This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Accutane (Isotretinoin) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (3065)
Death (20)
Life Threatening Events (2)
Disability (79)
Reports by Reaction Type
Inflammatory Bowel Disease (2158),
Colitis Ulcerative (1486),
Depression (1167),
Crohn's Disease (1107),
Irritable Bowel Syndrome (1049),
Injury (666),
Anxiety (592),
Emotional Distress (437),
Intestinal Obstruction (403),
Suicidal Ideation (328),
Intestinal Haemorrhage (258),
Stress (247)
Below are a few examples of reports where side effects / adverse reactions may be related to Accutane (Isotretinoin). For a complete list or a specific selection of reports, please use the links above.
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 74.5 kg (163.8 pounds)
Reactions: Colitis Ulcerative, Crohn's Disease, Intestinal Obstruction, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 86.3 kg (189.8 pounds)
Reactions: Colitis Ulcerative, Depression, Injury
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female
Reactions: Injury
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female
Reactions: Emotional Distress, Ovarian Cyst, Dysfunctional Uterine Bleeding, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 86.3 kg (189.8 pounds)
Reactions: Anxiety, Colitis Ulcerative, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne Cystic
Start date: 2002-10-30
End date: 2002-12-23
Accutane
Indication: Rosacea
Start date: 2000-12-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male, weighing 88.5 kg (194.8 pounds)
Reactions: Colitis Ulcerative, Haemorrhoids, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Rosacea
Accutane
Indication: Acne
Start date: 1997-06-27
End date: 1997-09-16
Possible Accutane side effects in female
Reported by a consumer/non-health professional from Canada on 2012-08-27
Patient: female
Reactions: Suicide Attempt, Depression
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female
Reactions: Anxiety, Arthralgia, Colitis Ulcerative, LIP DRY, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female, weighing 68.1 kg (149.8 pounds)
Reactions: Colitis Ulcerative, Stress, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Start date: 1987-02-10
End date: 1987-08-05
Accutane
Indication: Acne
Start date: 1986-01-01
Accutane
End date: 1988-01-01
Other drugs received by patient: Loestrin 1.5 / 30
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-27
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Crohn's Disease, Injury, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-27
Patient: male
Reactions: Anxiety, Colitis Ulcerative, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in
Reported by a lawyer from United States on 2012-08-27
Patient:
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Product Used FOR Unknown Indication
Start date: 2003-07-01
End date: 2003-12-01
Claravis
Indication: Product Used FOR Unknown Indication
Start date: 2004-04-01
End date: 2004-09-01
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-24
Patient: female, weighing 67.6 kg (148.7 pounds)
Reactions: Colitis Ulcerative, Fear, Sciatica, Autoimmune Thyroiditis, Fatigue, Irritable Bowel Syndrome, Mood Swings, Back Pain, Cardiac Murmur, Spondylolisthesis, Thyroid Cancer, Anaemia, Crohn's Disease, Hyperglycaemia, Breast Neoplasm, Anxiety, Arthralgia, Hypothyroidism, Colitis, Arthritis, Thyroid Neoplasm, Inflammatory Bowel Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 1994-01-01
End date: 1994-04-01
Accutane
Administration route: Oral
Start date: 2001-06-01
End date: 2001-10-01
Other drugs received by patient: Birth Control Pills NOS
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-24
Patient: male, weighing 56.8 kg (124.9 pounds)
Reactions: Colonic Polyp, Irritable Bowel Syndrome, Depression, Injury, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-24
Patient: male, weighing 63.6 kg (139.8 pounds)
Reactions: Emotional Distress, Colitis Ulcerative, Depression, Suicidal Ideation, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 1995-01-01
End date: 1996-01-01
Accutane
Start date: 2004-11-01
End date: 2005-01-01
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 93.1 kg (204.8 pounds)
Reactions: Emotional Distress, Urticaria, Colitis, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Small Intestinal Obstruction, Liposarcoma, Colitis Ulcerative, Crohn's Disease, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 44.5 kg (97.9 pounds)
Reactions: Colitis Ulcerative, LIP DRY, Chapped Lips, Anaemia, Musculoskeletal Discomfort, Gastritis Viral, Dermatitis, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 1995-05-17
End date: 1995-09-01
Accutane
Start date: 1999-03-08
End date: 1999-03-24
Accutane
Start date: 1999-03-24
End date: 1999-09-01
Other drugs received by patient: Kenalog; Birth Control Pills NOS
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 106.7 kg (234.7 pounds)
Reactions: Emotional Distress, Crohn's Disease, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 49.9 kg (109.9 pounds)
Reactions: Emotional Distress, Colitis Ulcerative, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 63.6 kg (139.8 pounds)
Reactions: Malnutrition, Crohn's Disease, Stress, Suicidal Ideation, Colitis Microscopic, Colonic Polyp, Post-Traumatic Stress Disorder, Pernicious Anaemia, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 1989-01-01
Accutane
Start date: 1990-04-01
End date: 1990-06-01
Other drugs received by patient: Aspirin
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male
Reactions: Anxiety, Irritable Bowel Syndrome, Arthritis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 72.6 kg (159.8 pounds)
Reactions: Emotional Distress, Colitis Ulcerative, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Accutane
Indication: Acne
Start date: 2001-01-01
End date: 2001-06-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 72.6 kg (159.7 pounds)
Reactions: Colitis Ulcerative, Crohn's Disease, Perirectal Abscess, Suicidal Ideation, Small Intestinal Obstruction, Anal Fistula, Irritable Bowel Syndrome, Depression, Gastrointestinal Injury, Periumbilical Abscess, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 54.5 kg (119.9 pounds)
Reactions: Emotional Distress, Colitis Ulcerative, Crohn's Disease, Chapped Lips, Intestinal Obstruction, DRY Skin, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Start date: 1999-01-01
End date: 2000-01-01
Accutane
Indication: Acne
Start date: 1994-09-14
End date: 1995-02-08
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 86.2 kg (189.6 pounds)
Reactions: Abdominal Pain, Blood Alkaline Phosphatase Increased, Rectal Polyp, Colitis Ulcerative, Nausea, Haemorrhoids, Rectal Haemorrhage, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Accutane
Indication: Acne
Start date: 1989-01-01
End date: 1992-01-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 54.4 kg (119.7 pounds)
Reactions: Intestinal Ulcer, Chapped Lips, Crohn's Disease, Intestinal Obstruction, DRY Skin, Colonic Polyp, Anal Fistula, Arthralgia, Oesophageal Disorder, Colitis, Depression, Arthritis, Gastrointestinal Injury, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Other drugs received by patient: Clarithromycin
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-23
Patient: male, weighing 66.7 kg (146.8 pounds)
Reactions: Intestinal Polyp, Crohn's Disease, Gastric Ulcer, Suicidal Ideation, Bipolar Disorder, Suicide Attempt, Irritable Bowel Syndrome, Depression
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 90.8 kg (199.8 pounds)
Reactions: Polyp, Alopecia, Crohn's Disease, Depression, Anal Fissure, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Other drugs received by patient: Tylenol
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-08-23
Patient: female, weighing 52.2 kg (114.9 pounds)
Reactions: Intestinal Haemorrhage, Colitis Ulcerative, Mental Disorder, Irritable Bowel Syndrome, Intestinal Obstruction, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Start date: 2000-08-01
End date: 2000-10-01
Accutane
Dosage: in early 1980's
Indication: Product Used FOR Unknown Indication
Accutane
Dosage: into 1990's
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