Drug information for ACTONEL WITH CALCIUM (COPACKAGED)

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, TABLET; ORAL EQ 500MG BASE,N/A;N/A,35MG **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   CALCIUM CARBONATE; RISEDRONATE SODIUM risedronic acid WARNER CHILCOTT 21823
2011-08-24 Letter
2011-02-02 Other
2011-02-01 Medication Guide
2011-01-27 Letter
2011-01-27 Letter
2011-01-26 Label
2011-01-26 Label
2008-01-07 Other Important Information from FDA
2006-09-18 Letter
2006-08-23 Label
2006-06-28 Letter
2006-01-30 Letter
2006-01-25 Label
2005-08-19 Letter
2005-08-15 Label

Drug Adverse Effects information for ACTONEL WITH CALCIUM (COPACKAGED)

Role code Indications Reaction # Reports
C ATRIAL FIBRILLATION ABDOMINAL WOUND DEHISCENCE 1
C ATRIAL FIBRILLATION ATRIAL FIBRILLATION 1
C ATRIAL FIBRILLATION CARDIO-RESPIRATORY ARREST 1
C ATRIAL FIBRILLATION DYSPNOEA 1
C ATRIAL FIBRILLATION GASTROINTESTINAL CARCINOMA 1
C ATRIAL FIBRILLATION HYPOTENSION 1
C ATRIAL FIBRILLATION HYPOXIA 1
C ATRIAL FIBRILLATION INTESTINAL OBSTRUCTION 1
C ATRIAL FIBRILLATION POSTOPERATIVE WOUND INFECTION 1
C ATRIAL FIBRILLATION RESPIRATORY FAILURE 1
C BRONCHITIS ABDOMINAL DISTENSION 1
C BRONCHITIS ABDOMINAL PAIN UPPER 1
C BRONCHITIS ADVERSE DRUG REACTION 1
C BRONCHITIS ARTHRALGIA 1
C BRONCHITIS BACK PAIN 1
C BRONCHITIS BONE PAIN 1
C BRONCHITIS BURSITIS 1
C BRONCHITIS CARPAL TUNNEL SYNDROME 1
C BRONCHITIS CHEST PAIN 1
C BRONCHITIS CONSTIPATION 1
C BRONCHITIS DYSPEPSIA 1
C BRONCHITIS DYSPHONIA 1
C BRONCHITIS HEPATITIS B 1
C BRONCHITIS HIATUS HERNIA 1
C BRONCHITIS HYPERLIPIDAEMIA 1
C BRONCHITIS INJURY ASSOCIATED WITH DEVICE 1
C BRONCHITIS MASS 1
C BRONCHITIS MEMORY IMPAIRMENT 1
C BRONCHITIS MUSCLE SPASMS 1
C BRONCHITIS MUSCULOSKELETAL CHEST PAIN 1
C BRONCHITIS MUSCULOSKELETAL PAIN 1
C BRONCHITIS MUSCULOSKELETAL STIFFNESS 1
C BRONCHITIS MYALGIA 1
C BRONCHITIS NASOPHARYNGITIS 1
C BRONCHITIS NECK PAIN 1
C BRONCHITIS OSTEOPOROSIS 1
C BRONCHITIS PAIN IN EXTREMITY 1
C BRONCHITIS TENDON PAIN 1
C BRONCHITIS TOOTH LOSS 1
C BRONCHITIS UNEVALUABLE EVENT 1
C BRONCHITIS UTERINE LEIOMYOMA 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS ABDOMINAL WOUND DEHISCENCE 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS ATRIAL FIBRILLATION 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS CARDIO-RESPIRATORY ARREST 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS DYSPNOEA 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS GASTROINTESTINAL CARCINOMA 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS HYPOTENSION 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS HYPOXIA 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS INTESTINAL OBSTRUCTION 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS POSTOPERATIVE WOUND INFECTION 1
C CEREBROVASCULAR ACCIDENT PROPHYLAXIS RESPIRATORY FAILURE 1
C GASTRIC DISORDER ARTERIAL THROMBOSIS LIMB 1
C GASTRIC DISORDER ARTERIOSCLEROSIS 1
C GASTRIC DISORDER KNEE ARTHROPLASTY 1
C GASTRIC DISORDER PERIPHERAL ARTERY ANEURYSM 1
C MUSCULOSKELETAL CHEST PAIN ABDOMINAL DISTENSION 1
C MUSCULOSKELETAL CHEST PAIN ABDOMINAL PAIN UPPER 1
C MUSCULOSKELETAL CHEST PAIN ADVERSE DRUG REACTION 1
C MUSCULOSKELETAL CHEST PAIN ARTHRALGIA 1
C MUSCULOSKELETAL CHEST PAIN BACK PAIN 1
C MUSCULOSKELETAL CHEST PAIN BONE PAIN 1
C MUSCULOSKELETAL CHEST PAIN BURSITIS 1
C MUSCULOSKELETAL CHEST PAIN CARPAL TUNNEL SYNDROME 1
C MUSCULOSKELETAL CHEST PAIN CHEST PAIN 1
C MUSCULOSKELETAL CHEST PAIN CONSTIPATION 1
C MUSCULOSKELETAL CHEST PAIN DYSPEPSIA 1
C MUSCULOSKELETAL CHEST PAIN DYSPHONIA 1
C MUSCULOSKELETAL CHEST PAIN HEPATITIS B 1
C MUSCULOSKELETAL CHEST PAIN HIATUS HERNIA 1
C MUSCULOSKELETAL CHEST PAIN HYPERLIPIDAEMIA 1
C MUSCULOSKELETAL CHEST PAIN INJURY ASSOCIATED WITH DEVICE 1
C MUSCULOSKELETAL CHEST PAIN MASS 1
C MUSCULOSKELETAL CHEST PAIN MEMORY IMPAIRMENT 1
C MUSCULOSKELETAL CHEST PAIN MUSCLE SPASMS 1
C MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL CHEST PAIN 1
C MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL PAIN 1
C MUSCULOSKELETAL CHEST PAIN MUSCULOSKELETAL STIFFNESS 1
C MUSCULOSKELETAL CHEST PAIN MYALGIA 1
C MUSCULOSKELETAL CHEST PAIN NASOPHARYNGITIS 1
C MUSCULOSKELETAL CHEST PAIN NECK PAIN 1
C MUSCULOSKELETAL CHEST PAIN OSTEOPOROSIS 1
C MUSCULOSKELETAL CHEST PAIN PAIN IN EXTREMITY 1
C MUSCULOSKELETAL CHEST PAIN TENDON PAIN 1
C MUSCULOSKELETAL CHEST PAIN TOOTH LOSS 1
C MUSCULOSKELETAL CHEST PAIN UNEVALUABLE EVENT 1
C MUSCULOSKELETAL CHEST PAIN UTERINE LEIOMYOMA 1
C OSTEOPOROSIS ABDOMINAL DISTENSION 1
C OSTEOPOROSIS ABDOMINAL PAIN UPPER 1
C OSTEOPOROSIS ADVERSE DRUG REACTION 1
C OSTEOPOROSIS ARTERIAL THROMBOSIS LIMB 1
C OSTEOPOROSIS ARTERIOSCLEROSIS 1
C OSTEOPOROSIS ARTHRALGIA 1
C OSTEOPOROSIS BACK PAIN 1
C OSTEOPOROSIS BONE PAIN 1
C OSTEOPOROSIS BURSITIS 1
C OSTEOPOROSIS CARPAL TUNNEL SYNDROME 1
C OSTEOPOROSIS CHEST PAIN 1
C OSTEOPOROSIS CONSTIPATION 1
C OSTEOPOROSIS DYSPEPSIA 1
C OSTEOPOROSIS DYSPHONIA 1
C OSTEOPOROSIS HEPATITIS B 1
C OSTEOPOROSIS HIATUS HERNIA 1
C OSTEOPOROSIS HYPERLIPIDAEMIA 1
C OSTEOPOROSIS INJURY ASSOCIATED WITH DEVICE 1
C OSTEOPOROSIS KNEE ARTHROPLASTY 1
C OSTEOPOROSIS MASS 1
C OSTEOPOROSIS MEMORY IMPAIRMENT 1
C OSTEOPOROSIS MUSCLE SPASMS 1
C OSTEOPOROSIS MUSCULOSKELETAL CHEST PAIN 1
C OSTEOPOROSIS MUSCULOSKELETAL PAIN 1
C OSTEOPOROSIS MUSCULOSKELETAL STIFFNESS 1
C OSTEOPOROSIS MYALGIA 1
C OSTEOPOROSIS NASOPHARYNGITIS 1
C OSTEOPOROSIS NECK PAIN 1
C OSTEOPOROSIS OSTEOPOROSIS 1
C OSTEOPOROSIS PAIN IN EXTREMITY 1
C OSTEOPOROSIS PERIPHERAL ARTERY ANEURYSM 1
C OSTEOPOROSIS TENDON PAIN 1
C OSTEOPOROSIS TOOTH LOSS 1
C OSTEOPOROSIS UNEVALUABLE EVENT 1
C OSTEOPOROSIS UTERINE LEIOMYOMA 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL DISTENSION 7
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN UPPER 7
C PRODUCT USED FOR UNKNOWN INDICATION ADVERSE DRUG REACTION 7
C PRODUCT USED FOR UNKNOWN INDICATION ARTERIAL THROMBOSIS LIMB 1
C PRODUCT USED FOR UNKNOWN INDICATION ARTERIOSCLEROSIS 1
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRALGIA 7
C PRODUCT USED FOR UNKNOWN INDICATION BACK PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION BONE PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION BURSITIS 7
C PRODUCT USED FOR UNKNOWN INDICATION CARPAL TUNNEL SYNDROME 7
C PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION CONSTIPATION 7
C PRODUCT USED FOR UNKNOWN INDICATION DYSPEPSIA 7
C PRODUCT USED FOR UNKNOWN INDICATION DYSPHONIA 7
C PRODUCT USED FOR UNKNOWN INDICATION HEPATITIS B 7
C PRODUCT USED FOR UNKNOWN INDICATION HIATUS HERNIA 7
C PRODUCT USED FOR UNKNOWN INDICATION HYPERLIPIDAEMIA 7
C PRODUCT USED FOR UNKNOWN INDICATION INJURY ASSOCIATED WITH DEVICE 7
C PRODUCT USED FOR UNKNOWN INDICATION KNEE ARTHROPLASTY 1
C PRODUCT USED FOR UNKNOWN INDICATION MASS 7
C PRODUCT USED FOR UNKNOWN INDICATION MEMORY IMPAIRMENT 7
C PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 7
C PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL CHEST PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION MUSCULOSKELETAL STIFFNESS 7
C PRODUCT USED FOR UNKNOWN INDICATION MYALGIA 7
C PRODUCT USED FOR UNKNOWN INDICATION NASOPHARYNGITIS 7
C PRODUCT USED FOR UNKNOWN INDICATION NECK PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION OSTEOPOROSIS 7
C PRODUCT USED FOR UNKNOWN INDICATION PAIN IN EXTREMITY 7
C PRODUCT USED FOR UNKNOWN INDICATION PERIPHERAL ARTERY ANEURYSM 1
C PRODUCT USED FOR UNKNOWN INDICATION TENDON PAIN 7
C PRODUCT USED FOR UNKNOWN INDICATION TOOTH LOSS 7
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 7
C PRODUCT USED FOR UNKNOWN INDICATION UTERINE LEIOMYOMA 7
C PROPHYLAXIS ABDOMINAL DISTENSION 1
C PROPHYLAXIS ABDOMINAL PAIN UPPER 1
C PROPHYLAXIS ADVERSE DRUG REACTION 1
C PROPHYLAXIS ARTHRALGIA 1
C PROPHYLAXIS BACK PAIN 1
C PROPHYLAXIS BONE PAIN 1
C PROPHYLAXIS BURSITIS 1
C PROPHYLAXIS CARPAL TUNNEL SYNDROME 1
C PROPHYLAXIS CHEST PAIN 1
C PROPHYLAXIS CONSTIPATION 1
C PROPHYLAXIS DYSPEPSIA 1
C PROPHYLAXIS DYSPHONIA 1
C PROPHYLAXIS HEPATITIS B 1
C PROPHYLAXIS HIATUS HERNIA 1
C PROPHYLAXIS HYPERLIPIDAEMIA 1
C PROPHYLAXIS INJURY ASSOCIATED WITH DEVICE 1
C PROPHYLAXIS MASS 1
C PROPHYLAXIS MEMORY IMPAIRMENT 1
C PROPHYLAXIS MUSCLE SPASMS 1
C PROPHYLAXIS MUSCULOSKELETAL CHEST PAIN 1
C PROPHYLAXIS MUSCULOSKELETAL PAIN 1
C PROPHYLAXIS MUSCULOSKELETAL STIFFNESS 1
C PROPHYLAXIS MYALGIA 1
C PROPHYLAXIS NASOPHARYNGITIS 1
C PROPHYLAXIS NECK PAIN 1
C PROPHYLAXIS OSTEOPOROSIS 1
C PROPHYLAXIS PAIN IN EXTREMITY 1
C PROPHYLAXIS TENDON PAIN 1
C PROPHYLAXIS TOOTH LOSS 1
C PROPHYLAXIS UNEVALUABLE EVENT 1
C PROPHYLAXIS UTERINE LEIOMYOMA 1
C PROSTATIC ADENOMA ARTERIAL THROMBOSIS LIMB 1
C PROSTATIC ADENOMA ARTERIOSCLEROSIS 1
C PROSTATIC ADENOMA KNEE ARTHROPLASTY 1
C PROSTATIC ADENOMA PERIPHERAL ARTERY ANEURYSM 1
C RHEUMATOID ARTHRITIS CEREBROVASCULAR ACCIDENT 2
C RHEUMATOID ARTHRITIS INFECTION 2
C RHEUMATOID ARTHRITIS PANCREATITIS 2
C RHEUMATOID ARTHRITIS URINARY TRACT INFECTION 2
C TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME ARTERIAL THROMBOSIS LIMB 1
C TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME ARTERIOSCLEROSIS 1
C TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME KNEE ARTHROPLASTY 1
C TUMOUR NECROSIS FACTOR RECEPTOR-ASSOCIATED PERIODIC SYNDROME PERIPHERAL ARTERY ANEURYSM 1
C UTERINE LEIOMYOMA ABDOMINAL DISTENSION 1
C UTERINE LEIOMYOMA ABDOMINAL PAIN UPPER 1
C UTERINE LEIOMYOMA ADVERSE DRUG REACTION 1
C UTERINE LEIOMYOMA ARTHRALGIA 1
C UTERINE LEIOMYOMA BACK PAIN 1
C UTERINE LEIOMYOMA BONE PAIN 1
C UTERINE LEIOMYOMA BURSITIS 1
C UTERINE LEIOMYOMA CARPAL TUNNEL SYNDROME 1
C UTERINE LEIOMYOMA CHEST PAIN 1
C UTERINE LEIOMYOMA CONSTIPATION 1
C UTERINE LEIOMYOMA DYSPEPSIA 1
C UTERINE LEIOMYOMA DYSPHONIA 1
C UTERINE LEIOMYOMA HEPATITIS B 1
C UTERINE LEIOMYOMA HIATUS HERNIA 1
C UTERINE LEIOMYOMA HYPERLIPIDAEMIA 1
C UTERINE LEIOMYOMA INJURY ASSOCIATED WITH DEVICE 1
C UTERINE LEIOMYOMA MASS 1
C UTERINE LEIOMYOMA MEMORY IMPAIRMENT 1
C UTERINE LEIOMYOMA MUSCLE SPASMS 1
C UTERINE LEIOMYOMA MUSCULOSKELETAL CHEST PAIN 1
C UTERINE LEIOMYOMA MUSCULOSKELETAL PAIN 1
C UTERINE LEIOMYOMA MUSCULOSKELETAL STIFFNESS 1
C UTERINE LEIOMYOMA MYALGIA 1
C UTERINE LEIOMYOMA NASOPHARYNGITIS 1
C UTERINE LEIOMYOMA NECK PAIN 1
C UTERINE LEIOMYOMA OSTEOPOROSIS 1
C UTERINE LEIOMYOMA PAIN IN EXTREMITY 1
C UTERINE LEIOMYOMA TENDON PAIN 1
C UTERINE LEIOMYOMA TOOTH LOSS 1
C UTERINE LEIOMYOMA UNEVALUABLE EVENT 1
C UTERINE LEIOMYOMA UTERINE LEIOMYOMA 1
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