Retinoid · Brand: Zenatane, Accutane + 5 more

Isotretinoin Side Effects: Common, Serious & FDA Warnings

Creator: MedivaScan
Published: 2026-05-28T04:28:23.034875+00:00

Verified from FDA on May 28, 2026Refreshes every 6 hoursFDA-Sourced

FDA-Approved For

Skin conditions

Quick answer

Based on 48,000+ FDA adverse event reports, the most-reported isotretinoin reactions include depression, inflammatory bowel disease, and colitis ulcerative. FDA reports 5 active Class II recalls of isotretinoin, primarily for failed dissolution specifications. The FDA-approved label carries a boxed warning.

For information only. MedivaScan summarizes public FDA data and is not medical advice. Consult a healthcare professional before changing any medication. If you experience a serious reaction, contact your doctor or call 911.

FDA Boxed Warning

CONTRAINDICATIONS AND WARNINGS Isotretinoin capsules must not be used by patients who are or may become pregnant. There is an extremely high risk that life-threatening birth defects will result if pregnancy occurs while taking isotretinoin capsules in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected. Birth defects which have been documented following isotretinoin capsules exposure include abnormalities of the face, eyes, ears, skull, central nervous system, cardiovascular system, and thymus and parathyroid glands. Cases of IQ scores less than 85 with or without other abnormalities have been reported. There is an increased risk of spontaneous abortion, and premature births have been reported. Documented external abnormalities include: skull abnormality; ear abnormalities (including anotia, micropinna, small or absent external auditory canals); eye abnormalities (including microphthalmia); facial dysmorphia; cleft palate. Documented internal abnormalities include: CNS abnormalities (including cerebral abnormalities, cerebellar malformation, hydrocephalus, microcephaly, cranial nerve deficit); cardiovascular abnormalities; thymus gland abnormality; parathyroid hormone deficiency. In some cases death has occurred with certain of the abnormalities previously noted. If pregnancy does occur during treatment of a patient who is taking isotretinoin capsules, isotretinoin capsules must be discontinued immediately and the patient should be referred to an Obstetrician-Gynecologist experienced in reproductive toxicity for further evaluation and counseling. Special Prescribing Requirements Because of isotretinoin teratogenicity and to minimize fetal exposure, isotretinoin capsules approved for marketing only under a special restricted distribution program approved by the Food and Drug Administration. This REMS is called iPLEDGE ® . Isotretinoin capsules must only be prescribed by prescribers who are enrolled and activated with the iPLEDGE REMS. Isotretinoin capsule s must only be dispensed by a pharmacy enrolled and activated with iPLEDGE, and must only be dispensed to patients who are enrolled and meet all the requirements of iPLEDGE (see PRECAUTIONS ).

Common Side Effects of Isotretinoin

The most-reported reactions in the FDA Adverse Event Reporting System (FAERS) for isotretinoin. Percentages reflect the share of reports mentioning each reaction; a single report may include multiple reactions. Reports indicate co-occurrence, not causation.

Reaction	Reports	% of total
Depression	5,738	11.9%
Inflammatory Bowel Disease	5,252	10.9%
Colitis Ulcerative	3,801	7.9%
Dry Skin	2,378	4.9%
Suicidal Ideation	2,132	4.4%
Pregnancy	2,078	4.3%
Irritable Bowel Syndrome	2,015	4.2%
Headache	1,962	4.1%
Arthralgia	1,942	4.0%
Unintended Pregnancy	1,906	4.0%

Source: FDA FAERS·Updated May 28, 2026·n=48,237+·verify on FDA →·Methodology

Serious Outcomes and FDA Warnings

FAERS reports flagged with a serious outcome (death, hospitalization, life-threatening, disability, or congenital anomaly), plus reactions surfaced in the FDA-approved label's Warnings section. Reports indicate co-occurrence, not causation.

Outcome flag	Reports	% of total
Serious reports (any flag)	—	—
Hospitalization	—	—

Isotretinoin Recalls

FDA enforcement actions matched to isotretinoin via openFDA's structured generic_name field and the NDC bridge. Ongoing recalls are listed below (verify on FDA →); closed recalls are grouped in the disclosure that follows.

Date	Reason	Class	Quantity	Status
2026-04-29	Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin Teva Pharmaceuticals USA, Inc	Class II	5,101 cartons	Ongoing
2026-04-15	Superpotent and Subpotent Teva Pharmaceuticals USA, Inc	Class II	21984 packages	Ongoing
2026-04-15	Superpotent and Subpotent Teva Pharmaceuticals USA, Inc	Class II	8376 packages	Ongoing
2026-03-11	Failed Dissolution Specifications MYLAN PHARMACEUTICALS INC	Class II	34850 blister packs	Ongoing
2024-04-17	Superpotent Drug: The 3-month stability result for assay was found to be above specification limit Teva Pharmaceuticals USA, Inc	Class II	5,304 3x10-cartons	Ongoing

Source: FDA Drug Enforcement Reports·Updated May 28, 2026·Refreshes every 6 hours·verify on FDA →

Show 11 closed recalls (2015 to 2019)

Includes resolved and terminated recalls matched to isotretinoin. Most recent first.

Date	Reason	Class	Quantity	Status
2019-11-20	Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. Amneal Pharmaceuticals, Inc.	Class III	2460 cartons/3 blister cards/10 capsules each	Terminated
2018-12-26	Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. Sun Pharmaceutical Industries, Inc.	Class III	47,520 prescription packs	Terminated
2017-06-14	Failed Dissolution Specifications: out of specification results observed for low dissolution. Dr. Reddy's Laboratories, Inc.	Class II	452,290 cartons	Terminated
2017-06-14	Failed Dissolution Specifications: out of specification results observed for low dissolution. Dr. Reddy's Laboratories, Inc.	Class II	89,118 cartons	Terminated
2017-06-14	Failed Dissolution Specifications: out of specification results observed for low dissolution. Dr. Reddy's Laboratories, Inc.	Class II	223,650 cartons	Terminated
2017-06-14	Failed Dissolution Specifications: out of specification results observed for low dissolution. Dr. Reddy's Laboratories, Inc.	Class II	13,221 cartons	Terminated
2017-03-08	Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc.	Class III	12132 cartons	Terminated
2017-03-08	Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc.	Class III	4404 cartons	Terminated
2017-03-08	Failed dissolution specifications - low dissolution results at S3 stage. Dr. Reddy's Laboratories, Inc.	Class III	4032 cartons	Terminated
2016-10-19	Failed Dissolution Specifications Dr. Reddy's Laboratories, Inc.	Class III	3,858 prescription packs (115,680 capsules)	Terminated
2015-08-12	Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. Ranbaxy Inc.	Class II	9,229 Boxes	Terminated

Isotretinoin Shortages

FDA-listed shortages of isotretinoin products. Strength and dosage-form level detail.

No active or recent shortages of isotretinoin are listed. We refresh this view daily.

Source: FDA Drug Shortages·Updated May 28, 2026

Is Isotretinoin Safe?

Isotretinoin is FDA-approved.

As with any prescription, the assessment of safety is individual; consult a clinician about your own risk profile.

Source: DailyMed (isotretinoin label)·Updated May 28, 2026

FDA-Approved Indications

Isotretinoin is FDA-approved for use in the condition categories below. The FDA-approved label’s Indications and Usage section is shown verbatim.

Skin conditions

INDICATIONS AND USAGE Severe Recalcitrant Nodular Acne Isotretinoin capsules are indicated for the treatment of severe recalcitrant nodular acne. Nodules are inflammatory lesions with a diameter of 5 mm or greater. The nodules may become suppurative or hemorrhagic. "Severe," by definition, 2 means "many" as opposed to "few or several" nodules. Because of significant adverse effects associated with its use, isotretinoin capsules should be reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics.
Show full Indications and UsageSee less
In addition, isotretinoin capsules are indicated only for those patients who are not pregnant, because isotretinoin capsules can cause life-threatening birth defects (see Boxed CONTRAINDICATIONS AND WARNINGS ). A single course of therapy for 15 to 20 weeks has been shown to result in complete and prolonged remission of disease in many patients. 1,3,4 If a second course of therapy is needed, it should not be initiated until at least 8 weeks after completion of the first course, because experience has shown that patients may continue to improve while off isotretinoin capsules. The optimal interval before retreatment has not been defined for patients who have not completed skeletal growth (see WARNINGS: Skeletal: Bone Mineral Density , Hyperostosis , Premature Epiphyseal Closure ).

Source: DailyMed (isotretinoin label)·Updated May 28, 2026·Section 1 (Indications and Usage)

Frequently Asked Questions

What are the most-reported side effects of isotretinoin?

Depression, inflammatory bowel disease, and colitis ulcerative are among the most-reported reactions in FDA FAERS data for isotretinoin. The full ranking, with reaction counts and the share of total reports, is in the Common Side Effects table above. Reports indicate co-occurrence, not causation; consult a clinician about your specific case.

Is isotretinoin the same as Zenatane?

Isotretinoin is the generic name; Zenatane is a brand name for the same active ingredient. Other brand names include Accutane, Absorica Ld, Claravis, Absorica, Myorisan, and Amnesteem. The active ingredient is identical; formulation and inactive ingredients may vary by manufacturer.

Has isotretinoin been recalled?

Yes. Isotretinoin has active and closed recalls on record in the FDA enforcement database. Reasons are dominated by failed dissolution specifications, subpotent or out-of-spec content, and contamination or foreign material. See the recalls table on this page for current counts, firm names, dates, and lot quantities.

What are isotretinoin's current ongoing recalls about?

Active isotretinoin recalls are listed in the recalls table above with their class, reason, firm, and affected lots. The dominant reasons across these recalls are subpotent or out-of-spec content, contamination or foreign material, and failed dissolution specifications. For lot numbers, distribution patterns, and the FDA enforcement record for any individual recall, follow the verify-on-FDA link from each row.

What do FDA recall classes mean?

Class I means a reasonable probability of serious adverse health consequences or death. Class II means temporary or medically reversible adverse health consequences with remote probability of serious harm. Class III means use of the product is unlikely to cause adverse health consequences. The class assignment is the FDA's, not the manufacturer's.

Does isotretinoin have an FDA boxed warning?

Yes. The FDA-approved label for isotretinoin carries a boxed warning. Boxed warnings are the FDA's strongest cautions. See the "FDA Boxed Warning" section above for the verbatim warning text.

Data Sources & Methodology

How each section of this page is sourced, and how often the data is refreshed.

Source	Endpoint	Refresh
FAERS reactions	openFDA `/drug/event.json` count API. Aggregated per drug per reaction term; we do not store individual reports.	Daily
Recalls	openFDA `/drug/enforcement.json`. Drugs matched via three confidence-tracked strategies: structured generic name (HIGH), NDC code bridge (MEDIUM), text token parse (LOW). Only HIGH and MEDIUM matches surface here.	6 hours
Shortages	FDA Drug Shortages list.	Daily
Boxed warnings & label sections	openFDA `/drug/label.json`. Labels are stable; monthly cadence is sufficient.	Monthly
Condition categories	Synonym-mapped from drug_labels.indications. Methodology at /methodology/.	Per-drug

What we do not do. We do not invent, paraphrase, or extrapolate drug claims. Every figure on this page comes from a query against an openFDA endpoint. If the data is unavailable, the section gracefully omits rather than filling the space with editorial guesswork.