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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