Drug information for MISOPROSTOL
Form
Dosage
Status
Therapeutic Equivalence
Active Ingred
Ref.
Sponsor
Document
TABLET; ORAL
0.1MG
Prescription
AB
MISOPROSTOL
Misoprostol
IVAX SUB TEVA PHARMS
76095
2005-07-29 Other Important Information from FDA
2005-07-22 Review
2002-07-10 Letter
TABLET; ORAL
0.2MG
Prescription
AB
MISOPROSTOL
Misoprostol
IVAX SUB TEVA PHARMS
"
Drug Adverse Effects information for MISOPROSTOL
Role code
Indications
Reaction
# Reports
PS
ARTHRALGIA
CARBOHYDRATE ANTIGEN 125 INCREASED
1
PS
ARTHRALGIA
OVARIAN CANCER METASTATIC
2
PS
CHEST PAIN
CARBOHYDRATE ANTIGEN 125 INCREASED
1
PS
CHEST PAIN
OVARIAN CANCER METASTATIC
2
PS
GASTROOESOPHAGEAL REFLUX DISEASE
CARBOHYDRATE ANTIGEN 125 INCREASED
1
PS
GASTROOESOPHAGEAL REFLUX DISEASE
OVARIAN CANCER METASTATIC
2
PS
MENOPAUSAL SYMPTOMS
CARBOHYDRATE ANTIGEN 125 INCREASED
1
PS
MENOPAUSAL SYMPTOMS
OVARIAN CANCER METASTATIC
2
PS
PROLONGED PREGNANCY
MATERNAL EXPOSURE DURING PREGNANCY
1
PS
PROLONGED PREGNANCY
UTERINE RUPTURE
1
SS
ABORTION INDUCED
ABDOMINAL PAIN
5
SS
ABORTION INDUCED
ABORTION
1
SS
ABORTION INDUCED
ABORTION INCOMPLETE
35
SS
ABORTION INDUCED
ANAEMIA
15
SS
ABORTION INDUCED
ASTHENIA
2
SS
ABORTION INDUCED
BACK PAIN
1
SS
ABORTION INDUCED
BREAST TENDERNESS
1
SS
ABORTION INDUCED
CHILLS
1
SS
ABORTION INDUCED
CONVULSION
1
SS
ABORTION INDUCED
DEEP VEIN THROMBOSIS
1
SS
ABORTION INDUCED
DIZZINESS
9
SS
ABORTION INDUCED
DYSPNOEA
2
SS
ABORTION INDUCED
ECTOPIC PREGNANCY
1
SS
ABORTION INDUCED
ENDOMETRIAL HYPERTROPHY
1
SS
ABORTION INDUCED
ENDOMETRITIS
6
SS
ABORTION INDUCED
HAEMATOMA
1
SS
ABORTION INDUCED
HAEMORRHAGE
41
SS
ABORTION INDUCED
HEADACHE
1
SS
ABORTION INDUCED
HYPERHIDROSIS
1
SS
ABORTION INDUCED
HYPERSENSITIVITY
1
SS
ABORTION INDUCED
HYPOTENSION
1
SS
ABORTION INDUCED
INFECTION
2
SS
ABORTION INDUCED
MENORRHAGIA
12
SS
ABORTION INDUCED
MUSCLE SPASMS
11
SS
ABORTION INDUCED
NAUSEA
4
SS
ABORTION INDUCED
PAIN
10
SS
ABORTION INDUCED
PELVIC INFLAMMATORY DISEASE
1
SS
ABORTION INDUCED
PELVIC PAIN
1
SS
ABORTION INDUCED
PREGNANCY
9
SS
ABORTION INDUCED
PYELONEPHRITIS
1
SS
ABORTION INDUCED
PYREXIA
6
SS
ABORTION INDUCED
RETAINED PRODUCTS OF CONCEPTION
1
SS
ABORTION INDUCED
SWELLING FACE
2
SS
ABORTION INDUCED
SYNCOPE
6
SS
ABORTION INDUCED
TENDERNESS
1
SS
ABORTION INDUCED
THROMBOSIS
2
SS
ABORTION INDUCED
UTERINE HAEMORRHAGE
1
SS
ABORTION INDUCED
VAGINAL DISCHARGE
1
SS
ABORTION INDUCED
VAGINAL ODOUR
2
SS
ABORTION INDUCED
VAGINITIS BACTERIAL
1
SS
ABORTION INDUCED
VOMITING
8
SS
ANAESTHESIA
RESPIRATORY DEPRESSION
1
SS
PRODUCT USED FOR UNKNOWN INDICATION
ASTHMA
44
SS
PRODUCT USED FOR UNKNOWN INDICATION
IDIOPATHIC THROMBOCYTOPENIC PURPURA
44
SS
PRODUCT USED FOR UNKNOWN INDICATION
MUSCULOSKELETAL STIFFNESS
11
SS
PRODUCT USED FOR UNKNOWN INDICATION
OSTEOARTHRITIS
44
SS
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
11
SS
PRODUCT USED FOR UNKNOWN INDICATION
RHEUMATOID ARTHRITIS
44
SS
PRODUCT USED FOR UNKNOWN INDICATION
SWELLING
11
SS
RHEUMATOID ARTHRITIS
CACHEXIA
6
SS
RHEUMATOID ARTHRITIS
CHEST DISCOMFORT
6
SS
RHEUMATOID ARTHRITIS
CHILLS
6
SS
RHEUMATOID ARTHRITIS
DECREASED APPETITE
6
SS
RHEUMATOID ARTHRITIS
DYSGEUSIA
6
SS
RHEUMATOID ARTHRITIS
DYSPNOEA EXERTIONAL
6
SS
RHEUMATOID ARTHRITIS
FATIGUE
6
SS
RHEUMATOID ARTHRITIS
HEADACHE
6
SS
RHEUMATOID ARTHRITIS
HUNGER
6
SS
RHEUMATOID ARTHRITIS
HYPOAESTHESIA
6
SS
RHEUMATOID ARTHRITIS
LOWER RESPIRATORY TRACT INFECTION
6
SS
RHEUMATOID ARTHRITIS
MALAISE
6
SS
RHEUMATOID ARTHRITIS
NASOPHARYNGITIS
6
SS
RHEUMATOID ARTHRITIS
OEDEMA PERIPHERAL
6
SS
RHEUMATOID ARTHRITIS
PNEUMONIA CRYPTOCOCCAL
6
SS
RHEUMATOID ARTHRITIS
PRODUCTIVE COUGH
6
SS
RHEUMATOID ARTHRITIS
PULMONARY MASS
6
SS
RHEUMATOID ARTHRITIS
PYREXIA
6
SS
RHEUMATOID ARTHRITIS
RHEUMATOID ARTHRITIS
6
C
ABORTION
ANXIETY
2
C
ABORTION
DEEP VEIN THROMBOSIS
2
C
ABORTION
INJURY
2
C
ABORTION
PAIN
2
C
ABORTION
PULMONARY EMBOLISM
2
C
ABORTION INDUCED
DYSKINESIA
2
C
ABORTION INDUCED
DYSTONIA
9
C
ABORTION INDUCED
MATERNAL EXPOSURE DURING PREGNANCY
2
C
ANALGESIC THERAPY
ABDOMINAL DISCOMFORT
1
C
ANALGESIC THERAPY
DIARRHOEA
1
C
ANALGESIC THERAPY
DISCOMFORT
1
C
ANALGESIC THERAPY
FATIGUE
1
C
ANALGESIC THERAPY
INTERVERTEBRAL DISC OPERATION
1
C
ANALGESIC THERAPY
MALAISE
1
C
ANALGESIC THERAPY
NASAL SEPTUM DEVIATION
1
C
ANALGESIC THERAPY
NAUSEA
1
C
ANALGESIC THERAPY
PAIN
1
C
ANALGESIC THERAPY
VOMITING
1
C
ANKYLOSING SPONDYLITIS
ABDOMINAL DISCOMFORT
1
C
ANKYLOSING SPONDYLITIS
DIARRHOEA
1
C
ANKYLOSING SPONDYLITIS
DISCOMFORT
1
C
ANKYLOSING SPONDYLITIS
FATIGUE
1
C
ANKYLOSING SPONDYLITIS
INTERVERTEBRAL DISC OPERATION
1
C
ANKYLOSING SPONDYLITIS
MALAISE
1
C
ANKYLOSING SPONDYLITIS
NASAL SEPTUM DEVIATION
1
C
ANKYLOSING SPONDYLITIS
NAUSEA
1
C
ANKYLOSING SPONDYLITIS
PAIN
1
C
ANKYLOSING SPONDYLITIS
VOMITING
1
C
ANXIETY
ANXIETY
2
C
ANXIETY
DEEP VEIN THROMBOSIS
2
C
ANXIETY
INJURY
2
C
ANXIETY
PAIN
2
C
ANXIETY
PULMONARY EMBOLISM
2
C
ATRIAL FIBRILLATION
ATRIAL FIBRILLATION
2
C
ATRIAL FIBRILLATION
BACK PAIN
1
C
ATRIAL FIBRILLATION
CAROTID ARTERY STENOSIS
1
C
ATRIAL FIBRILLATION
CORONARY ARTERY DISEASE
1
C
ATRIAL FIBRILLATION
DIARRHOEA
1
C
ATRIAL FIBRILLATION
ECONOMIC PROBLEM
1
C
ATRIAL FIBRILLATION
GINGIVAL INFECTION
1
C
ATRIAL FIBRILLATION
HYPERLIPIDAEMIA
1
C
ATRIAL FIBRILLATION
HYPERTENSION
1
C
ATRIAL FIBRILLATION
MULTIPLE INJURIES
1
C
ATRIAL FIBRILLATION
NAUSEA
1
C
ATRIAL FIBRILLATION
SYNCOPE
1
C
ATRIAL FIBRILLATION
TYPE 2 DIABETES MELLITUS
1
C
CONSTIPATION
ANAL SPHINCTER ATONY
2
C
CONSTIPATION
ANAL SPHINCTER HYPERTONIA
2
C
CONSTIPATION
ARTHRALGIA
2
C
CONSTIPATION
CHEILITIS
2
C
CONSTIPATION
CONSTIPATION
2
C
CONSTIPATION
COORDINATION ABNORMAL
2
C
CONSTIPATION
DRUG INEFFECTIVE
2
C
CONSTIPATION
EAR PAIN
2
C
CONSTIPATION
EPISCLERITIS
2
C
CONSTIPATION
ERYTHEMA
2
C
CONSTIPATION
FAECAL INCONTINENCE
2
C
CONSTIPATION
FALL
2
C
CONSTIPATION
FATIGUE
2
C
CONSTIPATION
FLUSHING
2
C
CONSTIPATION
FOLLICULITIS
2
C
CONSTIPATION
FUNCTIONAL GASTROINTESTINAL DISORDER
2
C
CONSTIPATION
IMPAIRED GASTRIC EMPTYING
2
C
CONSTIPATION
LIGAMENT SPRAIN
2
C
CONSTIPATION
LOWER RESPIRATORY TRACT INFECTION
2
C
CONSTIPATION
MUSCLE SPASTICITY
2
C
CONSTIPATION
NAIL INFECTION
2
C
CONSTIPATION
OEDEMA PERIPHERAL
2
C
CONSTIPATION
PAIN IN EXTREMITY
2
C
CONSTIPATION
RASH
2
C
CONSTIPATION
SKIN DISORDER
2
C
CONSTIPATION
TREMOR
2
C
CONSTIPATION
VULVOVAGINAL MYCOTIC INFECTION
2
C
CONTRACEPTION
ANXIETY
2
C
CONTRACEPTION
DEEP VEIN THROMBOSIS
2
C
CONTRACEPTION
DEVICE DISLOCATION
1
C
CONTRACEPTION
HAEMORRHAGE
1
C
CONTRACEPTION
INJURY
2
C
CONTRACEPTION
PAIN
3
C
CONTRACEPTION
PULMONARY EMBOLISM
2
C
DEPRESSION
GASTRIC DISORDER
1
C
DEPRESSION
OFF LABEL USE
1
C
DEPRESSION
PSYCHOTIC DISORDER
1
C
DEPRESSION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
C
GAIT DISTURBANCE
DRUG INEFFECTIVE
1
C
GAIT DISTURBANCE
DRY EYE
1
C
GAIT DISTURBANCE
INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION
1
C
GAIT DISTURBANCE
OPTIC ATROPHY
1
C
INSOMNIA
ANXIETY
2
C
INSOMNIA
DEEP VEIN THROMBOSIS
2
C
INSOMNIA
GASTRIC DISORDER
1
C
INSOMNIA
INJURY
2
C
INSOMNIA
OFF LABEL USE
1
C
INSOMNIA
PAIN
2
C
INSOMNIA
PSYCHOTIC DISORDER
1
C
INSOMNIA
PULMONARY EMBOLISM
2
C
INSOMNIA
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
C
MOOD ALTERED
ANXIETY
2
C
MOOD ALTERED
DEEP VEIN THROMBOSIS
2
C
MOOD ALTERED
INJURY
2
C
MOOD ALTERED
PAIN
2
C
MOOD ALTERED
PULMONARY EMBOLISM
2
C
MULTIPLE SCLEROSIS
ANAL SPHINCTER ATONY
1
C
MULTIPLE SCLEROSIS
ANAL SPHINCTER HYPERTONIA
1
C
MULTIPLE SCLEROSIS
ARTHRALGIA
1
C
MULTIPLE SCLEROSIS
CHEILITIS
1
C
MULTIPLE SCLEROSIS
CONSTIPATION
1
C
MULTIPLE SCLEROSIS
COORDINATION ABNORMAL
1
C
MULTIPLE SCLEROSIS
DRUG INEFFECTIVE
1
C
MULTIPLE SCLEROSIS
EAR PAIN
1
C
MULTIPLE SCLEROSIS
EPISCLERITIS
1
C
MULTIPLE SCLEROSIS
ERYTHEMA
1
C
MULTIPLE SCLEROSIS
FAECAL INCONTINENCE
1
C
MULTIPLE SCLEROSIS
FALL
1
C
MULTIPLE SCLEROSIS
FATIGUE
1
C
MULTIPLE SCLEROSIS
FLUSHING
1
C
MULTIPLE SCLEROSIS
FOLLICULITIS
1
C
MULTIPLE SCLEROSIS
FUNCTIONAL GASTROINTESTINAL DISORDER
1
C
MULTIPLE SCLEROSIS
IMPAIRED GASTRIC EMPTYING
1
C
MULTIPLE SCLEROSIS
LIGAMENT SPRAIN
1
C
MULTIPLE SCLEROSIS
LOWER RESPIRATORY TRACT INFECTION
1
C
MULTIPLE SCLEROSIS
MUSCLE SPASTICITY
1
C
MULTIPLE SCLEROSIS
NAIL INFECTION
1
C
MULTIPLE SCLEROSIS
OEDEMA PERIPHERAL
1
C
MULTIPLE SCLEROSIS
PAIN IN EXTREMITY
1
C
MULTIPLE SCLEROSIS
RASH
1
C
MULTIPLE SCLEROSIS
SKIN DISORDER
1
C
MULTIPLE SCLEROSIS
TREMOR
1
C
MULTIPLE SCLEROSIS
VULVOVAGINAL MYCOTIC INFECTION
1
C
MUSCLE RELAXANT THERAPY
ABDOMINAL DISCOMFORT
1
C
MUSCLE RELAXANT THERAPY
DIARRHOEA
1
C
MUSCLE RELAXANT THERAPY
DISCOMFORT
1
C
MUSCLE RELAXANT THERAPY
FATIGUE
1
C
MUSCLE RELAXANT THERAPY
INTERVERTEBRAL DISC OPERATION
1
C
MUSCLE RELAXANT THERAPY
MALAISE
1
C
MUSCLE RELAXANT THERAPY
NASAL SEPTUM DEVIATION
1
C
MUSCLE RELAXANT THERAPY
NAUSEA
1
C
MUSCLE RELAXANT THERAPY
PAIN
1
C
MUSCLE RELAXANT THERAPY
VOMITING
1
C
MUSCLE SPASMS
ABDOMINAL DISCOMFORT
1
C
MUSCLE SPASMS
DIARRHOEA
1
C
MUSCLE SPASMS
DISCOMFORT
1
C
MUSCLE SPASMS
FATIGUE
1
C
MUSCLE SPASMS
INTERVERTEBRAL DISC OPERATION
1
C
MUSCLE SPASMS
MALAISE
1
C
MUSCLE SPASMS
NASAL SEPTUM DEVIATION
1
C
MUSCLE SPASMS
NAUSEA
1
C
MUSCLE SPASMS
PAIN
1
C
MUSCLE SPASMS
VOMITING
1
C
OSTEOPOROSIS
ASTHMA
1
C
OSTEOPOROSIS
DYSPHAGIA
1
C
OSTEOPOROSIS
FATIGUE
1
C
OSTEOPOROSIS
GAIT DISTURBANCE
1
C
OSTEOPOROSIS
MALNUTRITION
1
C
OSTEOPOROSIS
OESOPHAGEAL ULCER
1
C
OSTEOPOROSIS
VISUAL ACUITY REDUCED
1
C
OSTEOPOROSIS
VOMITING
1
C
OSTEOPOROSIS
WEIGHT DECREASED
1
C
PAIN
ABDOMINAL DISCOMFORT
2
C
PAIN
DIARRHOEA
2
C
PAIN
DISCOMFORT
2
C
PAIN
FATIGUE
2
C
PAIN
INTERVERTEBRAL DISC OPERATION
2
C
PAIN
MALAISE
2
C
PAIN
NASAL SEPTUM DEVIATION
2
C
PAIN
NAUSEA
2
C
PAIN
PAIN
2
C
PAIN
VOMITING
2
C
PRODUCT USED FOR UNKNOWN INDICATION
ABDOMINAL DISCOMFORT
2
C
PRODUCT USED FOR UNKNOWN INDICATION
APPENDICECTOMY
12
C
PRODUCT USED FOR UNKNOWN INDICATION
C-REACTIVE PROTEIN ABNORMAL
15
C
PRODUCT USED FOR UNKNOWN INDICATION
CONDITION AGGRAVATED
15
C
PRODUCT USED FOR UNKNOWN INDICATION
DIARRHOEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DISCOMFORT
2
C
PRODUCT USED FOR UNKNOWN INDICATION
DIZZINESS
12
C
PRODUCT USED FOR UNKNOWN INDICATION
FATIGUE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
GASTRIC CANCER
2
C
PRODUCT USED FOR UNKNOWN INDICATION
HYPOAESTHESIA
12
C
PRODUCT USED FOR UNKNOWN INDICATION
INCORRECT DOSE ADMINISTERED
12
C
PRODUCT USED FOR UNKNOWN INDICATION
INJECTION SITE PAIN
12
C
PRODUCT USED FOR UNKNOWN INDICATION
INTERVERTEBRAL DISC OPERATION
2
C
PRODUCT USED FOR UNKNOWN INDICATION
MALAISE
2
C
PRODUCT USED FOR UNKNOWN INDICATION
MAMMOGRAM ABNORMAL
12
C
PRODUCT USED FOR UNKNOWN INDICATION
MUSCLE SPASMS
12
C
PRODUCT USED FOR UNKNOWN INDICATION
MUSCULOSKELETAL PAIN
12
C
PRODUCT USED FOR UNKNOWN INDICATION
NASAL SEPTUM DEVIATION
2
C
PRODUCT USED FOR UNKNOWN INDICATION
NAUSEA
2
C
PRODUCT USED FOR UNKNOWN INDICATION
OVARIAN CYST
12
C
PRODUCT USED FOR UNKNOWN INDICATION
PAIN
14
C
PRODUCT USED FOR UNKNOWN INDICATION
PAIN IN EXTREMITY
12
C
PRODUCT USED FOR UNKNOWN INDICATION
PNEUMOCYSTIS JIROVECI PNEUMONIA
15
C
PRODUCT USED FOR UNKNOWN INDICATION
PYREXIA
15
C
PRODUCT USED FOR UNKNOWN INDICATION
VOMITING
2
C
PRODUCT USED FOR UNKNOWN INDICATION
WRONG TECHNIQUE IN DRUG USAGE PROCESS
12
C
PSYCHOTIC DISORDER
GASTRIC DISORDER
1
C
PSYCHOTIC DISORDER
OFF LABEL USE
1
C
PSYCHOTIC DISORDER
PSYCHOTIC DISORDER
1
C
PSYCHOTIC DISORDER
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
C
RHEUMATOID ARTHRITIS
APPENDICECTOMY
1
C
RHEUMATOID ARTHRITIS
APPETITE DISORDER
1
C
RHEUMATOID ARTHRITIS
C-REACTIVE PROTEIN ABNORMAL
9
C
RHEUMATOID ARTHRITIS
CONDITION AGGRAVATED
9
C
RHEUMATOID ARTHRITIS
DIZZINESS
2
C
RHEUMATOID ARTHRITIS
GASTRIC CANCER
1
C
RHEUMATOID ARTHRITIS
HYPOAESTHESIA
1
C
RHEUMATOID ARTHRITIS
INCORRECT DOSE ADMINISTERED
1
C
RHEUMATOID ARTHRITIS
INJECTION SITE PAIN
1
C
RHEUMATOID ARTHRITIS
KNEE ARTHROPLASTY
1
C
RHEUMATOID ARTHRITIS
MAMMOGRAM ABNORMAL
1
C
RHEUMATOID ARTHRITIS
MUSCLE SPASMS
1
C
RHEUMATOID ARTHRITIS
MUSCULOSKELETAL PAIN
1
C
RHEUMATOID ARTHRITIS
OVARIAN CYST
1
C
RHEUMATOID ARTHRITIS
PAIN
1
C
RHEUMATOID ARTHRITIS
PAIN IN EXTREMITY
1
C
RHEUMATOID ARTHRITIS
PNEUMOCYSTIS JIROVECI PNEUMONIA
9
C
RHEUMATOID ARTHRITIS
PYREXIA
9
C
RHEUMATOID ARTHRITIS
WRONG TECHNIQUE IN DRUG USAGE PROCESS
1
C
SCHIZOPHRENIA
BREAST CANCER STAGE IV
1
C
SCHIZOPHRENIA
HALLUCINATION
1
C
SCHIZOPHRENIA
HEAD INJURY
1
C
SCHIZOPHRENIA
INTENTIONAL DRUG MISUSE
1
C
SCHIZOPHRENIA
OSTEOARTHRITIS
1
C
SCHIZOPHRENIA
RHEUMATOID ARTHRITIS
1
C
SCHIZOPHRENIA
STRESS
1
C
SCHIZOPHRENIA
VISUAL IMPAIRMENT
1
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