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Index of reports
> Cases with Gastrointestinal Disorder ()
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Accutane (Isotretinoin) where reactions include gastrointestinal disorder. The selected reports were submitted to the FDA during the sample period of about a year.
Reports 1 - 30 of Next >>
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-20
Patient: male, weighing 81.6 kg (179.5 pounds)
Reactions: Colitis Ulcerative, Crohn's Disease, Supraventricular Tachycardia, Anxiety, Intestinal Haemorrhage, Hypophosphataemia, Gastrointestinal Disorder, Colitis, Urinary Retention, Depression, Hypertension, Sinus Arrhythmia, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Dosage: indication reported as cystic acne and folliculitis.
Administration route: Oral
Indication: Acne Cystic
Accutane
Dosage: 40 mg biweekly after the first month. 40 mg every third day after the third month.
Administration route: Oral
Accutane
Dosage: 40 mg after biweekly for 1 month. 40mg every 10th day after the second month.
Administration route: Oral
Other drugs received by patient: Cozaar; Claritin-D; Fioricet
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-17
Patient: male
Reactions: Colonic Polyp, Colitis Ulcerative, Gastrointestinal Disorder, Blood Triglycerides Increased, Pancreatitis, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-13
Patient: male, weighing 90.7 kg (199.5 pounds)
Reactions: Abdominal Pain, Fistula, Crohn's Disease, Rectal Haemorrhage, Blood Triglycerides Increased, Dermatitis, Gastrointestinal Disorder, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Indication: Acne Cystic
Start date: 1995-01-01
End date: 1995-12-01
Accutane
Administration route: Oral
Start date: 1997-12-27
End date: 1998-06-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-13
Patient: male, weighing 104.4 kg (229.7 pounds)
Reactions: Colitis Ulcerative, Blood Triglycerides Increased, DRY Skin, Gastric Ulcer, Suicidal Ideation, Cheilitis, Visual Impairment, Gastrointestinal Disorder, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Other drugs received by patient: Tylenol
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-09
Patient: male
Reactions: Gastrointestinal Disorder, Irritable Bowel Syndrome, Pancreatitis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-08-07
Patient: male
Reactions: Gastrointestinal Disorder, Irritable Bowel Syndrome, Pancreatitis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-07-30
Patient: male
Reactions: Gastrointestinal Disorder, Irritable Bowel Syndrome, Pancreatitis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-07-13
Patient: male, weighing 76.2 kg (167.6 pounds)
Reactions: Weight Decreased, Abdominal Pain, Night Sweats, Chronic Fatigue Syndrome, Erythema, Anal Fistula, Dyspepsia, Oedema Peripheral, Mood Swings, Proctalgia, Crohn's Disease, Osteopenia, Stress, Internal Injury, Gastrointestinal Disorder, Insomnia, Vision Blurred, Colitis Ulcerative, Rectal Haemorrhage, Pain, Mucous Stools, Suicidal Ideation, Frequent Bowel Movements, Fatigue, Anorectal Disorder, Rectal Fissure, Abdominal Distension, Oedema, Depression, Lethargy, Decreased Appetite, Vomiting, Polyp, Cataract, Nausea, Haemorrhoids, Self Injurious Behaviour, Rash, Anal Fissure, Anxiety, Haematochezia, Intestinal Haemorrhage, Diarrhoea, Arthralgia, Bipolar Disorder, Arthritis, Asthenia, Inflammatory Bowel Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 1988-01-01
End date: 1991-01-01
Accutane
Dosage: still receiving treatment on 26 jun 2000
Administration route: Oral
Accutane
Administration route: Oral
Start date: 1994-01-01
End date: 1997-01-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-06-28
Patient: male, weighing 83.9 kg (184.6 pounds)
Reactions: Abdominal Pain, Obsessive-Compulsive Disorder, Alcohol Abuse, Colitis Ulcerative, Rectal Haemorrhage, Coma, Somnolence, Ketoacidosis, Delusion, Suicidal Ideation, Endodontic Procedure, Body Dysmorphic Disorder, Hepatotoxicity, Irritable Bowel Syndrome, Depression, Type 1 Diabetes Mellitus, Decreased Appetite, Abscess Limb, Cellulitis, Paranoia, Convulsion, Anxiety, Insomnia, Gastrointestinal Disorder, Colitis, Sleep Apnoea Syndrome, Bulimia Nervosa, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Start date: 2001-11-05
End date: 2001-11-14
Accutane
Indication: Acne
Start date: 2000-04-11
End date: 2000-09-01
Other drugs received by patient: Minocin
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-06-22
Patient: male, weighing 81.6 kg (179.5 pounds)
Reactions: Colitis Ulcerative, Supraventricular Tachycardia, Crohn's Disease, Hypophosphataemia, Anxiety, Intestinal Haemorrhage, Gastrointestinal Disorder, Colitis, Urinary Retention, Depression, Hypertension, Sinus Arrhythmia, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Dosage: indication reported as cystic acne and folliculitis.
Administration route: Oral
Indication: Acne Cystic
Accutane
Dosage: 40 mg biweekly after the first month. 40 mg every third day after the third month.
Administration route: Oral
Accutane
Dosage: 40 mg after biweekly for 1 month. 40mg every 10th day after the second month.
Administration route: Oral
Other drugs received by patient: Cozaar; Claritin-D; Fioricet
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-06-14
Patient: male, weighing 77.2 kg (169.8 pounds)
Reactions: Colitis Ulcerative, Gastrointestinal Disorder, Depression, Stress, Suicidal Ideation, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in
Reported by a consumer/non-health professional from United States on 2012-05-30
Patient:
Reactions: Abdominal Pain, Colitis Ulcerative, Anaemia, Rectal Haemorrhage, Crohn's Disease, Diarrhoea, Gastrointestinal Disorder, Colitis, Irritable Bowel Syndrome, Gastrointestinal Oedema, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2006-12-01
End date: 2007-05-01
Accutane
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2004-12-01
End date: 2005-05-01
Amnesteem
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2007-02-01
End date: 2007-06-01
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-05-23
Patient: female, weighing 47.6 kg (104.7 pounds)
Reactions: Colitis Ulcerative, Anal Stenosis, Anorectal Ulcer, Suicidal Ideation, Delusion, Anal Fistula, Colonic Fistula, Serositis, Pleural Effusion, Depression, Splenomegaly, Fistula, Anaemia, Crohn's Disease, Female Genital Tract Fistula, Osteopenia, Ascites, Anxiety, Arthralgia, Gastrointestinal Disorder, Colitis, Vision Blurred, Anal Abscess, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Dosage: the patient was prescribed accutane 40 mg #30 1 od with food along with 10 mg i od with food.
Administration route: Oral
Accutane
Administration route: Oral
Indication: Acne
Start date: 1997-11-03
End date: 1997-12-29
Other drugs received by patient: Ranitidine; Nutracort; Retin-A; Tetracyclin; Aclovate; Famvir; Benzamycin
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-05-22
Patient: female
Reactions: Abdominal Pain, Colitis Ulcerative, Anaemia, Crohn's Disease, Rectal Haemorrhage, Diarrhoea, Gastrointestinal Disorder, Irritable Bowel Syndrome, Colitis, Gastrointestinal Oedema, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Accutane
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 1999-01-01
End date: 2000-01-01
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2003-12-01
End date: 2004-01-01
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-05-14
Patient: female
Reactions: Abdominal Pain, Colitis Ulcerative, Anaemia, Crohn's Disease, Rectal Haemorrhage, Diarrhoea, Gastrointestinal Disorder, Colitis, Irritable Bowel Syndrome, Gastrointestinal Oedema, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Amnesteem
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2003-12-12
End date: 2004-04-23
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-06-27
End date: 2008-07-27
Accutane
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2004-05-10
End date: 2004-06-10
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-05-10
Patient: female, weighing 47.6 kg (104.7 pounds)
Reactions: Colitis Ulcerative, Anal Stenosis, Anorectal Ulcer, Delusion, Suicidal Ideation, Anal Fistula, Colonic Fistula, Serositis, Pleural Effusion, Depression, Splenomegaly, Fistula, Anaemia, Crohn's Disease, Female Genital Tract Fistula, Osteopenia, Ascites, Anxiety, Arthralgia, Gastrointestinal Disorder, Vision Blurred, Anal Abscess, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Dosage: the patient was prescribed accutane 40 mg #30 1 od with food along with 10 mg i od with food.
Administration route: Oral
Accutane
Administration route: Oral
Indication: Acne
Start date: 1997-11-03
End date: 1997-12-29
Other drugs received by patient: Famvir; Ranitidine; Retin-A; Tetracyclin; Aclovate; Benzamycin; Nutracort
Possible Accutane side effects in
Reported by a lawyer from United States on 2012-05-07
Patient:
Reactions: Abdominal Pain, Colitis Ulcerative, Rectal Haemorrhage, Anaemia, Crohn's Disease, Diarrhoea, Gastrointestinal Disorder, Irritable Bowel Syndrome, Oedema, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2006-05-27
End date: 2006-12-22
Accutane
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2006-07-27
End date: 2007-01-17
Possible Accutane side effects in
Reported by a lawyer from United States on 2012-05-04
Patient:
Reactions: Abdominal Pain, Colitis Ulcerative, Anaemia, Rectal Haemorrhage, Diarrhoea, Gastrointestinal Disorder, Oedema, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2008-01-24
End date: 2008-02-15
Accutane
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 1990-01-01
Possible Accutane side effects in
Reported by a lawyer from United States on 2012-05-04
Patient:
Reactions: Abdominal Pain, Colitis Ulcerative, Anaemia, Crohn's Disease, Rectal Haemorrhage, Diarrhoea, Gastrointestinal Disorder, Irritable Bowel Syndrome, Oedema, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2006-10-01
End date: 2007-03-31
Accutane
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 1983-01-01
Possible Accutane side effects in
Reported by a lawyer from United States on 2012-04-26
Patient:
Reactions: Abdominal Pain, Gastrointestinal Haemorrhage, Colitis Ulcerative, Rectal Haemorrhage, Diarrhoea, Gastrointestinal Disorder, Oedema, Colitis, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Isotretinoin
Dosage: unk
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2003-04-01
Amnesteem
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2003-02-01
End date: 2003-04-01
Accutane
Dosage: unk
Indication: Product Used FOR Unknown Indication
Start date: 2002-11-16
End date: 2003-02-01
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-04-25
Patient: male
Reactions: Emotional Distress, Gastrointestinal Disorder
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in female
Reported by a physician from United States on 2012-04-23
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Defaecation Urgency, Abdominal Pain, Cataract, Rectal Haemorrhage, Crohn's Disease, Osteopenia, Internal Injury, Intestinal Haemorrhage, Fatigue, Arthralgia, Gastrointestinal Disorder, Colitis, Abdominal Distension, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Other drugs received by patient: Demulen 1 / 35-21
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-04-12
Patient: male, weighing 83.9 kg (184.6 pounds)
Reactions: Abdominal Pain, Alcohol Abuse, Obsessive-Compulsive Disorder, Colitis Ulcerative, Rectal Haemorrhage, Coma, Ketoacidosis, Somnolence, Delusion, Suicidal Ideation, Body Dysmorphic Disorder, Endodontic Procedure, Hepatotoxicity, Irritable Bowel Syndrome, Depression, Type 1 Diabetes Mellitus, Abscess Limb, Decreased Appetite, Cellulitis, Paranoia, Convulsion, Anxiety, Insomnia, Gastrointestinal Disorder, Colitis, Sleep Apnoea Syndrome, Bulimia Nervosa, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Start date: 2001-11-05
End date: 2001-11-14
Accutane
Indication: Acne
Start date: 2000-04-11
End date: 2000-09-01
Other drugs received by patient: Minocin
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-03-26
Patient: male, weighing 95.3 kg (209.7 pounds)
Reactions: Abdominal Pain, Rectal Haemorrhage, Blood Triglycerides Increased, DRY Skin, Suicidal Ideation, Cheilitis, Haematochezia, Gastrointestinal Disorder, Blood Cholesterol Increased, Depression, Ulcer Haemorrhage, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-03-19
Patient: male, weighing 116.7 kg (256.7 pounds)
Reactions: Gastrointestinal Disorder, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-03-16
Patient: male, weighing 76.7 kg (168.8 pounds)
Reactions: Colitis Ulcerative, Crohn's Disease, Gastrointestinal Disorder, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Other drugs received by patient: Acetaminofen; Zofran; Asacol
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-03-14
Patient: male, weighing 90.8 kg (199.8 pounds)
Reactions: Gastrointestinal Disorder, Irritable Bowel Syndrome, Diverticular Perforation, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Start date: 1984-01-01
End date: 1986-01-01
Accutane
Indication: Product Used FOR Unknown Indication
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-03-14
Patient: female, weighing 47.6 kg (104.7 pounds)
Reactions: Colitis Ulcerative, Anal Stenosis, Delusion, Anorectal Ulcer, Suicidal Ideation, Anal Fistula, Colonic Fistula, Serositis, Pleural Effusion, Depression, Splenomegaly, Fistula, Crohn's Disease, Anaemia, Female Genital Tract Fistula, Osteopenia, Ascites, Anxiety, Arthralgia, Gastrointestinal Disorder, Colitis, Anal Abscess, Vision Blurred, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 1997-11-03
End date: 1997-12-29
Accutane
Dosage: the patient was prescribed accutane 40 mg #30 1 od with food along with 10 mg i od with food.
Administration route: Oral
Other drugs received by patient: Nutracort; Tetracyclin; Famvir; Ranitidine; Aclovate; Benzamycin; Retin-A
Possible Accutane side effects in female
Reported by a lawyer from United States on 2012-03-06
Patient: female, weighing 83.5 kg (183.7 pounds)
Reactions: Abdominal Pain, Colitis Ulcerative, Rectal Haemorrhage, Headache, Constipation, Suicidal Ideation, Weight Increased, Nephrolithiasis, Abdominal Discomfort, Fatigue, Ileitis, Depression, Gastrooesophageal Reflux Disease, Epistaxis, LIP DRY, Nausea, Hyperglycaemia, Crohn's Disease, Trichotillomania, DRY Skin, Nasal Congestion, Internal Injury, Hyperlipidaemia, Intestinal Haemorrhage, Rhinitis Allergic, Bipolar Disorder, Diarrhoea, Gastrointestinal Disorder, Colitis, DRY Eye, Calculus Ureteric, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Accutane
Administration route: Oral
Start date: 2003-06-26
End date: 2003-09-01
Other drugs received by patient: Loestrin 1.5 / 30; Paxil
Possible Accutane side effects in male
Reported by a lawyer from United States on 2012-03-06
Patient: male, weighing 76.2 kg (167.6 pounds)
Reactions: Weight Decreased, Night Sweats, Abdominal Pain, Chronic Fatigue Syndrome, Erythema, Anal Fistula, Dyspepsia, Oedema Peripheral, Mood Swings, Proctalgia, Crohn's Disease, Stress, Internal Injury, Insomnia, Gastrointestinal Disorder, Vision Blurred, Colitis Ulcerative, Pain, Rectal Haemorrhage, Mucous Stools, Suicidal Ideation, Fatigue, Frequent Bowel Movements, Anorectal Disorder, Rectal Fissure, Oedema, Abdominal Distension, Depression, Decreased Appetite, Lethargy, Polyp, Vomiting, Cataract, Nausea, Haemorrhoids, Rash, Self Injurious Behaviour, Anal Fissure, Intestinal Haemorrhage, Haematochezia, Anxiety, Diarrhoea, Bipolar Disorder, Arthralgia, Arthritis, Asthenia, Inflammatory Bowel Disease
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Accutane
Dosage: still receiving treatment on 26 jun 2000
Administration route: Oral
Accutane
Administration route: Oral
Indication: Acne
Start date: 1988-01-01
End date: 1991-01-01
Accutane
Administration route: Oral
Start date: 1994-01-01
End date: 1997-01-01
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