Home FDA labels 5be0bfc5-80d8-4f8a-afe3-eafa62312d38 FDA label 5be0bfc5-80d8-4f8a-afe3-eafa62312d38 openFDA label record# Cross-check layer: This is openFDA JSON-derived label data. Use the corresponding DailyMed SPL as the canonical 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 2026-08-01
Source partition 3
Source file https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256 bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run 20260801T225920Z
Imported at 2026-08-01 23:05:43 Harmonized identifier links# Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
Harmonized identifiers page 1 of 1 · 2 matching rows.
Adverse reactions cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions sections page 1 of 1 · 2 matching rows.
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>