Tesamorelin side effects and risks
A peptide approved for deep abdominal fat in adults with HIV lipodystrophy.
Also called: TH9507, TH-9507, Egrifta, Egrifta SV, Egrifta WR.
GHRH analogues · Growth hormone-releasing hormone receptor agonist · Evidence: Approved drug.
Reported side effects
- Injection-site redness, itching or pain: All injection site reactions: 25% versus 14% placebo over 26 weeks., mild. Rotate abdominal sites; seek care for spreading redness, warmth, pus or fever. (source)
- Joint pain: 13% versus 11% placebo in the pooled 26 week adverse reaction table., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Muscle pain: 6% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Swollen ankles or other fluid retention: 6% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Arm or leg pain: 6% versus 5% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Tingling: 5% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Reduced skin sensation: 4% versus 2% placebo., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Rash: 4% versus 2% placebo., mild. A rash with breathing trouble, facial swelling or faintness needs emergency care. (source)
- High blood sugar or new diabetes: HbA1c ≥6.5% developed in 5% versus 1% placebo by week 26., serious. Check glucose; the label advises reassessing treatment if glucose worsens without clear benefit. (source)
- Allergic reaction: 4% of tesamorelin trial participants; the warning gives no placebo rate., serious. Stop and seek prompt medical attention; use emergency care for breathing or circulation symptoms. (source)
- Carpal tunnel syndrome: 1% versus 0% placebo in the pooled adverse reaction table., moderate. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- Vomiting: 3% versus 0% placebo., moderate. Persistent vomiting needs review and assessment of hydration. (source)
- Stomach discomfort: Indigestion: 2% versus 1% placebo., mild. Discuss persistent symptoms and reassess the dose or need for treatment. (source)
- High IGF-1: IGF 1 >3 standard deviations above the age average: 36% at 26 weeks; 23% at 52 weeks among continuing patients., moderate. Monitor IGF-1; the label advises considering stopping if levels stay this high. (source)
Stop and get help if
- Trouble breathing, swelling of the face or tongue, widespread hives or faintness: Stop dosing and get emergency care now.
- New severe breathlessness, chest pain, fainting or rapidly worsening swelling: Get urgent medical care now; severe symptoms need emergency services.
- Marked thirst or frequent urination with vomiting, confusion or deep breathing: Check glucose if available and get urgent care for possible severe high blood sugar.
- New blurred vision, sudden vision loss or a curtain over vision: Get same-day eye assessment; sudden vision loss is an emergency.
- Spreading injection-site redness, heat, pus or fever: Stop using that vial and get prompt care for possible infection.
Who should avoid it
- pregnant: Contraindicated by the label. Changing pregnancy-related visceral fat has no known benefit and may harm the fetus.
- tryingToConceive: Listed as a reason to avoid it.
- breastfeeding: No human milk or infant-safety data. The product label says mothers receiving tesamorelin should not breastfeed.
- under18: Safety and effectiveness are not established; the label does not indicate pediatric use.
- activeCancer: Contraindicated because tesamorelin raises GH and IGF-1. Stop if a prior cancer recurs.
- cancerHistory: Past cancer must be inactive with treatment complete; review the possible risk of recurrence before starting.
- other: Contraindicated with pituitary-axis disruption, including pituitary tumor or surgery, head irradiation, hypopituitarism or relevant head trauma.
- other: Contraindicated after a known allergy to tesamorelin or an ingredient in the specific product.
- diabetes: New diabetes can develop. Existing diabetes needs glucose follow-up and retinal monitoring.
- diabeticRetinopathy: Raised IGF-1 may worsen retinal disease; the label calls for regular monitoring in people with diabetes.
- kidneyDisease: Drug levels and needed dose changes with kidney impairment are unknown.
- liverDisease: Drug levels and needed dose changes with liver impairment are unknown, including in advanced liver failure.
- heartCondition: Fluid retention may worsen swelling or heart-failure symptoms; long-term cardiovascular safety is unknown.
- surgeryPlanned: Critical illness after major surgery or trauma warrants reassessment; the label advises considering discontinuation in critically ill patients.
- other: Consider stopping during sudden breathing failure or severe critical illness. The warning comes from growth hormone drug treatment.
- testedAthlete: Prohibited at all times under the 2026 WADA List, section S2.2.4.
Interactions
- Insulin and sulfonylureas: Tesamorelin may raise blood sugar and change medication needs. Watch for highs or lows after diabetes medicines change.
- Glucocorticoid replacement: Growth hormone can reduce cortisone's conversion to cortisol. Clinicians may review routine or stress steroid replacement.
- Other growth hormone and IGF-1 drugs: May add to effects on blood sugar, swelling and tissue growth. Combination safety is unknown.
- Cyclosporine and some seizure medicines: Growth hormone may change drug breakdown. Clinicians can check drug effects and blood levels.
- Sex steroids: The label warns sex hormone breakdown may change. A clinician should review possible interactions.
- Simvastatin and ritonavir: Small crossover studies in healthy volunteers found no drug level changes requiring dose adjustment.
- Anticoagulants: No direct interaction is established. Injections can bruise; review medicines with a clinician if bleeding risk is high.
Product quality risks
- An FDA-approved molecule does not make an online vial an approved product. Identity, amount and injectable quality may differ.
- Poor preparation can cause contamination or too much or too little active drug; FDA describes serious injury and death from compounding failures.
- No independent tesamorelin retail-sampling study or drug-specific counterfeit-pen series was found. Do not borrow semaglutide contamination rates.
- A purity percentage alone does not establish the dose, sterility, endotoxin level or stability after mixing.
Related to Tesamorelin
- CJC-1295 without DAC: A peptide intended to trigger growth hormone release, with no human dosing study found.
- Sermorelin: An experimental short-acting peptide that triggers growth hormone release, with limited evidence of adult benefits.
- CJC-1295 with DAC: An experimental long-acting peptide that triggers growth hormone release, with no proven muscle or recovery benefit.
- Tirzepatide: A weekly GIP/GLP-1 injection with strong diabetes and weight-loss evidence and common stomach side effects.
- Retatrutide: An experimental weekly injection with phase 3 weight-loss results.
- Ipamorelin: An experimental peptide that triggers growth hormone release.
Sources
- Compounding and the FDA: Questions and Answers, FDA · FDA · 2026
- Purple Book Search, FDA · 2026
- Search results summary, Health Canada · 2026
- The 2026 Prohibited List, World Anti-Doping Agency · WADA · 2026
- Therapeutic Goods (Poisons Standard—October 2026) Instrument 2026, Australian Government · Australian Government · 2026
- EGRIFTA WR (tesamorelin) for injection, for subcutaneous use, U.S. Food and Drug Administration · FDA · 2025
- Supply unlicensed medicinal products (specials), MHRA · 2025
- EGRIFTA SV (tesamorelin) for injection, for subcutaneous use, 2024
- Egrifta, 2012
- EGRIFTA (tesamorelin for injection) for Subcutaneous Use, 2010
- EGRIFTA: Chemistry Review, NDA 22-505, 2010
- EGRIFTA: Clinical Pharmacology and Biopharmaceutics Review, NDA 22-505, 2010
- EGRIFTA: Clinical Review, NDA 22-505, 2010
- Body composition, hepatic fat, metabolic, and safety outcomes of Tesamorelin, a GHRH analogue, in HIV-associated lipodystrophy: A meta-analysis of randomized controlled trials., Badran AS et al. · Obesity research & clinical practice · 2026
- Differing Presentations of Excess Visceral Abdominal Fat in People Living With HIV: Two Clinical Cases Highlighting Distinct Therapeutic Pathways With Tesamorelin and Glucagon-Like Peptide-1 Receptor Agonists., Beach R et al. · Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2026
Sources checked: 2026-10-18.
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