Tretinoin Side Effects: Severity Distribution by Patient Phenotype

Does severity vary by skin type, age or comorbidity?

The Renova figures describe patients overall, not irritation severity by skin type, age or other health conditions [2].

Skin condition is what the label treats as a modifier. Renova's warnings say tretinoin has been reported to cause severe irritation on eczematous skin and should be used only with caution there [2], and the dosage section says not to use the cream if the patient is sunburned or has eczema or other chronic skin conditions of the face, or is inherently sensitive to sunlight [2].

What the label reports about severity

Across the double-blind, vehicle-controlled studies of 339 patients applying Renova 0.02% cream to the face, almost all reported one or more local reactions: peeling, dry skin, burning, stinging, erythema and pruritus. In 32% of all study patients, skin irritation was severe, led to temporary discontinuation, or led to use of a mild topical corticosteroid. About 7% of Renova users versus less than 1% of controls needed a short-term mild topical corticosteroid for irritation, and about 4% discontinued because of adverse reactions [2].

Darker skin: pigmentation rather than irritation severity

A review of post-inflammatory hyperpigmentation in skin of color describes it as a common sequel of inflammatory dermatoses that tends to affect darker-skinned patients with greater frequency and severity [1]. In spontaneous postmarketing reporting for Renova 0.05%, about 2% of reports were for skin hypo- or hyperpigmentation [2].

What else the label flags

The Renova label says the cream should not be administered if the patient is also taking drugs known to be photosensitizers (thiazides, tetracyclines, fluoroquinolones, phenothiazines, sulfonamides) because of possible augmented phototoxicity [2]. It says medicated or abrasive soaps, strong drying cosmetics, high-alcohol products, astringents, permanent wave solutions and waxes may increase irritation [2]. FDA states that adverse-event report counts cannot estimate how often a reaction occurs or show that a drug caused it [3].

Topical tretinoin is a prescription product [2]. HealthRX.com offers tretinoin by prescription.