This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Sotret (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 (111)
Death (2)
Disability (1)
Reports by Reaction Type
Inflammatory Bowel Disease (91),
Colitis Ulcerative (47),
Depression (33),
Irritable Bowel Syndrome (29),
Crohn's Disease (28),
Anxiety (23),
Blood Cholesterol Increased (19),
Blood Triglycerides Increased (18),
LIP DRY (13),
DRY Skin (13),
Suicidal Ideation (8),
Intestinal Obstruction (8)
Below are a few examples of reports where side effects / adverse reactions may be related to Sotret (Isotretinoin). For a complete list or a specific selection of reports, please use the links above.
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-08-09
Patient: male
Reactions: Crohn's Disease, Irritable Bowel Syndrome
Adverse event resulted in: death
Drug(s) suspected as cause:
Sotret
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2004-07-01
End date: 2004-12-01
Accutane
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2004-07-01
End date: 2004-12-01
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-07-23
Patient: female, weighing 43.1 kg (94.9 pounds)
Reactions: Pyelonephritis Acute, LIP DRY, Blood Triglycerides Increased, DRY Skin, Intestinal Obstruction, Suicidal Ideation, Hepatic Enzyme Increased, Volvulus, Iron Deficiency Anaemia, Irritable Bowel Syndrome, Blood Cholesterol Increased, Depression, Molluscum Contagiosum, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sotret
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Sotret
Start date: 2009-01-01
End date: 2010-01-01
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-07-16
Patient: male
Reactions: Abdominal Pain, Colitis Ulcerative, Crohn's Disease, Rectal Haemorrhage, Anaemia, Diarrhoea, Gastrointestinal Disorder, Colitis, Irritable Bowel Syndrome, Gastrointestinal Oedema, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Sotret
Dosage: unknown
Administration route: Oral
Indication: Acne
Amnesteem
Dosage: unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-06-22
Patient: female, weighing 43.1 kg (94.9 pounds)
Reactions: LIP DRY, Pyelonephritis Acute, Blood Triglycerides Increased, DRY Skin, Intestinal Obstruction, Hepatic Enzyme Increased, Suicidal Ideation, Volvulus, Iron Deficiency Anaemia, Blood Cholesterol Increased, Irritable Bowel Syndrome, Depression, Molluscum Contagiosum, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Sotret
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Sotret
Start date: 2009-01-01
End date: 2010-01-01
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-06-20
Patient: male, weighing 77.2 kg (169.8 pounds)
Reactions: Colitis Ulcerative, LIP DRY, Crohn's Disease, Acne, Suicidal Ideation, Anxiety, Arthralgia, Irritable Bowel Syndrome, Depression, Epistaxis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 2006-05-25
End date: 2006-12-20
Sotret
Administration route: Oral
Indication: Acne
Start date: 2006-05-27
End date: 2006-12-22
Accutane
End date: 2007-01-17
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-06-20
Patient: male, weighing 84.0 kg (184.8 pounds)
Reactions: Anxiety, Colitis Ulcerative, DRY Skin, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Accutane
Administration route: Oral
Indication: Acne
Start date: 2003-01-01
End date: 2006-01-01
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-06-11
Patient: female, weighing 56.8 kg (124.9 pounds)
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2008-06-27
End date: 2008-07-27
Amnesteem
Indication: Product Used FOR Unknown Indication
Start date: 2003-12-12
End date: 2004-04-23
Accutane
Indication: Acne
Start date: 2004-05-10
End date: 2004-06-10
Other drugs received by patient: Insulin
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-06-11
Patient: male, weighing 86.3 kg (189.8 pounds)
Reactions: Rectal Polyp, Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2006-10-01
End date: 2007-03-31
Accutane
Start date: 1984-01-01
Accutane
Indication: Acne
Start date: 1983-01-01
Possible Sotret side effects in 37 year old female
Reported by a consumer/non-health professional from Hungary on 2012-06-06
Patient: 37 year old female, weighing 70.0 kg (154.0 pounds)
Reactions: Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Sotret
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-05-29
Patient: male, weighing 62.1 kg (136.6 pounds)
Reactions: Intestinal Haemorrhage, Small Intestinal Obstruction, Colitis Ulcerative, Perirectal Abscess, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2004-03-01
End date: 2004-06-01
Accutane
Indication: Acne
Start date: 2004-03-01
End date: 2004-06-01
Possible Sotret side effects in 37 year old female
Reported by a consumer/non-health professional from Hungary on 2012-05-24
Patient: 37 year old female
Reactions: Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Sotret
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-05-21
Patient: male
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Amnesteem
Indication: Acne
Start date: 2007-02-01
End date: 2007-06-01
Sotret
Indication: Acne
Start date: 2006-12-01
End date: 2007-05-01
Accutane
Indication: Acne
Start date: 2004-12-01
End date: 2005-05-01
Possible Sotret side effects in 37 year old female
Reported by a physician from Hungary on 2012-05-18
Patient: 37 year old female
Reactions: Pregnancy
Drug(s) suspected as cause:
Sotret
Possible Sotret side effects in
Reported by a lawyer from United States on 2012-05-17
Patient:
Reactions: Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Start date: 2005-04-14
End date: 2005-05-15
Accutane
Indication: Acne
Start date: 1994-04-08
End date: 1994-08-26
Amnesteem
Indication: Acne
Start date: 2005-03-14
End date: 2005-04-14
Sotret
Indication: Acne
Start date: 2005-04-18
End date: 2005-05-18
Sotret
Start date: 2005-07-21
End date: 2005-08-21
Possible Sotret side effects in
Reported by a lawyer from United States on 2012-05-11
Patient:
Reactions: 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: 1999-01-01
End date: 2000-01-01
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2003-12-01
End date: 2004-01-01
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-05-11
Patient: female
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2008-06-27
End date: 2008-07-27
Amnesteem
Indication: Product Used FOR Unknown Indication
Start date: 2003-12-12
End date: 2004-04-23
Accutane
Indication: Product Used FOR Unknown Indication
Start date: 2004-05-10
End date: 2004-06-10
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-05-10
Patient: female, weighing 43.1 kg (94.9 pounds)
Reactions: LIP DRY, Pyelonephritis Acute, Blood Triglycerides Increased, Intestinal Obstruction, DRY Skin, Suicidal Ideation, Hepatic Enzyme Increased, Volvulus, Irritable Bowel Syndrome, Blood Cholesterol Increased, Depression, Molluscum Contagiosum, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sotret
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Sotret
Start date: 2009-01-01
End date: 2010-01-01
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-04-26
Patient: male
Reactions: Anxiety, Anhedonia, Colitis Ulcerative, Anaemia, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Product Used FOR Unknown Indication
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2008-01-24
End date: 2008-02-15
Possible Sotret side effects in
Reported by a lawyer from United States on 2012-04-25
Patient:
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2006-10-01
End date: 2007-03-31
Accutane
Indication: Acne
Start date: 1983-01-01
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-04-25
Patient: male
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2006-05-27
End date: 2006-12-22
Accutane
Indication: Product Used FOR Unknown Indication
Start date: 2006-07-27
End date: 2007-01-17
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-04-23
Patient: female, weighing 43.1 kg (94.9 pounds)
Reactions: LIP DRY, Pyelonephritis Acute, Blood Triglycerides Increased, Intestinal Obstruction, DRY Skin, Suicidal Ideation, Hepatic Enzyme Increased, Volvulus, Irritable Bowel Syndrome, Blood Cholesterol Increased, Depression, Molluscum Contagiosum, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Sotret
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Sotret
Start date: 2009-01-01
End date: 2010-01-01
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-04-19
Patient: male, weighing 62.1 kg (136.6 pounds)
Reactions: Intestinal Haemorrhage, Small Intestinal Obstruction, Colitis Ulcerative, Perirectal Abscess, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2004-03-01
End date: 2004-06-01
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2004-03-01
End date: 2004-06-01
Possible Sotret side effects in
Reported by a lawyer from United States on 2012-04-13
Patient:
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2001-01-01
Accutane
Start date: 2006-01-01
Sotret
Start date: 2006-01-01
Sotret
Indication: Acne
Start date: 2001-01-01
Possible Sotret side effects in
Reported by a lawyer from United States on 2012-04-09
Patient:
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2001-01-01
Sotret
Indication: Acne
Start date: 2006-01-01
Possible Sotret side effects in female
Reported by a lawyer from United States on 2012-04-05
Patient: female, weighing 43.1 kg (94.9 pounds)
Reactions: Pyelonephritis Acute, Blood Triglycerides Increased, Intestinal Obstruction, DRY Skin, Suicidal Ideation, Hepatic Enzyme Increased, Volvulus, Blood Cholesterol Increased, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Sotret
Start date: 2009-01-01
End date: 2010-01-01
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Sotret
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-03-21
Patient: male, weighing 62.1 kg (136.6 pounds)
Reactions: Small Intestinal Obstruction, Intestinal Haemorrhage, Colitis Ulcerative, Perirectal Abscess, Depression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2004-03-01
End date: 2004-06-01
Sotret
Indication: Product Used FOR Unknown Indication
Start date: 2004-03-01
End date: 2004-06-01
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-03-19
Patient: male, weighing 63.6 kg (139.8 pounds)
Reactions: Haematochezia, Colitis Ulcerative, Cheilosis, Ileitis, Colitis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 2005-11-11
Sotret
Start date: 2005-04-05
Sotret
Administration route: Oral
Indication: Acne
Start date: 2005-11-11
Accutane
Start date: 2005-04-05
Other drugs received by patient: Bactroban; Zyrtec; Clobex
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-03-16
Patient: male, weighing 108.9 kg (239.6 pounds)
Reactions: Colitis Ulcerative, Blood Cholesterol Increased, Blood Triglycerides Increased, Depression, Rectal Abscess, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Amnesteem
Indication: Acne
Sotret
Administration route: Oral
Indication: Acne
Accutane
Start date: 1996-09-13
End date: 1996-11-01
Accutane
Indication: Acne
Start date: 1993-02-10
End date: 1994-01-01
Accutane
Accutane
Start date: 1998-01-12
End date: 1998-03-01
Other drugs received by patient: Minocycline HCL; Tylenol; Sulfacet-R; Aspirin; Nyquil; Cephalexin
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-03-09
Patient: male, weighing 63.6 kg (139.8 pounds)
Reactions: Colitis Ulcerative, Irritable Bowel Syndrome, Injury, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Sotret
Accutane
Sotret
Accutane
Indication: Acne
Accutane
Sotret
Indication: Acne
Possible Sotret side effects in male
Reported by a lawyer from United States on 2012-03-06
Patient: male, weighing 108.9 kg (239.6 pounds)
Reactions: Colitis Ulcerative, Blood Triglycerides Increased, Blood Cholesterol Increased, Depression, Rectal Abscess, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Start date: 1998-01-12
End date: 1998-03-01
Accutane
Start date: 1996-09-13
End date: 1996-11-01
Accutane
Accutane
Sotret
Administration route: Oral
Indication: Acne
Accutane
Indication: Acne
Start date: 1993-02-10
End date: 1994-01-01
Amnesteem
Indication: Acne
Other drugs received by patient: Nyquil; Sulfacet-R; Minocycline HCL; Aspirin; Acetaminophen; Cephalexin
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