Side Effects > Renova

Renova Side Effects

Please note - some side effects for Renova 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 Renova - for the Consumer

Renova Emollient 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 Renova Emollient Cream:

Burning; dry skin; itching; peeling; redness; stinging or warmth at application site; unusual sensitivity to wind and cold.

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

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

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Renova Side Effects - for the Professional

Renova Cream

In double-blind, vehicle-controlled studies involving 339 patients who applied Renova 0.02% to their faces, adverse reactions associated with the use of Renova were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 32% of all study patients, skin irritation was reported that was severe, led to temporary discontinuation of Renova 0.02%, or led to use of a mild topical corticosteroid. About 7% of patients using Renova 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of Renova because of adverse reactions.

Approximately 2% of spontaneous post-marketing adverse event reporting for Renova 0.05% were for skin hypo- or hyperpigmentation. Other spontaneously reported adverse events for Renova 0.05% predominantly appear to be local reactions similar to those seen in clinical trials.

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Side Effects by Body System

Dermatologic

A severe cutaneous reaction was reported in a patient who had an ice pack placed over an area treated with topical tretinoin. The area became pigmented and indurated, and the pigmentation persisted for an extensive length of time.

Dermatologic side effects are the most frequently reported side effects with the use of tretinoin topical. In double-blind, vehicle-controlled studies involving 339 patients who applied tretinoin topical 0.02% to their faces, adverse reactions associated with the use of tretinoin topical were limited primarily to the skin. Almost all patients reported one or more local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus. In 24% of all study patients, skin irritation was reported that was either severe (about 7%), led to temporary discontinuation of tretinoin topical 0.02% (about 20%), or led to use of a mild topical corticosteroid. About 5% of patients using tretinoin topical 0.02%, compared to less than 1% of the control patients, had sufficiently severe local irritation to warrant short-term use of mild topical corticosteroids to alleviate local irritation. About 4% of patients had to discontinue use of tretinoin topical because of adverse reactions. Tretinoin may induce photosensitivity in some individuals, as well as an increased susceptibility to irritation from wind, cold, and dryness.

Local

Local side effects including a retinoid dermatitis has been reported to occur frequently at the areas treated with topical tretinoin and is characterized by erythema, dryness, scaling, pruritus, and variable degrees of irritation.

Local reaction is commonly observed during the initial phase of therapy, but may not appear until as late as ten weeks into treatment. The dermatitis generally subsides with prolonged use of the medication, although in some cases may require a dosage adjustment or discontinuation of therapy. True contact dermatitis has been reported and confirmed with patch testing and leukocyte migration inhibition studies, but is uncommon. Rarely, there may be temporary hyper- or hypopigmentation following repeated applications.

Ocular

Ocular side effects including ectropions may develop infrequently and are reversible. A transient and harmless stinging of the eye may occur when tretinoin is applied onto the surrounding skin, generally lasting about 30 to 60 seconds.

Hepatic

Hepatic side effects including reversible, clinically insignificant changes in liver function tests have been reported following both oral and topical administration of tretinoin. These abnormalities include elevations in serum bilirubin, alkaline phosphatase, glutamic-oxaloacetic transaminase, and glutamic-pyruvic transaminase.

Nervous system

Nervous system side effects including a case of neurotoxicity in a patient with liver disease have been reported.

The patient developed neurological side effects following 4 weeks of tretinoin administration. Symptoms included headache, memory loss, truncal ataxia, and dysarthria, all of which improved upon temporary discontinuation of medication and recurred when the patient resumed usage. Upon withdrawal of medication a second time, the symptoms resolved within 4 weeks.

Genitourinary

Estrogen levels appeared not to have been affected.

Genitourinary side effects including an isolated case of vaginal bleeding related to tretinoin use has been reported in a post-menopausal woman and confirmed upon rechallenge.

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