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What the label lists and what reports show

Tesamorelin side effects

Tesamorelin's FDA label: “Most commonly reported adverse reactions (>5%): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia.” FAERS holds 1,586 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is injection site pain (141 reports).

  • No generic listed

Check it at the source: the tesamorelin FDA label on DailyMed (effective July 29, 2026, Theratechnologies Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of EGRIFTA SV?

EGRIFTA SV may cause serious side effects, including: increase risk of new cancer in HIV positive patients or your cancer coming back (reactivation). Stop using EGRIFTA SV if any cancer symptoms come back. increased levels of your insulin-like growth factor-1 (IGF-1). Your healthcare provider will do blood tests to check your IGF-1 levels while you are taking EGRIFTA SV. swelling (fluid retention). EGRIFTA SV can cause swelling in some parts of your body. Call your healthcare provider if you have swelling, an increase in joint pain or pain or numbness in your hands or wrist (carpal tunnel syndrome). Joint pain and swelling of your arms, hands, legs and feet are common side effects of EGRIFTA SV, but may sometimes be serious. increase in blood sugar (glucose) or diabetes. […]

Source: FDA drug label, Theratechnologies Inc., effective July 29, 2026 (SPL set 3d783378-b02d-4f19-99dd-0fc91a042224), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most commonly reported adverse reactions (>5%): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia.

From the label: adverse reactions, continued

The following important adverse reactions are also described elsewhere in the labeling: Increased risk of neoplasms [see Warnings and Precautions ( 5.1 )] Elevated IGF-1 levels [see Warnings and Precautions ( 5.2 )] Fluid retention [see Warnings and Precautions ( 5.3 )] Glucose intolerance or diabetes mellitus [see Warnings and Precautions ( 5.4 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.5 )] Injection site reactions [see Warnings and Precautions ( 5.6 )] Most commonly reported adverse reactions (>5%): Arthralgia, injection site erythema, injection site pruritus, pain in extremity, peripheral edema, and myalgia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact THERA patient support ® toll free at 1-833-23THERA (1-833-238-4372) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of EGRIFTA SV (2 mg/vial formulation) has been established based on clinical trials conducted with EGRIFTA (1 mg/vial formulation). …

Source: FDA drug label, Theratechnologies Inc., effective July 29, 2026 (SPL set 3d783378-b02d-4f19-99dd-0fc91a042224), via openFDA; the full label on DailyMed

What do FAERS reports show?

1,586 reports list tesamorelin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 31 are coded as a death and 123 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Product Dose Omission Issue (a use or a product term, not a reaction)285
  • Incorrect Dose Administered (a use or a product term, not a reaction)164
  • Injection Site Pain (named in the label)141
  • Drug Ineffective (a use or a product term, not a reaction)128
  • Product Preparation Issue121
  • Weight Increased97
  • Arthralgia (named in the label)95
  • Injection Site Bruising89
  • Therapeutic Product Effect Incomplete (a use or a product term, not a reaction)86
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)78
  • Injection Site Pruritus (named in the label)77
  • Pain In Extremity (named in the label)70
  • Fatigue59
  • Peripheral Swelling55
  • Product Dose Omission In Error (a use or a product term, not a reaction)51
  • Myalgia (named in the label)49
  • Pruritus (named in the label)49
  • Pain47
  • Injection Site Mass43
  • Diarrhoea42
  • Intentional Dose Omission (a use or a product term, not a reaction)39
  • Back Pain37
  • Hypoaesthesia (named in the label)36
  • Abdominal Distension34
  • Blood Glucose Increased34

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Tesamorelin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions