Home FDA labels 5be0bfc5-80d8-4f8a-afe3-eafa62312d38 FDA label 5be0bfc5-80d8-4f8a-afe3-eafa62312d38 openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)
SPL set ID 3c88f4f7-564d-423d-a94d-92d02b8f0925
SPL ID 5be0bfc5-80d8-4f8a-afe3-eafa62312d38
Version 1
Effective date 2010-06-01
Source export date 2026-10-12
Source partition 4
Source file https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
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adverse reactions ADVERSE REACTIONS: In controlled clinical trials, local cutaneous irritation was monitored in 285 acne patients who used adapalene cream once daily for 12 weeks. The frequency and severity of erythema, scaling, dryness, pruritus and burning were assessed during these studies. The incidence of local cutaneous irritation with adapalene cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritations with Adapalene Cream from Controlled Clinical Studies (N=285) None Mild Moderate Severe Erythema 52% (148) 38% (108) 10% (28) <1% (1) Scaling 58% (166) 35% (100) 6% (18) <1% (1) Dryness 48% (136) 42% (121) 9% (26) <1% (2) Pruritis (persistent) 74% (211) 21% (61) 4% (12) <1% (1) Burning/Stinging (persistent) 71% (202) 24% (69) 4% (12) <1% (2) Other reported local cutaneous adverse events in patients who used adapalene cream once daily included: sunburn (2%), skin discomfort-burning and stinging (1%) and skin irritation (1%). Events occurring in less than 1% of patients treated with adapalene cream included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
adverse reactions table <table ID="t301" width="100%"> <caption>Incidence of Local Cutaneous Irritations with Adapalene Cream from Controlled Clinical Studies (N=285) </caption> <col width="33.080%" align="left"/> <col width="16.920%" align="left"/> <col width="16.920%" align="left"/> <col width="16.920%" align="left"/> <col width="16.160%" align="left"/> <tbody> <tr> <td align="left" valign="top" styleCode="Toprule Botrule Lrule Rrule"/> <td align="center" valign="top" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">None</content> </td> <td align="center" valign="top" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">Mild</content> </td> <td align="center" valign="top" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">Moderate</content> </td> <td align="center" valign="top" styleCode="Toprule Botrule Rrule"> <content styleCode="bold">Severe</content> </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Erythema </td> <td align="center" valign="top" styleCode="Botrule Rrule">52% (148) </td> <td align="center" valign="top" styleCode="Botrule Rrule">38% (108) </td> <td align="center" valign="top" styleCode="Botrule Rrule">10% (28) </td> <td align="center" valign="top" styleCode="Botrule Rrule"><1% (1) </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Scaling </td> <td align="center" valign="top" styleCode="Botrule Rrule">58% (166) </td> <td align="center" valign="top" styleCode="Botrule Rrule">35% (100) </td> <td align="center" valign="top" styleCode="Botrule Rrule">6% (18) </td> <td align="center" valign="top" styleCode="Botrule Rrule"><1% (1) </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Dryness </td> <td align="center" valign="top" styleCode="Botrule Rrule">48% (136) </td> <td align="center" valign="top" styleCode="Botrule Rrule">42% (121) </td> <td align="center" valign="top" styleCode="Botrule Rrule">9% (26) </td> <td align="center" valign="top" styleCode="Botrule Rrule"><1% (2) </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Pruritis (persistent) </td> <td align="center" valign="top" styleCode="Botrule Rrule">74% (211) </td> <td align="center" valign="top" styleCode="Botrule Rrule">21% (61) </td> <td align="center" valign="top" styleCode="Botrule Rrule">4% (12) </td> <td align="center" valign="top" styleCode="Botrule Rrule"><1% (1) </td> </tr> <tr> <td align="left" valign="top" styleCode="Botrule Lrule Rrule">Burning/Stinging (persistent) </td> <td align="center" valign="top" styleCode="Botrule Rrule">71% (202) </td> <td align="center" valign="top" styleCode="Botrule Rrule">24% (69) </td> <td align="center" valign="top" styleCode="Botrule Rrule">4% (12) </td> <td align="center" valign="top" styleCode="Botrule Rrule"><1% (2) </td> </tr> </tbody> </table>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.