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Prescription medicine

Alitretinoin Brand names: Panretin

Alitretinoin (Panretin) is a prescription medicine with an FDA approval on record since 1999. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the alitretinoin FDA label on DailyMed (effective November 25, 2025, Advanz Pharma (US) Corp.); the NDA 20886 record on Drugs@FDA; every alitretinoin label on DailyMed.

Highlights of the record

FDA label of November 25, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS).

Forms and strengths

  • 60 mg/60g

Gel.

On the market

Earliest approval on file
February 2, 1999 Panretin, Advanz Pharma; Drugs@FDA’s file, where older or withdrawn approvals can be missing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)
No recall recorded
FAERS reports
117 through July 30, 2026

What is alitretinoin used for?

From the label: indications and usage

Kaposi’s Sarcoma PANRETIN GEL is indicated for topical treatment of cutaneous lesions in adults with AIDS related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-KS therapy is required (including more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement) [see Clinical Studies ( 14.1 )]. PANRETIN GEL is a retinoid indicated for the topical treatment of cutaneous lesions in adults with AIDS-related Kaposi’s sarcoma (KS). Limitations of Use: PANRETIN GEL is not indicated when systemic anti-Kaposi’s sarcoma therapy is required.

FDA pharmacologic class: Retinoid.

Source: FDA drug label (PANRETIN), Advanz Pharma (US) Corp., effective November 25, 2025 (SPL set 49c16717-7d86-4257-80c9-baa1417e5555), via openFDA; the full label on DailyMed

Is there a generic for alitretinoin (Panretin)?

No generic alitretinoin is approved (Drugs@FDA, October 8, 2026).

  • 1999 earliest approval on file

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the alitretinoin label say about other medicines?

The alitretinoin label names no other medicine on this site. The labels of 1 other medicine name alitretinoin. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Other labels that name alitretinoin

Check alitretinoin against other medicines

Source: FDA drug label (PANRETIN), Advanz Pharma (US) Corp., effective November 25, 2025 (SPL set 49c16717-7d86-4257-80c9-baa1417e5555), via openFDA; the full label on DailyMed

What do FAERS reports show for alitretinoin?

The FDA Adverse Event Reporting System holds 117 reports that list alitretinoin among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5 are coded as a death and 27 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.

The most reported reactions

  • Off Label Use (a use or a product term, not a reaction)23
  • Drug Ineffective (a use or a product term, not a reaction)22
  • Drug Intolerance9
  • Headache9
  • Hypercholesterolaemia8
  • Treatment Failure (a use or a product term, not a reaction)8
  • Vomiting8
  • Product Use In Unapproved Indication (a use or a product term, not a reaction)7

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Other retinoids
the pharmacologic class, with prices and generics
Alitretinoin side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other