Compound monograph · §4

Tesamorelin — safety

Adverse events as reported, contraindications, warnings, and an explicit statement of what the safety evidence does not establish.

Document identifier: CEI-MN-021/4
Series: Compound monograph
Version: 4.2
Published: 01 Dec 2023
Last reviewed: 01 Sep 2024
Next review: 01 Sep 2026
Identifier: 10.71829/cei.mono.21
Certainty: Moderate
Cycle: 2023 Q4

§4Safety

§4.1Adverse events reported in controlled trials

Table 4. Adverse events for Tesamorelin as reported in the trial safety tables the Institute holds. Percentages are of randomised participants in the stated trial and arm.

Event	Active, %	Comparator, %	Difference, pp	Source
Injection-site erythema	25.0	5.0	+20.0	Pivotal pooled
Arthralgia	13.0	9.0	+4.0	Pivotal pooled
Peripheral oedema	6.0	2.0	+4.0	Pivotal pooled
Myalgia	5.0	2.0	+3.0	Pivotal pooled
Paraesthesia	5.0	1.0	+4.0	Pivotal pooled
Glucose intolerance / raised HbA1c	—	—	—	A recognised class effect of growth-hormone-axis stimulation; monitoring advised
IGF-1 above the reference range	34.0	—	—	Pivotal pooled
Hypersensitivity reaction	—	—	—	Reported at low incidence
A difference column is computed by the Institute from the two reported percentages and is not itself a published figure. Confidence intervals for adverse-event differences are not reported in the contributing trials and are not constructed here.

§4.2Contraindications

Disruption of the hypothalamic-pituitary axis from hypophysectomy, hypopituitarism, pituitary tumour or surgery, or head irradiation
Active malignancy
Pregnancy
Known hypersensitivity to tesamorelin or mannitol

§4.3Warnings and precautions

Neoplasia — the compound stimulates a growth-promoting axis; a malignancy assessment is required before initiation
Glucose intolerance and new-onset diabetes
Fluid retention
Injection-site reactions are common
IGF-1 monitoring is required and the dose should be reconsidered if levels persist above the reference range

§4.4What this section does not establish

What this document does not establish

Rare events. A trial programme of the size available for this compound could not detect an event occurring at a rate below approximately one in several hundred exposed participants. The absence of such an event in the tables above is uninformative, not reassuring.
Long-latency events. The longest randomised exposure in the contributing evidence is measured in months to a small number of years. Outcomes with a longer latency are outside what any contributing trial could observe.
Harms of the supplied material as distinct from the compound. Every incidence above was measured in a trial using material manufactured under a regulated quality system. Harms attributable to impurities, counter-ion load, endotoxin or incorrect content in research-supply material are not represented in any of these figures.

References cited on this page

References are numbered in order of first citation in this document. Each superscript in the text links to its entry below.

Falutz J, Allas S, Blot K, Potvin D, Kotler D, Somero M, Berger D, Brown S, Richmond G, Fessel J, Turner R, Grinspoon S. Metabolic effects of a growth hormone-releasing factor in patients with HIV. New England Journal of Medicine 2007;357(23):2359–2370. doi:10.1056/NEJMoa072375 · PMID 18052660
Prakash A, Goa KL. Sermorelin: a review of its use in the diagnosis and treatment of children with idiopathic growth hormone deficiency. BioDrugs 1999;12(2):139–157. doi:10.2165/00063030-199912020-00007 · PMID 18031173

Identifiers are reproduced only where the Institute holds them. Where a digital object identifier or PubMed identifier is not shown, the Institute has recorded the journal and year and has not constructed an identifier.

Compound Evidence Institute · CEI-MN-021/4 · https://compoundevidence.com/monographs/tesamorelin/safety/ · retrieved 30 July 2026