Actonel Safety Questions, Actonel Answers
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Actonel Safety Reports
Total Actonel reports: 219.Actonel FDA safety alerts: 2007 2008 .
Reported deaths: 9 Reported hospitalizations: 87.
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Reported Actonel Side Effects: osteonecrosis, arthralgia, bone pain, pain in jaw, pain in extremity, myalgia, jaw disorder, chest pain, nausea, condition aggravated, fall.
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Actonel Side Effects Report #5070010-2Physician from IRELAND reported ACTONEL problem on July 24, 2006. Female patient, 56 years of age, weighting 121.3 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: injury, osteonecrosis, tooth disorder. ACTONEL dosage: 35 MG, 1/WEEK, ORAL. During the same period patient was treated with FOLATE, METHOTREXATE, CALCICHEW D, PRAVASTATIN. Patient recovered.
Actonel Side Effects Report #5070016-3
ACTONEL problem was reported by a Health Professional from FRANCE on July 25, 2006. Female patient, 68 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: abscess jaw, disease recurrence, jaw disorder, osteonecrosis. ACTONEL dosage: unknown. During the same period patient was treated with FOSAMAX, PREDNISONE, OMEPRAZOLE, PLAVIX, ATACAND, AMLODIPINE BESYLATE, CACIT D, TOCOPHEROX. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5069868-2
Physician from UNITED STATES reported ACTONEL problem on Aug 02, 2006. Female patient, 83 years of age, weighting 105.0 lb, was diagnosed with osteonecrosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. ACTONEL dosage: unknown. During the same period patient was treated with LANOXIN. Patient recovered.
Actonel Side Effects Report #5073201-X
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on July 19, 2006. Female patient was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: thyroidectomy. ACTONEL dosage: MG, 1/WEEK, ORAL. Patient recovered.
Actonel Side Effects Report #5074867-0
Physician from UNITED STATES reported ACTONEL problem on July 28, 2006. Female patient, 53 years of age, weighting 84.00 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: hospitalisation, osteonecrosis, tooth discolouration, tooth extraction. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL; SEE IMAGE. During the same period patient was treated with FOSAMAX, PERIDEX, NYSTATIN, FERROUS SULPHATE, CALCIUM. Patient was hospitalized and became disabled. Patient recovered.
Actonel Side Effects Report #5075010-4
ACTONEL problem was reported by a Physician from UNITED STATES on July 20, 2006. Female patient was diagnosed with osteoporosis postmenopausal and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: metastases to lung, sarcoma. ACTONEL dosage: unknown. Patient recovered.
Actonel Side Effects Report #5075688-5
Physician from SWITZERLAND reported ACTONEL problem on July 27, 2006. Female patient, 65 years of age, weighting 112.4 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: bone erosion, osteonecrosis. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with CALPEROS D, LIVIAL. Patient recovered.
Actonel Side Effects Report #5075905-1
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 07, 2006. Female patient, 53 years of age, weighting 178.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: arthralgia, bedridden, bone pain, chills, dysstasia, fatigue, gait disturbance, hyperhidrosis. ACTONEL dosage: ONE @35MG. ONCE A WEEK PILL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5078814-7
Pharmacist from UNITED STATES reported ACTONEL problem on Aug 02, 2006. Female patient, 74 years of age, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: duodenal ulcer haemorrhage. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with ASPIRIN, UNIRETIC, MILK OF MAGNESIA. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5078936-0
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 09, 2006. Female patient, 48 years of age, weighting 140.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: chills, diarrhoea, headache, hyperhidrosis, malaise, muscle spasms, myalgia, nausea, vomiting. ACTONEL dosage: 35MG ONCE-A-WEEK PO. Patient recovered.
Actonel Side Effects Report #5078947-5
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Aug 09, 2006. Female patient, 53 years of age, weighting 196.0 lb, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: arthralgia, bone pain, mobility decreased, muscular weakness, myalgia. ACTONEL dosage: 35MG. WEEKLY PO. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5080778-7
ACTONEL problem was reported by a Physician from JAPAN on July 25, 2006. Female patient, 83 years of age, was diagnosed with osteoporosis, diabetes mellitus, insomnia, cardiac failure and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, anorexia, aspartate aminotransferase increased, bilirubin conjugated increased, blood alkaline phosphatase increased, blood bilirubin increased, blood lactate dehydrogenase increased, gamma-glutamyltransferase increased, gastritis. ACTONEL dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with STARLIX, PLATIBIT, VIT K CAP, PRORENAL, NEUROVITAN, DICLOFENAC, DEPAS, TORSEMIDE. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5081131-2
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Aug 14, 2006. Female patient, 61 years of age, weighting 115.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: arthralgia, back injury, back pain, blood pressure increased, buttock pain, dyspnoea, urticaria. ACTONEL dosage: 35 MG 1/WEEK PO. Patient recovered.
Actonel Side Effects Report #5084753-8
ACTONEL problem was reported by a Health Professional from FRANCE on Aug 03, 2006. Female patient, 63 years of age, was diagnosed with osteoporosis, arrhythmia, depression, spinal fracture and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: convulsion, hyponatraemia. ACTONEL dosage: 35 MG, DAILY, ORAL. During the same period patient was treated with LASIX, OXAZEPAM, SOTALOL, ISRADIPINE, TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5084754-X
Health Professional from FRANCE reported ACTONEL problem on Aug 03, 2006. Female patient, 65 years of age, weighting 110.2 lb, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: alopecia, arthralgia, condition aggravated, rheumatoid arthritis, scleritis, synovitis, visual acuity reduced. ACTONEL dosage: unknown. During the same period patient was treated with ARAVA, ENBREL, PREDNISONE, SULFASALAZINE. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5085005-2
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Aug 04, 2006. Female patient, 54 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: gingival infection, impaired healing, osteonecrosis, tooth extraction. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with AMBIEN, CALCIUM. Patient recovered.
Actonel Side Effects Report #5087202-9
Health Professional from GREECE reported ACTONEL problem on Aug 08, 2006. Female patient, 74 years of age, weighting 172.0 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: back pain, bedridden, bone pain, chest pain, hypoaesthesia, myalgia, respiratory distress. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5087203-0
ACTONEL problem was reported by a Physician from ESTONIA on Aug 07, 2006. Female patient, 68 years of age, weighting 154.3 lb, was diagnosed with osteoporosis postmenopausal and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, alveolitis, aspartate aminotransferase increased, asthenia, blood creatinine increased, blood potassium increased, blood sodium decreased, dehydration, dementia. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with CARDACE, GASEC, MEDROL, IMURAN. Patient was hospitalized. Patient died on 07/11/2006.
Actonel Side Effects Report #5088343-2
Pharmacist from UNITED STATES reported ACTONEL problem on Aug 08, 2006. Male patient, 75 years of age, was diagnosed with osteitis deformans and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: fall. ACTONEL dosage: 30 MG DAILY, ORAL. During the same period patient was treated with OXYCONTIN. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5088344-4
ACTONEL problem was reported by a Physician from UNITED STATES on Aug 07, 2006. Female patient was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: abortion spontaneous. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. Patient recovered.
Actonel Side Effects Report #5092044-4
Consumer or non-health professional from BRAZIL reported ACTONEL problem on Aug 14, 2006. Female patient, 77 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: chest pain, gastric disorder, oesophageal pain. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5092395-3
ACTONEL problem was reported by a Physician from UNITED STATES on Aug 15, 2006. Female patient, 72 years of age, weighting 134.9 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: anxiety, arrhythmia, bone density decreased, fatigue, heart rate decreased, ventricular extrasystoles. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with ESTRADIOL, LIPITOR, NEXIUM, ASPIRIN, VITAMINS. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5092396-5
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Aug 16, 2006. Female patient, 42 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: uterine cancer. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with GLUCOPHAGE, ATENOLOL, ASTELIN, FLONASE, HOMEOPATIC PREPARATION, ASCORBIC ACID, FISH OIL. Patient recovered.
Actonel Side Effects Report #5094209-4
ACTONEL problem was reported by a Pharmacist from UNITED STATES on Aug 30, 2006. Female patient was diagnosed with osteopenia, osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: back pain, chest pain. ACTONEL dosage: 35 MG 1Q WEEK PO [ONLY ONE DOSE TAKEN]. During the same period patient was treated with MIDRIN, TOPROL, LEXAPRO. Patient recovered.
Actonel Side Effects Report #5095481-7
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Sept 01, 2006. Male patient, weighting 190.0 lb, was diagnosed with arthritis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: pain in jaw, tooth extraction, tooth infection. ACTONEL dosage: 30MG WEEKLY ORAL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5099930-X
ACTONEL problem was reported by a Health Professional from FRANCE on Aug 23, 2006. Female patient, 74 years of age, was diagnosed with osteoporosis, cystitis, hypovitaminosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: blood creatine phosphokinase increased, c-reactive protein increased, condition aggravated, cyanosis, dermatomyositis, pain in extremity, raynaud's phenomenon, rhabdomyolysis. ACTONEL dosage: 35 MG, 1/WEEK, ORAL. During the same period patient was treated with ENOXOR, IDEOS. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5103629-0
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Sept 11, 2006. Female patient, 53 years of age, weighting 178.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: abasia, ill-defined disorder, movement disorder. ACTONEL dosage: 35MG WEEKLY PO. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5103715-5
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 11, 2006. Female patient, 60 years of age, weighting 140.0 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: bone neoplasm, breast cancer female, carbohydrate antigen 27.29 increased, disease recurrence, hepatic neoplasm malignant recurrent. ACTONEL dosage: 35 MG 1XDAY. Patient recovered.
Actonel Side Effects Report #5114793-1
Consumer or non-health professional from AUSTRALIA reported ACTONEL problem on Sept 15, 2006. Female patient was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: breast cancer female. ACTONEL dosage: unknown. Patient recovered.
Actonel Side Effects Report #5114984-X
ACTONEL problem was reported by a Physician from UNITED STATES on Sept 15, 2006. Female patient, 53 years of age, weighting 83.78 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: adverse event, anaemia, cytomegalovirus chorioretinitis, cytomegalovirus oesophagitis, gastrooesophageal reflux disease, hepatic cirrhosis, jaw disorder, lymphoproliferative disorder, meningitis. ACTONEL dosage: unknown. During the same period patient was treated with DIDRONEL, FOSAMAX, NYSTATIN, FERROUS SULPHATE. Patient was hospitalized and became disabled. Patient recovered.
Actonel Side Effects Report #5120672-6
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 03, 2006. Female patient, 56 years of age, weighting 132.0 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, chest pain, gastric ulcer, inflammation. ACTONEL dosage: 35 MG /WEEKLY (1 DOSE). During the same period patient was treated with CLIMARA, NORTRIPTYLINE, NORCO. Patient recovered.
Actonel Side Effects Report #5122459-7
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 19, 2006. Female patient, 53 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: gallbladder disorder, gastric disorder. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with FOSAMAX, WELLBUTRIN. Patient recovered.
Actonel Side Effects Report #5122676-6
Consumer or non-health professional from FRANCE reported ACTONEL problem on Sept 25, 2006. Female patient, 74 years of age, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: arthralgia, hypercalcaemia, hypovitaminosis, vitamin d deficiency. ACTONEL dosage: 35 MG, 1/WEEK, ORAL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5122837-6
ACTONEL problem was reported by a Physician from UNITED STATES on Oct 04, 2006. Female patient was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: jaw disorder, osteonecrosis. ACTONEL dosage: 5 MG QD. During the same period patient was treated with FOSAMAX. Patient recovered.
Actonel Side Effects Report #5126023-5
Health Professional from FRANCE reported ACTONEL problem on Oct 04, 2006. Female patient, 50 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: aphasia, cerebral haemorrhage, convulsion, injury, international normalised ratio increased, miosis, mydriasis, subdural haematoma. ACTONEL dosage: unknown. During the same period patient was treated with TAREG, DIFFU K, VASTAREL, PREVISCAN, PLAVIX. Patient died on 07/21/2006.
Actonel Side Effects Report #5126430-0
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Sept 26, 2006. Female patient, 82 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: cholecystectomy, myocardial infarction, renal impairment. ACTONEL dosage: 35 MG, ONCE WEEKLY, ORAL. During the same period patient was treated with COZAAR, ASPIRIN, POTASSIUM, LASIX, PRAVACHOL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5126568-8
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 12, 2006. Female patient, weighting 100.0 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: arthralgia, bone pain. ACTONEL dosage: unknown. Patient recovered.
Actonel Side Effects Report #5126756-0
ACTONEL problem was reported by a Physician from UNITED STATES on Oct 12, 2006. Female patient, 53 years of age, weighting 114.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: dyspepsia, oesophageal pain. ACTONEL dosage: 35 MG X1/WK. During the same period patient was treated with ACIPHEX. Patient recovered.
Actonel Side Effects Report #5127261-8
Consumer or non-health professional from UNITED KINGDOM reported ACTONEL problem on Sept 28, 2006. Female patient, 78 years of age, weighting 154.3 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: eczema, hyperkeratosis palmaris and plantaris. ACTONEL dosage: unknown. During the same period patient was treated with ARTHROTEC, DIDRONEL PMO, NEBIVOLOL, SERETIDE, SPIRIVA, VISCOTEARS. Patient recovered.
Actonel Side Effects Report #5132377-6
ACTONEL problem was reported by a Health Professional from UNITED STATES on Oct 20, 2006. Female patient, 53 years of age, weighting 135.0 lb, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: activities of daily living impaired, arthralgia, dyspnoea, muscle spasms, pain. ACTONEL dosage: 35 MG Q WEEK PO. Patient recovered.
Actonel Side Effects Report #5138796-6
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 11, 2006. Female patient, 73 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: back pain, heat rash, ovarian cancer, rash pruritic. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with COREG, INSULIN, IRON, ESZOPICLONE, ASCORBIC ACID, HERBAL PREPARATION, CALCIUM. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5139747-0
ACTONEL problem was reported by a Health Professional from MEXICO on Oct 06, 2006. Female patient, 59 years of age, weighting 130.1 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: eye pain, glaucoma, photophobia. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with CALCITRIOL. Patient recovered.
Actonel Side Effects Report #5140226-5
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 10, 2006. Female patient, 54 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: dysgeusia, gastrooesophageal reflux disease, gingival infection, hypoaesthesia oral, impaired healing, mastication disorder, oral discomfort, oral intake reduced, osteonecrosis. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with AMBIEN, CLONAZEPAM, CALCIUM. Patient recovered.
Actonel Side Effects Report #5140801-8
ACTONEL problem was reported by a Consumer or non-health professional from GERMANY on Oct 18, 2006. Female patient, 50 years of age, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: blood pressure increased, gastrointestinal disorder, headache, influenza like illness, myalgia, weight decreased. ACTONEL dosage: 35 MG, 1/WEEK, ORAL. Patient was hospitalized. Patient recovered.
Actonel Side Effects Report #5141533-2
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 12, 2006. Female patient was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: blood parathyroid hormone increased, breast cancer, parathyroid gland enlargement, unevaluable event. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with EVISTA, ASACOL, MERCAPTOPURINE, PREDNISONE, VITAMIN D. Patient recovered.
Actonel Side Effects Report #5143560-8
ACTONEL problem was reported by a Physician from UNITED STATES on Oct 17, 2006. Female patient, 80 years of age, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: osteonecrosis, pain in jaw. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with CALCIUM, VITAMIN D, MOBIC, PAXIL, FOLIC ACID, ASCORBIC ACID, SINGULAIR, ADVAIR. Patient recovered.
Actonel Side Effects Report #5143561-X
Physician from UNITED STATES reported ACTONEL problem on Oct 17, 2006. Female patient, 61 years of age, was diagnosed with osteopenia and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: endodontic procedure, joint dislocation, mastication disorder, osteonecrosis, pain in jaw, temporomandibular joint syndrome. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with NEXIUM, CITRACAL, NABUMETONE, LEVOXYL, PRINIVIL, ACETYLSALICYLIC ACID, OLEANDOMYCIN. Patient recovered.
Actonel Side Effects Report #5146782-5
ACTONEL problem was reported by a Consumer or non-health professional from UNITED STATES on Nov 07, 2006. Female patient, 58 years of age, weighting 125.0 lb, was diagnosed with bone density decreased and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: bone pain, myalgia. ACTONEL dosage: 35 MG 1 PO. Patient recovered.
Actonel Side Effects Report #5149040-8
Consumer or non-health professional from UNITED STATES reported ACTONEL problem on Oct 26, 2006. Female patient, 89 years of age, was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: dizziness, fall, hypertension, nausea, renal failure. ACTONEL dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with NAMENDA, ASPIRIN, CALCARB WITH VITAMIN D, METAMUCIL. Patient recovered.
Actonel Side Effects Report #5151095-1
ACTONEL problem was reported by a Health Professional from UNITED STATES on Nov 14, 2006. Female patient, 54 years of age, weighting 100.0 lb, was diagnosed with osteoporosis and was treated with ACTONEL. After drug was administered, patient experienced the following problems/side effects: anger, device breakage, feeling abnormal, jaw disorder, oral intake reduced, osteonecrosis, weight decreased. ACTONEL dosage: 35 MG OCE A WEEK PO. Patient recovered.
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Drug Information: Risedronate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a601247.html
(ris ed' roe nate)IMPORTANT WARNING:
| [Posted 01/07/2008] FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates and http://www.fda.gov/cder/drug/infopage/bisphosphonates/default.htm.[Posted 10/01/2007] FDA issued an early communication about the ongoing review of new safety data regarding the association of atrial fibrillation with the use of bisphosphonates. Bisphosphonates are a class of drugs used primarily to increase bone mass and reduce the risk for fracture in patients with osteoporosis, slow bone turnover in patients with Paget’s disease of the bone, treat bone metastases, and lower elevated levels of blood calcium in patients with cancer.FDA reviewed spontaneous postmarketing reports of atrial fibrillation reported in association with oral and intravenous bisphosphonates and did not identify a population of bisphosphonate users at increased risk of atrial fibrillation. In addition, as part of the data review for the recent approval of once-yearly Reclast for the treatment of postmenopausal osteoporosis, FDA evaluated the possible association between atrial fibrillation and the use of Reclast (zoledronic acid). Most cases of atrial fibrillation occurred more than a month after drug infusion. Also, in a subset of patients monitored by electrocardiogram up to the 11th day following infusion, there was no significant difference in the prevalence of atrial fibrillation between patients who received Reclast and patients who received placebo.Upon initial review, it is unclear how these data on serious atrial fibrillation should be interpreted. Therefore, FDA does not believe that healthcare providers or patients should change either their prescribing practices or their use of bisphosphonates at this time. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Bisphosphonates and http://www.fda.gov/cder/drug/early_comm/bisphosphonates.htm. |
Why is this medication prescribed?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Risedronate is used to prevent and treat osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (change of life; end of menstrual periods) and in men and women who are taking glucocorticoids (corticosteroids; a type of medication that may cause osteoporosis). Risedronate is also used to treat osteoporosis in men. Risedronate is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Risedronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).
How should this medicine be used?
Risedronate comes as a tablet to take by mouth. It is usually taken on an empty stomach once a day in the morning or once a week in the morning. If you are taking risedronate once a week, take it on the same day every week. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take risedronate exactly as directed. Do not take more or less of it or take it more often or for a longer period of time than prescribed by your doctor.
Risedronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:
- You must take risedronate immediately after you get out of bed in the morning and before you eat or drink anything. Never take risedronate at bedtime or before you wake up and get out of bed for the day.
- Swallow the tablets with a full glass (6 to 8 ounces) of plain water while you are sitting or standing. Never take risedronate with tea, coffee, juice, mineral water, milk, other dairy drinks, or any liquid other than plain water.
- Swallow the tablets whole. Do not split, chew, or crush them. Do not suck on the tablets or hold them in your mouth for any length of time.
- After you take risedronate, do not eat, drink, or take any other medications for at least 30 minutes. Do not lie down for at least 30 minutes after you take risedronate. Sit upright or stand upright until at least 30 minutes have passed.
Risedronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. Risedronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take risedronate even if you feel well. Do not stop taking risedronate without talking to your doctor.
Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.
Other uses for this medicine
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
What special precautions should I follow?
Before taking risedronate,
- tell your doctor and pharmacist if you are allergic to risedronate or any other medications.
- tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn);cancer chemotherapy;and oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
- if you are taking any other oral medications including vitamins, supplements, or antacids, take them at least 30 minutes after you take risedronate.
- tell your doctor if you have or have ever had a low level of calcium in your blood and if you are unable to sit upright or stand upright for at least 30 minutes. Your doctor may tell you that you should not take risedronate.
- tell your doctor if you are undergoing radiation therapy; if you have or have ever had difficulty swallowing; heartburn, ulcers, or other problems with your stomach or esophagus; anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); cancer; any type of infection, especially in your mouth; problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; dental or kidney disease.
- tell your doctor if you are pregnant or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because risedronate may remain in your body for years after you stop taking it. Call your doctor if you become pregnant during or after your treatment with risedronate.
- you should know that risedronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments before you start to take risedronate. Be sure to brush your teeth and clean your mouth properly while you are taking risedronate. Talk to your doctor before having any dental treatments while you are taking this medication.
- talk to your doctor about other things you can do to prevent osteoporosis from developing or worsening. Your doctor will probably tell you to avoid smoking and drinking large amounts of alcohol and to follow a regular program of weight-bearing exercise.
What special dietary instructions should I follow?
You should eat plenty of foods that are rich in calcium and vitamin D while you are taking risedronate. Your doctor will tell you which foods are good sources of these nutrients and how many servings you need each day. If you find it difficult to eat enough of these foods, tell your doctor. In that case, your doctor can prescribe or recommend a supplement.
What should I do if I forget a dose?
If you miss a dose of once-daily risedronate, do not take it later in the day. Skip the missed dose and take one dose the next morning as usual. If you miss a dose of once-weekly risedronate, do not take it later in the day. Take one dose the morning after you remember. Then return to taking one dose once each week on your regularly scheduled day. Never take a double dose to make up for a missed one, and never take more than one dose in one day.
What side effects can this medication cause?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Risedronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- burping
- dry mouth
- stomach pain
- diarrhea
- constipation
- gas
- headache
- dizziness
- depression
- anxiety
- weakness
- leg cramps
- bone, joint, and/or muscle pain
- back pain
- flu-like symptoms
- fever, chills, sore throat, cough, and other signs of infection
- frequent or urgent need to urinate
- painful urination
- runny nose
- dry eyes
- ringing in the ears
Some side effects can be serious. If you experience any of the following side effects, call your doctor immediately before you take any more risedronate:
- difficulty swallowing or pain when swallowing
- new or worsening heartburn
- chest pain
- bloody vomit
- vomiting material that looks like coffee grounds
- black, tarry, or bloody stools
- itching
- rash
- hives
- blisters on skin
- swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
- difficulty breathing
- hoarseness
- swollen, red, or painful eyes
- sensitivity to light
Risedronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.
What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.
In case of emergency/overdose
In case of overdose, give the victim a full glass of milk and call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Symptoms of overdose may include:
- numbness or tingling around mouth or in hands or feet
- muscle spasms, cramps, or twitches
- seizures
What other information should I know?
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor and the laboratory.
Before having any laboratory test or bone imaging study, tell your doctor and the laboratory personnel that you are taking risedronate.
Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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