This grade answers one narrow question: how strong is the public evidence and safety record behind this drug, and how clean is its money trail and court record? It is not a verdict on whether the drug is right for you.
WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY Isotretinoin capsules can cause severe life-threatening birth defects and is contraindicated in pregnancy. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking any amount of isotretinoin capsules 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. If pregnancy occurs, discontinue isotretinoin capsules immediately and refer the patient to an Obstetrician- Gynecologist experienced in reproductive toxicity for further evaluation and counseling [see Contraindications (4) , Warnings and Precautions (5.1) , and Use in Specific Populations (8.1) ]. Because of the risk of embryo-fetal toxicity, isotretinoin capsules are available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the iPLEDGE REMS [see Warnings and Precautions (5.2) ] . WARNING: EMBRYO-FETAL TOXICITY – CONTRAINDICATED IN PREGNANCY See full prescribing information for complete boxed warning. Isotretinoin capsules can cause life-thr...
Isotretinoin capsules 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. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. Limitations of Use : If a second course of isotretinoin capsules therapy is needed, it is not recommended before a two-month waiting period because the patient’s acne may continue to improve following a 15 to 20-week course of therapy [see Dosage and Administration (2.2) ]. Isotretinoin capsules are retinoids 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. Because of significant adverse reactions associated with its use, isotretinoin capsules are reserved for patients with severe nodular acne who are unresponsive to conventional therapy, including systemic antibiotics. (1) Limitations of Use: If a second course of isotretinoi...
Pregnancy ( 4.1 , 8.1 ) Hypersensitivity to this product or any of its components ( 4.2 , 5.14 ) 4.1 Pregnancy Isotretinoin capsules are contraindicated in pregnancy [see Warnings and Precautions (5.1) and Use in Specific Populations (8.1) ]. 4.2 Hypersensitivity Isotretinoin capsules are contraindicated in patients with hypersensitivity to isotretinoin (or Vitamin A, given the chemical similarity to isotretinoin) or to any of its components (anaphylaxis and other allergic reactions have occurred) [see Warnings and Precautions (5.14) ] .
Psychiatric Disorders (depression, psychosis, suicidal thoughts and behavior, and aggressive and/or violent behaviors): Prior to and during therapy assess for these conditions; stop if these conditions occur on therapy (5.4) Intracranial Hypertension (Pseudotumor Cerebri) : Avoid use with concomitant tetracyclines (5.5) Serious Skin Reactions : Monitor for Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and other serious skin reactions (5.6) Acute Pancreatitis : If occurs, discontinue treatment (5.7) Lipid Abnormalities (hypertriglyceridemia, low HDL, and elevation of cholesterol): Monitor lipid levels at regular intervals; stop if hypertriglyceridemia cannot be controlled (5.8) Hearing Impairment : Discontinue and refer to specialized care (5.9) Hepatotoxicity : Monitor liver function tests prior to and during therapy (5.10 , 5.15) Inflammatory Bowel Disease : Discontinue for abdominal pain, rectal bleeding, or severe diarrhea (5.11) Musculoskeletal Abnormalities : Arthralgias, back pain, decreases in bone mineral density and premature epiphyseal closure (5.12) Ocular Abnormalities e.g., corneal opacities, decreased night vision: If visual symptoms occur, discont...
The following adverse reactions with isotretinoin capsules or other isotretinoin capsule products are described in more detail in other sections of the labeling: Embryo-Fetal Toxicity [see Warnings and Precautions ( 5.1 )] Psychiatric Disorders [see Warnings and Precautions ( 5.4 )] Intracranial Hypertension (Pseudotumor Cerebri) [see Warnings and Precautions ( 5.5 )] Serious Skin Reactions [see Warnings and Precautions ( 5.6 )] Pancreatitis [see Warnings and Precautions ( 5.7 )] Lipid Abnormalities [see Warnings and Precautions ( 5.8 )] Hearing Impairment [see Warnings and Precautions ( 5.9 )] Hepatotoxicity [see Warnings and Precautions ( 5.10 )] Inflammatory Bowel Disease [see Warnings and Precautions ( 5.11 )] Musculoskeletal Abnormalities [see Warnings and Precautions ( 5.12 )] Ocular Abnormalities [see Warnings and Precautions ( 5.13 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.14 )] The following adverse reactions associated with the use of isotretinoin capsules were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably es...
Source: FDA SPL label for Isotretinoin (Sun Pharmaceutical Industries, Inc.), effective 20240110. Full label on DailyMed.
These are counts of reports people filed, not rates of harm. Anyone can file one, and nobody checks whether the drug was the cause. Millions of doses are taken for every report sent, so the useful part is how this drug compares with the average across all drugs.
| 2019 | 2020 | 2021 | 2022 | 2023 | 2024 | 2025 | 2026 |
|---|---|---|---|---|---|---|---|
| 2,687 | 3,606 | 3,372 | 3,888 | 3,591 | 4,481 | 3,822 | 1,637 |
Source: the FDA's Adverse Event Reporting System (FAERS). Reports are voluntary and unverified. Drugs that are prescribed a lot, in the news, or in lawsuits attract more reports, so the percentages are compared with the whole database to correct for that partly, not fully.
| Date | Class | Firm | Reason |
|---|---|---|---|
| 04/2026 | Class II | Teva Pharmaceuticals USA, Inc | Failed Impurities/Degradation Specifications: Out of specification for specific impurity Tretinoin |
| 02/2026 | Class II | MYLAN PHARMACEUTICALS INC | Failed Dissolution Specifications |
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent and Subpotent |
| 01/2026 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent and Subpotent |
| 03/2024 | Class II | Teva Pharmaceuticals USA, Inc | Superpotent Drug: The 3-month stability result for assay was found to be above specification limit |
| 10/2019 | Class III | Amneal Pharmaceuticals, Inc. | Failed Impurities/Degradation Specifications: Tretinoin levels slightly above specification limits. |
| 12/2018 | Class III | Sun Pharmaceutical Industries, Inc. | Subpotent Drug: Isotretinoin content results were lower than the specification limit obtained during routing product monitoring. |
| 06/2015 | Class II | Ranbaxy Inc. | Incorrect/Undeclared Excipients: Product contains undeclared FD&C Yellow No. 5 in the capsule shell. |
Class I = reasonable probability of serious harm. Class II = temporary or reversible harm. Class III = unlikely to harm. Most generic recalls are manufacturing or labeling defects for one lot, not a verdict on the molecule.
Counts measure how much evidence exists and how transparent it is, not how big the benefit is. For that, ask your prescriber: if 100 people like me took this, how many would get better because of it, and how many would be harmed? (Doctors call these the "number needed to treat" and "number needed to harm.") It differs by condition and is the number drug ads leave out. Sources: PubMed, ClinicalTrials.gov.
In 2024, drug companies reported $0 in payments to US physicians and hospitals tied to this drug across 0 transactions.
No pending federal MDL names this drug or its brands.
Not named in any federal pharmaceutical settlement of $100M or more on record.
Sources: CMS Open Payments (Sunshine Act); Judicial Panel on Multidistrict Litigation pending docket list; DOJ settlements as tabulated on Wikipedia with links to the primary record. State-court and individual suits are not included.
| Product | Fills | $/fill |
|---|---|---|
| Isotretinoin | 7,711 | $197 |
| Claravis | 4,013 | $148 |
| Zenatane | 3,444 | $158 |
| Amnesteem | 1,519 | $146 |
| Accutane | 476 | $147 |
| Absorica | 24 | $1,674 |
1 drug in the same class grades a letter or more higher than isotretinoin on this site. Worth asking whether one of them would do the same job for you.
Same ATC pharmacological class, graded ones first, best grade at the top. Being in the same class does not make them interchangeable for your condition; it makes them worth asking about.