Drug information for AMNESTEEM
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
CAPSULE; ORAL
10MG
Prescription
AB
ISOTRETINOIN
Isotretinoin
MYLAN
75945
2012-03-28 Review
2012-03-28 Review
2003-12-17 Other Important Information from FDA
2002-11-08 Letter
CAPSULE; ORAL
20MG
Prescription
AB (Reference Drug)
ISOTRETINOIN
Isotretinoin
MYLAN
"
CAPSULE; ORAL
40MG
Prescription
AB (Reference Drug)
ISOTRETINOIN
Isotretinoin
MYLAN
"
Drug Adverse Effects information for AMNESTEEM
Role code
Indications
Reaction
# Reports
PS
ACNE
BLOOD CHOLESTEROL INCREASED
1
PS
ACNE
BLOOD TRIGLYCERIDES INCREASED
1
PS
ACNE
CONVULSION
1
PS
ACNE
DEPRESSION
1
PS
ACNE
EPISTAXIS
1
PS
ACNE
EYE PAIN
1
PS
ACNE
FEMALE REPRODUCTIVE NEOPLASM
1
PS
ACNE
HEADACHE
1
PS
ACNE
MAJOR DEPRESSION
1
PS
ACNE
SUICIDAL IDEATION
2
PS
ACNE CYSTIC
BLOOD CHOLESTEROL INCREASED
1
PS
ACNE CYSTIC
BLOOD TRIGLYCERIDES INCREASED
1
PS
ACNE CYSTIC
FEMALE REPRODUCTIVE NEOPLASM
1
PS
ACNE CYSTIC
MOOD ALTERED
1
PS
ACNE CYSTIC
PULMONARY EMBOLISM
1
PS
ACNE CYSTIC
SUICIDAL IDEATION
1
PS
CELLULITIS
PULMONARY EMBOLISM
1
PS
CYST
DEPRESSION
1
PS
CYST
SUICIDAL IDEATION
1
PS
FOLLICULITIS
DEPRESSION
1
PS
FOLLICULITIS
SUICIDAL IDEATION
1
SS
ACNE
ABDOMINAL PAIN
1
SS
ACNE
ACNE
4
SS
ACNE
ACUTE FEBRILE NEUTROPHILIC DERMATOSIS
3
SS
ACNE
ALANINE AMINOTRANSFERASE INCREASED
8
SS
ACNE
ALOPECIA
1
SS
ACNE
ANAEMIA
7
SS
ACNE
ANAL ABSCESS
7
SS
ACNE
ANAL FISSURE
15
SS
ACNE
ANAL FISTULA
9
SS
ACNE
ANXIETY
43
SS
ACNE
APHTHOUS STOMATITIS
3
SS
ACNE
ARTHRALGIA
8
SS
ACNE
ARTHRITIS
6
SS
ACNE
ASPARTATE AMINOTRANSFERASE INCREASED
23
SS
ACNE
BACK PAIN
13
SS
ACNE
BLOOD CHOLESTEROL INCREASED
10
SS
ACNE
BLOOD TRIGLYCERIDES INCREASED
42
SS
ACNE
BRONCHITIS
3
SS
ACNE
CHAPPED LIPS
6
SS
ACNE
CHEILITIS
3
SS
ACNE
CHEST PAIN
1
SS
ACNE
CLOSTRIDIUM DIFFICILE COLITIS
3
SS
ACNE
COLITIS
28
SS
ACNE
COLITIS ULCERATIVE
59
SS
ACNE
COLONIC POLYP
3
SS
ACNE
COUGH
1
SS
ACNE
CROHN'S DISEASE
40
SS
ACNE
DEPRESSION
40
SS
ACNE
DERMAL CYST
3
SS
ACNE
DERMATITIS CONTACT
13
SS
ACNE
DRY EYE
5
SS
ACNE
DRY MOUTH
3
SS
ACNE
DRY SKIN
22
SS
ACNE
EAR PAIN
13
SS
ACNE
ECZEMA
13
SS
ACNE
EMOTIONAL DISTRESS
15
SS
ACNE
EXTERNAL EAR CELLULITIS
3
SS
ACNE
FATIGUE
5
SS
ACNE
FEMALE REPRODUCTIVE NEOPLASM
1
SS
ACNE
FOLLICULITIS
4
SS
ACNE
FUNGAL INFECTION
3
SS
ACNE
GASTRITIS
1
SS
ACNE
GENITAL HERPES
3
SS
ACNE
GOITRE
13
SS
ACNE
HAEMORRHOIDS
19
SS
ACNE
HEADACHE
11
SS
ACNE
HYPOAESTHESIA
1
SS
ACNE
HYPOTHYROIDISM
13
SS
ACNE
ILEAL STENOSIS
4
SS
ACNE
INFLAMMATORY BOWEL DISEASE
108
SS
ACNE
INJURY
16
SS
ACNE
INTERVERTEBRAL DISC DEGENERATION
13
SS
ACNE
INTESTINAL HAEMORRHAGE
12
SS
ACNE
INTESTINAL OBSTRUCTION
12
SS
ACNE
INTESTINAL PERFORATION
1
SS
ACNE
IRON DEFICIENCY ANAEMIA
3
SS
ACNE
IRRITABLE BOWEL SYNDROME
34
SS
ACNE
LIP DRY
38
SS
ACNE
LIPIDS INCREASED
13
SS
ACNE
LIVER FUNCTION TEST ABNORMAL
5
SS
ACNE
MENTAL DISORDER
2
SS
ACNE
MUSCULOSKELETAL PAIN
6
SS
ACNE
NASAL DRYNESS
3
SS
ACNE
NAUSEA
4
SS
ACNE
OBSESSIVE-COMPULSIVE DISORDER
3
SS
ACNE
OESOPHAGITIS
4
SS
ACNE
ORAL HERPES
9
SS
ACNE
PANIC ATTACK
2
SS
ACNE
PHOTOPSIA
13
SS
ACNE
POLYP
5
SS
ACNE
PROCTITIS
13
SS
ACNE
PROTEINURIA
1
SS
ACNE
PYODERMA GANGRENOSUM
3
SS
ACNE
QUALITY OF LIFE DECREASED
1
SS
ACNE
RASH PRURITIC
3
SS
ACNE
RECTAL ABSCESS
8
SS
ACNE
SINUSITIS
1
SS
ACNE
SMALL INTESTINAL OBSTRUCTION
8
SS
ACNE
STRESS
4
SS
ACNE
SUBCUTANEOUS ABSCESS
1
SS
ACNE
SUICIDAL IDEATION
12
SS
ACNE
TINEA INFECTION
3
SS
ACNE
TOOTH EXTRACTION
3
SS
ACNE
ULCER
1
SS
ACNE
UPPER RESPIRATORY TRACT INFECTION
13
SS
ACNE
URINARY TRACT INFECTION
8
SS
ACNE
VIRAL INFECTION
13
SS
ACNE
XEROSIS
13
SS
ACNE CYSTIC
ABDOMINAL PAIN
1
SS
ACNE CYSTIC
ACNE
4
SS
ACNE CYSTIC
ALOPECIA
1
SS
ACNE CYSTIC
ANXIETY
1
SS
ACNE CYSTIC
ARTHRALGIA
1
SS
ACNE CYSTIC
BLOOD CHOLESTEROL INCREASED
2
SS
ACNE CYSTIC
BLOOD TRIGLYCERIDES INCREASED
3
SS
ACNE CYSTIC
CHAPPED LIPS
4
SS
ACNE CYSTIC
CHEST PAIN
1
SS
ACNE CYSTIC
COLITIS ULCERATIVE
4
SS
ACNE CYSTIC
COUGH
1
SS
ACNE CYSTIC
CROHN'S DISEASE
3
SS
ACNE CYSTIC
DEPRESSION
17
SS
ACNE CYSTIC
DRY SKIN
16
SS
ACNE CYSTIC
EMOTIONAL DISTRESS
1
SS
ACNE CYSTIC
FEMALE REPRODUCTIVE NEOPLASM
1
SS
ACNE CYSTIC
GASTRITIS
1
SS
ACNE CYSTIC
GASTROINTESTINAL HAEMORRHAGE
4
SS
ACNE CYSTIC
HAEMORRHOIDS
4
SS
ACNE CYSTIC
HYPOAESTHESIA
1
SS
ACNE CYSTIC
ILEAL STENOSIS
1
SS
ACNE CYSTIC
INFLAMMATORY BOWEL DISEASE
7
SS
ACNE CYSTIC
INJURY
1
SS
ACNE CYSTIC
INTESTINAL OBSTRUCTION
2
SS
ACNE CYSTIC
INTESTINAL PERFORATION
1
SS
ACNE CYSTIC
IRRITABLE BOWEL SYNDROME
4
SS
ACNE CYSTIC
LIP DRY
13
SS
ACNE CYSTIC
OESOPHAGITIS
1
SS
ACNE CYSTIC
ORAL HERPES
1
SS
ACNE CYSTIC
PROTEINURIA
1
SS
ACNE CYSTIC
PULMONARY EMBOLISM
1
SS
ACNE CYSTIC
QUALITY OF LIFE DECREASED
1
SS
ACNE CYSTIC
RASH
4
SS
ACNE CYSTIC
SINUSITIS
1
SS
ACNE CYSTIC
STRESS
1
SS
ACNE CYSTIC
SUBCUTANEOUS ABSCESS
1
SS
ACNE CYSTIC
SUICIDAL IDEATION
12
SS
ACNE CYSTIC
ULCER
1
SS
BLOOD CHOLESTEROL INCREASED
ACNE
2
SS
BLOOD CHOLESTEROL INCREASED
CHAPPED LIPS
2
SS
BLOOD CHOLESTEROL INCREASED
COLITIS ULCERATIVE
2
SS
BLOOD CHOLESTEROL INCREASED
DEPRESSION
2
SS
BLOOD CHOLESTEROL INCREASED
DRY SKIN
2
SS
BLOOD CHOLESTEROL INCREASED
GASTROINTESTINAL HAEMORRHAGE
2
SS
BLOOD CHOLESTEROL INCREASED
HAEMORRHOIDS
2
SS
BLOOD CHOLESTEROL INCREASED
INFLAMMATORY BOWEL DISEASE
2
SS
BLOOD CHOLESTEROL INCREASED
IRRITABLE BOWEL SYNDROME
2
SS
BLOOD CHOLESTEROL INCREASED
RASH
2
SS
CELLULITIS
PULMONARY EMBOLISM
1
SS
COLITIS ULCERATIVE
ACNE
8
SS
COLITIS ULCERATIVE
ANAEMIA
8
SS
COLITIS ULCERATIVE
ARTHRALGIA
8
SS
COLITIS ULCERATIVE
COLITIS ULCERATIVE
8
SS
COLITIS ULCERATIVE
DEPRESSION
8
SS
COLITIS ULCERATIVE
FOLLICULITIS
8
SS
COLITIS ULCERATIVE
INFLAMMATORY BOWEL DISEASE
8
SS
COLITIS ULCERATIVE
INTESTINAL HAEMORRHAGE
8
SS
COLITIS ULCERATIVE
INTESTINAL OBSTRUCTION
8
SS
COLITIS ULCERATIVE
NAUSEA
8
SS
CONTRACEPTION
ABORTION SPONTANEOUS
4
SS
CONTRACEPTION
ACNE
2
SS
CONTRACEPTION
BLIGHTED OVUM
4
SS
CONTRACEPTION
CHAPPED LIPS
2
SS
CONTRACEPTION
COLITIS ULCERATIVE
2
SS
CONTRACEPTION
DEPRESSION
2
SS
CONTRACEPTION
DRY SKIN
2
SS
CONTRACEPTION
GASTROINTESTINAL HAEMORRHAGE
2
SS
CONTRACEPTION
HAEMORRHOIDS
2
SS
CONTRACEPTION
INFLAMMATORY BOWEL DISEASE
2
SS
CONTRACEPTION
IRRITABLE BOWEL SYNDROME
2
SS
CONTRACEPTION
MATERNAL EXPOSURE BEFORE PREGNANCY
4
SS
CONTRACEPTION
RASH
2
SS
CONTRACEPTION
VAGINAL HAEMORRHAGE
4
SS
CYST
DEPRESSION
1
SS
CYST
SUICIDAL IDEATION
1
SS
FOLLICULITIS
DEPRESSION
1
SS
FOLLICULITIS
SUICIDAL IDEATION
1
SS
HYPERTENSION
ANXIETY
3
SS
HYPERTENSION
BLOOD CHOLESTEROL INCREASED
3
SS
HYPERTENSION
BLOOD TRIGLYCERIDES INCREASED
3
SS
HYPERTENSION
CHEST PAIN
3
SS
HYPERTENSION
COUGH
3
SS
HYPERTENSION
CROHN'S DISEASE
3
SS
HYPERTENSION
EMOTIONAL DISTRESS
3
SS
HYPERTENSION
HYPOAESTHESIA
3
SS
HYPERTENSION
INFLAMMATORY BOWEL DISEASE
3
SS
HYPERTENSION
INJURY
3
SS
HYPERTENSION
INTESTINAL OBSTRUCTION
3
SS
HYPERTENSION
SINUSITIS
3
SS
HYPOTHYROIDISM
ABDOMINAL PAIN
1
SS
HYPOTHYROIDISM
ALOPECIA
1
SS
HYPOTHYROIDISM
ARTHRALGIA
1
SS
HYPOTHYROIDISM
BLOOD TRIGLYCERIDES INCREASED
1
SS
HYPOTHYROIDISM
CROHN'S DISEASE
1
SS
HYPOTHYROIDISM
DEPRESSION
1
SS
HYPOTHYROIDISM
ILEAL STENOSIS
1
SS
HYPOTHYROIDISM
INFLAMMATORY BOWEL DISEASE
1
SS
HYPOTHYROIDISM
INTESTINAL PERFORATION
1
SS
HYPOTHYROIDISM
LIP DRY
1
SS
HYPOTHYROIDISM
PROTEINURIA
1
SS
HYPOTHYROIDISM
QUALITY OF LIFE DECREASED
1
SS
HYPOTHYROIDISM
STRESS
1
SS
HYPOTHYROIDISM
SUBCUTANEOUS ABSCESS
1
SS
NASOPHARYNGITIS
BLOOD CHOLESTEROL INCREASED
4
SS
NASOPHARYNGITIS
BLOOD TRIGLYCERIDES INCREASED
4
SS
NASOPHARYNGITIS
COLITIS ULCERATIVE
4
SS
NASOPHARYNGITIS
DEPRESSION
4
SS
NASOPHARYNGITIS
INFLAMMATORY BOWEL DISEASE
4
SS
NASOPHARYNGITIS
RECTAL ABSCESS
4
SS
PAIN
BLOOD CHOLESTEROL INCREASED
2
SS
PAIN
BLOOD TRIGLYCERIDES INCREASED
2
SS
PAIN
COLITIS ULCERATIVE
2
SS
PAIN
DEPRESSION
2
SS
PAIN
INFLAMMATORY BOWEL DISEASE
2
SS
PAIN
RECTAL ABSCESS
2
SS
PRODUCT USED FOR UNKNOWN INDICATION
ANXIETY
6
SS
PRODUCT USED FOR UNKNOWN INDICATION
COLITIS ULCERATIVE
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
EMOTIONAL DISTRESS
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
INFLAMMATORY BOWEL DISEASE
7
SS
PRODUCT USED FOR UNKNOWN INDICATION
INJURY
4
SS
PRODUCT USED FOR UNKNOWN INDICATION
IRRITABLE BOWEL SYNDROME
4
SS
SEBACEOUS HYPERPLASIA
COLITIS ULCERATIVE
1
SS
SEBACEOUS HYPERPLASIA
EMOTIONAL DISTRESS
1
SS
SEBACEOUS HYPERPLASIA
INFLAMMATORY BOWEL DISEASE
1
SS
SEBACEOUS HYPERPLASIA
MENTAL DISORDER
1
SS
STOMATITIS
CROHN'S DISEASE
1
SS
STOMATITIS
GASTRITIS
1
SS
STOMATITIS
INFLAMMATORY BOWEL DISEASE
1
SS
STOMATITIS
INTESTINAL OBSTRUCTION
1
SS
STOMATITIS
OESOPHAGITIS
1
SS
STOMATITIS
ORAL HERPES
1
SS
STOMATITIS
ULCER
1
C
ACNE
ABDOMINAL PAIN
1
C
ACNE
ABORTION SPONTANEOUS
1
C
ACNE
ANXIETY
2
C
ACNE
CHEST PAIN
1
C
ACNE
CHOLECYSTITIS CHRONIC
1
C
ACNE
DEEP VEIN THROMBOSIS
1
C
ACNE
DYSPNOEA
1
C
ACNE
EMOTIONAL DISTRESS
2
C
ACNE
FEAR
1
C
ACNE
GALLBLADDER NON-FUNCTIONING
1
C
ACNE
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
ACNE
INJURY
2
C
ACNE
MENTAL DISORDER
1
C
ACNE
MUSCLE SWELLING
1
C
ACNE
OEDEMA PERIPHERAL
1
C
ACNE
PAIN
2
C
ACNE
PAIN IN EXTREMITY
1
C
ACNE
PULMONARY EMBOLISM
1
C
ACNE
PULMONARY INFARCTION
1
C
ACNE
THROMBOPHLEBITIS SUPERFICIAL
1
C
ACNE
THROMBOSIS
1
C
ACNE CYSTIC
ABORTION SPONTANEOUS
3
C
ACNE CYSTIC
ANXIETY
3
C
ACNE CYSTIC
CHEST PAIN
3
C
ACNE CYSTIC
DEEP VEIN THROMBOSIS
3
C
ACNE CYSTIC
DYSPNOEA
3
C
ACNE CYSTIC
EMOTIONAL DISTRESS
3
C
ACNE CYSTIC
FEAR
3
C
ACNE CYSTIC
GENERAL PHYSICAL HEALTH DETERIORATION
3
C
ACNE CYSTIC
INJURY
3
C
ACNE CYSTIC
MUSCLE SWELLING
3
C
ACNE CYSTIC
OEDEMA PERIPHERAL
3
C
ACNE CYSTIC
PAIN
3
C
ACNE CYSTIC
PAIN IN EXTREMITY
3
C
ACNE CYSTIC
PULMONARY EMBOLISM
3
C
ACNE CYSTIC
PULMONARY INFARCTION
3
C
ACNE CYSTIC
THROMBOPHLEBITIS SUPERFICIAL
3
C
ACNE CYSTIC
THROMBOSIS
3
C
CONTRACEPTION
ABDOMINAL PAIN
1
C
CONTRACEPTION
ABORTION SPONTANEOUS
1
C
CONTRACEPTION
ANXIETY
2
C
CONTRACEPTION
CHEST PAIN
1
C
CONTRACEPTION
CHOLECYSTITIS CHRONIC
1
C
CONTRACEPTION
DEEP VEIN THROMBOSIS
1
C
CONTRACEPTION
DYSPNOEA
1
C
CONTRACEPTION
EMOTIONAL DISTRESS
2
C
CONTRACEPTION
FEAR
1
C
CONTRACEPTION
GALLBLADDER NON-FUNCTIONING
1
C
CONTRACEPTION
GENERAL PHYSICAL HEALTH DETERIORATION
2
C
CONTRACEPTION
INJURY
2
C
CONTRACEPTION
MENTAL DISORDER
1
C
CONTRACEPTION
MUSCLE SWELLING
1
C
CONTRACEPTION
OEDEMA PERIPHERAL
1
C
CONTRACEPTION
PAIN
2
C
CONTRACEPTION
PAIN IN EXTREMITY
1
C
CONTRACEPTION
PULMONARY EMBOLISM
1
C
CONTRACEPTION
PULMONARY INFARCTION
1
C
CONTRACEPTION
THROMBOPHLEBITIS SUPERFICIAL
1
C
CONTRACEPTION
THROMBOSIS
1
C
INFECTION
ABORTION SPONTANEOUS
1
C
INFECTION
ANXIETY
1
C
INFECTION
CHEST PAIN
1
C
INFECTION
DEEP VEIN THROMBOSIS
1
C
INFECTION
DYSPNOEA
1
C
INFECTION
EMOTIONAL DISTRESS
1
C
INFECTION
FEAR
1
C
INFECTION
GENERAL PHYSICAL HEALTH DETERIORATION
1
C
INFECTION
INJURY
1
C
INFECTION
MUSCLE SWELLING
1
C
INFECTION
OEDEMA PERIPHERAL
1
C
INFECTION
PAIN
1
C
INFECTION
PAIN IN EXTREMITY
1
C
INFECTION
PULMONARY EMBOLISM
1
C
INFECTION
PULMONARY INFARCTION
1
C
INFECTION
THROMBOPHLEBITIS SUPERFICIAL
1
C
INFECTION
THROMBOSIS
1
Ads by Google