pharmacopeia
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/api/v1/drug/adapalene

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Transcription Factor Activity.

Indications

Sourced from openFDA
  • Use For the treatment of acneICD-10: L70.0

Dosage & administration

Sourced from openFDA

Directions Directions Adults and children 12 years of age and older: ▪ use once daily ▪ clean the skin gently and pat dry before applying the product ▪ cover the entire affected area with a thin layer. For example, if your acne is on the face, apply the product to the entire face. ▪ do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age: ask a doctor

Warnings & precautions

Sourced from openFDA

For external use only Do not use ▪on damaged skin (cuts, abrasions, eczema, sunburn) ▪ if you are allergic to adapalene or any of the ingredients in this product If pregnant or breast-feeding, ask a doctor before use. When using this product ▪ limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors. ▪ do not wax to remove hair in areas where the product has been applied ▪ during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that becomes severe ▪ irritation (redness, itching, dryness, burning) is more likely to occur: ▪ in the first few weeks of use ▪ if using more than one topical acne medication at a time ▪ but irritation usually lessens with continued use of this product ▪ it may take up to 3 months of once daily use to see results ▪ avoid product contact with the eyes, lips, and mouth. If contact occurs, immediately flush the area with water. ▪ wash hands after use Stop use and ask a doctor if ▪ you become pregnant, or are planning to become pregnant while using the product ▪ you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath) ▪ irritation becomes severe ▪ you see no improvement after 3 months of once daily use Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Approval history

Sourced from openFDA
  • May 31, 1996NDANDA020380Galderma Labs Lp
  • May 26, 2000NDANDA020748Galderma Labs Lp
  • Jun 19, 2007NDANDA021753Galderma Labs Lp
  • Dec 8, 2008NDANDA022320Galderma Labs Lp
  • Jun 2, 2010ANDAANDA090962P And L
  • Jul 15, 2015NDANDA207917Galderma Labs
  • Oct 20, 2023NDANDA216632Bausch
  • May 22, 2026NDANDA220736Galderma Laboratories, L.p

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
182,354 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective53,13829%
  2. 2Dry Skin45,63425%
  3. 3Skin Burning Sensation42,13323%
  4. 4Acne39,56922%
  5. 5Erythema38,87021%
  6. 6Skin Irritation26,58215%
  7. 7Skin Exfoliation21,53412%
  8. 8Inappropriate Schedule Of Product Administration16,2408.9%
  9. 9Rash15,7898.7%
  10. 10Overdose13,2197.2%
  11. 11Pain Of Skin12,4146.8%
  12. 12Pruritus12,0196.6%
  13. 13Hypersensitivity8,4534.6%
  14. 14Condition Aggravated5,2962.9%
  15. 15Underdose4,9682.7%

Literature

View JSON

Recent PubMed references pinned to Adapalene as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 115 ClinicalTrials.gov registrations naming Adapalene as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Adapalene work?
Mechanism-of-action class: Transcription Factor Activity.
What is Adapalene used for?
According to FDA labeling, Adapalene carries indications including: Use For the treatment of acne. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Adapalene?
Adapalene is classified as Retinoids for topical use in acne, Retinoid, Transcription Factor Activity, Cellular Division Phase Alteration, Cellular Growth Phase Arrest, Decreased Epithelial Proliferation, Decreased Immunologically Active Molecule Activity, Decreased Sebaceous Gland Activity, Keratin Alteration.
What are the brand names for Adapalene?
Adapalene is marketed under brand names including Cabtreo, Differin, Epiduo.
Note. Data for adapalene is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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