This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Amnesteem (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 (986)
Death (12)
Life Threatening Events (5)
Disability (4)
Reports by Reaction Type
Inflammatory Bowel Disease (271),
Colitis Ulcerative (85),
Depression (83),
Arthralgia (77),
Blood Triglycerides Increased (73),
Crohn's Disease (58),
Headache (55),
LIP DRY (55),
DRY Skin (54),
Anxiety (54),
Irritable Bowel Syndrome (51),
Maternal Exposure During Pregnancy (49)
Below are a few examples of reports where side effects / adverse reactions may be related to Amnesteem (Isotretinoin). For a complete list or a specific selection of reports, please use the links above.
Possible Amnesteem side effects in 35 year old female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 35 year old female
Reactions: Hospitalisation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amnesteem
End date: 2011-12-01
Amnesteem
Start date: 2012-07-01
Possible Amnesteem side effects in 27 year old female
Reported by a physician from United States on 2012-08-20
Patient: 27 year old female, weighing 104.3 kg (229.5 pounds)
Reactions: Vomiting, Nausea, Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem side effects in 17 year old female
Reported by a consumer/non-health professional from United States on 2012-08-17
Patient: 17 year old female
Reactions: Depression, Suicidal Ideation
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: Oral Contraceptive NOS; Zoloft
Possible Amnesteem side effects in 32 year old female
Reported by a physician from United States on 2012-08-17
Patient: 32 year old female
Reactions: Maternal Exposure Before Pregnancy, Headache
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: YAZ
Possible Amnesteem side effects in 41 year old female
Reported by a physician from United States on 2012-08-15
Patient: 41 year old female, weighing 53.5 kg (117.7 pounds)
Reactions: Rectal Haemorrhage, DRY Skin, Constipation, DRY Eye
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: Vivelle; Prozac; Seroquel
Possible Amnesteem side effects in male
Reported by a lawyer from United States on 2012-08-15
Patient: male, weighing 61.3 kg (134.8 pounds)
Reactions: Anxiety, Colitis Ulcerative, Crohn's Disease, Aspartate Aminotransferase Increased, Irritable Bowel Syndrome, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2006-10-01
End date: 2006-12-01
Amnesteem
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2006-10-04
End date: 2006-11-06
Other drugs received by patient: Imodium A-D; Differin; Clinda
Possible Amnesteem side effects in 12 year old female
Reported by a physician from United States on 2012-08-15
Patient: 12 year old female
Reactions: LIP DRY, DRY Skin, Depression, Headache, Abdominal Pain Upper, Suicidal Ideation
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem side effects in male
Reported by a lawyer from United States on 2012-08-07
Patient: male, weighing 47.6 kg (104.7 pounds)
Reactions: Back Pain, Pain in Extremity, Anaemia, Crohn's Disease, Arthritis Enteropathic, Rheumatoid Arthritis, Arthralgia, Neck Pain, Systemic Inflammatory Response Syndrome, Vision Blurred, Depression, Gastrointestinal Injury, Arthritis, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Administration route: Oral
Indication: Acne
Start date: 2007-02-01
End date: 2007-03-28
Accutane
Administration route: Oral
Start date: 2007-03-29
End date: 2007-08-17
Amnesteem
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Motrin
Possible Amnesteem side effects in 26 year old female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: 26 year old female
Reactions: Irritability, Abdominal Pain, Migraine, Arthralgia, Deafness
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem side effects in 20 year old female
Reported by a physician from United States on 2012-08-02
Patient: 20 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Spontaneous
Drug(s) suspected as cause:
Amnesteem
Administration route: Oral
End date: 2012-05-01
Amnesteem
Administration route: Oral
Start date: 2011-10-04
End date: 2012-01-01
Other drugs received by patient: Oral Contraceptive NOS; Emergency Contraceptives
Possible Amnesteem side effects in 19 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 19 year old female
Reactions: Pain in Extremity, Oedema Peripheral, Erythema, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amnesteem
Dosage: 40 mg, unk
YAZ
Dosage: unk
Administration route: Oral
Indication: Contraception
Start date: 2012-01-01
End date: 2012-06-15
Possible Amnesteem side effects in male
Reported by a lawyer from United States on 2012-07-31
Patient: male
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: 2002-06-01
End date: 2005-07-01
Amnesteem
Indication: Product Used FOR Unknown Indication
Start date: 2005-08-01
End date: 2009-03-01
Possible Amnesteem side effects in male
Reported by a lawyer from United States on 2012-07-26
Patient: male, weighing 56.8 kg (124.9 pounds)
Reactions: Colitis Ulcerative, Xerosis, Stress, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Start date: 2003-10-01
End date: 2004-04-01
Accutane
Start date: 2005-09-01
End date: 2006-02-01
Amnesteem
Indication: Product Used FOR Unknown Indication
Amnesteem
Start date: 2005-01-01
End date: 2006-01-01
Other drugs received by patient: Clindamycin; Cleocin T; Clarinex; Albuterol; Tazorac
Possible Amnesteem side effects in 27 year old female
Reported by a physician from United States on 2012-07-26
Patient: 27 year old female, weighing 104.3 kg (229.5 pounds)
Reactions: Vomiting, Nausea, Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem 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:
Accutane
Indication: Acne
Start date: 2008-11-01
End date: 2009-12-04
Amnesteem
Start date: 2009-01-01
End date: 2010-01-01
Amnesteem
Indication: Acne
Start date: 2004-01-01
End date: 2005-01-01
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 Amnesteem side effects in 19 year old female
Reported by a physician from United States on 2012-07-19
Patient: 19 year old female
Reactions: Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Amnesteem
Administration route: Oral
End date: 2012-03-01
Amnesteem
Administration route: Oral
Start date: 2011-12-23
Other drugs received by patient: Oral Contraceptive NOS
Possible Amnesteem side effects in female
Reported by a lawyer from United States on 2012-07-19
Patient: female
Reactions: Abdominal Pain, Frequent Bowel Movements, Diarrhoea, Colitis Ulcerative, Pain, Rectal Haemorrhage, Inflammatory Bowel Disease
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Accutane
Dosage: unknown
Administration route: Oral
Indication: Acne
Amnesteem
Dosage: unk
Administration route: Oral
Indication: Acne
Start date: 2005-05-01
End date: 2005-12-01
Isotretinoin
Dosage: unknown
Administration route: Oral
Indication: Acne
Possible Amnesteem 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:
Amnesteem
Dosage: unknown
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Sotret
Dosage: unknown
Administration route: Oral
Indication: Acne
Possible Amnesteem side effects in 19 year old female
Reported by a physician from United States on 2012-07-13
Patient: 19 year old female, weighing 54.4 kg (119.7 pounds)
Reactions: Migraine, Lymphadenopathy, Sleep Disorder, Rectal Haemorrhage
Drug(s) suspected as cause:
Amnesteem
Dosage: 80mg qd on wed, sun
Administration route: Oral
Start date: 2012-02-27
End date: 2012-03-29
Amnesteem
Dosage: 40mg m, t, th, fri, sat
Administration route: Oral
Indication: Acne
Start date: 2012-02-27
End date: 2012-03-29
Other drugs received by patient: Allegra; Albuterol; Singulair; Symbicort
Possible Amnesteem side effects in 27 year old female
Reported by a physician from United States on 2012-07-13
Patient: 27 year old female
Reactions: Maternal Exposure Before Pregnancy
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-12
Patient: 31 year old female
Reactions: Maternal Exposure During Pregnancy
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: Contraceptive
Possible Amnesteem side effects in 31 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-10
Patient: 31 year old female
Reactions: Maternal Exposure During Pregnancy, Blood Cholesterol Increased
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: Contraceptive
Possible Amnesteem side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-06
Patient: female
Reactions: Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amnesteem
Dosage: 40 mg, unk
YAZ
Dosage: unk
Administration route: Oral
Possible Amnesteem side effects in male
Reported by a lawyer from United States on 2012-07-05
Patient: male
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: 2010-02-01
End date: 2010-03-01
Amnesteem
Indication: Product Used FOR Unknown Indication
Start date: 2010-03-01
End date: 2010-06-01
Claravis
Indication: Product Used FOR Unknown Indication
Start date: 2009-10-01
End date: 2010-01-01
Possible Amnesteem side effects in 16 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-03
Patient: 16 year old male
Reactions: Depression, Suicidal Ideation
Drug(s) suspected as cause:
Amnesteem
Administration route: Oral
Start date: 2011-11-21
End date: 2012-04-01
Amnesteem
Administration route: Oral
Indication: Acne
Start date: 2011-11-21
End date: 2012-04-01
Other drugs received by patient: Concerta
Possible Amnesteem side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-29
Patient: female
Reactions: Dehydration, Colonic Obstruction, Gallbladder Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Amnesteem
Possible Amnesteem side effects in 17 year old female
Reported by a physician from United States on 2012-06-29
Patient: 17 year old female
Reactions: Maternal Exposure During Pregnancy, Abortion Induced
Drug(s) suspected as cause:
Amnesteem
Administration route: Oral
Amnesteem
Administration route: Oral
Start date: 2012-04-01
End date: 2012-01-01
Other drugs received by patient: Oral Contraceptive NOS
Possible Amnesteem side effects in 32 year old female
Reported by a physician from United States on 2012-06-28
Patient: 32 year old female
Reactions: Maternal Exposure Before Pregnancy, Headache
Drug(s) suspected as cause:
Amnesteem
Other drugs received by patient: YAZ
Possible Amnesteem side effects in female
Reported by a lawyer from United States on 2012-06-22
Patient: female, weighing 53.6 kg (117.9 pounds)
Reactions: Colitis Ulcerative, Malnutrition, Stress, Suicidal Ideation, Cheilitis, Xerosis, Irritable Bowel Syndrome, Depression, Crying, Inflammatory Bowel Disease
Drug(s) suspected as cause:
Accutane
Indication: Acne
Accutane
Accutane
Start date: 2002-01-01
End date: 2003-01-01
Amnesteem
Indication: Product Used FOR Unknown Indication
Possible Amnesteem 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
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