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Total Risedronate reports: 33.Risedronate FDA safety alerts: 2007 .
Reported deaths: 3 Reported hospitalizations: 23.
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FDA Reported Risedronate Side Effects: osteomyelitis acute, hepatic function abnormal, blood alkaline phosphatase increased, pyrexia, condition aggravated, lymphocyte stimulation test positive, thrombocytopenia, haemorrhage subcutaneous, jaundice, cerebral haemorrhage, shock.
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Risedronate Side Effects Report #5252864-X
Physician from JAPAN reported RISEDRONATE problem on Feb 14, 2007. Female patient was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, jaundice. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with ONEALFA, IBRUPROFEN. Patient recovered.
Risedronate Side Effects Report #5266652-1
RISEDRONATE problem was reported by a Physician from JAPAN on Feb 26, 2007. Female patient, 57 years of age, was diagnosed with osteoporosis, back pain and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: hepatic failure, hepatitis fulminant, jaundice, malaise. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with ONEALFA, BRUFEN. Patient died.
Risedronate Side Effects Report #5318501-0
Physician from JAPAN reported RISEDRONATE problem on Apr 20, 2007. Male patient, 82 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: haemorrhage subcutaneous, purpura, thrombocytopenia. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with NORVASC, ANTIHYPERTENSIVES. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5330619-5
RISEDRONATE problem was reported by a Physician from FINLAND on May 08, 2007. Female patient, 68 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: gingival recession, open wound, tooth fracture, tooth infection. RISEDRONATE dosage: 35 MG ONCE WEEKLY, ORAL. During the same period patient was treated with DIFORMIN, DIOVAN COMP. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5339473-9
Physician from JAPAN reported RISEDRONATE problem on May 14, 2007. Female patient, 86 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: osteomyelitis acute, poor personal hygiene, purulent discharge, swelling face, trismus. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with ALFAROL, VOLTAREN, MYONAL, MUCOSTA, MOHRUS. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5353152-3
RISEDRONATE problem was reported by a Physician from JAPAN on May 23, 2007. Male patient, 76 years of age, was diagnosed with osteoporosis, musculoskeletal pain and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: hepatic function abnormal, lymphocyte stimulation test positive. RISEDRONATE dosage: unknown. During the same period patient was treated with RHEUMATREX, LIPOVAS. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5357142-6
Physician from JAPAN reported RISEDRONATE problem on May 31, 2007. Female patient, 81 years of age, was diagnosed with osteoporosis, hypertension, hyperlipidaemia and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: liver disorder. RISEDRONATE dosage: unknown. During the same period patient was treated with BLOPRESS, LIPITOR, STOGAR. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5357153-0
RISEDRONATE problem was reported by a Physician from JAPAN on May 30, 2007. Female patient, 54 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: condition aggravated, diabetes mellitus, treatment noncompliance. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with PELETON, NATEGLINIDE, AMARYL, NEOPHAGEN, MOHRUS, NEO VITACAIN. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5368302-2
Health Professional from SPAIN reported RISEDRONATE problem on June 07, 2007. Female patient, 70 years of age, weighting 176.4 lb, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: hallucination. RISEDRONATE dosage: 35 MG, 1/DAY, ORAL. During the same period patient was treated with PLAVIX, APOCARD, CIMASCAL DTE, FORTZAAR, BRISTACOL, DEANXIT. Patient recovered.
Risedronate Side Effects Report #5066135-8
RISEDRONATE problem was reported by a Physician from JAPAN on July 11, 2006. Female patient, 58 years of age, was diagnosed with osteoporosis prophylaxis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: alpha 1 foetoprotein increased, ascites, bile duct cancer, blood albumin decreased, carbohydrate antigen 19-9 increased, carcinoembryonic antigen increased, cholangitis sclerosing, haemorrhage, hepatic failure. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with HORMONES AND RELATED AGENTS, PREDNISOLONE, PENTASA, NEO MINOPHAGEN C, URSO, PREDONINE. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5070017-5
Physician from JAPAN reported RISEDRONATE problem on July 18, 2006. Female patient, 70 years of age, was diagnosed with osteoporosis prophylaxis, asthma and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: c-reactive protein increased, disseminated intravascular coagulation, thrombocytopenia, white blood cell count increased. RISEDRONATE dosage: 2.5 MG, DAILY, ORAL. During the same period patient was treated with BAKUMONDOUTO, LASIX, DIGOXIN, WARFARIN, ALLOPURINOL, PROCATEROL, ONON, ISOSORBIDE DINITRATE. Patient died on 03/07/2006.
Risedronate Side Effects Report #5083662-8
RISEDRONATE problem was reported by a Health Professional from JAPAN on Aug 08, 2006. Female patient, 82 years of age, was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: fall, loss of consciousness. RISEDRONATE dosage: 2.5 MG. During the same period patient was treated with MYSLEE. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5094337-3
Physician from JAPAN reported RISEDRONATE problem on Aug 10, 2006. Female patient, 61 years of age, was diagnosed with reflux oesophagitis, arthralgia and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: agranulocytosis, arthralgia, back pain, neutropenia, neutrophil percentage increased, non-hodgkin's lymphoma, pyrexia, reflux oesophagitis, white blood cell count decreased. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with LANSOPRAZOLE, OSTELUC, PREDNISOLONE, RITUXAN, CYCLOPHOSPHAMIDE, DOXORUBICIN, ONCOVIN. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5126429-4
RISEDRONATE problem was reported by a Health Professional from UNITED STATES on Sept 25, 2006. Female patient, 52 years of age, weighting 259.0 lb, was diagnosed with osteitis deformans and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: blood alkaline phosphatase increased, blood parathyroid hormone increased, calcium ionised decreased, dysarthria, hungry bone syndrome, hypocalcaemia, mental status changes, myoclonus, procollagen type i c-terminal propeptide increased. RISEDRONATE dosage: 30 MG, DAILY, ORAL. During the same period patient was treated with ALBUTEROL, FUROSEMIDE, AMLODIPINE, IBUPROFEN. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5140802-X
Physician from JAPAN reported RISEDRONATE problem on Oct 19, 2006. Female patient, 71 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: alanine aminotransferase increased, aspartate aminotransferase increased, bilirubin conjugated increased, blood alkaline phosphatase increased, blood bilirubin increased, blood cholinesterase increased, gamma-glutamyltransferase increased, hepatic function abnormal, jaundice. RISEDRONATE dosage: 2.5 MG, DAILY, ORAL. During the same period patient was treated with PENFILL R. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5142922-2
RISEDRONATE problem was reported by a Physician from JAPAN on Oct 20, 2006. Female patient, 35 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: blood creatinine decreased, granulocytopenia, white blood cell count decreased. RISEDRONATE dosage: 2.5 MG, DAILY, ORAL. During the same period patient was treated with BONALON, FAMOTIDINE, PREDNISOLONE, SULFAMETHOXAZOLE, ALFAROL, PERSANTIN. Patient recovered.
Risedronate Side Effects Report #5159320-8
Physician from JAPAN reported RISEDRONATE problem on Nov 07, 2006. Female patient, 35 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: basophil count decreased, blood alkaline phosphatase increased, blood creatinine decreased, condition aggravated, eosinophil count decreased, granulocytopenia, lymphocyte count increased, monocyte count increased, neutrophil count decreased. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with BONALON, FAMOTIDINE, PREDNISOLONE, SULFAMETHOXAZOLE, ALFAROL, PERSANTIN. Patient recovered.
Risedronate Side Effects Report #5170853-0
RISEDRONATE problem was reported by a Consumer or non-health professional from UNITED STATES on Dec 06, 2006. Female patient, 84 years of age, weighting 131.6 lb, was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: chest pain. RISEDRONATE dosage: unknown. Patient recovered.
Risedronate Side Effects Report #5196419-4
Consumer or non-health professional from SPAIN reported RISEDRONATE problem on Dec 12, 2006. Female patient, 75 years of age, was diagnosed with osteoporosis, pulmonary embolism, cardiac failure, respiratory disorder, gastric ulcer, electrolyte imbalance, cough, candidiasis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: blood disorder, eosinophilic pneumonia, sepsis, thrombocytopenia. RISEDRONATE dosage: 35 MG, 1 ONLY, ORAL. During the same period patient was treated with HIBOR, SEGURIL, TAVANIC, OMEPRAZOLE, URBASON, BOI K, CODEISAN, MYCOSTATIN. Patient was hospitalized. Patient died on 07/21/2006.
Risedronate Side Effects Report #5199500-9
RISEDRONATE problem was reported by a Health Professional from JAPAN on Dec 19, 2006. Male patient was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: haemorrhage subcutaneous, platelet count decreased, purpura. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with NORVASC. Patient recovered.
Risedronate Side Effects Report #5382290-4
Physician from JAPAN reported RISEDRONATE problem on June 20, 2007. Female patient, 83 years of age, was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: anaemia macrocytic, aplasia pure red cell, enterocolitis bacterial, lymphocyte stimulation test positive. RISEDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5400554-2
RISEDRONATE problem was reported by a Physician from JAPAN on July 09, 2007. Female patient, 67 years of age, was diagnosed with osteoporosis, hypertension, hyperlipidaemia, gastritis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: autoimmune hepatitis, basophil percentage decreased, haematocrit decreased, haemoglobin decreased, hepatic function abnormal, monocyte percentage increased, red blood cell count decreased. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with BLOPRESS, LIPITOR, STOGAR, ALFAROL. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5401425-8
Physician from JAPAN reported RISEDRONATE problem on July 12, 2007. Female patient, 81 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: blood pressure decreased, dizziness, headache, nausea, pyrexia, shock, sudden hearing loss, tinnitus, vomiting. RISEDRONATE dosage: 17.5 MG, 1/WEEK, ORAL. During the same period patient was treated with LANSOPRAZOLE, NORVASC, ASPIRIN, ENALAPRIL MALEATE, GOSYAZINKIGAN, MUCOSTA, DEPAS. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5401426-X
RISEDRONATE problem was reported by a Physician from JAPAN on July 13, 2007. Female patient, 77 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: cholelithiasis, condition aggravated, hypertension, shock. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with LOXONIN, MUCOSTA, MOBIC, IRGAS. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5404293-3
Physician from JAPAN reported RISEDRONATE problem on July 19, 2007. Female patient, 66 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: osteomyelitis, tooth extraction. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5406727-7
RISEDRONATE problem was reported by a Physician from JAPAN on July 19, 2007. Female patient, 75 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: osteomyelitis. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with DEPAS, LOXONIN. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5409366-7
Physician from JAPAN reported RISEDRONATE problem on July 24, 2007. Female patient, 80 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: osteomyelitis, pain in jaw. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with BLOPRES, PRAVASTATIN, NILZIPIN, SIGMART. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5413265-4
RISEDRONATE problem was reported by a Physician from JAPAN on July 26, 2007. Female patient, 76 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with KIPRES, HUSTAZOL, MUCOSOLVAN, NIVADIL, LIVALO, ASPARA. Patient recovered.
Risedronate Side Effects Report #5429292-7
Health Professional from JAPAN reported RISEDRONATE problem on Aug 10, 2007. Female patient, 83 years of age, was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: anaemia macrocytic, aplasia pure red cell, bone marrow failure, chills, diarrhoea, enterocolitis bacterial, large granular lymphocytosis, lymphocyte stimulation test positive, pyrexia. RISEDRONATE dosage: unknown. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5447419-8
RISEDRONATE problem was reported by a Physician from JAPAN on Aug 21, 2007. Female patient, 67 years of age, was diagnosed with osteoporosis, hypertension, hyperlipidaemia, gastritis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: antimitochondrial antibody positive, antinuclear antibody positive, autoimmune hepatitis, basophil count decreased, haematocrit normal, haemoglobin decreased, lymphocyte count decreased, monocyte count increased, neutrophil percentage increased. RISEDRONATE dosage: 2.5MG DAILY, ORAL; 2.5 MG DAILY, ORAL. During the same period patient was treated with CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL, LIPITOR, STOGAR, ALFAROL. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5458145-3
Physician from JAPAN reported RISEDRONATE problem on Aug 31, 2007. Female patient, 71 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: breast cancer female. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with ASPARA, MOBIC, MUCOSTA, ONEALFA. Patient was hospitalized. Patient recovered.
Risedronate Side Effects Report #5467312-4
RISEDRONATE problem was reported by a Physician from JAPAN on Sept 06, 2007. Female patient, 76 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: cerebral haemorrhage. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with KIPRESS, HUSTAZOL, MUCOSOLVAN, NIVADIL, LIVALO, ASPARA, TIZANIDINE. Patient was hospitalized and became disabled. Patient recovered.
Risedronate Side Effects Report #5472737-7
Physician from JAPAN reported RISEDRONATE problem on Sept 13, 2007. Female patient, 94 years of age, was diagnosed with osteoporosis and was treated with RISEDRONATE. After drug was administered, patient experienced the following problems/side effects: skin ulcer. RISEDRONATE dosage: 2.5 MG DAILY, ORAL. During the same period patient was treated with AMLODIPINE BESYLATE, CALFALEAD, ASPIRIN, MENIACE, HUSCODE, CLEANAL. Patient recovered.
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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