DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more

Amnesteem (Isotretinoin) - Side Effect Reports to FDA

 
 



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 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 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 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 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 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 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 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 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 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 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 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 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

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017