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What the label lists and what reports show

Isotretinoin side effects

Isotretinoin's FDA label: “Most common adverse reactions (incidence ≥5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract …” FAERS holds 49,172 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is depression (5,803 reports).

  • Generic listed
  • Boxed warning

Check it at the source: the isotretinoin FDA label on DailyMed (effective August 19, 2026, Sun Pharmaceutical Industries, Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of ABSORICA and ABSORICA LD?

ABSORICA and ABSORICA LD can cause serious side effects, including: See “ What is the most important information I should know about ABSORICA and ABSORICA LD ?” increased pressure in the brain (intracranial hypertension). ABSORICA and ABSORICA LD can increase the pressure in your brain. This can lead to permanent loss of eyesight, and in rare cases, death. Stop taking ABSORICA or ABSORICA LD and tell your healthcare provider right away if you get any of these signs of increased brain pressure: bad headache blurred vision or other vision problems dizziness nausea or vomiting seizures (convulsions) stroke serious skin problems. Skin rash can happen in patients taking ABSORICA or ABSORICA LD. Sometimes rash can be severe and may be life-threatening and lead to hospitalization or death. […]

Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective August 19, 2026 (SPL set 3ef0cff8-19c1-4441-b780-fca6c7ee1615), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence ≥5%) are: dry lips, dry skin, back pain, dry eye, arthralgia, epistaxis, headache, nasopharyngitis, chapped lips, dermatitis, increased creatine kinase, cheilitis, musculoskeletal discomfort, upper respiratory tract infection, reduced visual acuity.

From the label: adverse reactions, continued

The following adverse reactions with ABSORICA/ABSORICA LD 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 trials or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Dose Relationship Cheilitis and hypertriglyceridemia were dose related. …

Source: FDA drug label, Sun Pharmaceutical Industries, Inc., effective August 19, 2026 (SPL set 3ef0cff8-19c1-4441-b780-fca6c7ee1615), via openFDA; the full label on DailyMed

What do FAERS reports show?

49,172 reports list isotretinoin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 885 are coded as a death and 4,349 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 21 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Depression5,803
  • Inflammatory Bowel Disease (named in the label)5,252
  • Colitis Ulcerative3,808
  • Dry Skin (named in the label)2,425
  • Suicidal Ideation (named in the label)2,146
  • Pregnancy (named in the label)2,079
  • Irritable Bowel Syndrome2,014
  • Headache (named in the label)1,992
  • Arthralgia (named in the label)1,966
  • Anxiety (named in the label)1,926
  • Unintended Pregnancy1,919
  • Product Dose Omission Issue (a use or a product term, not a reaction)1,763
  • Exposure During Pregnancy (a use or a product term, not a reaction)1,710
  • Crohn^S Disease1,679
  • Lip Dry1,581
  • Adverse Drug Reaction1,558
  • Blood Triglycerides Increased1,461
  • Abortion Induced1,395
  • Mood Altered1,289
  • Gastrointestinal Injury1,261
  • Drug Ineffective (a use or a product term, not a reaction)1,251
  • Drug Exposure During Pregnancy (a use or a product term, not a reaction)1,214
  • Crohn'S Disease1,140
  • Treatment Noncompliance1,121
  • Epistaxis (named in the label)989

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Isotretinoin: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions