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Side Effects > Differin

Differin Side Effects

Please note - some side effects for Differin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Differin - for the Consumer

Differin Cream

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Differin Cream:

Temporary burning and stinging; dry skin; feeling of warmth; irritation; itching; peeling; redness; scaling.

Seek medical attention right away if any of these SEVERE side effects occur when using Differin Cream:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; crusting; excessive redness or peeling; swelling.

Differin Pads

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Differin Pads:

Acne; dry skin; feeling of warmth; irritation; itching; peeling; redness; scaling; sunburn; temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using Differin Pads:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; crusting; excessive redness or peeling; swelling.

Differin Solution

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Differin Solution:

Acne; dry skin; feeling of warmth; irritation; itching; peeling; redness; scaling; sunburn; temporary burning or stinging.

Seek medical attention right away if any of these SEVERE side effects occur when using Differin Solution:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blistering; crusting; excessive redness or peeling; swelling.

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Differin Side Effects - for the Professional

Differin

In the multi-center, controlled clinical trial, signs and symptoms of local cutaneous irritation were monitored in 258 acne patients who used Differin® Gel, 0.3% once daily for 12 weeks. Of the patients who experienced cutaneous irritation (erythema, scaling, dryness, and/or burning/stinging), the majority of cases were mild to moderate in severity, occurred early in treatment and decreased thereafter. The incidence of local cutaneous irritation with Differin® Gel, 0.3% from the controlled clinical study is provided in the following table:

Table 2: Physician assessed local cutaneous irritation with Differin® Gel
Incidence of Local Cutaneous Irritation with Differin® Gel, 0.3% from Controlled Clinical Study
(N = 253*)
Maximum Severity Scores Higher Than Baseline
Mild Moderate Severe
*  Total number of subjects with local cutaneous data for at least one post-Baseline evaluation.
Erythema 66 (26.1%) 33 (13.0%) 1 (0.4%)
Scaling 110 (43.5%) 47 (18.6%) 3 (1.2%)
Dryness 113 (44.7%) 43 (17.0%) 2 (0.8%)
Burning/Stinging 72 (28.5%) 36 (14.2%) 9 (3.6%)
Table 3: Patient reported local cutaneous adverse events with Differin® Gel
Differin® (adapalene) Gel, 0.3% Vehicle Gel
N=258 N=134
*  Selected adverse events defined by investigator as Possibly, Probably or Definitely Related
Related* Adverse Events 57 (22.1%) 6 (4.5%)
        Dry Skin 36 (14%) 2 (1.5%)
        Skin Discomfort 15 (5.8%) 0 (0.0%)
        Desquamation 4 (1.6%) 0 (0.0%)

Related adverse events from the controlled clinical trial that occurred in greater than 1% of patients who used Differin® Gel, 0.3% once daily included: dry skin (14.0%), skin discomfort (5.8%), pruritus (1.9%), desquamation (1.6%), and sunburn (1.2%). The following selected adverse events occurred in less than 1% of patients: acne flare, contact dermatitis, eyelid edema, conjunctivitis, erythema, pruritus, skin discoloration, rash, and eczema.

In a one-year, open-label safety study of 551 patients with acne who received Differin® Gel, 0.3%, the pattern of adverse events was similar to the 12-week controlled study.

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Side Effects by Body System

Local

Local side effects have included erythema, scaling, dryness, burning, and pruritus in 30 to 60% of patients. Persistent pruritus and stinging have been reported in up to 24% of patients. Skin irritation, acne flares, sunburn, and skin discoloration have been reported rarely (less than 1%).

Erythema, scaling, dryness, burning, and pruritus usually occur during the first 2 to 4 weeks of therapy and lessen with continued use. Burning and itching immediately after application occurs in approximately 20% to 30% of patients.

All local side effects occurring with adapalene topical appear to be reversible upon discontinuation of therapy.

Dermatologic

Dermatologic side effects have rarely included dermatitis, contact dermatitis, rash and eczema.

Ocular

Ocular side effects have rarely included eyelid edema and conjunctivitis.

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