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Sotret (Isotretinoin) - Side Effect Reports to FDA

 
 



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 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 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 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 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

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 2012-05-10

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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