Tretinoin

RETIN-A

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Pronunciation: TRET-i-noe-in (RE-tin)

Tretinoin ballicule: receptor binding, kinetics and half-life diagram — Mechanism of action: Tretinoin ballicule

What it isRAR agonist retinoid; topical treatment of acne and systemic differentiation therapy for acute promyelocytic leukemia.

Why it mattersThe same molecule is routine acne therapy on skin and lifesaving maturation therapy for malignant promyelocytes.

What it changesTopical use irritates and photosensitizes; systemic use is teratogenic and can cause differentiation syndrome.

Tretinoin molecular structure (skeletal formula) — Molecular structure: Tretinoin

FDA-approved for

acute promyelocytic leukemia (1995)
acne (topical) (1971)

FDA label

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FDA dosing	Population	Start	Target	Max
Acne vulgaris	Patients with acne (age not specified)	Thin layer to affected area QHS (cream 0.025–0.1% or gel 0.01–0.025%)	QHS; once controlled, less frequent application may maintain improvement	QD

Renal Undefined

Hepatic Undefined

Results noticed after 2 to 3 weeks; more than 6 weeks may be needed for definite benefit.

Instructions

Apply once daily before retiring, enough to lightly cover the entire affected area
Cleanse area thoroughly before application; cosmetics may be used
Gel 'pills' with excessive application; transient warmth or slight stinging may occur
Early apparent flare of inflammatory lesions is expected — not a reason to stop
If irritation: reduce frequency or interrupt, then resume/increase as tolerated

Available strengths

cream 0.02, 0.025, 0.05, 0.1 %
gel 0.01, 0.025, 0.04, 0.05, 0.06, 0.08, 0.1 %
cap 10 mg
lotion 0.05 %

Adverse reactions

Excessive redness, edema, blistering, or crusting (sensitive skin)
Transient warmth/stinging on application
Temporary hyper- or hypopigmentation
Heightened sun sensitivity
True contact allergy (rare)

Pregnancy Oral tretinoin teratogenic in animals, topical results equivocal; holoprosencephaly case reports (no causal link) — use only if benefit justifies fetal risk.

Lactation Unknown whether excreted in human milk; use with caution when nursing.

Cost

Tretinoin (RETIN-A)

Strength		#/mo	CostPlus
0.02 %	cream	per unit	not offered
0.025 %	cream	per unit	not offered
0.05 %	cream	per unit	not offered
0.1 %	cream	per unit	not offered
0.01 %	gel	per unit	not offered
0.025 %	gel	per unit	not offered
0.04 %	gel	per unit	not offered
0.05 %	gel	per unit	not offered
0.06 %	gel	per unit	not offered
0.08 %	gel	per unit	not offered
0.1 %	gel	per unit	not offered

NADAC is a voluntary CMS survey of what retail community pharmacies pay for the drugs they stock. Tretinoin is dispensed outside retail pharmacies, so it rarely appears on surveyed invoices.

Generic entry1998

NO BOXED WARNINGS

Principal riskIrritation and photosensitivity

Classes and tags

Clinical profile

Therapeutic safety burden1 / 4

Overdose danger0 / 4

Weight-gain liability0 / 4

Sedation liability0 / 4

QT / Torsades0 / 4

Direct muscarinic antagonism0 / 4

Embryofetal risk0 / 4

Legacy pregnancy categoryNot assigned — PLLR-era drug

Defining liabilityLocal irritation or hypersensitivity; systemic toxicity is minimal with correct local use.

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