Prescription medicine
Tesamorelin Brand names: Egrifta
Tesamorelin (Egrifta) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the tesamorelin FDA label on DailyMed (effective July 29, 2026, Theratechnologies Inc.); the BLA 22505 record on Drugs@FDA; every tesamorelin label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageEGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.
Forms and strengths
Kit.
On the market
- Earliest approval on file
- November 10, 2010 Egrifta, Theratechnologies; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 0 since 2018 0 Class I among all firms' recalls; 2 more by firms not listed as its makers
- FAERS reports
- 1,586 through July 30, 2026
What is tesamorelin used for?
From the label: indications and usageEGRIFTA SV is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy. Limitations of Use: Long-term cardiovascular safety of EGRIFTA SV has not been established. Consider risk/benefit of continuation of treatment in patients who have not had a reduction in visceral adipose tissue. EGRIFTA SV is not indicated for weight loss management as it has a weight neutral effect. There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking EGRIFTA SV. […]
Source: FDA drug label (EGRIFTA SV), Theratechnologies Inc., effective July 29, 2026 (SPL set 3d783378-b02d-4f19-99dd-0fc91a042224), via openFDA; the full label on DailyMed
Is there a generic for tesamorelin (Egrifta)?
No generic tesamorelin is approved (Drugs@FDA, October 8, 2026).
- 2010 earliest approval on file
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has tesamorelin been recalled?
The FDA's Enforcement Report lists 2 recalls naming tesamorelin since 2018: 0 Class I (the most serious), 2 Class II, 0 Class III; 1 still ongoing. 2 of them are by firms that FDA's NDC Directory does not list as a maker of tesamorelin and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| July 30, 2025 | Class II | GenoGenix LLC not a listed maker | Lack of Assurance of Sterility |
| September 28, 2018 | Class II | Tailor Made Compounding not a listed maker | Labeling: Incorrect or Missing Lot and/or Expiration Date; vial indicates a 1 year expiration date instead of a 6 month expiration date |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the tesamorelin label say about other medicines?
The tesamorelin label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Cortisone | drug interactions | Glucocorticoids GH inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1), a microsomal enzyme required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. |
| Cyclosporine | drug interactions | These data suggest that GH may alter the clearance of compounds known to be metabolized by CYP450 liver enzymes (e.g., corticosteroids, sex steroids, anticonvulsants, and cyclosporine). |
| Prednisone | drug interactions | Patients treated with cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. |
| Simvastatin | drug interactions | Cytochrome P450-Metabolized Drugs Co-administration of tesamorelin with simvastatin, a CYP3A substrate had no significant impact on the pharmacokinetics profiles of simvastatin in healthy subjects [see Clinical Pharmacology ( 12.3 )]. |
Source: FDA drug label (EGRIFTA SV), 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 for tesamorelin?
The FDA Adverse Event Reporting System holds 1,586 reports that list tesamorelin among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Tesamorelin side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other