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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