Differin Lotion .1
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"What is acne?
Acne (acne vulgaris, common acne) is a disease of the hair follicles of the face, chest, and back that affects almost all males and females during puberty; the only exception being teenage members of a few primitive i"...
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Differin Lotion .1
Differin Lotion .1 Side Effects Center
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Differin Lotion .1 in Detail - Patient Information: Side Effects
Stop using this medication and get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
During your first 4 weeks of using adapalene topical, your skin may be dry, red, or scaly. You may also feel some burning or stinging. Call your doctor if these side effects are severe.
Less serious side effects are more likely to occur, such as mild burning, warmth, stinging, tingling, itching, redness, or irritation.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Differin Lotion .1 (Adapalene Lotion .1%) »
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Differin Lotion .1 FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Studies Experience
Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
A total of 2141 subjects with acne vulgaris, 12 years and older, were treated once daily for 12 weeks. Of these, 1068 were exposed to DIFFERIN (adapalene lotion .1%) Lotion during the clinical trials. A total of 1057 subjects completed at least one post treatment evaluation.
Related adverse reactions that were reported in at least 1% of patients treated with DIFFERIN (adapalene lotion .1%) Lotion or with the Vehicle Lotion are presented in Table 1.
The majority of cases was transient, mild to moderate in severity and was managed with moisturizers.
Table 1 : Adverse Reactions Reported in Clinical Trials by
At Least 1% of Patients
| System Organ Class /Preferred Term | Adapalene Lotion 0.1% N = 1068 |
Vehicle Lotion N = 1073 |
| Subjects with Related AR(s) | 10.2% | 4.6% |
| Dry skin | 7.7% | 3.0% |
| Skin irritation | 1.5% | 0.7% |
| Skin burning/skin discomfort | 0.9% | 0.0% |
| Sunburn | 0.6% | 0.6% |
Local tolerability evaluations, presented in Table 2, were conducted at each study visit in clinical trials. Erythema, scaling, dryness, burning/stinging were assessed:
Table 2: Incidence of Local Cutaneous Irritation, for Subjects
Whose Irritation Score was Higher than at Baseline, in Controlled Clinical Studies
Adverse Reactions (Differin (adapalene lotion .1%) Lotion Group N=1057*)
| Combined Study 1 and Study 2 | Maximum Severity During Treatment (N= 1057) |
Week 12 Treatment Severity (N= 950) |
||||
| Local Cutaneous Irritation (skin irritation) | Mild | Moderate | Severe | Mild | Moderate | Severe |
| Erythema | 21.8% | 8.0% | 0.2% | 7.9% | 2.6% | 0.2% |
| Scaling | 25.3% | 6.5% | 0.1% | 5.3% | 1.1% | 0 |
| Dryness | 36.1% | 7.3% | 0.3% | 7.6% | 2.0% | 0 |
| Stinging/burning | 22.1% | 7.0% | 0.9% | 4.6% | 1.0% | 0.4% |
| *Data from 11 subjects with missing data are not included. | ||||||
Local tolerability scores for erythema, scaling, dryness, burning/stinging rose during the first two weeks of treatment and generally decreased thereafter.
Read the entire FDA prescribing information for Differin Lotion .1 (Adapalene Lotion .1%) »
Additional Differin Lotion .1 Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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