Drug information for ANAPROX DS

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL EQ 500MG BASE Prescription AB (Reference Drug) NAPROXEN SODIUM Naproxen ROCHE PALO 18164
2009-11-16 Medication Guide

2008-07-30 Letter

2008-07-29 Label

2007-09-26 Label

2007-09-25 Letter

2007-04-25 Letter

2006-03-23 Letter

2006-03-14 Label

2006-01-30 Letter

2006-01-25 Label

2005-07-28 Other Important Information from FDA

2004-11-16 Letter

2004-11-16 Letter

2004-11-16 Label

2004-11-16 Label

2003-05-29 Letter

Drug Adverse Effects information for ANAPROX DS

Role code Indications Reaction # Reports
C ACNE DEEP VEIN THROMBOSIS 3
C ACNE INJURY 3
C ACNE LOSS OF CONSCIOUSNESS 1
C ACNE OEDEMA PERIPHERAL 3
C ACNE PAIN IN EXTREMITY 3
C ACNE SYNCOPE 1
C ACNE URINARY TRACT INFECTION 1
C ARTHRALGIA CEREBROVASCULAR ACCIDENT 1
C ARTHRALGIA CHOLECYSTITIS CHRONIC 1
C ARTHRALGIA GALLBLADDER DISORDER 1
C ARTHRALGIA INJURY 1
C CONTRACEPTION ABORTION SPONTANEOUS 1
C CONTRACEPTION ANTIBIOTIC RESISTANT STAPHYLOCOCCUS TEST POSITIVE 1
C CONTRACEPTION BACTERAEMIA 1
C CONTRACEPTION BLOOD CHOLESTEROL INCREASED 1
C CONTRACEPTION BRONCHIAL HYPERREACTIVITY 1
C CONTRACEPTION CERVICAL INCOMPETENCE 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION CHORIOAMNIONITIS 1
C CONTRACEPTION CONDITION AGGRAVATED 1
C CONTRACEPTION DEEP VEIN THROMBOSIS 4
C CONTRACEPTION DIZZINESS 1
C CONTRACEPTION DYSMENORRHOEA 1
C CONTRACEPTION EMOTIONAL DISTRESS 1
C CONTRACEPTION FALL 1
C CONTRACEPTION FATIGUE 1
C CONTRACEPTION GALLBLADDER DISORDER 1
C CONTRACEPTION HAEMODYNAMIC INSTABILITY 1
C CONTRACEPTION HYPERCHOLESTEROLAEMIA 1
C CONTRACEPTION HYPERTENSION 1
C CONTRACEPTION INJECTION SITE PHLEBITIS 1
C CONTRACEPTION INJURY 3
C CONTRACEPTION INTERNATIONAL NORMALISED RATIO INCREASED 1
C CONTRACEPTION LOSS OF CONSCIOUSNESS 2
C CONTRACEPTION LOW DENSITY LIPOPROTEIN INCREASED 1
C CONTRACEPTION MATERNAL EXPOSURE DURING PREGNANCY 1
C CONTRACEPTION NAUSEA 1
C CONTRACEPTION OEDEMA PERIPHERAL 3
C CONTRACEPTION OVARIAN CYST 1
C CONTRACEPTION OVARIAN CYSTECTOMY 1
C CONTRACEPTION PAIN 1
C CONTRACEPTION PAIN IN EXTREMITY 3
C CONTRACEPTION PALPITATIONS 1
C CONTRACEPTION PELVIC PAIN 1
C CONTRACEPTION POST PROCEDURAL INFECTION 1
C CONTRACEPTION PREGNANCY WITH CONTRACEPTIVE DEVICE 1
C CONTRACEPTION PREMATURE RUPTURE OF MEMBRANES 1
C CONTRACEPTION PULMONARY EMBOLISM 1
C CONTRACEPTION RETAINED PLACENTA OR MEMBRANES 1
C CONTRACEPTION SEASONAL ALLERGY 1
C CONTRACEPTION SYNCOPE 2
C CONTRACEPTION TYPE 2 DIABETES MELLITUS 1
C CONTRACEPTION URINARY TRACT INFECTION 1
C CONTRACEPTION UTERINE LEIOMYOMA 1
C CONTRACEPTION VAGINITIS BACTERIAL 1
C CONTRACEPTION VENTRICULAR HYPERTROPHY 1
C MUSCLE SPASMS CEREBROVASCULAR ACCIDENT 1
C MUSCLE SPASMS CHOLECYSTITIS CHRONIC 1
C MUSCLE SPASMS GALLBLADDER DISORDER 1
C MUSCLE SPASMS INJURY 1
C ORAL CONTRACEPTION CEREBROVASCULAR ACCIDENT 1
C ORAL CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C ORAL CONTRACEPTION GALLBLADDER DISORDER 1
C ORAL CONTRACEPTION INJURY 1
C PAIN CEREBROVASCULAR ACCIDENT 3
C PAIN CHOLECYSTITIS CHRONIC 3
C PAIN CHOLELITHIASIS 1
C PAIN EMOTIONAL DISTRESS 1
C PAIN GALLBLADDER DISORDER 4
C PAIN INJURY 3
C PAIN PAIN 1
C PELVIC PAIN CEREBROVASCULAR ACCIDENT 1
C PELVIC PAIN CHOLECYSTITIS CHRONIC 1
C PELVIC PAIN GALLBLADDER DISORDER 1
C PELVIC PAIN INJURY 1
C PULMONARY EMBOLISM CYSTITIS 1
C PULMONARY EMBOLISM DEMYELINATION 1
C PULMONARY EMBOLISM DIZZINESS 1
C PULMONARY EMBOLISM DYSPNOEA 1
C PULMONARY EMBOLISM HYPERCOAGULATION 1
C PULMONARY EMBOLISM HYPOKALAEMIA 1
C PULMONARY EMBOLISM IRON DEFICIENCY ANAEMIA 1
C PULMONARY EMBOLISM NEUROPATHY PERIPHERAL 1
C PULMONARY EMBOLISM NOCTURNAL DYSPNOEA 1
C PULMONARY EMBOLISM PULMONARY EMBOLISM 1
C PULMONARY EMBOLISM SNORING 1
C PULMONARY EMBOLISM URINARY TRACT INFECTION 1
C PULMONARY EMBOLISM VERTIGO 1
C PULMONARY EMBOLISM VULVOVAGINAL MYCOTIC INFECTION 1
C SACROILIITIS CEREBROVASCULAR ACCIDENT 1
C SACROILIITIS CHOLECYSTITIS CHRONIC 1
C SACROILIITIS GALLBLADDER DISORDER 1
C SACROILIITIS INJURY 1
C UTERINE LEIOMYOMA CYSTITIS 1
C UTERINE LEIOMYOMA DEMYELINATION 1
C UTERINE LEIOMYOMA DIZZINESS 1
C UTERINE LEIOMYOMA DYSPNOEA 1
C UTERINE LEIOMYOMA HYPERCOAGULATION 1
C UTERINE LEIOMYOMA HYPOKALAEMIA 1
C UTERINE LEIOMYOMA IRON DEFICIENCY ANAEMIA 1
C UTERINE LEIOMYOMA NEUROPATHY PERIPHERAL 1
C UTERINE LEIOMYOMA NOCTURNAL DYSPNOEA 1
C UTERINE LEIOMYOMA PULMONARY EMBOLISM 1
C UTERINE LEIOMYOMA SNORING 1
C UTERINE LEIOMYOMA URINARY TRACT INFECTION 1
C UTERINE LEIOMYOMA VERTIGO 1
C UTERINE LEIOMYOMA VULVOVAGINAL MYCOTIC INFECTION 1
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