Differin Lotion .1
- Generic Name: adapalene lotion .1%
- Brand Name: Differin Lotion .1
Differin Lotion .1(Adapalene Lotion .1%) side effects drug center
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Differin Lotion .1 Side Effects Center
Differin (adapalene) Lotion 0.1% is a topical (applied to the skin) medication similar to vitamin A used to treat severe acne in people who are at least 12 years old. Common side effects of Differin Lotion 0.1% include:
- skin burning
- warmth
- stinging
- tingling
- itching
- redness
- dryness
- scaling
- irritation, or
- worsening of acne, especially during the first 4 weeks of using this drug
Apply a thin film dose of Differin Lotion to the entire face and other affected areas of the skin once daily, after washing gently with a mild soapless cleanser. Dispense a nickel size amount of Differin Lotion (3-4 actuations of the pump) to cover the entire face. Avoid application to the areas of skin around eyes, lips and mucous membranes. Differin may interact with other drugs. Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant during treatment with Differin. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Differin (adapalene) Lotion 0.1% Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Differin Lotion .1 Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives, itching; chest pain, difficult breathing; swelling of your face, lips, tongue, or throat.
Stop using this medicine and call your doctor at once if you have:
- skin redness, stinging, burning, or peeling after sun exposure.
Some side effects may occur during the first 4 weeks of using this medicine. These side effects should become less noticeable with continued use.
Common side effects may include:
- dry, red, or scaly skin;
- feeling of warmth and mild stinging or burning;
- peeling skin; or
- skin pain.
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.
Read the entire detailed patient monograph for Differin Lotion .1 (Adapalene Lotion .1%)
Differin Lotion .1 Professional Information
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 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 subjects treated with DIFFERIN Lotion or with the Vehicle Lotion are presented in Table 1.
The majority of cases were transient, mild to moderate in severity and were managed with moisturizers.
Table 1: Adverse Reactions Reported in Clinical Trials
by At Least 1% of Subjects
| 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 Trials Adverse Reactions (DIFFERIN Lotion Group N = 1057*)
| Combined Trial 1 and Trial 2 | Maximum Severity During Treatment (N = 1057) |
Week 12 Treatment Severity (N =950) |
||||
| Local Cutaneous Irritation (skin irritation | Mild | Moderate | Severe | MM | 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.
In an open label postmarketing pharmacokinetic trial of 13 adolescent subjects, the adverse reaction of pruritus was reported in 8 out of 13 subjects.
Read the entire FDA prescribing information for Differin Lotion .1 (Adapalene Lotion .1%)
&Copy; Differin Lotion .1 Patient Information is supplied by Cerner Multum, Inc. and Differin Lotion .1 Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.