FDA label d972a09a-e421-403c-b9bf-9cbd738fa99c

openFDA label record#

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SPL set ID
fb57f9d4-54d6-412c-aeb4-00a8bd46f958
SPL ID
d972a09a-e421-403c-b9bf-9cbd738fa99c
Version
1
Effective date
2011-01-21
Source export date
2026-08-01
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:36:55

Adverse reactions cross-check#

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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 width="90%" ID="i9c7f909d-908e-4438-81cf-4db4ee5c06ff"> <caption>Incidence of Local Cutaneous Irritation with DIFFERIN<sup>&#xAE;</sup> Cream from Controlled Clinical Studies (N=285)</caption> <thead> <tr> <td> </td> <td> <content styleCode="bold">None</content> </td> <td> <content styleCode="bold">Mild</content> </td> <td> <content styleCode="bold">Moderate</content> </td> <td> <content styleCode="bold">Severe</content> </td> </tr> </thead> <tbody> <tr> <td> <paragraph>Erythema</paragraph> </td> <td>52% (148)</td> <td>38% (108) </td> <td>10% (28)</td> <td>&lt;1% (1)</td> </tr> <tr> <td> <paragraph>Scaling</paragraph> </td> <td>58% (166)</td> <td>35% (100)</td> <td>6% (18)</td> <td>&lt;1% (1)</td> </tr> <tr> <td>Dryness</td> <td>48% (136)</td> <td>42% (121)</td> <td>9% (26)</td> <td>&lt;1% (2)</td> </tr> <tr> <td>Pruritus (persistent)</td> <td>74% (211)</td> <td>21% (61)</td> <td>4% (12)</td> <td>&lt;1% (1)</td> </tr> <tr> <td>Burning/Stinging (persistent)</td> <td>71% (202)</td> <td>24% (69)</td> <td>4% (12)</td> <td>&lt;1% (2)</td> </tr> </tbody> </table>