Home FDA labels 3704e230-6ad8-448d-a4bf-a86c449837b9 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 E. Fougera & Co. a division of Fougera Pharmaceuticals, LLC
Product type HUMAN PRESCRIPTION DRUG
SPL set ID 276f7cce-5f54-40f8-8321-9192d0e52a73
SPL ID 3704e230-6ad8-448d-a4bf-a86c449837b9
Version 10
Effective date 2026-01-30
Source export date 2026-09-28
Source partition 11
Source file https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-09-28/aa96b5a2be6b394393acd0090f6948bdf99e0e8e00666f81608929c8fa83db77/drug-label-0011-of-0014.json.zip
Source manifest SHA-256 cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run 20260929T050834Z
Imported at 2026-09-29 06:17:23 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 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 Irritation 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) 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 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 width="100%"><col width="33%"/><col width="17%"/><col width="17%"/><col width="17%"/><col width="16%"/><tbody><tr><td colspan="5" styleCode="Rrule Botrule Lrule Toprule " valign="top"><list listType="ordered"><item><caption> </caption><content styleCode="bold"> Incidence of Local Cutaneous Irritation with Adapalene Cream </content> <content styleCode="bold">from Controlled Clinical Studies (N=285)</content></item></list></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"/><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">None</content></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Mild</content></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Moderate</content></paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><content styleCode="bold">Severe</content></paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Erythema </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>52% (148) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>38% (108) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>10% (28) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><1% (1) </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Scaling </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>58% (166) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>35% (100) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>6% (18) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><1% (1) </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Dryness </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>48% (136) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>42% (121) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>9% (26) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><1% (2) </paragraph></td></tr><tr><td styleCode="Rrule Lrule Botrule " valign="top"><paragraph>Pruritus (persistent) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>74% (211) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>21% (61) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4% (12) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><1% (1) </paragraph></td></tr><tr><td styleCode="Rrule Botrule Lrule " valign="top"><paragraph>Burning/Stinging (persistent) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>71% (202) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>24% (69) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph>4% (12) </paragraph></td><td align="center" styleCode="Rrule Botrule " valign="top"><paragraph><1% (2) </paragraph></td></tr></tbody></table>
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