Home FDA labels 16ad92c8-1cf8-441b-adbc-9abf2e91aa41 FDA label 16ad92c8-1cf8-441b-adbc-9abf2e91aa41 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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SPL set ID ab4b2120-57fc-6c61-b239-37c21789c065
SPL ID 16ad92c8-1cf8-441b-adbc-9abf2e91aa41
Version 9
Effective date 2026-06-11
Source export date 2026-10-12
Source partition 7
Source file https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-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 DIFFERIN ® 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 DIFFERIN ® Cream from the controlled clinical studies is provided in the following table: Incidence of Local Cutaneous Irritation with DIFFERIN® 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 DIFFERIN ® 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 DIFFERIN ® Cream 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"><colgroup><col/><col/><col/><col/><col/></colgroup><tbody><tr><td align="center" colspan="5" styleCode="Botrule Lrule Rrule Toprule"><content styleCode="bold">Incidence of Local Cutaneous Irritation with DIFFERIN® Cream from Controlled Clinical Studies (N=285)</content></td></tr><tr><td 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 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 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 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 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 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>
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.