Two medicines, side by side
Isotretinoin vs tretinoin
Isotretinoin and tretinoin are both labeled for acne. Drugs@FDA records approvals of isotretinoin since 1982 and of tretinoin since 1971. Pharmacies paid $11.94 per isotretinoin 10 mg capsule and $0.506 per gram (Tretinoin 0.025% cream) (NADAC, October 7, 2026); the strengths differ, so the two prices are not like for like. Only the isotretinoin label carries a boxed warning.
Check it at the source: the isotretinoin FDA label on DailyMed (effective August 19, 2026); the tretinoin FDA label on DailyMed (effective May 17, 2024).
Highlights of the isotretinoin record
Isotretinoin (Accutane) · label of August 19, 2026
EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY ABSORICA/ABSORICA LD can cause life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking any amount of ABSORICA/ABSORICA LD even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining prenatally whether an exposed fetus has been affected.
Used for
From the label: indicationsABSORICA and ABSORICA LD are indicated for the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater. […]
On the market
- Earliest approval on file
- May 7, 1982
- Generic labelers
- 13 labelers
- Pharmacy cost
- $11.94 per capsule
Supply and safety
- Shortage
- No current entry
- Recalls
- 16
Highlights of the tretinoin record
Tretinoin (Retin-A) · label of May 17, 2024
Used for
From the label: indicationsRETIN-A is indicated for topical application in the treatment of acne vulgaris. The safety and efficacy of the long-term use of this product in the treatment of other disorders have not been established.
On the market
- Earliest approval on file
- October 20, 1971
- Generic labelers
- 23 labelers
- Pharmacy cost
- $0.506 per gram
Supply and safety
- Shortage
- No current entry
- Recalls
- 2
Source: FDA drug labels via openFDA (Isotretinoin label of August 19, 2026, Tretinoin label of May 17, 2024); NDC Directory, Drugs@FDA, NADAC, FDA shortages and recalls (October 8, 2026)
How do isotretinoin and tretinoin differ on the record?
Only the isotretinoin label carries a boxed warning.
Both are in FDA's class retinoids.
Generics: isotretinoin since 2002; tretinoin since 1998 (Drugs@FDA).
| Isotretinoin | Tretinoin | |
|---|---|---|
| Labeled for | Acne | Acne |
| Pharmacologic class | Retinoid | Retinoid |
| How it works (label) | The exact mechanism of action of ABSORICA/ABSORICA LD in the treatment of severe recalcitrant nodular acne in non-pregnant patients 12 years of age and older with multiple inflammatory nodules with a diameter of 5 mm or greater who are … | n/a |
| Half-life (label) | n/a | n/a |
| Earliest approval on file (Drugs@FDA) | May 7, 1982 | October 20, 1971 |
| First generic approved | November 8, 2002 | June 19, 1998 |
| Generic labelers (NDC) | 13 labelers | 23 labelers |
| Pharmacy cost (NADAC, each one's most listed form; strengths differ) | $11.94 per capsule (Isotretinoin 10 mg capsule) | $0.506 per gram (Tretinoin 0.025% cream) |
| 12-month price change | +6% | -49% |
| Boxed warning | Yes | No |
| Shortage now | No current entry | No current entry |
| Recalls recorded | 16 | 2 |
| FAERS reports (a report is not proof of cause; counts follow how widely a medicine is used) | 49,172 | 8,069 |
| DEA schedule | none | none |
Source: Drugs@FDA, FDA NDC Directory, CMS NADAC of October 7, 2026, FDA shortages and recalls, FAERS via openFDA (FDA files October 8, 2026)
What next?
- Alternatives to isotretinoin
- every medicine labeled for the same conditions