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This is an index of reports of adverse events (side effects, adverse reactions, etc.) related to Accutane (Isotretinoin). Click on the relevant link below to view a selection of reports according to the event's seriousness level and/or the nature of the side effect / adverse reaction. Or scroll down to view a sample of recent reports further on this page.
Our database includes reports from Jan 2007 to Dec 2007. The information is not vetted and should not be cosidered as verified clinical evidence.
All cases (678)
Cases resulting in a serious event (676)
Cases resulting in death (22)
Cases resulting in life threatening events (13)
Cases resulting in hospitalization (368)
Cases resulting in disability (207)
Cases resulting in other serious reactions (445)
Below is a sample of reports where side effects / adverse reactions may be related to Accutane (Isotretinoin). For a complete list and/or a specific selection of reports, please use the links in the index above.
Adverse event in 19 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-31
Patient: 19 year old male, weighing 65.8 kg (144.8 pounds)
Adverse reactions / side effects: Weight Decreased, Anorectal Stenosis, Gastrointestinal Haemorrhage, Colitis Ulcerative, Tachycardia, Ileal Stenosis, Pulmonary Embolism, Pouchitis, Failure TO Thrive, Iron Deficiency Anaemia, Chest Pain, Mesenteric Vein Thrombosis, Pneumoperitoneum, Depression, Venous Thrombosis Limb, Hiatus Hernia, Portal Vein Thrombosis, Anaemia, Paraesthesia, Ileus Paralytic, Small Intestinal Obstruction, Colitis, Bronchial Hyperreactivity, Bradycardia, Hyperthyroidism, Deep Vein Thrombosis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Zithromax
Adverse event in 21 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-31
Patient: 21 year old female
Adverse reactions / side effects: Weight Decreased, Aphthous Stomatitis, Abdominal Pain, Polyp, Colitis Ulcerative, Crohn's Disease, Rectal Haemorrhage, Intestinal Stenosis, Intestinal Haemorrhage, Diarrhoea, Colitis, Irritable Bowel Syndrome, Oesophageal Ulcer, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Oral Contraceptive NOS
Adverse event in male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-31
Patient: male, weighing 70.3 kg (154.7 pounds)
Adverse reactions / side effects: Weight Decreased, Colitis Ulcerative, Pouchitis, Rectal Tenesmus, Suicidal Ideation, Fatigue, Ileitis, Depression, Gastrooesophageal Reflux Disease, Stomatitis, Hiatus Hernia, Crohn's Disease, Anaemia, Immunodeficiency, DRY Skin, Hernia, Anxiety, Arthralgia, Alopecia, Insomnia, Colitis, Gastroenteritis, Drug Dependence, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Vitamin E
Adverse event in 22 year old male receiving Accutane (Isotretinoin)
Reported by a physician from United States on 2007-10-31
Patient: 22 year old male, weighing 89.8 kg (197.6 pounds)
Adverse reactions / side effects: Crohn's Disease, Irritable Bowel Syndrome, Depression, Panic Disorder, Paraesthesia, Anal Fissure
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Doxycycline; Cleocin T; Neurontin
Adverse event in 16 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-31
Patient: 16 year old male, weighing 65.8 kg (144.8 pounds)
Adverse reactions / side effects: Haemorrhage, Colitis Ulcerative, LIP DRY, Anaemia, Rash, DRY Skin, Headache, Intestinal Obstruction, Appendicitis, Anxiety, Emotional Distress, Fatigue, Irritable Bowel Syndrome, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Prednisone; Erythromycin; Triamcinolone; Zithromax; Doxycycline; Benzamycin; Sumycin; Retin-A; Differin
Adverse event in 16 year old male receiving Accutane (Isotretinoin)
Reported by a physician from United States on 2007-10-30
Patient: 16 year old male
Adverse reactions / side effects: Haematochezia
Suspect drug(s):
Accutane
Dosage: the patient was dispensed 40 mg accutane on 11 april 2007 and 16 may 2007
Indication: Drug USE FOR Unknown Indication
Amnesteem
Dosage: the patient was dispensed 40 mg amnesteem on 30 december 2006 and 25 january 2007
Indication: Drug USE FOR Unknown Indication
Sotret
Dosage: the patient was dispensed 40 mg sotret on 05 march 2007
Indication: Drug USE FOR Unknown Indication
Adverse event in 18 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 18 year old female
Adverse reactions / side effects: Colitis Ulcerative, Blood Triglycerides Increased, Menstruation Irregular, Dermatitis, Irritable Bowel Syndrome, Blood Cholesterol Increased, Lipoma, Depression, Back Pain, Crohn's Disease, Alanine Aminotransferase Increased, Otitis Externa, Musculoskeletal Discomfort, DRY Skin, Arthralgia, Aspartate Aminotransferase Increased, Disturbance in Attention, Inguinal Hernia, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Accutane
Administration route: Oral
Start date: 1992-11-18
End date: 1992-12-01
Accutane
Administration route: Oral
Start date: 1992-12-01
End date: 1993-05-19
Accutane
Administration route: Oral
Start date: 1998-06-17
End date: 1999-05-01
Other drugs received by patient: Advil; Desogen; Aleve
Adverse event in 25 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 25 year old female, weighing 59.0 kg (129.8 pounds)
Adverse reactions / side effects: Night Blindness, Agoraphobia, Aggression, Epstein-Barr Virus Infection, Anxiety, Psychotic Disorder, Panic Attack, Mood Altered, Colitis, Pancreatitis, Cholecystectomy, Depression, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane
Administration route: Oral
Indication: Acne
Start date: 1997-03-01
End date: 1997-04-15
Accutane
Administration route: Oral
Start date: 1997-04-16
End date: 1997-05-06
Accutane
Administration route: Oral
Start date: 1997-05-07
End date: 1998-01-01
Accutane
Administration route: Oral
Start date: 1998-06-23
End date: 1998-09-13
Accutane
Administration route: Oral
Start date: 1998-09-14
Accutane
Administration route: Oral
Start date: 1999-04-07
End date: 1999-09-01
Accutane
Administration route: Oral
Start date: 1999-11-19
End date: 2000-07-14
Accutane
Administration route: Oral
Start date: 2000-07-15
End date: 2000-10-05
Accutane
Administration route: Oral
Start date: 2001-04-05
End date: 2001-07-16
Accutane
Administration route: Oral
Start date: 2001-08-14
End date: 2001-12-04
Other drugs received by patient: Fluticasone Propionate; Serevent; LO / Ovral
Adverse event in 16 year old male receiving Accutane (Isotretinoin)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-30
Patient: 16 year old male, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Colitis Ulcerative, Headache, Myalgia, Fatigue, Nasal Dryness, Gastrointestinal Injury, LIP DRY, Acne, Crohn's Disease, Proctocolitis, LIP Pain, Hepatic Enzyme Increased, Intestinal Haemorrhage, Proctitis Ulcerative, Arthritis, Inflammatory Bowel Disease
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Tylenol (Caplet)
Adverse event in 23 year old female receiving Accutane (Isotretinoin)
Reported by a physician from United States on 2007-10-30
Patient: 23 year old female, weighing 46.7 kg (102.7 pounds)
Adverse reactions / side effects: Weight Decreased, Proctitis, Abdominal Pain, Colitis Ulcerative, Rectal Haemorrhage, Headache, Gastritis, Gallbladder Injury, Depression, Cholecystitis, Dyspareunia, Colon Cancer, Hydronephrosis, Internal Hernia, Proctocolitis, Anaemia, Intestinal Haemorrhage, Small Intestinal Obstruction, Arthralgia, Diarrhoea, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Birth Control Pills NOS; Prednisone
Adverse event in 27 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 27 year old male, weighing 79.4 kg (174.7 pounds)
Adverse reactions / side effects: Weight Decreased, Proctitis, Colitis Ulcerative, Thrombocythaemia, Skin Fissures, Dyspepsia, Ileus, Irritable Bowel Syndrome, Depression, Megacolon, Pseudopolyp, Anaemia, Crohn's Disease, Malnutrition, Ileus Paralytic, Hepatic Enzyme Increased, Intestinal Haemorrhage, Insomnia, Colitis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Adverse event in 26 year old male receiving Accutane (Isotretinoin)
Reported by a physician from United States on 2007-10-30
Patient: 26 year old male, weighing 77.1 kg (169.6 pounds)
Adverse reactions / side effects: Proctitis, Colitis Ulcerative, Sciatica, Haemorrhoidal Haemorrhage, Multiple Injuries, Irritable Bowel Syndrome, Gastrointestinal Injury, Intestinal Polyp, Intervertebral Disc Protrusion, Back Pain, Neuropathy, Haemorrhoids, Anal Fissure, Intestinal Haemorrhage, Arthralgia, Colitis, Proctitis Ulcerative, Back Injury, Inflammatory Bowel Disease
Suspect drug(s):
Accutane (Isotretinoin)
Adverse event in 29 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 29 year old female, weighing 61.2 kg (134.6 pounds)
Adverse reactions / side effects: Colitis Ulcerative, Crohn's Disease, Headache, Hunger, Blood Cholesterol Increased, Colitis, Dizziness, Inflammatory Bowel Disease
Suspect drug(s):
Accutane
Start date: 2001-11-30
End date: 2002-06-01
Accutane
Start date: 2002-06-01
End date: 2002-12-01
Other drugs received by patient: Contraceptive; Lexapro; Wellbutrin; Effexor XR
Adverse event in 16 year old male receiving Accutane (Isotretinoin)
Reported by a physician from United States on 2007-10-30
Patient: 16 year old male
Adverse reactions / side effects: Weight Decreased, Abdominal Pain, Liver Injury, Pseudopolyposis, Colitis Ulcerative, Oral Candidiasis, Oesophagitis, Intervertebral Disc Disorder, Hepatotoxicity, Irritable Bowel Syndrome, Depression, Hiatus Hernia, Malnutrition, Anaemia, Crohn's Disease, Hepatic Enzyme Increased, Intestinal Haemorrhage, Anxiety, Diarrhoea, Arthralgia, Gastrointestinal Disorder, Dehydration, Colitis, Arthritis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Adverse event in 30 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 30 year old male, weighing 93.4 kg (205.5 pounds)
Adverse reactions / side effects: Anxiety, Bipolar Disorder, Colitis Ulcerative, Anger, Impulsive Behaviour, Depressed Mood, Suicidal Ideation
Suspect drug(s):
Accutane (Isotretinoin)
Adverse event in 44 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 44 year old male, weighing 74.8 kg (164.6 pounds)
Adverse reactions / side effects: Colitis Ulcerative, Crohn's Disease, Thrombocythaemia, Post Herpetic Neuralgia, Pulmonary Embolism, Herpes Zoster, Nephrolithiasis, Iron Deficiency Anaemia, Fungal Skin Infection, Brachial Plexus Injury, Pancreatitis, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Soma Compound; Anaprox
Adverse event in 17 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 17 year old female
Adverse reactions / side effects: Proctitis, Colitis Ulcerative, Haemorrhage, Blepharitis Allergic, Headache, Gastritis, Oesophageal Stenosis, Upper Respiratory Tract Infection, Acquired Oesophageal WEB, Melanocytic Naevus, Migraine, Intestinal Polyp, Cellulitis, Hiatus Hernia, Eye Inflammation, Anaemia, Haemorrhoids, Anal Fissure, Alopecia, Colitis, Proctitis Ulcerative, Lymphoid Tissue Hyperplasia, Inflammatory Bowel Disease
Adverse event resulted in: disablity
Suspect drug(s):
Accutane
Administration route: Oral
Start date: 1995-01-01
Accutane
Administration route: Oral
Start date: 1997-01-01
Other drugs received by patient: Ortho TRI-Cyclen LO
Adverse event in 18 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 18 year old female, weighing 147.0 kg (323.4 pounds)
Adverse reactions / side effects: Oral Intake Reduced, Bronchopneumonia, Blood Albumin Decreased, Upper Respiratory Tract Infection, Iron Deficiency Anaemia, Oedema Peripheral, Deafness Unilateral, Irritable Bowel Syndrome, Ventricular Extrasystoles, Back Pain, Pneumonia, Visual Field Defect, Supraventricular Tachycardia, Pleurisy, Crohn's Disease, Hypoaesthesia, LIP Ulceration, Hepatic Steatosis, Rhinitis Allergic, Dependence, Insomnia, Dehydration, Anorexia, Gastrointestinal Disorder, Colitis, Colitis Ulcerative, Blood Triglycerides Increased, Oral Herpes, Constipation, Gastric Ulcer, Microcytic Anaemia, Glycosylated Haemoglobin Increased, Liver Function Test Abnormal, Pharyngolaryngeal Pain, Blood Cholesterol Increased, Depression, Eczema Nummular, Injury, Nocturnal Dyspnoea, Sinusitis, Oesophageal Ulcer, Thrombocytopenia, Blood Glucose Increased, Megacolon, Neck Injury, Bruxism, Anxiety, Skin Papilloma, Arthritis, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Tylenol (Caplet); Unspecified Antibiotics
Adverse event in 20 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 20 year old female, weighing 44.5 kg (97.9 pounds)
Adverse reactions / side effects: Colitis Ulcerative, Acne, Anaemia, Colitis, Intestinal Obstruction, Eye Pain, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane
Administration route: Oral
Start date: 1996-07-18
End date: 1996-10-18
Accutane
Dosage: dosage regimen reported as 1-2-1.
Administration route: Oral
Start date: 1996-10-18
End date: 1996-10-31
Accutane
Administration route: Oral
Start date: 1998-05-04
End date: 1998-08-03
Accutane
Dosage: dosage regimen reported as 1-2-1.
Administration route: Oral
Start date: 1998-08-03
End date: 1998-09-22
Accutane
Administration route: Oral
Start date: 1998-09-22
Adverse event in 15 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 15 year old male, weighing 54.4 kg (119.7 pounds)
Adverse reactions / side effects: Gastrointestinal Haemorrhage, Rheumatic Fever, Hepatic Failure, Loss of Consciousness, Substance Abuse, Rheumatoid Arthritis, Ureteric Obstruction, Musculoskeletal Disorder, Ileitis, Tendonitis, Pneumonia, Crohn's Disease, Anaemia, Intestinal Obstruction, Tendon Calcification, Ligament Calcification, Autoimmune Disorder, Gastrointestinal Disorder, Suicide Attempt, Homicidal Ideation, Hepatitis C, Rectal Haemorrhage, Intentional Drug Misuse, Suicidal Ideation, Gastritis, Depression, Intussusception, Polyp, Vomiting, Nausea, Suicidal Behaviour, Neck Injury, Panic Attack, Multi-Organ Disorder, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization, disablity
Suspect drug(s):
Accutane
Indication: Acne
Start date: 1996-10-03
End date: 1996-11-01
Accutane
Start date: 1996-11-01
End date: 1997-08-18
Valium
Indication: Drug USE FOR Unknown Indication
Start date: 2004-10-03
End date: 2004-10-03
Adverse event in female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: female, weighing 48.5 kg (106.7 pounds)
Adverse reactions / side effects: Abdominal Pain, Weight Decreased, Colitis Ulcerative, Osteoporosis, Rectal Haemorrhage, Headache, Lymphadenitis, Anal Fistula, Iron Deficiency Anaemia, Oesophagitis, Irritable Bowel Syndrome, Gastrooesophageal Reflux Disease, Pharyngitis, Vomiting, Pseudopolyp, Nausea, Anaemia, Haemorrhoids, Crohn's Disease, Osteopenia, Intestinal Haemorrhage, Arthralgia, Colitis, Arthritis, Inflammatory Bowel Disease
Suspect drug(s):
Accutane
Administration route: Oral
Start date: 1989-03-09
End date: 1989-08-01
Accutane
Administration route: Oral
Start date: 1992-08-01
End date: 1992-12-01
Other drugs received by patient: Cleocin Hydrochloride; Prednisone; Retin-A; Tetracycline; Amoxicillin
Adverse event in 23 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-30
Patient: 23 year old female, weighing 74.8 kg (164.6 pounds)
Adverse reactions / side effects: Breast Cancer, Polyp, Colitis Ulcerative, Rectal Haemorrhage, Anaemia, Crohn's Disease, Ill-Defined Disorder, Fibrous Histiocytoma, Emotional Distress, Blood Disorder, Irritable Bowel Syndrome, Colitis, Emotional Disorder, Gastrointestinal Tract Adenoma, Inflammatory Bowel Disease
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Advil; Tylenol (Caplet)
Adverse event in 21 year old female receiving Accutane (Isotretinoin)
Reported by a health professional (non-physician/pharmacist) from United States on 2007-10-29
Patient: 21 year old female
Adverse reactions / side effects: NO Adverse Reaction, Pregnancy
Suspect drug(s):
Accutane (Isotretinoin)
Other drugs received by patient: Birth Control Pills NOS
Adverse event in 18 year old male receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-29
Patient: 18 year old male, weighing 74.8 kg (164.6 pounds)
Adverse reactions / side effects: Cellulitis, Colitis Ulcerative, Anaemia, Crohn's Disease, Psoriasis, Ileus, Ileitis, Colitis, Proctitis Ulcerative, Inflammatory Bowel Disease
Adverse event resulted in: hospitalization
Suspect drug(s):
Accutane
Administration route: Oral
Start date: 1997-03-01
End date: 1997-05-01
Accutane
Administration route: Oral
Start date: 1998-02-19
End date: 1998-05-19
Accutane
Administration route: Oral
Other drugs received by patient: Amoxil; Sporanox; Doxycycline
Adverse event in 26 year old female receiving Accutane (Isotretinoin)
Reported by a lawyer from United States on 2007-10-29
Patient: 26 year old female, weighing 76.7 kg (168.7 pounds)
Adverse reactions / side effects: NO Adverse Reaction, Pregnancy
Suspect drug(s):
Accutane
Start date: 1998-03-07
End date: 1998-04-07
Accutane
Start date: 1998-04-07
Accutane
Start date: 1998-05-14
End date: 1998-05-25
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