Drug information for AXERT

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL EQ 12.5MG BASE Prescription  (Reference Drug) ALMOTRIPTAN MALATE almotriptan JANSSEN PHARMS 21001
2009-05-11 Label
2009-05-11 Label
2009-05-06 Letter
2009-04-03 Label
2009-04-03 Label
2009-04-01 Letter
2009-04-01 Letter
2004-06-07 Letter
2004-04-15 Review
2003-12-08 Other Important Information from FDA
2001-05-07 Letter
2001-05-07 Label
TABLET; ORAL EQ 6.25MG BASE Prescription   ALMOTRIPTAN MALATE almotriptan JANSSEN PHARMS   "

Drug Adverse Effects information for AXERT

Role code Indications Reaction # Reports
C ACNE INJURY 1
C ACNE MYOCARDIAL INFARCTION 1
C ACNE PAIN 1
C ACNE PULMONARY EMBOLISM 1
C CONTRACEPTION ABDOMINAL DISTENSION 3
C CONTRACEPTION ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED 2
C CONTRACEPTION ADENOIDAL HYPERTROPHY 1
C CONTRACEPTION ALOPECIA 3
C CONTRACEPTION AMNESIA 7
C CONTRACEPTION ASTHMA 2
C CONTRACEPTION BALANCE DISORDER 4
C CONTRACEPTION BLOOD CHOLESTEROL INCREASED 1
C CONTRACEPTION BLOOD TRIGLYCERIDES INCREASED 2
C CONTRACEPTION BRADYCARDIA 4
C CONTRACEPTION BRAIN INJURY 4
C CONTRACEPTION CEREBRAL HAEMORRHAGE 4
C CONTRACEPTION CEREBRAL THROMBOSIS 4
C CONTRACEPTION CEREBROVASCULAR ACCIDENT 4
C CONTRACEPTION CHEST PAIN 2
C CONTRACEPTION CHOLECYSTECTOMY 1
C CONTRACEPTION CHOLECYSTITIS ACUTE 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION COAGULOPATHY 1
C CONTRACEPTION COGNITIVE DISORDER 4
C CONTRACEPTION CONFUSIONAL STATE 3
C CONTRACEPTION CONSTIPATION 3
C CONTRACEPTION DEEP VEIN THROMBOSIS 5
C CONTRACEPTION DEPRESSION 4
C CONTRACEPTION DILATATION VENTRICULAR 2
C CONTRACEPTION DIZZINESS 3
C CONTRACEPTION DRUG HYPERSENSITIVITY 3
C CONTRACEPTION DRUG INEFFECTIVE 1
C CONTRACEPTION DYSPNOEA 2
C CONTRACEPTION EFFUSION 1
C CONTRACEPTION EMOTIONAL DISTRESS 4
C CONTRACEPTION ENDOMETRIAL HYPERPLASIA 1
C CONTRACEPTION FATIGUE 2
C CONTRACEPTION FLATULENCE 3
C CONTRACEPTION FUNGAL INFECTION 1
C CONTRACEPTION GAIT DISTURBANCE 4
C CONTRACEPTION GRAND MAL CONVULSION 4
C CONTRACEPTION HAEMATEMESIS 1
C CONTRACEPTION HEADACHE 2
C CONTRACEPTION HEPATIC ENZYME INCREASED 2
C CONTRACEPTION HEPATIC STEATOSIS 3
C CONTRACEPTION HYPERCOAGULATION 2
C CONTRACEPTION HYPERLIPIDAEMIA 3
C CONTRACEPTION HYPOAESTHESIA 3
C CONTRACEPTION HYPOTENSION 5
C CONTRACEPTION INJURY 2
C CONTRACEPTION INSOMNIA 3
C CONTRACEPTION INTERNATIONAL NORMALISED RATIO DECREASED 2
C CONTRACEPTION LEUKOCYTOSIS 1
C CONTRACEPTION LIVER DISORDER 2
C CONTRACEPTION MALAISE 1
C CONTRACEPTION MENORRHAGIA 1
C CONTRACEPTION MENSTRUATION IRREGULAR 2
C CONTRACEPTION MIGRAINE 5
C CONTRACEPTION MYOCARDIAL INFARCTION 1
C CONTRACEPTION NAUSEA 2
C CONTRACEPTION NERVOUS SYSTEM DISORDER 4
C CONTRACEPTION OVARIAN CYST 1
C CONTRACEPTION PAIN 6
C CONTRACEPTION PARAESTHESIA 3
C CONTRACEPTION PELVIC VENOUS THROMBOSIS 4
C CONTRACEPTION PNEUMONIA 6
C CONTRACEPTION POLYCYSTIC OVARIES 4
C CONTRACEPTION PRESYNCOPE 2
C CONTRACEPTION PROTHROMBIN TIME PROLONGED 2
C CONTRACEPTION PRURITUS 2
C CONTRACEPTION PULMONARY EMBOLISM 7
C CONTRACEPTION RASH 4
C CONTRACEPTION RASH PRURITIC 1
C CONTRACEPTION RETCHING 1
C CONTRACEPTION SINUS BRADYCARDIA 2
C CONTRACEPTION SMEAR CERVIX ABNORMAL 1
C CONTRACEPTION SNORING 3
C CONTRACEPTION SPEECH DISORDER 4
C CONTRACEPTION SUPERIOR SAGITTAL SINUS THROMBOSIS 3
C CONTRACEPTION SYNCOPE 3
C CONTRACEPTION THROMBOSIS 4
C CONTRACEPTION TRANSVERSE SINUS THROMBOSIS 4
C CONTRACEPTION URINARY TRACT INFECTION 3
C CONTRACEPTION VOMITING 1
C CONTRACEPTION WEIGHT INCREASED 3
C CONVULSION INJURY 1
C CONVULSION MYOCARDIAL INFARCTION 1
C CONVULSION PAIN 1
C CONVULSION PULMONARY EMBOLISM 1
C DEPRESSION CHOLECYSTITIS ACUTE 1
C DEPRESSION CHOLELITHIASIS 1
C DEPRESSION EFFUSION 1
C DEPRESSION LEUKOCYTOSIS 1
C DEPRESSION PNEUMONIA 1
C DEPRESSION PULMONARY EMBOLISM 1
C HORMONE LEVEL ABNORMAL CONFUSIONAL STATE 1
C HORMONE LEVEL ABNORMAL MUSCULOSKELETAL STIFFNESS 1
C HORMONE LEVEL ABNORMAL RASH GENERALISED 1
C INSOMNIA AMNESIA 1
C INSOMNIA BALANCE DISORDER 1
C INSOMNIA BRAIN INJURY 1
C INSOMNIA CEREBRAL HAEMORRHAGE 1
C INSOMNIA CEREBRAL THROMBOSIS 1
C INSOMNIA CEREBROVASCULAR ACCIDENT 1
C INSOMNIA COGNITIVE DISORDER 1
C INSOMNIA DEPRESSION 1
C INSOMNIA EMOTIONAL DISTRESS 1
C INSOMNIA GAIT DISTURBANCE 1
C INSOMNIA GRAND MAL CONVULSION 1
C INSOMNIA MIGRAINE 1
C INSOMNIA NERVOUS SYSTEM DISORDER 1
C INSOMNIA PAIN 1
C INSOMNIA PELVIC VENOUS THROMBOSIS 1
C INSOMNIA SPEECH DISORDER 1
C INSOMNIA THROMBOSIS 1
C INSOMNIA TRANSVERSE SINUS THROMBOSIS 1
C JUVENILE ARTHRITIS ABDOMINAL DISCOMFORT 1
C JUVENILE ARTHRITIS ANAEMIA 1
C JUVENILE ARTHRITIS ARTHRALGIA 1
C JUVENILE ARTHRITIS CLOSTRIDIAL INFECTION 1
C JUVENILE ARTHRITIS DEHYDRATION 1
C JUVENILE ARTHRITIS DIARRHOEA 1
C JUVENILE ARTHRITIS DYSGEUSIA 1
C JUVENILE ARTHRITIS HYPOTENSION 1
C JUVENILE ARTHRITIS INFECTION 1
C JUVENILE ARTHRITIS MALAISE 1
C JUVENILE ARTHRITIS NAUSEA 1
C JUVENILE ARTHRITIS PAIN 1
C JUVENILE ARTHRITIS RASH 1
C JUVENILE ARTHRITIS UROSEPSIS 1
C JUVENILE ARTHRITIS VOMITING 1
C MIGRAINE ABDOMINAL DISCOMFORT 3
C MIGRAINE ABDOMINAL DISTENSION 3
C MIGRAINE ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED 2
C MIGRAINE ADENOIDAL HYPERTROPHY 1
C MIGRAINE ALOPECIA 3
C MIGRAINE AMNESIA 8
C MIGRAINE ANAEMIA 3
C MIGRAINE ARTHRALGIA 6
C MIGRAINE ASTHMA 2
C MIGRAINE BALANCE DISORDER 2
C MIGRAINE BAND SENSATION 3
C MIGRAINE BLOOD CHOLESTEROL INCREASED 1
C MIGRAINE BLOOD TRIGLYCERIDES INCREASED 2
C MIGRAINE BRADYCARDIA 4
C MIGRAINE BRAIN INJURY 2
C MIGRAINE CEREBRAL HAEMORRHAGE 2
C MIGRAINE CEREBRAL THROMBOSIS 2
C MIGRAINE CEREBROVASCULAR ACCIDENT 2
C MIGRAINE CHEST PAIN 2
C MIGRAINE CHOLECYSTECTOMY 1
C MIGRAINE CHOLECYSTITIS CHRONIC 1
C MIGRAINE CLOSTRIDIAL INFECTION 3
C MIGRAINE COAGULOPATHY 1
C MIGRAINE COGNITIVE DISORDER 2
C MIGRAINE CONFUSIONAL STATE 3
C MIGRAINE CONSTIPATION 3
C MIGRAINE DEEP VEIN THROMBOSIS 5
C MIGRAINE DEHYDRATION 3
C MIGRAINE DEPRESSION 2
C MIGRAINE DIARRHOEA 3
C MIGRAINE DILATATION VENTRICULAR 2
C MIGRAINE DIZZINESS 3
C MIGRAINE DRUG HYPERSENSITIVITY 3
C MIGRAINE DRUG INEFFECTIVE 1
C MIGRAINE DYSGEUSIA 3
C MIGRAINE DYSPNOEA 2
C MIGRAINE EMOTIONAL DISTRESS 2
C MIGRAINE ENDOMETRIAL HYPERPLASIA 1
C MIGRAINE FATIGUE 2
C MIGRAINE FLATULENCE 3
C MIGRAINE FUNGAL INFECTION 1
C MIGRAINE GAIT DISTURBANCE 2
C MIGRAINE GRAND MAL CONVULSION 2
C MIGRAINE HAEMATEMESIS 1
C MIGRAINE HEADACHE 2
C MIGRAINE HEPATIC ENZYME INCREASED 2
C MIGRAINE HEPATIC STEATOSIS 3
C MIGRAINE HYPERCOAGULATION 2
C MIGRAINE HYPERLIPIDAEMIA 3
C MIGRAINE HYPOAESTHESIA 3
C MIGRAINE HYPOTENSION 8
C MIGRAINE INFECTION 3
C MIGRAINE INJURY 1
C MIGRAINE INSOMNIA 3
C MIGRAINE INTERNATIONAL NORMALISED RATIO DECREASED 2
C MIGRAINE LIVER DISORDER 2
C MIGRAINE MALAISE 4
C MIGRAINE MENORRHAGIA 1
C MIGRAINE MENSTRUATION IRREGULAR 2
C MIGRAINE MIGRAINE 3
C MIGRAINE NAUSEA 5
C MIGRAINE NERVOUS SYSTEM DISORDER 2
C MIGRAINE OVARIAN CYST 1
C MIGRAINE PAIN 6
C MIGRAINE PARAESTHESIA 6
C MIGRAINE PELVIC VENOUS THROMBOSIS 2
C MIGRAINE PNEUMONIA 5
C MIGRAINE POLYCYSTIC OVARIES 4
C MIGRAINE PRESYNCOPE 2
C MIGRAINE PROTHROMBIN TIME PROLONGED 2
C MIGRAINE PRURITUS 2
C MIGRAINE PULMONARY EMBOLISM 5
C MIGRAINE RASH 7
C MIGRAINE RASH PRURITIC 1
C MIGRAINE RETCHING 1
C MIGRAINE SINUS BRADYCARDIA 2
C MIGRAINE SMEAR CERVIX ABNORMAL 1
C MIGRAINE SNORING 3
C MIGRAINE SPEECH DISORDER 2
C MIGRAINE SUPERIOR SAGITTAL SINUS THROMBOSIS 3
C MIGRAINE SYNCOPE 3
C MIGRAINE THROMBOSIS 2
C MIGRAINE TRANSVERSE SINUS THROMBOSIS 2
C MIGRAINE URINARY TRACT INFECTION 3
C MIGRAINE UROSEPSIS 3
C MIGRAINE VOMITING 4
C MIGRAINE WEIGHT INCREASED 3
C MULTIPLE ALLERGIES CHOLECYSTITIS ACUTE 1
C MULTIPLE ALLERGIES CHOLELITHIASIS 1
C MULTIPLE ALLERGIES EFFUSION 1
C MULTIPLE ALLERGIES LEUKOCYTOSIS 1
C MULTIPLE ALLERGIES PNEUMONIA 1
C MULTIPLE ALLERGIES PULMONARY EMBOLISM 1
C MULTIPLE SCLEROSIS AMNESIA 1
C MULTIPLE SCLEROSIS ARTHRALGIA 1
C MULTIPLE SCLEROSIS BAND SENSATION 1
C MULTIPLE SCLEROSIS CHOLECYSTITIS ACUTE 2
C MULTIPLE SCLEROSIS CHOLELITHIASIS 2
C MULTIPLE SCLEROSIS EFFUSION 2
C MULTIPLE SCLEROSIS FATIGUE 1
C MULTIPLE SCLEROSIS LEUKOCYTOSIS 2
C MULTIPLE SCLEROSIS PARAESTHESIA 1
C MULTIPLE SCLEROSIS PHOTOSENSITIVITY REACTION 1
C MULTIPLE SCLEROSIS PNEUMONIA 2
C MULTIPLE SCLEROSIS PULMONARY EMBOLISM 2
C OPTIC NEURITIS AMNESIA 1
C OPTIC NEURITIS ARTHRALGIA 1
C OPTIC NEURITIS BAND SENSATION 1
C OPTIC NEURITIS PARAESTHESIA 1
C POOR QUALITY SLEEP AMNESIA 1
C POOR QUALITY SLEEP BALANCE DISORDER 1
C POOR QUALITY SLEEP BRAIN INJURY 1
C POOR QUALITY SLEEP CEREBRAL HAEMORRHAGE 1
C POOR QUALITY SLEEP CEREBRAL THROMBOSIS 1
C POOR QUALITY SLEEP CEREBROVASCULAR ACCIDENT 1
C POOR QUALITY SLEEP COGNITIVE DISORDER 1
C POOR QUALITY SLEEP DEPRESSION 1
C POOR QUALITY SLEEP EMOTIONAL DISTRESS 1
C POOR QUALITY SLEEP GAIT DISTURBANCE 1
C POOR QUALITY SLEEP GRAND MAL CONVULSION 1
C POOR QUALITY SLEEP MIGRAINE 1
C POOR QUALITY SLEEP NERVOUS SYSTEM DISORDER 1
C POOR QUALITY SLEEP PAIN 1
C POOR QUALITY SLEEP PELVIC VENOUS THROMBOSIS 1
C POOR QUALITY SLEEP SPEECH DISORDER 1
C POOR QUALITY SLEEP THROMBOSIS 1
C POOR QUALITY SLEEP TRANSVERSE SINUS THROMBOSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION CHOLECYSTITIS ACUTE 9
C PRODUCT USED FOR UNKNOWN INDICATION CHOLELITHIASIS 9
C PRODUCT USED FOR UNKNOWN INDICATION EFFUSION 9
C PRODUCT USED FOR UNKNOWN INDICATION LEUKOCYTOSIS 9
C PRODUCT USED FOR UNKNOWN INDICATION PNEUMONIA 9
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 9
C RELAPSING-REMITTING MULTIPLE SCLEROSIS AGGRESSION 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS CRYING 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS DEPRESSION 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS ECZEMA 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS FATIGUE 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS FEELING ABNORMAL 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS HEADACHE 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS HYPERSOMNIA 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS IMPAIRED WORK ABILITY 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS IRRITABILITY 1
C RELAPSING-REMITTING MULTIPLE SCLEROSIS SUICIDAL IDEATION 1
C RHEUMATOID ARTHRITIS ABDOMINAL DISCOMFORT 1
C RHEUMATOID ARTHRITIS ANAEMIA 1
C RHEUMATOID ARTHRITIS ARTHRALGIA 1
C RHEUMATOID ARTHRITIS CANDIDIASIS 1
C RHEUMATOID ARTHRITIS CLOSTRIDIAL INFECTION 1
C RHEUMATOID ARTHRITIS CONFUSIONAL STATE 3
C RHEUMATOID ARTHRITIS DEHYDRATION 1
C RHEUMATOID ARTHRITIS DIARRHOEA 1
C RHEUMATOID ARTHRITIS DYSGEUSIA 1
C RHEUMATOID ARTHRITIS HYPOTENSION 1
C RHEUMATOID ARTHRITIS INFECTION 1
C RHEUMATOID ARTHRITIS MALAISE 1
C RHEUMATOID ARTHRITIS MUSCULOSKELETAL STIFFNESS 3
C RHEUMATOID ARTHRITIS NAUSEA 1
C RHEUMATOID ARTHRITIS PAIN 1
C RHEUMATOID ARTHRITIS RASH 1
C RHEUMATOID ARTHRITIS RASH GENERALISED 3
C RHEUMATOID ARTHRITIS UROSEPSIS 1
C RHEUMATOID ARTHRITIS VOMITING 1
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