tretinoin
Pharmaranks rates Tretinoin 3.4/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Tretinoin is a retinoid used to treat Acne Vulgaris, Facial Dermatoses, Acute Promyelocytic Leukemia, Hyperpigmentation.
Retinoid · by Aurobindo Pharma Ltd
Generic of Retin-A
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Tretinoin
- Drug class
- Retinoid
- Form
- Capsule, Topical
- Strength
- Tretinoin 0.025%
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- Manufacturer
- Aurobindo Pharma Ltd
- What the pharmacy pays
- ~$1.05 per gm — not your price
- FDA application
- ANDA218245
What is Tretinoin?
From the FDA label:Tretinoin gel, USP, containing tretinoin USP, is used for the topical treatment of acne vulgaris. Tretinoin gel, USP contains tretinoin USP (retinoic acid, vitamin A acid) 0.25 mg (0.025%) by weight, in a gel vehicle of alcohol (90.5% w/w), butylated hydroxytoluene and hydroxypropyl cellulose. Chemically, tretinoin is all - trans -retinoic acid and has the following structure: Chemical Structure
How to use
Tretinoin is sold in more than one form (Capsule and Topical), and each is dosed differently. The instructions below come from the FDA label for application ANDA218245 — follow the label that came with the product you were actually prescribed.
Tretinoin gel should be applied once a day, before retiring, to the skin where acne lesions appear, using enough to cover the entire affected area lightly. Excessive application results in “pilling” of the gel, which minimizes the likelihood of overapplication by the patient. Application may cause a transitory feeling of warmth or slight stinging. In cases where it has been necessary to temporarily discontinue therapy or to reduce the frequency of application, therapy may be resumed or frequency of application increased when the patients become able to tolerate the treatment. Alterations of vehicle, drug concentration, or dose frequency should be closely monitored by careful observation of the clinical therapeutic response and skin tolerance. During the early weeks of therapy, an apparent exacerbation of inflammatory lesions may occur. This is due to the action of the medication on deep, previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after 2 to 3 weeks but more than 6 weeks of therapy may be required before definite beneficial effects are seen. Once the acne lesions have responded satisfactorily, it may be possible to maintain the improvement with less frequent applications, or other dosage forms. Patients treated with tretinoin gel acne treatment may use cosmetics, but the area to be treated should…
Side effects
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. 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. To date, all adverse effects of tretinoin have been reversible upon discontinuance of therapy (see DOSAGE AND ADMINISTRATION ). To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Warnings
Important safety information
Keep out of reach of children. Keep tube tightly closed. Do not expose to heat or store at temperatures above 120°F (49° C).
Who should not take Tretinoin
Use of the product should be discontinued if hypersensitivity to any of the ingredients is noted.
Overdose — what happens if you take too much
If medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. Oral ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
Interactions
Concomitant topical medication, medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices or lime should be used with caution because of possible interaction with tretinoin. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid with tretinoin. It also is advisable to “rest” a patient’s skin until the effects of such preparations subside before use of tretinoin is begun.
Storing Tretinoin, and how long it keeps
Quoted from this product’s own FDA label. Storage belongs to the product and its device, not to the drug in general — a pen and a tablet of the same medicine are kept completely differently.
- “Conditions: Tretinoin Gel, USP: store below 30°C (86°F).”
Drug class
How this class works, per Tretinoin - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Tretinoin ranks — best-rated retinoid for:
Dosage forms
Capsule and Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Tretinoin treat?
- Tretinoin (Tretinoin) may be used to treat acne vulgaris, facial dermatoses, acute promyelocytic leukemia, hyperpigmentation, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Tretinoin work?
- Tretinoin is a retinoid. Retinoids are vitamin A derivatives that enter skin cells and switch on retinoic acid receptors in the nucleus, which changes how genes are read. This normalizes how skin cells grow and shed, unclogs pores, calms inflammation, and over time boosts collagen production.
- How is Tretinoin rated?
- pharmaranks gives Tretinoin a composite score of 3.4 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Tretinoin cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $1.05 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Tretinoin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Tretinoin. To pay less, Tretinoin is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Tretinoin?
- Tretinoin is marketed by Aurobindo Pharma Ltd. You can see Aurobindo Pharma Ltd's full profile, rating, and other products on pharmaranks.
- Is Tretinoin a brand-name or generic drug?
- Tretinoin is a generic medication; its active ingredient is Tretinoin. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Tretinoin available over the counter?
- No. Tretinoin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Tretinoin come in?
- Tretinoin is currently marketed as capsule and topical, per the FDA's National Drug Code Directory.
- What class of drug is Tretinoin?
- Tretinoin is classified as retinoid, per the FDA's Established Pharmacologic Class.
- Is Tretinoin FDA-registered?
- Tretinoin is on record with the U.S. FDA under application number ANDA218245. You can verify this on its official FDA label.
- Has Tretinoin been recalled by the FDA?
- Tretinoin has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Tretinoin safe?
- There's no single safe-or-not verdict. pharmaranks gives Tretinoin a recall-safety score of 68/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Tretinoin?
- Tretinoin's side effects are taken directly from its FDA label. From the label: 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.… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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tretinoin
68/100