package insert and speak with your own clinician about questions or concerns.
This page covers compounded and brand medications that work on the GLP-1 or GLP-1/GIP pathways, including compounded semaglutide, compounded tirzepatide, Ozempic®, Wegovy®, Mounjaro®, and Zepbound®.
General GLP-1 / GLP-1+GIP Warning (Thyroid C-Cell Tumors)
Medicines in this class caused thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in animal studies. It is not known if they cause thyroid tumors in people. Because of this:
- Do not use these medicines if you or a family member has ever had MTC or if you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
- Contact your healthcare provider right away if you develop a lump or swelling in your neck, hoarseness, trouble swallowing, or shortness of breath.
Compounded Medications
CPG Telehealth providers may prescribe compounded medicines when appropriate. These prescriptions are filled by licensed U.S. compounding pharmacies. Compounded medications:
- Are prepared to meet an individual patient’s needs (for example, strength or formulation) and may differ from commercially available products.
- Are not reviewed by the FDA for safety, effectiveness, or manufacturing quality.
- May be used during drug shortages or when an FDA-approved option is not a good fit for a specific patient.
Trademarks
Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company. CPG Telehealth does not own these brand names and does not manufacture brand-name medications.
If you experience side effects, notify your CPG Telehealth provider and the pharmacy that dispensed your prescription. Suspected serious adverse reactions can also be reported to the FDA at 1-800-FDA-1088 or via the MedWatch program at www.fda.gov/medwatch. In an emergency, call 911 or go to the nearest emergency room.
Compounded GLP-1 (semaglutide) ▶
Compounded semaglutide is a GLP-1–based injectable medicine prepared by a compounding pharmacy. FDA-approved semaglutide products are available; compounded versions have not been reviewed by the FDA for safety, effectiveness, or quality.
Serious symptoms – get urgent care
Stop the medicine and contact a doctor immediately (and seek in-person care) if you notice:
- Severe, ongoing nausea or vomiting, or signs of dehydration (very dry mouth, dizziness, little or no urine).
- Worsening kidney function, especially if you already have kidney disease (swelling, fatigue, changes in urination).
- Possible thyroid tumor symptoms: neck lump or swelling, hoarseness, trouble swallowing, or shortness of breath.
- Signs of pancreatitis: strong pain in the upper abdomen or back that does not go away, with or without vomiting.
- Possible gallbladder problems: pain under the right ribs or in the upper middle abdomen, fever, yellowing of the skin or eyes, or pale/clay-colored stools.
- Signs of liver inflammation: yellow skin or eyes, dark urine, right-sided abdominal pain.
- New or worsening vision problems, especially in people with diabetic eye disease.
- Severe stomach or intestinal problems or a history of severe gastrointestinal disease.
- Symptoms of low blood sugar (hypoglycemia), particularly if also using insulin or sulfonylureas: shakiness, sweating, dizziness, headache, confusion, fast heartbeat, slurred speech, or feeling very irritable or anxious.
- Rapid heart rate, major mood changes, worsening depression, or thoughts of self-harm.
Low blood sugar and other medicines
Hypoglycemia is more likely when semaglutide is used with insulin or medicines that cause the pancreas to release insulin (such as sulfonylureas). Your other diabetes medicines may need dose adjustments.
Drug interactions
- Compounded semaglutide can interact with alcohol and other prescription or non-prescription medicines and supplements.
- It slows stomach emptying, which can change how oral medicines are absorbed.
- Medicines with a narrow therapeutic range (such as warfarin) may need closer blood-level monitoring.
- If you take thyroid hormone or other “papillary” hormone medicines, your prescriber may need to adjust timing or dosing.
Pregnancy and contraception
- Do not use semaglutide if you are pregnant, planning pregnancy, or breastfeeding.
- Because semaglutide stays in the body for weeks, many prescribers recommend stopping it at least 2 months before trying to conceive.
Never share your injection pen or vials with another person, even if you change the needle.
Compounded GLP-1+GIP (tirzepatide) ▶
Compounded tirzepatide is a dual-acting GIP/GLP-1 medicine prepared by a compounding pharmacy. FDA-approved tirzepatide products exist, but compounded versions are not evaluated by the FDA for safety or effectiveness.
Thyroid tumor warning
- Tirzepatide may increase the risk of thyroid C-cell tumors. Watch for neck swelling or lumps, hoarseness, trouble swallowing, or shortness of breath.
- Do not use if you or a family member has had MTC or if you have MEN 2.
Serious side effects – seek medical care
- Severe or persistent stomach pain or cramping, which may indicate serious gastrointestinal problems or pancreatitis.
- Diarrhea, nausea, or vomiting that leads to dehydration and kidney problems (reduced urination, swelling, or fatigue).
- Gallbladder symptoms: upper abdominal pain, fever, jaundice, or pale/clay-colored stools.
- Signs of a serious allergic reaction: swelling of the face, lips, tongue, or throat; trouble breathing; rash; or very fast heartbeat.
- Low blood sugar, especially when used with insulin or other glucose-lowering medicines (see hypoglycemia symptoms above).
- New vision changes or significant mood changes, including depression or suicidal thoughts.
Common side effects
Frequently reported effects include:
- Nausea, vomiting, or diarrhea
- Constipation or stomach pain
- Indigestion or heartburn
- Fatigue
- Belching, bloating, or gas
- Injection-site irritation
- Occasional hair shedding or rash/allergic-type skin reactions
These are not all possible side effects. Talk to your provider if symptoms are severe or do not improve.
Drug interactions and contraception
- Compounded tirzepatide can interact with alcohol, other diabetes medicines, and various prescriptions or supplements.
- It slows stomach emptying, which can alter absorption of oral drugs, especially those with narrow therapeutic ranges.
- Tirzepatide may reduce the effectiveness of oral birth control pills. Providers may recommend a non-oral or backup method for several weeks after starting or increasing the dose.
Always review your full medication list with your CPG Telehealth provider before starting compounded tirzepatide.
Mounjaro® (tirzepatide) ▶
Mounjaro is an FDA-approved injectable medicine for adults with type 2 diabetes, used with diet and exercise to improve blood sugar. It is not for type 1 diabetes or diabetic ketoacidosis, and its safety in children under 18 is not established.
Do not use Mounjaro if you have:
- Type 1 diabetes or diabetic ketoacidosis
- History of MTC or MEN 2
- Past or current thyroid cancer
- Known severe allergy to tirzepatide or any component
- Severe, uncontrolled kidney disease or a history of pancreatitis
Serious risks
- Possible thyroid tumors, including thyroid cancer (see general boxed warning above).
- Pancreatitis: severe, constant abdominal pain that may radiate to the back, with or without vomiting.
- Low blood sugar, especially when combined with insulin or sulfonylureas.
- Serious allergic reactions: swelling of the face, lips, tongue, or throat; trouble breathing; severe rash; or very fast heartbeat.
- Worsening kidney function due to dehydration from vomiting or diarrhea.
- Severe or persistent stomach problems or new vision changes.
- Gallbladder disease (upper abdominal pain, fever, jaundice, clay-colored stools).
Common side effects
- Nausea, vomiting, or diarrhea
- Decreased appetite
- Constipation or stomach pain
- Indigestion or heartburn
- Injection-site reactions
Before and while using Mounjaro
- Review all medical conditions with your provider, especially kidney, pancreas, or stomach motility problems and eye disease.
- If you take birth control pills by mouth, Mounjaro may reduce their effectiveness. A non-oral or backup method is often recommended for 4 weeks after starting and 4 weeks after each dose increase.
- Discuss signs and management of low blood sugar with your provider.
Ozempic® (semaglutide) ▶
Ozempic is an FDA-approved once-weekly semaglutide injection used to improve blood sugar in adults with type 2 diabetes and, in some cases, to reduce cardiovascular risk. It is not for type 1 diabetes or diabetic ketoacidosis.
Boxed thyroid warning & contraindications
- Do not use Ozempic if you or a family member has had MTC or if you have MEN 2.
- Do not use if you have had a serious allergic reaction to semaglutide.
Use with caution / tell your provider if you have:
- Kidney, liver, or pancreas disease
- History of pancreatitis or gallstones
- Severe gastrointestinal disease or gastroparesis
- Diabetic eye disease
- Depression or mood-related conditions
Pregnancy and breastfeeding
- Do not take Ozempic if you are pregnant, trying to become pregnant, or breastfeeding.
- Because semaglutide remains in the body for weeks, many clinicians recommend stopping it at least 2 months before attempting pregnancy.
Serious side effects
- Severe or persistent abdominal pain (possible pancreatitis or gallbladder disease).
- Kidney problems or worsening kidney function due to dehydration.
- Serious allergic reactions (swelling of face, lips, tongue, or throat; difficulty breathing; severe rash; fainting; very fast heartbeat).
- Signs of thyroid tumor (see general warning above) or severe mood changes.
Drug interactions
- Using Ozempic with insulin or sulfonylureas increases the risk of low blood sugar; doses of those medicines may need adjustment.
- Because Ozempic slows stomach emptying, it can influence absorption of oral medications, especially those with narrow therapeutic ranges (for example, warfarin).
- If you use thyroid hormone, timing may need to be adjusted in coordination with your prescriber.
Wegovy® (semaglutide) ▶
Wegovy is an FDA-approved higher-dose semaglutide injection for chronic weight management in certain adults with obesity or overweight plus weight-related conditions, used alongside a reduced calorie diet and increased physical activity.
Boxed thyroid warning & contraindications
- Do not use Wegovy if you or a family member has had MTC or if you have MEN 2.
- Do not use if you are pregnant, planning pregnancy, or breastfeeding.
- Avoid use if you have had a serious allergic reaction to semaglutide.
Serious warnings
- Severe nausea/vomiting and dehydration; kidney injury can occur, especially in those with prior kidney disease.
- Pancreatitis, gallbladder disease, or severe stomach pain.
- Possible thyroid tumor symptoms (see general warning).
- Low blood sugar (particularly in people with type 2 diabetes using other glucose-lowering medicines).
- Increased heart rate, mood changes, or suicidal thoughts.
Common side effects
- Nausea, vomiting, diarrhea, or constipation
- Stomach pain, bloating, or gas
- Headache, dizziness, or fatigue
- Indigestion or reflux
- Injection-site reactions
- Common cold-type symptoms
Drug interactions
- Higher risk of hypoglycemia when used with insulin or sulfonylureas.
- Delayed gastric emptying may affect absorption of oral medications, including warfarin and thyroid hormone (monitor levels as appropriate).
Zepbound® (tirzepatide) ▶
Zepbound is an FDA-approved tirzepatide injection used with diet and physical activity to help adults with obesity, or overweight plus weight-related medical problems, lose weight and maintain weight loss.
Do not use Zepbound if you have:
- MTC or MEN 2, or a family history of MTC
- Type 1 diabetes or diabetic ketoacidosis
- Severe kidney disease or significant diabetic eye disease
- History of pancreatitis or severe gallbladder disease unless cleared by a specialist
- Known allergy to tirzepatide or ingredients in Zepbound
Serious risks
- Possible thyroid tumors and thyroid cancer (see general warning).
- Severe stomach problems or persistent abdominal pain (possible pancreatitis or severe GI effects).
- Kidney injury from dehydration caused by vomiting or diarrhea.
- Gallbladder problems: upper abdominal pain, fever, jaundice, or clay-colored stools.
- Severe allergic reactions or significant low blood sugar when used with other glucose-lowering medicines.
Common side effects
- Acid or sour stomach, burping
- Constipation, diarrhea, or upset stomach
- Abdominal pain or discomfort
- Injection-site reactions
- Low blood sugar in people on other diabetes medicines
- Gallbladder events or hypersensitivity reactions
Additional considerations
- Zepbound should not be used with other tirzepatide products or GLP-1 receptor agonists.
- Safety in people with prior pancreatitis or in children under 18 is not established.
- As with tirzepatide in general, it may reduce the effectiveness of oral birth control pills; a backup or non-oral method is often recommended when starting or increasing the dose.
This summary does not include every possible risk, side effect, or drug interaction. Always refer to the official Prescribing Information and Medication Guides for each medicine and consult your CPG Telehealth provider or local clinician before starting, changing, or stopping any GLP-1 or GLP-1/GIP therapy.
