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Retin-A Micro (Tretinoin Topical) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

Irritation Potential

Acne clinical trial results

In separate clinical trials for each concentration, acne patients treated with Retin-A Micro® (tretinoin gel) microsphere, 0.1% or 0.04%, analysis over the twelve week period showed that cutaneous irritation scores for erythema, peeling, dryness, burning/stinging, or itching peaked during the initial two weeks of therapy, decreasing thereafter.

Approximately half of the patients treated with Retin-A Micro® (tretinoin gel) microsphere, 0.04% had cutaneous irritation at Week 2. Of those patients who did experience cutaneous side effects, most had signs or symptoms that were mild in severity (severity was ranked on a 4-point ordinal scale: 0=none, 1=mild, 2=moderate, and 3=severe). Less than 10% of patients experienced moderate cutaneous irritation and there was no severe irritation at Week 2.

In studies on Retin-A Micro® (tretinoin gel) microsphere, 0.04%, throughout the treatment period the majority of patients experienced some degree of irritation (mild, moderate, or severe) with 1% (2/225) of patients having scores indicative of a severe irritation rating; and 1.3% (3/225) of patients treated with Retin-A Micro® (tretinoin gel) microsphere, 0.04%, discontinued treatment due to irritation, which included dryness in one patient and peeling and urticaria in another.

In studies on Retin-A Micro® (tretinoin gel) microsphere, 0.1%, no more than 3% of patients had cutaneous irritation scores indicative of severe irritation rating; although, 6% (14/224) of patients treated with Retin-A Micro® (tretinoin gel) microsphere, 0.1% discontinued treatment due to irritation. Of these 14 patients, four have severe irritation after 3 to 5 days of treatment, with blistering in one patient.

Results in studies of subjects without acne

In a half-face comparison trial conducted for up to 14 days in women with sensitive skin, but without acne, Retin-A Micro® (tretinoin gel) microsphere, 0.1% was statistically less irritating than tretinoin cream, 0.1%. In addition, a cumulative 21 day irritation evaluation in subjects with normal skin showed that Retin-A Micro® (tretinoin gel) microsphere, 0.1%, had a lower irritation profile than tretinoin cream, 0.1%. The clinical significance of these irritation studies for patients with acne is not established. Comparable effectiveness of Retin-A Micro® (tretinoin gel) microsphere, 0.1% and tretinoin cream, 0.1%, has not been established. The lower irritancy of Retin-A Micro® (tretinoin gel) microsphere, 0.1% in subjects without acne may be attributable to the properties of its vehicle. The contribution of decreased irritancy by the MICROSPONGE System has not been established. No irritation studies have been performed to compare Retin-A Micro® (tretinoin gel) microsphere, 0.04%, with either Retin-A Micro® (tretinoin gel) microsphere, 0.1%, or tretinoin cream, 0.1%.

The skin of certain sensitive individuals may become excessively red, edematous, blistered, or crusted. If these effects occur, the medication should either be discontinued until the integrity of the skin is restored, or the medication should be adjusted to a level the patient can tolerate. However, efficacy has not been established for lower dosing frequencies (see DOSAGE AND ADMINISTRATION Section).

True contact allergy to topical tretinoin is rarely encountered. Temporary hyper-or hypopigmentation has been reported with repeated application of tretinoin. Some individuals have been reported to have heightened susceptibility to sunlight while under treatment with tretinoin.



REPORTS OF SUSPECTED RETIN-A MICRO SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Retin-A Micro. The information is not vetted and should not be considered as verified clinical evidence.

Possible Retin-A Micro side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-11-03

Patient: 45 year old female weighing 56.7 kg (124.7 pounds)

Reactions: Protein Urine Present, Dizziness, Headache, Albumin Urine Present

Suspect drug(s):
Retin-A Micro

Other drugs received by patient: Aspirin; Bioessence Dietary Supplement; Atenolol



Possible Retin-A Micro side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-11-04

Patient: 45 year old female weighing 56.7 kg (124.7 pounds)

Reactions: Protein Urine Present, Dizziness, Headache, Albumin Urine Present

Suspect drug(s):
Retin-A Micro
    Dosage: ndc# 011448848a
    Administration route: Topical
    Indication: Acne
    Start date: 2011-09-06
    End date: 2011-10-08

Tretinoin
    Dosage: ndc# 011448848a
    Administration route: Topical
    Indication: Acne
    Start date: 2010-01-01
    End date: 2011-08-01

Other drugs received by patient: Aspirin; Atenolol; Bioessence Dietary Supplement



Possible Retin-A Micro side effects / adverse reactions in 45 year old female

Reported by a consumer/non-health professional from United States on 2011-11-10

Patient: 45 year old female weighing 56.7 kg (124.7 pounds)

Reactions: Protein Urine Present, Albumin Urine Present

Suspect drug(s):
Retin-A Micro

Other drugs received by patient: Aspirin; Atenolol; Bioessence Dietary Supplement



See index of all Retin-A Micro side effect reports >>

Drug label data at the top of this Page last updated: 2013-05-29

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