Panretin Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions


Panretin® gel could cause fetal harm if significant absorption were to occur in a pregnant woman. 9-cis-Retinoic acid has been shown to be teratogenic in rabbits and mice. An increased incidence of fused sternebrae and limb and craniofacial defects occurred in rabbits given oral doses of 0.5 mg/kg/day (about five times the estimated daily human topical dose on a mg/m2 basis, assuming complete systemic absorption of 9-cis-retinoic acid, when Panretin® gel is administered as a 60 g tube over 1 month in a 60 kg human) during the period of organogenesis. Limb and craniofacial defects also occurred in mice given a single oral dose of 50 mg/kg on day eleven of gestation (about 127 times the estimated daily human topical dose on a mg/m2 basis). Oral 9-cis-retinoic acid was also embryocidal, as indicated by early resorptions and post-implantation loss when it was given during the period of organogenesis to rabbits at doses of 1.5 mg/kg/day (about 15 times the estimated daily human topical dose on a mg/m2 basis) and to rats at doses of 5 mg/kg/day (about 25 times the estimated daily human topical dose on a mg/m2 basis). Animal reproduction studies with topical 9-cis-retinoic acid have not been conducted. It is not known whether topical Panretin® gel can modulate endogenous 9-cis-retinoic acid levels in a pregnant woman nor whether systemic exposure is increased by application to ulcerated lesions or by duration of treatment. There are no adequate and well-controlled studies in pregnant women. If Panretin® gel is used during pregnancy, or if the patient becomes pregnant while taking it, the patient should be apprised of the potential hazard to the fetus. Women of child-bearing potential should be advised to avoid becoming pregnant.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


Panretin® gel is indicated for topical treatment of cutaneous lesions in patients with AIDS-related Kaposi's sarcoma. Panretin® gel is not indicated when systemic anti-KS therapy is required (e.g., more than 10 new KS lesions in the prior month, symptomatic lymphedema, symptomatic pulmonary KS, or symptomatic visceral involvement). There is no experience to date using Panretin® gel with systemic anti-KS treatment.


There is currently no drug history available for this drug.

Other Information

Panretin® gel 0.1% contains alitretinoin and is intended for topical application only. The chemical name is 9-cis-retinoic acid and the structural formula is as follows:


Chemically, alitretinoin is related to vitamin A. It is a yellow powder with a molecular weight of 300.44 and a molecular formula of C20H28O2. It is slightly soluble in ethanol (7.01 mg/g at 25°C) and insoluble in water. Panretin® gel is a clear, yellow gel containing 0.1% (w/w) alitretinoin in a base of dehydrated alcohol USP, polyethylene glycol 400 NF, hydroxypropyl cellulose NF, and butylated hydroxytoluene NF.

Panretin Manufacturers

  • Eisai Inc.
    Panretin (Alitretinoin) Gel [Eisai Inc.]

Login To Your Free Account