82/100 · Critical
Manufactured by JG Pharma Inc.
Isotretinoin Adverse Events: High Concern for Mental Health and Gastrointestinal Issues
86,016 FDA adverse event reports analyzed
Last updated: 2026-05-12
ISOTRETINOIN is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by JG Pharma Inc.. Based on analysis of 86,016 FDA adverse event reports, ISOTRETINOIN has a safety score of 82 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for ISOTRETINOIN include DEPRESSION, INFLAMMATORY BOWEL DISEASE, COLITIS ULCERATIVE, DRY SKIN, SUICIDAL IDEATION. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for ISOTRETINOIN.
Isotretinoin has a safety concern score of 82 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 86,016 adverse event reports for this medication, which is primarily manufactured by Jg Pharma Inc..
The most commonly reported adverse events include Depression, Inflammatory Bowel Disease, Colitis Ulcerative. Of classified reports, 56.6% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. Isotretinoin is associated with a high incidence of serious mental health issues such as depression and suicidal ideation.
Gastrointestinal disorders, including colitis and irritable bowel syndrome, are frequent adverse events. The drug is linked to a significant number of serious pregnancy-related outcomes, highlighting the need for strict contraception measures.
Patients taking Isotretinoin should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Isotretinoin is contraindicated in pregnant women and requires strict contraception measures. It can interact with other drugs, potentially affecting their efficacy or increasing side effects. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Isotretinoin received a safety concern score of 82/100 (high concern). This is based on a 56.6% serious event ratio across 47,514 classified reports. The score accounts for 86,016 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Female: 25,114, Male: 14,175, Unknown: 395. The most frequently reported age groups are age 16 (2,183 reports), age 17 (2,171 reports), age 15 (1,656 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 47,514 classified reports for ISOTRETINOIN:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Isotretinoin is contraindicated in pregnant women and requires strict contraception measures. It can interact with other drugs, potentially affecting their efficacy or increasing side effects.
If you are taking Isotretinoin, here are important things to know. The most commonly reported side effects include depression, inflammatory bowel disease, colitis ulcerative, dry skin, suicidal ideation. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Strictly adhere to prescribed dosages and follow-up schedules. Report any signs of depression or suicidal thoughts immediately to your healthcare provider. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
Regulatory oversight is stringent, with mandatory pregnancy testing and contraception counseling before and during treatment. Healthcare providers must monitor patients closely for adverse events.
The FDA has received approximately 86,016 adverse event reports associated with Isotretinoin. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Isotretinoin include Depression, Inflammatory Bowel Disease, Colitis Ulcerative, Dry Skin, Suicidal Ideation. By volume, the top reported reactions are: Depression (5,697 reports), Inflammatory Bowel Disease (5,253 reports), Colitis Ulcerative (3,797 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Isotretinoin.
Out of 47,514 classified reports, 26,880 (56.6%) were classified as serious and 20,634 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Isotretinoin break down by patient sex as follows: Female: 25,114, Male: 14,175, Unknown: 395. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Isotretinoin adverse events are: age 16: 2,183 reports, age 17: 2,171 reports, age 15: 1,656 reports, age 18: 1,601 reports, age 19: 1,199 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Isotretinoin adverse event reports is Jg Pharma Inc.. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Isotretinoin include: Pregnancy, Irritable Bowel Syndrome, Headache, Arthralgia, Anxiety. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Isotretinoin to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Isotretinoin has a safety concern score of 82 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. Isotretinoin is associated with a high incidence of serious mental health issues such as depression and suicidal ideation.
Key safety signals identified in Isotretinoin's adverse event data include: High frequency of depression and suicidal ideation reports.. Multiple gastrointestinal issues, including colitis and irritable bowel syndrome.. Serious pregnancy-related outcomes, including abortion and maternal exposure during pregnancy.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Isotretinoin is contraindicated in pregnant women and requires strict contraception measures. It can interact with other drugs, potentially affecting their efficacy or increasing side effects. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Isotretinoin.
Strictly adhere to prescribed dosages and follow-up schedules. Report any signs of depression or suicidal thoughts immediately to your healthcare provider.
Isotretinoin has 86,016 adverse event reports on file with the FDA. Gastrointestinal disorders, including colitis and irritable bowel syndrome, are frequent adverse events. The volume of reports for Isotretinoin reflects both the drug's usage level and the vigilance of the reporting community.
Regulatory oversight is stringent, with mandatory pregnancy testing and contraception counseling before and during treatment. Healthcare providers must monitor patients closely for adverse events. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
The following drugs share commonly reported adverse reactions with ISOTRETINOIN:
Drugs related to ISOTRETINOIN based on therapeutic use, drug class, or shared indications: