Important Safety Information
This page contains full safety information for compounded semaglutide and compounded tirzepatide prescribed through Ondra Health. Read before starting treatment.
Regulatory Status
Compounded semaglutide and compounded tirzepatide dispensed through Ondra Health are not FDA-approved finished drug products. The FDA has not evaluated these compounded preparations for safety, effectiveness, or manufacturing quality.
Compounded semaglutide ≠ Ozempic®/Wegovy®. Compounded tirzepatide ≠ Mounjaro®/Zepbound®. Clinical trial data from the STEP 1 (semaglutide) and SURMOUNT-1 (tirzepatide) trials reflects FDA-approved brand-name products — not compounded versions. Individual results vary.
Compounded medications are permitted under Section 503A of the Federal Food, Drug, and Cosmetic Act when prescribed by a licensed provider for an individual patient with documented clinical justification. All prescriptions through Ondra Health are issued by independent licensed providers at Wasef Health, PC or Arora Health & Aesthetics, LLC at their sole clinical discretion.
Boxed Warning — Thyroid C-Cell Tumors
In rodent studies, semaglutide and tirzepatide caused dose-dependent and duration-dependent thyroid C-cell tumors at clinically relevant exposures. It is unknown whether these findings translate to humans.
Compounded semaglutide and compounded tirzepatide are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2).
Patients should be counseled about the potential risk of MTC and the symptoms of thyroid tumors (e.g., a mass in the neck, dysphagia, dyspnea, persistent hoarseness). Routine serum calcitonin monitoring or thyroid ultrasound has not been established to have clinical benefit in patients treated with GLP-1 receptor agonists and is not recommended. If MTC is suspected, treatment should be discontinued and the patient should be evaluated appropriately.
Contraindications
Do not use if any of the following apply.
Serious Warnings & Precautions
Acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, has been reported with GLP-1 receptor agonists. Discontinue promptly if suspected. Do not restart if confirmed.
Symptoms to watch for: Persistent severe abdominal pain, sometimes radiating to the back, which may or may not be accompanied by vomiting. Contact your provider or seek emergency care immediately if these occur.
Use with caution in patients with a history of pancreatitis. Inform your provider of any history of pancreatitis before starting treatment.
Risk of hypoglycemia increases when combined with insulin or sulfonylureas (e.g., glipizide, glyburide). Dose reduction of those medications may be required.
Symptoms: Dizziness, confusion, sweating, shakiness. Severe cases can cause loss of consciousness. Disclose all diabetes medications to your provider.
Worsening of diabetic retinopathy has been observed in semaglutide trials, particularly with rapid glucose improvement. Monitor patients with a history of diabetic retinopathy.
GLP-1 medications are associated with increased risk of gallstones and gallbladder inflammation. Rapid weight loss is also an independent risk factor. Discontinue and seek evaluation if suspected.
GLP-1 receptor agonists may increase resting heart rate. Monitor pulse periodically and discuss with your provider if you have known cardiac conditions.
Acute kidney injury has been reported. GI side effects can cause dehydration, worsening kidney function. Ensure adequate hydration throughout treatment, especially during dose escalation.
If you experience depression, suicidal thoughts, or unusual mood changes, discontinue and contact your provider immediately. In a mental health emergency, call or text 988 (Suicide & Crisis Lifeline) or go to your nearest emergency room.
Common Side Effects
The following side effects are common and typically occur during the first weeks of treatment or following dose increases. They generally improve as the body adjusts. Contact your provider if they are severe, persistent, or affect your ability to eat, drink, or function normally.
- Nausea — most common, especially early
- Vomiting
- Diarrhea
- Constipation
- Abdominal pain or discomfort
- Bloating / flatulence
- Reduced appetite — expected effect, not a side effect per se
- Heartburn / acid reflux
- Belching
Eating smaller, lower-fat meals and avoiding lying down after eating can help reduce GI symptoms.
- Fatigue
- Headache
- Dizziness
- Hair thinning — often related to rapid weight loss and inadequate protein intake, not a direct drug effect
- Decreased energy — usually temporary
- Dry mouth
- Taste changes
- Muscle loss — discuss protein intake and activity with your provider, who can advise on what is appropriate for you
Mild injection site reactions are common and include redness, bruising, itching, or mild swelling at the injection site. These typically resolve within a few days. Rotating injection sites (abdomen, thigh, or upper arm) with each dose reduces this risk.
Seek immediate medical attention if you experience severe injection site pain, significant swelling, warmth, or signs of infection (increasing redness, pus, fever) at the injection site.
Serious Side Effects — When to Seek Immediate Care
Stop treatment and seek emergency care or call 911 immediately if you experience any of the following:
- Severe persistent abdominal pain, especially radiating to the back — possible pancreatitis
- Severe allergic reaction (anaphylaxis): swelling of the face, lips, tongue, or throat; difficulty breathing; rapid heartbeat; dizziness or loss of consciousness
- Signs of thyroid tumor: lump or swelling in the neck, difficulty swallowing, persistent hoarseness, shortness of breath
- Symptoms of low blood sugar (severe): seizures, loss of consciousness — particularly if taking insulin or sulfonylureas
- Sudden vision changes — particularly in patients with diabetic retinopathy
- Severe vomiting or diarrhea leading to significant dehydration — signs of dehydration include extreme thirst, dry mouth, dark urine, very low urine output, confusion
- Suicidal thoughts or severe mood changes — call 988 immediately or go to the nearest emergency room
Before You Start — Tell Your Provider
Inform your provider of all of the following before starting compounded semaglutide or tirzepatide. Failure to disclose relevant medical history may affect the safety of your treatment.
- Personal or family history of thyroid cancer or MEN 2
- History of pancreatitis
- Gallbladder disease or gallstones
- Diabetic retinopathy
- Kidney disease or reduced kidney function
- Liver disease
- Heart disease or history of arrhythmia
- History of eating disorders
- Depression, suicidal ideation, or mental health conditions
- Type 1 diabetes or diabetic ketoacidosis (DKA)
- All insulin medications
- Sulfonylureas (glipizide, glyburide, glimepiride)
- Other GLP-1 medications (Ozempic, Wegovy, Mounjaro, Zepbound, Saxenda, Victoza)
- Oral contraceptives
- Blood thinners (warfarin)
- Any weight loss supplements or medications
- All prescription and over-the-counter medications
- Herbal supplements
Drug Interactions
Pregnancy & Breastfeeding
GLP-1 medications should not be used during pregnancy. Based on animal studies, there may be potential risks to the unborn baby from exposure during pregnancy. There is no benefit to weight loss during pregnancy and it may cause harm to the developing fetus.
If you are of reproductive potential: Discontinue compounded semaglutide or tirzepatide at least 2 months before a planned pregnancy, as the medications can persist in the body for this duration.
If you become pregnant while taking compounded semaglutide or tirzepatide, discontinue immediately and contact your provider.
GLP-1 medications slow gastric emptying, which may affect the absorption of oral contraceptives and reduce their effectiveness.
For tirzepatide specifically: Use a non-oral backup contraceptive method (such as a condom or other barrier method) for 4 weeks after initiating tirzepatide and for 4 weeks after each dose escalation. This is consistent with the FDA prescribing information for Zepbound (tirzepatide).
For semaglutide, discuss timing of oral contraceptive doses with your provider. If you use oral contraceptives, inform your provider before starting treatment.
Storage & Handling
Ondra Health — Provider & Pharmacy Roles
All prescriptions issued to Ondra Health patients are made by independent, licensed providers at one of two clinical groups: Wasef Health, PC or Arora Health & Aesthetics, LLC.
Ondra Health is a telehealth platform that connects patients with these providers. Ondra Health does not prescribe medication. All clinical decisions — including the initial prescription, dosing, titration schedule, and any decision to continue, adjust, or discontinue treatment — are made solely at the discretion of the licensed provider.
Provider profiles are available at ondra.health/meet-our-doctors. NPI numbers are publicly verifiable at the CMS NPPES NPI Registry.
Also known as Wasef Health Group. A physician-led national telemedicine provider network founded by Michael Wasef, MD, with board-certified physicians across internal medicine, obesity medicine, family medicine, and emergency medicine.
Medical Director: David Wasef, MD (NPI 1790366326)
Coverage: All 50 U.S. states and eligible patients in Puerto Rico
Contact: contact@wasef-health.com
Website: wasef-health.com
An independent clinical group led by board-certified physicians Sean Arora, MD (Founder and CEO) and Shannon Arora, MD (Chief Medical Officer).
Coverage: All 50 U.S. states
Office: 300 Lenora Street, Seattle, WA 98121
Provider questions: medicalcompliance@arorahealthgroup.com
Website: arora-health.com
Medications prescribed through Ondra Health are filled by one of seven state-licensed compounding pharmacy partners. Patients may request a preferred pharmacy during intake; availability depends on state, medication, prescription, and pharmacy inventory. All partners are U.S.-licensed and regulated under Section 503A or 503B. 503A pharmacy partners follow USP <797> sterile compounding standards.
503A pharmacies: Hallandale Pharmacy, Boudreaux's New Drug Store, Vials RX, Optio RX, Southend Pharmacy, Drug Crafters Pharmacy.
503B outsourcing facility: Hyalo Pharmacy, fulfilled through Quaker Community Pharmacy / New Life RX (tirzepatide only). Hyalo is an FDA-registered outsourcing facility subject to enhanced federal oversight.
Availability by state and formulation is listed at ondra.health/pharmacy-partners and ondra.health/service-areas.
Formulation Additives
Some Ondra Health pharmacy partners include supportive co-factors in their compounded GLP-1 formulations. These additives are not present in FDA-approved brand-name GLP-1 products and are not FDA-reviewed in this context. Disclose any known allergies or sensitivities to these ingredients to your provider before starting treatment.
Water-soluble vitamin included in some formulations as a supportive co-factor. Supports energy metabolism and nerve function. Available through Vials RX (semaglutide and tirzepatide) and Drug Crafters Pharmacy (tirzepatide only).
Note: If you are sensitive to cobalt or have a history of Leber's disease (hereditary optic neuropathy), inform your provider before use.
Non-essential amino acid used as a peptide stabilizer to help preserve the structural integrity of the active peptide during storage. Available through Boudreaux's New Drug Store, Vials RX, and Drug Crafters Pharmacy (semaglutide and tirzepatide). At Vials RX and Drug Crafters Pharmacy, Glycine is offered as its own formulation, separate from the B12 or B6 options.
Water-soluble vitamin included in some formulations. Supports protein metabolism and neurotransmitter synthesis. Available through Southend Pharmacy (semaglutide and tirzepatide) and Drug Crafters Pharmacy (semaglutide only).
Note: High doses of B6 over extended periods may cause peripheral neuropathy. Discuss any concerns about B6 content with your provider.
Water-soluble vitamin included in some formulations as a supportive co-factor. Supports energy metabolism. Available through Optio RX (semaglutide and tirzepatide).
Note: Disclose any known allergies or sensitivities and discuss any concerns about B3 content with your provider.
Pure compounded semaglutide and tirzepatide with no additives is available through Hallandale Pharmacy (both medications) and Quaker Community Pharmacy / New Life RX via Hyalo Pharmacy (tirzepatide only).
Primary Sources & References
- FDA — Unapproved GLP-1 Drugs & Safety Concerns
- FDA — Compounding Laws and Policies
- FDA — Section 503A of the FD&C Act
- FDA — Wegovy (semaglutide) Full Prescribing Information (2023)
- FDA — Zepbound (tirzepatide) Full Prescribing Information (2023)
- Wilding JPH et al. — STEP 1 (semaglutide). NEJM 2021;384:989–1002
- Jastreboff AM et al. — SURMOUNT-1 (tirzepatide). NEJM 2022;387:205–216
- FDA — Human Drug Compounding
- USP — General Chapter <797> Sterile Compounding
- CMS — NPPES NPI Registry
- FDA — MedWatch Adverse Event Reporting Program
Reporting Adverse Events
If you experience a serious adverse event or unexpected side effect while taking a compounded medication prescribed through Ondra Health, you are encouraged to report it through the following channels.
The FDA Safety Information and Adverse Event Reporting Program accepts reports from patients and healthcare professionals.
Online: fda.gov/medwatch
Report adverse events to your provider through the patient portal and to the dispensing pharmacy directly.
Care team: care@ondra.health
Patient portal: care.ondra.health
Full Regulatory Disclosure
Compounded semaglutide and compounded tirzepatide dispensed through Ondra Health are not FDA-approved finished drug products. The FDA has not evaluated these compounded preparations for safety, effectiveness, or manufacturing quality. Compounded semaglutide ≠ Ozempic®/Wegovy®. Compounded tirzepatide ≠ Mounjaro®/Zepbound®.
Ozempic® and Wegovy® are registered trademarks of Novo Nordisk A/S. Mounjaro® and Zepbound® are registered trademarks of Eli Lilly and Company.
This document does not constitute medical advice. All prescriptions are issued solely by independent licensed providers at Wasef Health, PC or Arora Health & Aesthetics, LLC. Ondra Health does not prescribe medication.
Clinical trial data (STEP 1, SURMOUNT-1) reflects FDA-approved brand-name products — not compounded versions. Individual results vary. This is a summary — always consult your provider for individualized guidance.
For questions about your treatment, contact your care team at care@ondra.health. For medical emergencies, call 911. For mental health crises, call or text 988.