Home FDA labels 0a564c3c-85dd-4fb8-8bb8-27a9e24c5723 Adapalene openFDA label record# This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
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Brand name Adapalene
Generic name ADAPALENE
Manufacturer Padagis Israel Pharmaceuticals Ltd
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 94cf9af1-afab-4064-a2ca-619b54218262
SPL ID 0a564c3c-85dd-4fb8-8bb8-27a9e24c5723
Version 4
Effective date 2023-07-25
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
Imported at 2026-10-13 01:37:15 Harmonized routes table Harmonized routes TOPICAL
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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, 0.1% 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, 0.1% from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with Adapalene Cream, 0.1% 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) Pruritus (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, 0.1% 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, 0.1% included: acne flare, dermatitis and contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.
adverse reactions table <table border="1" cellpadding="4" cellspacing="0"><caption>Incidence of Local Cutaneous Irritation with Adapalene Cream, 0.1% from Controlled Clinical Studies (N=285)</caption><colgroup><col/><col/><col/><col/><col/></colgroup><tbody><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule"/><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">None</content></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Mild</content></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Moderate</content></td><td align="center" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Severe</content></td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule">Erythema</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">52% (148)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">38% (108)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">10% (28)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">‹1% (1)</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule">Scaling</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">58% (166)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">35% (100)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">6% (18)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">‹1% (1)</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule">Dryness</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">48% (136)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">42% (121)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">9% (26)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">‹1% (2)</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule">Pruritus (persistent)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">74% (211)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">21% (61)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">4% (12)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">‹1% (1)</td></tr><tr><td align="left" styleCode="Botrule Lrule Rrule Toprule">Burning/Stinging (persistent)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">71% (202)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">24% (69)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">4% (12)</td><td align="center" styleCode="Botrule Lrule Rrule Toprule">‹1% (2)</td></tr></tbody></table>
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