Boniva Side Effects
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Boniva Safety Reports reported to FDA
Total Boniva reports: 1022.Boniva FDA safety alerts: 2007 2008 .
Reported deaths: 49 Reported hospitalizations: 357.
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Reported Boniva Side Effects: arthralgia, bone pain, chest pain, back pain, pain in extremity, pain in jaw, myalgia, nausea, dyspnoea, influenza like illness, diarrhoea.
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Boniva Side Effects Report #5263661-3Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 12, 2007. Female patient, 62 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: depression, influenza like illness, pain, pain in extremity, suicidal ideation. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5263962-9
BONIVA problem was reported by a Physician from UNITED STATES on Mar 05, 2007. Female patient was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: hepatic failure, renal failure, thrombotic thrombocytopenic purpura, white blood cell count increased. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5264009-0
Physician from UNITED STATES reported BONIVA problem on Mar 06, 2007. Female patient, 77 years of age, was diagnosed with osteoporosis, breast cancer, ill-defined disorder, hypothyroidism, blood pressure and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: lichenoid keratosis, palpable purpura, rash. BONIVA dosage: unknown. During the same period patient was treated with ARIMIDEX, NEXIUM, LEVOTHYROXINE, NIFEDIPINE. Patient recovered.
Boniva Side Effects Report #5264642-6
BONIVA problem was reported by a Physician from UNITED STATES on Mar 02, 2007. Female patient, 80 years of age, weighting 91.93 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal pain upper, anorexia, arthropathy, asthenia, back pain, bone pain, burning sensation, chest pain. BONIVA dosage: unknown. Patient was hospitalized and became disabled. Patient recovered.
Boniva Side Effects Report #5265111-X
Physician from UNITED STATES reported BONIVA problem on Mar 06, 2007. Male patient, 85 years of age, weighting 114.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, asthenia, cardiac failure congestive, chills, diarrhoea, dry skin, dysphagia, hypersensitivity, incoherent. BONIVA dosage: unknown. Patient was hospitalized and became disabled. Patient died on 01/04/2007.
Boniva Side Effects Report #5266129-3
BONIVA problem was reported by a Physician from UNITED STATES on Mar 06, 2007. Male patient, 85 years of age, weighting 114.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, asthenia, cardiac failure congestive, chills, diarrhoea, dry skin, dysphagia, hypersensitivity, incoherent. BONIVA dosage: unknown. Patient was hospitalized and became disabled. Patient died on 01/04/2007.
Boniva Side Effects Report #5266297-3
Physician from UNITED STATES reported BONIVA problem on Mar 05, 2007. Female patient, 63 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: cerebrovascular accident, fatigue, rash, visual disturbance. BONIVA dosage: unknown. During the same period patient was treated with BACTRIM, PROZAC, INDERAL, LUNESTA, CALCIUM, WELCHOL. Patient was hospitalized. Patient died on 12/01/2006.
Boniva Side Effects Report #5266357-7
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 07, 2007. Female patient, 55 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: back pain, chest pain, dysphagia, dyspnoea, glossitis, hypoaesthesia, lip swelling, mouth haemorrhage, movement disorder. BONIVA dosage: unknown. During the same period patient was treated with CYMBALTA, PRILOSEC, PREDNISONE. Patient recovered.
Boniva Side Effects Report #5266972-0
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 06, 2007. Female patient, 59 years of age, weighting 117.1 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: pain, pitting oedema, weight increased. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5267216-6
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 07, 2007. Female patient, 73 years of age, weighting 149.9 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: resorption bone increased, tooth loss. BONIVA dosage: unknown. During the same period patient was treated with SYNTHROID. Patient recovered.
Boniva Side Effects Report #5267435-9
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 06, 2007. Male patient, 85 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: hypersensitivity, incoherent. BONIVA dosage: unknown. Patient was hospitalized. Patient died on 01/04/2007.
Boniva Side Effects Report #5269008-0
BONIVA problem was reported by a Physician from UNITED STATES on Mar 09, 2007. Female patient, 62 years of age, weighting 110.0 lb, was diagnosed with osteoporosis, somnolence and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: cellulitis, hypersensitivity. BONIVA dosage: unknown. During the same period patient was treated with MIACALCIN, PAMELOR, DETROL. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5269009-2
Physician from UNITED STATES reported BONIVA problem on Mar 08, 2007. Female patient, 78 years of age, weighting 121.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: deafness neurosensory, ear pain. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5269103-6
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 09, 2007. Female patient, 74 years of age, weighting 103.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: dysphagia, throat tightness. BONIVA dosage: unknown. During the same period patient was treated with CALCIUM. Patient recovered.
Boniva Side Effects Report #5270175-3
Physician from UNITED STATES reported BONIVA problem on Mar 08, 2007. Female patient, 61 years of age, weighting 201.9 lb, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: anaphylactic shock, hypersensitivity. BONIVA dosage: unknown. During the same period patient was treated with LIBRAX, ELAVIL, CELEXA, POTASSIUM CHLORIDE, ARTHROTEC, NEXIUM, INDERAL, ZEPHREX. Patient recovered.
Boniva Side Effects Report #5271151-7
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Female patient, 80 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: fatigue, parathyroid disorder. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5272392-5
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 20, 2007. Female patient, 49 years of age, weighting 210.0 lb, was diagnosed with resorption bone increased and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain upper, arthralgia, back pain, gastrointestinal pain, impaired work ability, insomnia, musculoskeletal pain, neck pain, oral intake reduced. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5272814-X
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 13, 2007. Female patient, 79 years of age, weighting 98.99 lb, was diagnosed with osteoporosis, hypothyroidism, glaucoma, hypertension and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, dyspepsia, gastric ulcer, pancreatitis. BONIVA dosage: unknown. During the same period patient was treated with CALCIUM NOS, VITAMINS NOS, LEVOXYL, OCULAR EYE DROPS. Patient recovered.
Boniva Side Effects Report #5273758-X
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 21, 2007. Female patient, 61 years of age, weighting 169.0 lb, was diagnosed with osteopenia and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, bone pain, diarrhoea, hair disorder, toothache. BONIVA dosage: 150 MG PO MONTHLY. During the same period patient was treated with CRESTOR, LEVOTHYROXINE, REGLAN, CYMBALTA. Patient recovered.
Boniva Side Effects Report #5273954-1
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 12, 2007. Female patient, 76 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: dyspepsia, fall. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5273955-3
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 12, 2007. Female patient, weighting 115.1 lb, was diagnosed with osteopenia and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, asthenia, bone pain, muscular weakness, myalgia, pyrexia, vitamin d deficiency. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5274125-5
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 15, 2007. Female patient was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: impaired healing, osteonecrosis, tooth extraction. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5277493-3
Physician from UNITED STATES reported BONIVA problem on Mar 19, 2007. Female patient was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: hepatic failure, renal failure, thrombotic thrombocytopenic purpura, white blood cell count increased. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5277536-7
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 21, 2007. Female patient, 82 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cold sweat, feeling abnormal, feeling hot, ill-defined disorder, loss of consciousness, malaise, mydriasis. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5278819-7
Physician from UNITED STATES reported BONIVA problem on Mar 19, 2007. Female patient, 55 years of age, weighting 160.9 lb, was diagnosed with osteopenia, depression, gastrooesophageal reflux disease and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: back pain, chest pain, dysphagia, dyspnoea, glossitis, hypersensitivity, hypoaesthesia, lip swelling, mouth haemorrhage. BONIVA dosage: unknown. During the same period patient was treated with CYMBALTA, PRILOSEC, PREDNISONE. Patient recovered.
Boniva Side Effects Report #5279227-5
BONIVA problem was reported by a Physician from UNITED STATES on Mar 21, 2007. Female patient, 65 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: diarrhoea, gastrointestinal disorder, ileal ulcer, muscle spasms. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5281362-2
Pharmacist from UNITED STATES reported BONIVA problem on Mar 23, 2007. Female patient, 51 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: pain in extremity, swelling. BONIVA dosage: 3MG Q 3 MONTHS IV. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5284330-X
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 21, 2007. Female patient, 82 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: anaphylactic reaction, cold sweat, feeling abnormal, feeling hot, ill-defined disorder, loss of consciousness, malaise, mydriasis. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5288165-3
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Apr 02, 2007. Female patient, 63 years of age, weighting 167.0 lb, was diagnosed with osteopenia and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, asthenia, back pain, chills, condition aggravated, diarrhoea, fatigue, headache, influenza like illness. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5288278-6
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 21, 2007. Female patient, 82 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: cold sweat, feeling abnormal, feeling hot, hypersensitivity, hypotension, ill-defined disorder, loss of consciousness, malaise, mydriasis. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5288293-2
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Mar 26, 2007. Female patient, 66 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal discomfort, abdominal distension, pyloric stenosis. BONIVA dosage: unknown. During the same period patient was treated with ASPIRIN. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5289254-X
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 03, 2007. Female patient, 84 years of age, weighting 105.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, asthenia, bone pain, fall, loss of consciousness, walking aid user, wheelchair user. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5289558-0
Physician from UNITED STATES reported BONIVA problem on Mar 26, 2007. Male patient, 85 years of age, weighting 114.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: acute myocardial infarction, asthenia, cardiac failure congestive, cardio-respiratory arrest, chills, chronic obstructive pulmonary disease, diarrhoea, dry skin, dysphagia. BONIVA dosage: unknown. Patient was hospitalized and became disabled. Patient died on 01/04/2007.
Boniva Side Effects Report #5289571-3
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Mar 29, 2007. Female patient, 54 years of age, weighting 289.9 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: dental caries, jaw disorder, pain in jaw. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5292225-0
Physician from UNITED STATES reported BONIVA problem on Apr 03, 2007. Female patient, 43 years of age, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: gastric ulcer. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5292255-9
BONIVA problem was reported by a Physician from UNITED STATES on Mar 30, 2007. Female patient, 45 years of age, weighting 121.0 lb, was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: failure of implant, jaw disorder, no therapeutic response. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5294961-9
Physician from UNITED STATES reported BONIVA problem on Apr 03, 2007. Female patient, 54 years of age, weighting 136.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abasia, agitation, arthralgia, bone pain, nausea, pain in extremity. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5294968-1
BONIVA problem was reported by a Physician from UNITED STATES on Apr 03, 2007. Female patient, 54 years of age, weighting 289.9 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: dental caries, impaired healing, jaw disorder, pain in jaw, post procedural cellulitis. BONIVA dosage: unknown. During the same period patient was treated with COUMADIN. Patient recovered.
Boniva Side Effects Report #5296511-X
Physician from UNITED STATES reported BONIVA problem on Apr 04, 2007. Female patient, 64 years of age, weighting 188.9 lb, was diagnosed with osteopenia, irritable bowel syndrome, depression and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: costochondritis. BONIVA dosage: unknown. During the same period patient was treated with FENTANYL TRANSDERMAL SYSTEM, LIPITOR, ZELNORM, LEXAPRO. Patient recovered.
Boniva Side Effects Report #5296512-1
BONIVA problem was reported by a Physician from UNITED STATES on Apr 04, 2007. Female patient, 58 years of age, weighting 128.1 lb, was diagnosed with bone density decreased and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: chest pain, dysphagia, dyspnoea, heart rate increased, hypersensitivity, lip swelling, nausea, oedema peripheral, pharyngeal oedema. BONIVA dosage: unknown. During the same period patient was treated with WELCHOL, VITAMIN D, TOPROL, HYDROCHLOROTHIAZIDE, GREEN TEA, GLUCOSAMINE SULPHATE, CALCIUM NOS, SUPPLEMENTS. Patient recovered.
Boniva Side Effects Report #5296515-7
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Apr 02, 2007. Female patient, 61 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arrhythmia. BONIVA dosage: unknown. During the same period patient was treated with COUMADIN. Patient recovered.
Boniva Side Effects Report #5297984-9
BONIVA problem was reported by a Physician from UNITED STATES on Apr 06, 2007. Female patient, 71 years of age, weighting 134.9 lb, was diagnosed with osteoporosis prophylaxis, pain and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, arthritis, cardiac disorder, depression, fatigue, influenza like illness, joint swelling, lethargy, myelitis transverse. BONIVA dosage: unknown. During the same period patient was treated with ANALGESICS, NARCOTIC ANALGESIC NOS, THYROID HORMONE NOS, ADVAIR DISKUS, SINGULAIR, ASPIRIN, VITAMINS NOS, ASCORBIC ACID. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5298118-7
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Apr 05, 2007. Female patient, 71 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: chills, diarrhoea, dyspepsia, nausea, pyrexia, vomiting. BONIVA dosage: unknown. During the same period patient was treated with PERCOCET. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5299246-2
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 06, 2007. Female patient, 55 years of age, weighting 163.4 lb, was diagnosed with osteopenia, depression, gastrooesophageal reflux disease and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: back pain, barrett's oesophagus, bone pain, chest pain, dysphagia, dyspnoea, glossitis, hypersensitivity, hypoaesthesia. BONIVA dosage: unknown. During the same period patient was treated with CYMBALTA, PRILOSEC, PREDNISONE. Patient recovered.
Boniva Side Effects Report #5299263-2
Consumer or non-health professional from UNITED STATES reported BONIVA problem on Apr 10, 2007. Female patient was diagnosed with pain and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: abdominal pain, brain neoplasm malignant, cardiovascular disorder, demyelination, eye pain, mood altered. BONIVA dosage: unknown. During the same period patient was treated with MORPHINE. Patient was hospitalized. Patient died on 11/04/2006.
Boniva Side Effects Report #5299266-8
BONIVA problem was reported by a Physician from UNITED STATES on Apr 09, 2007. Female patient, 82 years of age, weighting 89.95 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: lung neoplasm malignant. BONIVA dosage: unknown. Patient was hospitalized. Patient died on 03/23/2007.
Boniva Side Effects Report #5299275-9
Physician from UNITED STATES reported BONIVA problem on Apr 05, 2007. Female patient, 59 years of age, was diagnosed with osteoporosis postmenopausal and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: osteonecrosis. BONIVA dosage: unknown. Patient recovered.
Boniva Side Effects Report #5299402-3
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 11, 2007. Female patient, 80 years of age, weighting 158.0 lb, was diagnosed with osteoporosis, vitamin d decreased and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: asthenia, breast pain, chills, decreased appetite, musculoskeletal chest pain, musculoskeletal pain, neck pain, pain in extremity, vertigo. BONIVA dosage: unknown. During the same period patient was treated with VITAMIN D. Patient recovered.
Boniva Side Effects Report #5300892-8
Physician from UNITED STATES reported BONIVA problem on Apr 06, 2007. Female patient, 75 years of age, weighting 136.0 lb, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: arthralgia, back pain, bone pain, oedema peripheral, pain in extremity. BONIVA dosage: unknown. Patient was hospitalized. Patient recovered.
Boniva Side Effects Report #5301886-9
BONIVA problem was reported by a Consumer or non-health professional from UNITED STATES on Apr 12, 2007. Female patient, 65 years of age, was diagnosed with osteoporosis and was treated with BONIVA. After drug was administered, patient experienced the following problems/side effects: gastrooesophageal reflux disease. BONIVA dosage: unknown. During the same period patient was treated with HYDROCHLOROTHIAZIDE, ASPIRIN, TOPRAL, CALCIUM. Patient was hospitalized. Patient recovered.
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Drug Information: Ibandronate
URL of this page: http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a605035.html
(i ban' droh 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.
Ibandronate 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). Ibandronate 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?
Ibandronate comes as a tablet to take by mouth. The 2.5-mg tablet is usually taken once a day in the morning on an empty stomach and the 150-mg tablet is usually taken once a month in the morning on an empty stomach. The 150-mg tablet should be taken on the same date each month. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take ibandronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.
Ibandronate 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 ibandronate just after you get out of bed in the morning, before you eat or drink anything. Never take ibandronate 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, about 1 cup) of plain water. Never take ibandronate with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.
- Swallow the tablets whole; do not split, chew, or crush them. Do not suck on the tablets.
- After you take ibandronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 60 minutes. Do not lie down for at least 60 minutes after you take ibandronate. Sit upright or stand upright for at least 60 minutes.
Ibandronate controls osteoporosis but does not cure it. Ibandronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take ibandronate even if you feel well. Do not stop taking ibandronate 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 ibandronate,
- tell your doctor and pharmacist if you are allergic to ibandronate or any other medications, or any of the ingredients in ibandronate tablets. Ask your pharmacist for a list of the ingredients.
- 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 (Naprosyn, Aleve) 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 oral medications, including supplements, vitamins, or antacids, take them at least 60 minutes after you take ibandronate.
- tell your doctor if you are unable to sit upright or stand upright for at least 60 minutes and if you have or have ever had a low level of calcium in your blood. Your doctor may tell you not to take ibandronate.
- tell your doctor if are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body); difficulty swallowing; heartburn; ulcers or other problems with your stomach or esophagus; 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; or dental or kidney disease.
- tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding.Also tell your doctor if you plan to become pregnant at any time in the future, because ibandronate may remain in your body for many years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.
- you should know that ibandronate 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 ibandronate. Be sure to brush your teeth and clean your mouth properly while you are taking ibandronate. 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 and drink plenty of foods and drinks that are rich in calcium and vitamin D while you are taking ibandronate. Your doctor will tell you which foods and drinks 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 may prescribe or recommend a supplement.
What should I do if I forget a dose?
If you forget to take the daily 2.5-mg tablet, do not take it later in the day.Skip the missed dose and continue your regular dosing schedule the next morning. Do not take two tablets of ibandronate on the same day.
If you forget to take the once-monthly 150-mg tablet, and your next scheduled day to take ibandronate is more than 7 days away, take one tablet the morning after you remember. Then return to taking one tablet each month on the regularly scheduled date. If you forget to take the once-monthly 150-mg tablet and your next scheduled day to take ibandronate is 7 or fewer days away, skip the dose and wait for your next scheduled day. You should not take two 150-mg tablets of ibandronate within 1 week.
If you are not sure what to do if you miss a dose of ibandronate, call your doctor.
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.
Ibandronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
- nausea
- stomach pain
- diarrhea
- constipation
- back pain
- bone, joint, or muscle pain
- pain in the arms or legs
- weakness
- dizziness
- headache
- flu-like symptoms
- fever, sore throat, chills, cough, and other signs of infection
- frequent or urgent need to urinate
- painful urination
Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before you take any more ibandronate:
- new or worsening heartburn
- difficulty swallowing
- pain on swallowing
- chest pain
- rash
- painful or swollen gums
- loosening of the teeth
- numbness or heavy feeling in the jaw
- poor healing of the jaw
- eye pain
Ibandronate 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. Do not allow the victim to lie down and do not try to make the victim vomit. Do not lie down.
Symptoms of overdose may include:
- nausea
- stomach pain
- heartburn
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. Your doctor may order certain tests to check your body's response to ibandronate.
Before having any bone imaging study, tell your doctor and health care personnel that you are taking ibandronate
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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