GLP-1 Medication Safety Information
Emergency Information
If you believe you are experiencing a medical emergency, call 911 or go to the nearest emergency room immediately. Do not wait for a reply by email, phone, chat, or through the patient portal.
For a suspected overdose or dosing error, call Poison Control at 1-800-222-1222. If the person collapses, has a seizure, has trouble breathing, or cannot be awakened, call 911.
About This Information
This page provides general safety information for adults who are prescribed a medication containing semaglutide or tirzepatide through Livbetr. It does not replace your prescription label, pharmacy instructions, medication guide, or advice from your prescribing clinician. Livbetr LLC facilitates access to telehealth services and does not manufacture, compound, or dispense medication. A licensed clinician determines whether a prescription is medically appropriate; a prescription is not guaranteed. Medication is dispensed by the state-licensed pharmacy identified on the prescription label.
Always follow the directions on your current prescription and pharmacy label.
Formulations, ingredients, concentrations, dosage forms, syringes, storage requirements, and beyond-use dates may differ between prescriptions and pharmacies.
Important Information About Compounded Medications
Compounded semaglutide and compounded tirzepatide are not FDA-approved. The FDA does not review compounded medications for safety, effectiveness, or quality before they are marketed.
A compounded medication is not an FDA-approved generic drug and should not be assumed to be the same as, equivalent to, or interchangeable with an FDA-approved brand medication. FDA-approved medications containing semaglutide or tirzepatide are commercially available. The FDA recommends that a compounded drug be used only when a patient's medical needs cannot be met by an available FDA-approved drug.
Whether a compounded medication is appropriate and available depends on the patient's individual medical needs, clinician judgment, and pharmacy availability. A prescription and product availability are not guaranteed.
Because compounded products have not undergone FDA approval, their complete risks, side-effect frequencies, absorption, effectiveness, and quality may not be established. Some of the safety information below comes from FDA-approved labeling for products containing semaglutide or tirzepatide and from FDA reports involving compounded products. This does not mean a compounded product is the same as an FDA-approved medication.
Before Starting or Continuing Treatment
Tell your prescribing clinician about all medical conditions, allergies, prescription medicines, over-the-counter medicines, vitamins, and supplements you use. In particular, tell your clinician if you:
- You or a family member have had medullary thyroid carcinoma, or you have Multiple Endocrine Neoplasia syndrome type 2 (MEN 2);
- Have had a serious allergic reaction to semaglutide, tirzepatide, or an ingredient in your prescribed formulation;
- Have or have had problems involving your pancreas, gallbladder, kidneys, stomach, or intestines, including severe gastroparesis;
- Have diabetes, diabetic retinopathy, changes in vision, or take insulin or a sulfonylurea;
- Use another GLP-1, semaglutide, tirzepatide, diabetes, or weight-management medication;
- Use oral hormonal contraceptives or another oral medicine that requires close monitoring;
- Are scheduled for surgery or a procedure involving anesthesia or deep sedation; or
- Are pregnant, may be pregnant, plan to become pregnant, or are breastfeeding.
FDA-approved products containing semaglutide or tirzepatide carry boxed warnings concerning thyroid C-cell tumors observed in rodents. It is unknown whether these medications cause thyroid C-cell tumors, including medullary thyroid carcinoma, in humans. Do not use a medication containing semaglutide or tirzepatide if you or a family member have had medullary thyroid carcinoma or if you have MEN 2.
Weight-loss treatment should not be used during pregnancy. If you become pregnant, stop the medication and contact your clinician promptly. Semaglutide should be stopped at least two months before a planned pregnancy. Ask your clinician when tirzepatide should be stopped before a planned pregnancy and whether treatment is appropriate while breastfeeding. Tirzepatide may reduce the effectiveness of oral hormonal contraceptives. Ask your clinician about using a non-oral contraceptive method or adding a barrier method for four weeks after starting tirzepatide and for four weeks after each dose increase.
Serious Symptoms
Stop using the medication and seek prompt medical advice if directed below. Call 911 for severe or life-threatening symptoms.
- Possible pancreatitis: severe, persistent abdominal pain that may spread to the back, with or without vomiting. Stop using the medication and contact a clinician immediately.
- Possible gallbladder problem: upper abdominal pain, fever, yellowing of the skin or eyes, or clay-colored stools.
- Severe dehydration or kidney problem: persistent vomiting or diarrhea, inability to keep fluids down, faintness, or reduced urination.
- Severe stomach or intestinal problem: repeated vomiting, severe or persistent abdominal pain, severe constipation, abdominal swelling, or inability to pass stool or gas.
- Serious allergic reaction: swelling of the face, lips, tongue, or throat; difficulty breathing or swallowing; severe rash; fainting; or severe dizziness. Call 911.
- Low blood sugar: sweating, shakiness, hunger, blurred vision, confusion, weakness, dizziness, slurred speech, or a fast heartbeat, particularly when used with insulin or a sulfonylurea. Call 911 for loss of consciousness, seizure, or severe confusion.
- Vision changes: new or worsening changes in vision, especially if you have diabetes or diabetic retinopathy.
- Possible thyroid tumor symptoms: a lump or swelling in the neck, persistent hoarseness, trouble swallowing, or shortness of breath.
Semaglutide and tirzepatide delay stomach emptying. Tell your surgeon, anesthesiologist, dentist, or other procedural clinician that you use one of these medications before any procedure involving anesthesia or deep sedation.
Other Possible Side Effects
FDA-approved products containing semaglutide or tirzepatide commonly list gastrointestinal side effects such as nausea, diarrhea, vomiting, constipation, abdominal pain, indigestion, decreased appetite, bloating, belching, and heartburn. Other reported effects can include fatigue, headache, dizziness, hair loss, and injection-site reactions.
The complete risks and frequency of side effects for a compounded formulation may be different or unknown. Contact your clinician about any symptom that is severe, persistent, worsening, or concerning.
Dosing and Administration Safety
Compounded medications may come in different concentrations and dosage forms. Confusing milligrams, milliliters, and syringe “units” can cause a serious overdose.
- Use only the medication, dose, frequency, route, and syringe listed on your current prescription and pharmacy label.
- Before every dose, confirm the medication name, concentration, prescribed dose, injection volume, and correct syringe marking.
- If any direction is missing, inconsistent, or unclear, do not take or inject the medication until the prescribing clinician or dispensing pharmacy confirms it.
- Never use a universal dosing chart or copy the number of “units” used for another vial. A refill may have a different concentration.
- Do not calculate a new dose yourself, increase the dose early, double a missed dose, change the route, or take doses more frequently than prescribed.
- Dose increases are not automatic. A clinician must determine whether an increase is appropriate based on your prescription, response, and side effects.
- Do not combine or “stack” semaglutide, tirzepatide, or another GLP-1 medication unless your prescribing clinician has expressly instructed you to do so.
- Never share medication, vials, pens, needles, or syringes. Use a new sterile needle and syringe for every injection and dispose of used sharps safely.
If you may have used the wrong dose, contact your clinician and Poison Control at 1-800-222-1222. Call 911 for severe symptoms.
Oral and Combination Formulations
The FDA has not approved an oral tirzepatide product. A compounded oral semaglutide product should not be assumed to be equivalent to an FDA-approved oral or injectable semaglutide product. Compounded oral, sublingual, troche, and combination formulations may have different absorption, exposure, ingredients, effectiveness, and risks.
A compounded prescription may contain an additional ingredient, such as a vitamin, amino acid, or other substance. The FDA has not determined that adding another ingredient improves weight loss, safety, effectiveness, energy, focus, liver function, or tolerability. Added ingredients may create additional side effects, interactions, contraindications, or allergy risks. Review the complete ingredient list on your pharmacy label. If the ingredients are missing, unclear, or different from what you expected, do not use the medication until the dispensing pharmacy or your clinician provides clarification.
Do not use a product labeled as containing semaglutide sodium or semaglutide acetate. The FDA has stated that these salt forms are different active ingredients from the semaglutide used in FDA-approved products and that it is unaware of a lawful basis for their use in compounding.
Storage, Shipping, and Product Quality
- Follow the dispensing pharmacy's label for refrigeration, room-temperature limits, light protection, storage, and handling.
- Do not use medication if the pharmacy label is missing or incomplete, the seal is broken, the container is leaking or damaged, or the product appears discolored, cloudy, contaminated, frozen, or contains unexpected particles.
- Do not assume that storage guidance for a prior shipment, another pharmacy, or a brand medication applies to your current prescription.
- Keep medication and injection supplies out of the reach of children and pets.
If You Receive an FDA-Approved Brand Medication
Use the Medication Guide, Instructions for Use, prescribing information, and storage directions supplied with that exact product. FDA-approved semaglutide and tirzepatide products have different approved uses, devices, concentrations, schedules, and instructions.
Do not apply compounded-medication instructions to a branded product or instructions for one brand to another product.
Questions and Adverse-Event Reporting
For non-emergency medical questions: Message your prescribing clinician through the Livbetr patient portal.
For help reaching your care team or resolving an order issue: Call 1-888-664-9435 or email support@livbetr.com.
For questions about ingredients, concentration, preparation, storage, or the beyond-use date: Contact the dispensing pharmacy listed on your prescription label.
To report a side effect or product-quality problem to the FDA: Visit FDA MedWatch or call 1-800-FDA-1088.
Additional Information
This is not a complete list of warnings, risks, side effects, interactions, contraindications, or instructions. Your prescription label and the information supplied by the dispensing pharmacy control if they differ from this general summary.
For current federal information, review the FDA's Concerns with Unapproved GLP-1 Drugs Used for Weight Loss.
