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Atralin, Avita, Renova, Retin-A, Retin-A Micro, Vesanoid

Pharmacologic class: Retinoid

Therapeutic class: Antineoplastic, dermatologic agent (topical)

Pregnancy risk category C (topical), D (oral)

FDA Box Warning

• Patients with acute promyelocytic leukemia (APL) are at high risk in general and may have severe adverse reactions. Give drug under supervision of physician experienced in managing patients with acute leukemia, in facility with laboratory and supportive resources sufficient to monitor drug tolerance and protect and maintain patient compromised by drug toxicity.

• Before using drug, physician must conclude that possible benefit to patient outweighs the following known adverse effects:

• Retinoic acid-APL (RA-APL syndrome), which may be accompanied by impaired myocardial contractility, hypotension, and progressive hypoxemia. Several patients have died with multiorgan failure. Syndrome generally occurs during first month of therapy (in some cases, after first dose).

• Leukocytosis at presentation or evolving rapidly during drug therapy. Patients with high white blood cell (WBC) at diagnosis (above 5 × 109/L) have increased risk of further rapid rise in WBC counts. Rapidly evolving leukocytosis raises risk of life-threatening complications.

• Teratogenic effects. Drug therapy during pregnancy carries high risk of severe birth defects. Nonetheless, if drug is best available treatment for pregnant woman or woman of childbearing potential, ensure that she has received full information and warnings of risk to fetus and of risk of possible contraception failure, and has been taught to use two reliable contraceptive methods simultaneously during therapy and for 1 month afterward.


Unknown. Thought to cause differentiation of promyelocytic leukemic blast cells, leading to apoptosis (cell shrinkage and death) and cancer remission.


Capsules: 10 mg

Topical cream: 0.02%, 0.025%, 0.05%, 0.1%

Topical gel: 0.01%, 0.025%, 0.04%, 0.1%

Indications and dosages

APL when anthracycline chemotherapy fails or is contraindicated

Adults and children ages 1 and older: 45 mg/m2/day P.O. in two evenly divided doses. Discontinue after 90 days of therapy or 30 days after complete remission occurs, whichever comes first.

Acne vulgaris

Adults: Apply Avita cream, Retin-A cream gel, or Retin-A Micro gel daily before bedtime or in evening. Cover entire affected area lightly.

Adjunct for mitigating fine wrinkles in patients who use comprehensive skin care and sun avoidance programs

Adults: Apply Renova 0.02% cream to face daily in evening for up to 52 weeks, using only enough to lightly cover entire affected area.

Adjunct for mitigating fine wrinkles, mottled hyperpigmentation, and tactile roughness of facial skin when comprehensive skin care and sun avoidance programs alone fail

Adults ages 50 and younger: Apply Renova 0.05% cream to face daily in evening for up to 48 weeks, using only enough to lightly cover entire affected area.


• Hypersensitivity to drug or parabens

• Pregnancy or breastfeeding (oral use)


Use cautiously in:

• eczema, sunburn, photosensitivity

• concurrent use of over-the-counter (OTC) acne products or abrasive soaps or cleansers with strong drying effects or high alcohol or lime content (with all topical forms)

• concurrent use of astringents, spices, permanent wave solutions, electrolysis, hair depilatories or waxes, or photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides)

• heavily pigmented, elderly, pregnant, or breastfeeding patients (safety and efficacy not established for topical use)

• children younger than age 1 for oral use or younger than age 18 for topical use (safety and efficacy not established).


• Verify that female patient has had required pregnancy test before P.O. therapy starts.

• Know that Renova topical cream isn't indicated for acne vulgaris, and that other topical forms are indicated only for acne vulgaris. Also know that some absorption of topical products occurs.

Adverse reactions

CNS: dizziness, headache, asthenia, paresthesia, confusion, agitation, hallucinations, anxiety, aphasia, depression, agnosia, insomnia, asterixis, cerebellar edema, hypotaxia, drowsiness, slow speech, facial paralysis, hemiplegia, hyporeflexia, hypotaxia, dementia, spinal cord disorder, tremors, dysarthria, cerebrovascular accident (CVA), coma, seizures, intracranial hypertension, cerebral hemorrhage

CV: heart murmur, chest discomfort, peripheral edema, hypertension, hypotension, phlebitis, edema, enlarged heart, ischemia, arrhythmias, secondary cardiomyopathy, myocarditis, myocardial infarction (MI), heart failure, pericardial effusion, impaired myocardial contractility, progressive hypoxemia

EENT: vision disturbances, visual acuity changes, visual field defect, absence of light reflex, hearing loss, earache, full sensation in ears

GI: nausea, vomiting, constipation, diarrhea, abdominal pain and distention, GI disorders, mucositis, dyspepsia, ulcer, anorexia, GI hemorrhage

GU: dysuria, urinary frequency, enlarged prostate, renal insufficiency, renal tubular necrosis, acute renal failure

Hematologic: leukocytosis, disseminated intravascular coagulation (DIC), hemorrhage

Hepatic: ascites, hepatosplenomegaly, hepatitis

Metabolic: fluid imbalance, acidosis

Musculoskeletal: bone pain or inflammation, myalgia, flank pain

Respiratory: respiratory tract disorders, dyspnea, expiratory wheezing, crackles, pneumonia, laryngeal edema, pulmonary infiltrates, pleural effusion, bronchial asthma, pulmonary hypertension

Skin: rash; pallor; flushing; diaphoresis; alopecia; dry skin and mucous membranes; skin changes; pruritus; cellulitis; burning, erythema, peeling, and stinging (with topical use)

Other: weight changes, fever, lymphatic disorder, hypothermia, infections, facial edema, pain, RA-APL syndrome, multisystem failure, septicemia


Drug-drug. Photosensitizing drugs (such as fluoroquinolones, phenothiazines, tetracyclines, thiazides): increased risk of photosensitivity reaction (with topical forms)

Drug-diagnostic tests. Cholesterol, triglycerides: increased levels

Drug-food. Any food: enhanced tretinoin absorption

Drug-behaviors. Sun exposure: increased risk of photosensitivity

Patient monitoring

Watch closely for septicemia, multisystem failure, and retinoic acid-APL syndrome (which causes pulmonary and pericardial effusion, fever, weight gain, and dyspnea).

Monitor for significant adverse CNS reactions, including seizures, CVA, and cerebral hemorrhage.

Monitor cardiovascular status. Stay alert for signs and symptoms of arrhythmias, MI, and heart failure.

Closely monitor liver and kidney function tests. Watch for evidence of hepatitis and renal failure.

Monitor coagulation studies. Watch closely for DIC and hemorrhage.

• Evaluate respiratory status. Stay alert for indications of pulmonary hypertension and respiratory insufficiency.

• Frequently assess lipid panel and CBC with white cell differential.

Patient teaching

• Instruct patient to take oral doses with food.

Teach patient to recognize and immediately report serious adverse reactions.

• Tell patient he will undergo regular blood testing during oral therapy.

• Instruct patient using topical form to gently wash face with mild soap, pat skin dry, and then wait 20 to 30 minutes before applying. Advise him to apply to face in evening, using only enough to cover entire affected area lightly and only for prescribed duration.

• Caution patient to avoid OTC acne drugs and extreme weather conditions (such as wind and cold). Urge him to adhere to prescribed skin care and sunlight avoidance programs when using topical form.

• Tell patient using topical form that transient burning, erythema, peeling, pruritus, and stinging may occur. Advise him to notify prescriber if these symptoms become severe.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and behaviors mentioned above.

triamcinolone acetonide

Adcortyl (UK), Kenalog, Kenalog-10, Kenalog-40, Nasacort AQ, Triaderm (CA)


A trademark for the drug tretinoin.


a trademark for an antiacne medication (tretinoin).


Tretinoin Dermatology A topical vitamin A formulation used to manage wrinkling, age spots, acne


A brand name for TRETINOIN.
References in periodicals archive ?
Gasiorowski has tried the relatively new Retin-A Micro: "I don't like this stuff.
Because Retin-A causes a gradual thinning of the top layer of the skin, it allows greater penetration of UV light, so everyone who is given Retin-A should wear a sunscreen at all times - and you have to keep on using it.
The sentencing was the culmination of a four-year Justice Department investigation into allegations of Ortho's involvement and cover-up of an illegal promotion of Retin-A as an anti-aging drug.
Subsequent research found that Retin-A can reduce fine wrinkles, restore collagen formation, and produce rosier skin - to some extent.
Retin-A has also been associated with skin irritation, redness, flaking and high incidences of allergic reactions.
Retin-A is the brand name for tretinoin, a derivative of vitamin A, and it's been around for 20 years for the treatment of acne.
A tour through the inner workings of the J&J empire suggests that, in the case of at least four drugs - Zomax, Suprol, Ortho-Novum birth-control pills, and Retin-A - J&J, under Burke's leadership, willfully disregarded public safety in order to push its products.
Retin-A has been extensively publicized for making the skin look younger.
M2 EQUITYBITES-January 26, 2016-Perrigo Closes Acquisition of Generic Retin-A Portfolio from Matawan
According to the company, the increase in 2016 EPS is due to the completion of the USD500m share buyback in the Q4 2015; the acquisition of Entocort (budesonide) capsules, with the authorized generic capsules expected to be more than accretive to 2016 adjusted EPS after the exclusion of estimates for intangible amortization, transaction costs and integration related expenses; and the acquisition of a portfolio of generic dosage forms and strengths of Retin-A (tretinoin).