Drug information for ATELVIA

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, DELAYED RELEASE; ORAL 35MG Prescription  (Reference Drug) RISEDRONATE SODIUM risedronic acid WARNER CHILCOTT 22560
2012-03-22 Label

2012-03-22 Label

2011-12-20 Other Important Information from FDA

2011-08-24 Letter

2011-03-21 Review

2011-03-21 Summary Review

2011-02-15 Letter

2011-02-15 Letter

2011-02-02 Other

2011-02-01 Medication Guide

2010-10-19 Letter

2010-10-18 Label

Drug Adverse Effects information for ATELVIA

Role code Indications Reaction # Reports
PS BONE DISORDER ABDOMINAL DISTENSION 1
PS BONE DISORDER GASTRIC DISORDER 1
PS BONE SCAN ABDOMINAL DISCOMFORT 1
PS BONE SCAN ARTHRALGIA 1
PS BONE SCAN ASTHENIA 1
PS BONE SCAN BLOOD GLUCOSE INCREASED 1
PS BONE SCAN HEADACHE 1
PS BONE SCAN PAIN 1
PS BONE SCAN RENAL PAIN 1
PS BONE SCAN TENSION 1
PS OSTEOPENIA DIARRHOEA 1
PS OSTEOPENIA INFLUENZA LIKE ILLNESS 1
PS OSTEOPENIA VOMITING 1
PS OSTEOPOROSIS ABDOMINAL DISCOMFORT 1
PS OSTEOPOROSIS ABDOMINAL PAIN UPPER 1
PS OSTEOPOROSIS ARTHRALGIA 3
PS OSTEOPOROSIS ASTHENIA 2
PS OSTEOPOROSIS BLOOD GLUCOSE INCREASED 2
PS OSTEOPOROSIS CHILLS 1
PS OSTEOPOROSIS EYE PAIN 1
PS OSTEOPOROSIS GASTRITIS 1
PS OSTEOPOROSIS HEADACHE 3
PS OSTEOPOROSIS INFLUENZA LIKE ILLNESS 1
PS OSTEOPOROSIS NAUSEA 1
PS OSTEOPOROSIS PAIN 2
PS OSTEOPOROSIS PYREXIA 1
PS OSTEOPOROSIS RENAL PAIN 2
PS OSTEOPOROSIS TENSION 2
PS OSTEOPOROSIS URINARY TRACT INFECTION 1
PS OSTEOPOROSIS POSTMENOPAUSAL ARTHRALGIA 1
PS OSTEOPOROSIS POSTMENOPAUSAL INITIAL INSOMNIA 1
PS OSTEOPOROSIS POSTMENOPAUSAL MUSCULOSKELETAL STIFFNESS 1
PS OSTEOPOROSIS POSTMENOPAUSAL PHOTOPHOBIA 1
PS OSTEOPOROSIS POSTMENOPAUSAL PHOTOPSIA 1
PS OSTEOPOROSIS POSTMENOPAUSAL RESTLESSNESS 1
PS OSTEOPOROSIS POSTMENOPAUSAL VISION BLURRED 1
PS OSTEOPOROSIS POSTMENOPAUSAL VISUAL ACUITY REDUCED 1
PS OSTEOPOROSIS POSTMENOPAUSAL VITREOUS FLOATERS 1
SS CHRONIC MYELOID LEUKAEMIA PAIN 1
SS CHRONIC MYELOID LEUKAEMIA PELVIC FRACTURE 1
SS CHRONIC MYELOID LEUKAEMIA PYREXIA 1
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