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Accutane (Isotretinoin) - Side Effect Reports to FDA

 
 



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 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 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 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 2012-08-24

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 2012-08-23

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



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

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