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Risedronate Side Effects

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Common Risedronate Side Effects


The most commonly reported Risedronate side effects (click to view or check a box to report):

Femur Fracture (44)
Fall (19)
Pathological Fracture (16)
Osteomyelitis (16)
Aspartate Aminotransferase Increased (16)
Arthralgia (16)
Alanine Aminotransferase Increased (15)
Pain In Extremity (15)
Condition Aggravated (15)
Pyrexia (14)
Malaise (12)
Blood Alkaline Phosphatase Increased (11)
Osteonecrosis (11)
Stress Fracture (10)
Pain (10)
Dyspnoea (10)
Atypical Femur Fracture (10)
Hepatic Function Abnormal (9)
White Blood Cell Count Decreased (9)
Leukopenia (9)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Risedronate Side Effects Reported to FDA



Risedronate Side Effect Report#9695781
Rash Pruritic, Dysgeusia, Parosmia
This is a report of a 69-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Risedronate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Rash Pruritic, Dysgeusia, Parosmia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate treatment in female patients, resulting in Rash Pruritic side effect.
Risedronate Side Effect Report#9610861
Eye Disorder, Oral Mucosal Exfoliation, Melanocytic Naevus, Scab, Oral Pain, Conjunctivitis, Erythema
This report suggests a potential Risedronate Sodium Eye Disorder side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from GB was diagnosed with the following symptoms/conditions: bone density abnormal and used Risedronate Sodium (dosage: 35 Mg, Qw) starting
Aug 04, 2013. After starting Risedronate Sodium the patient began experiencing various side effects, including: Eye Disorder, Oral Mucosal Exfoliation, Melanocytic Naevus, Scab, Oral Pain, Conjunctivitis, ErythemaAdditional drugs used concurrently:
  • Alendronic Acid
  • Bendroflumethiazide (2.5 Mg, Unk)
  • Adcal (2 Df, Qd)
  • Glucosamine Sulphate
  • Paracetamol (2 Df, Qhs)
  • Prednisolone (5 Mg, Bid)
Although Risedronate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Eye Disorder, may still occur.
Risedronate Side Effect Report#9442895
Allergic Myocarditis
This Allergic Myocarditis problem was reported by a physician from GB. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jun 05, 2013 this consumer started treatment with Risedronate Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Calcichew D3
  • Glycerol
  • Glycerol
  • Co-codamol
  • Magnesium Citrate
When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: Allergic MyocarditisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Allergic Myocarditis, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#9171064
Atypical Femur Fracture, Fracture Delayed Union, Pain In Extremity
This Atypical Femur Fracture side effect was reported by a health professional from GR. A 65-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Risedronate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Alendronate (alendronate Sodium)
.After starting to take Risedronate the consumer reported adverse symptoms, such as: Atypical Femur Fracture, Fracture Delayed Union, Pain In ExtremityThese side effects may potentially be related to Risedronate.
Risedronate Side Effect Report#9159854
Balance Disorder, Dizziness, Loss Of Control Of Legs, Ventricular Tachycardia
This is a report of a 85-year-old male patient (weight: NA) from SE, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Risedronate Sodium (dosage: NA, start time: NS), combined with:
  • Tradil (dexibuprofen)
  • Cialis (tadalafil)
  • Kalcipos-d (calcium Carbonate, Colecalciferol)
  • Atrovent (ipratropium Bromide)
  • Avamys (fluticasone Furoate)
  • Serevent (salmeterol Xinafoate)
  • Citodon/00116401/(codeine Phosphate, Paracetamol)
  • Becotide (beclometasone Dipropionate)
and developed a serious reaction and side effect(s): Balance Disorder, Dizziness, Loss Of Control Of Legs, Ventricular Tachycardia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate Sodium treatment in male patients, resulting in Balance Disorder side effect. The patient was hospitalized.
Risedronate Side Effect Report#8984420
Cardiac Failure Congestive, Aortic Stenosis, Mitral Valve Incompetence, Pulmonary Embolism, Clostridium Difficile Colitis, Urinary Tract Infection Pseudomonal, Anaemia, Suffocation Feeling, Dyspnoea
This report suggests a potential Risedronate Cardiac Failure Congestive side effect(s) that can have serious consequences. A 90-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: bone mass decreased,trochanteric femoral fracture and used Risedronate (dosage: NA) starting
Nov 14, 2011. After starting Risedronate the patient began experiencing various side effects, including: Cardiac Failure Congestive, Aortic Stenosis, Mitral Valve Incompetence, Pulmonary Embolism, Clostridium Difficile Colitis, Urinary Tract Infection Pseudomonal, Anaemia, Suffocation Feeling, DyspnoeaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Risedronate demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Cardiac Failure Congestive, may still occur.
Risedronate Side Effect Report#8958651
Arthralgia, Myalgia, Pain In Extremity, Pain In Extremity
This Arthralgia problem was reported by a health professional from US. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteopenia. On
Dec 02, 2012 this consumer started treatment with Risedronate Sodium (dosage: 1-35 Mg Tablet Weekly Po). The following drugs were being taken at the same time: NA. When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: Arthralgia, Myalgia, Pain In Extremity, Pain In ExtremityAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#8923254
Atypical Femur Fracture, Fall
This Atypical Femur Fracture side effect was reported by a health professional from JP. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Risedronate (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Menatetrenone
.After starting to take Risedronate the consumer reported adverse symptoms, such as: Atypical Femur Fracture, FallThese side effects may potentially be related to Risedronate.
Risedronate Side Effect Report#8909237
Atypical Femur Fracture, Femur Fracture, Arthralgia, Tenderness, Impaired Healing
This is a report of a 65-year-old female patient (weight: NA) from GB, suffering from the following health symptoms/conditions: osteoporosis,vertebral fracture, who was treated with Risedronate (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Atypical Femur Fracture, Femur Fracture, Arthralgia, Tenderness, Impaired Healing after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate treatment in female patients, resulting in Atypical Femur Fracture side effect. The patient was hospitalized.
Risedronate Side Effect Report#8816645
Osteoarthritis
This report suggests a potential Risedronate Sodium Osteoarthritis side effect(s) that can have serious consequences. A 46-year-old female patient (weight: NA) from ES was diagnosed with the following symptoms/conditions: NA and used Risedronate Sodium (dosage: NA) starting NS. After starting Risedronate Sodium the patient began experiencing various side effects, including: OsteoarthritisAdditional drugs used concurrently:
  • Lormetazepam
  • Glizolan (diacerein)
Although Risedronate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Osteoarthritis, may still occur.
Risedronate Side Effect Report#8685036
Atypical Femur Fracture, Fracture Delayed Union, Fall, Bone Pain
This Atypical Femur Fracture problem was reported by a health professional from JP. A 74-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: osteoporosis. On 200906 this consumer started treatment with Risedronate Sodium (dosage: 17.5 Mg Weekly, Oral). The following drugs were being taken at the same time:
  • Loxonin (loxoprofen Sodium)
  • Stomatidin /00027901/ (hexetidine)
  • Lyrica
When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: Atypical Femur Fracture, Fracture Delayed Union, Fall, Bone PainThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atypical Femur Fracture, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#8681488
Atypical Femur Fracture, Low Turnover Osteopathy, Osteoporosis, Calcium Metabolism Disorder, Femur Fracture
This Atypical Femur Fracture side effect was reported by a health professional from JP. A 69-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Risedronate Sodium (drug dosage: Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Risedronate Sodium the consumer reported adverse symptoms, such as: Atypical Femur Fracture, Low Turnover Osteopathy, Osteoporosis, Calcium Metabolism Disorder, Femur FractureThese side effects may potentially be related to Risedronate Sodium.
Risedronate Side Effect Report#8635018
Oesophageal Stenosis, Dehydration, Pneumonia, Dysphagia, Oesophagitis, Decreased Appetite, Cough, Fatigue, Gastrooesophageal Reflux Disease
This is a report of a 74-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Risedronate Sodium (dosage: NA, start time:
May 15, 2008), combined with:
  • Fareston
  • Femara
and developed a serious reaction and side effect(s): Oesophageal Stenosis, Dehydration, Pneumonia, Dysphagia, Oesophagitis, Decreased Appetite, Cough, Fatigue, Gastrooesophageal Reflux Disease after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate Sodium treatment in female patients, resulting in Oesophageal Stenosis side effect. The patient was hospitalized.
Risedronate Side Effect Report#8635009
Atypical Femur Fracture, Bone Disorder, Impaired Healing, Disease Complication, Injury
This report suggests a potential Risedronate Sodium Atypical Femur Fracture side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from JP was diagnosed with the following symptoms/conditions: NA and used Risedronate Sodium (dosage: , Oral) starting NS. After starting Risedronate Sodium the patient began experiencing various side effects, including: Atypical Femur Fracture, Bone Disorder, Impaired Healing, Disease Complication, InjuryAdditional drugs used concurrently: NA. Although Risedronate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Atypical Femur Fracture, may still occur.
Risedronate Side Effect Report#8473426-7
Pleurisy
This Pleurisy problem was reported by a health professional from Sweden. A 73-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Nov 03, 2010 this consumer started treatment with Risedronate Sodium (dosage: Unk). The following drugs were being taken at the same time:
  • Enbrel (50 Mg, Weekly)
  • Methotrexate Sodium (10 Mg/ml, Pre-filled Syring)
  • Prednisolone (Unk)
  • Methotrexate Sodium (10 Mg/ml, Unk)
When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: PleurisyThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Pleurisy, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#8458479-4
Blood Albumin Decreased, Exostosis, Dysstasia, Pain, Fall, Blood Creatine Phosphokinase Increased, White Blood Cell Count Decreased, Atypical Femur Fracture, Haemoglobin Decreased
This Blood Albumin Decreased side effect was reported by a health professional from Japan. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Risedronate Sodium (drug dosage: 2.5 Mg Daily, Oral), which was initiated on NS. Concurrently used drugs: NA..After starting to take Risedronate Sodium the consumer reported adverse symptoms, such as: Blood Albumin Decreased, Exostosis, Dysstasia, Pain, Fall, Blood Creatine Phosphokinase Increased, White Blood Cell Count Decreased, Atypical Femur Fracture, Haemoglobin DecreasedThese side effects may potentially be related to Risedronate Sodium. The patient was hospitalized.
Risedronate Side Effect Report#8452008-7
Carotid Aneurysm Rupture
This is a report of a 68-year-old male patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: NA, who was treated with Risedronate Sodium (dosage: NA, start time:
Jun 01, 2011), combined with:
  • Bucillamine
  • Lorcam
  • Voltaren
  • Orencia
  • Prednisolone
  • Selbex
  • Loxonin
and developed a serious reaction and side effect(s): Carotid Aneurysm Rupture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate Sodium treatment in male patients, resulting in Carotid Aneurysm Rupture side effect. The patient was hospitalized.
Risedronate Side Effect Report#8448414-7
Pneumonia
This report suggests a potential Risedronate Sodium Pneumonia side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: osteitis deformans and used Risedronate Sodium (dosage: NA) starting
Apr 21, 2012. After starting Risedronate Sodium the patient began experiencing various side effects, including: PneumoniaAdditional drugs used concurrently: NA.The patient was hospitalized. Although Risedronate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pneumonia, may still occur.
Risedronate Side Effect Report#8446411
Gastric Cancer
This Gastric Cancer problem was reported by a health professional from JP. A 94-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Risedronate Sodium (dosage: Oral). The following drugs were being taken at the same time: NA. When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: Gastric CancerAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Gastric Cancer, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#8444967
Femur Fracture, Bone Pain, Traumatic Fracture
This Femur Fracture side effect was reported by a health professional from JP. A 79-year-old female patient (weight:NA) experienced the following symptoms/conditions: osteoporosis.The patient was prescribed Risedronate Sodium (drug dosage: NA), which was initiated on 200411. Concurrently used drugs:
  • Norvasc
  • Myonal /00287502/ (epirizole Hydrochloride)
  • Celecoxib
  • Aspara-ca (aspartate Calcium)
  • Onealfa (alfacalcidol)
  • Blopress (candesartan Cilexetil)
  • Takepron (lansoprazole)
  • Benet (risedronate Sodium) Tablet
.After starting to take Risedronate Sodium the consumer reported adverse symptoms, such as: Femur Fracture, Bone Pain, Traumatic FractureThese side effects may potentially be related to Risedronate Sodium. The patient was hospitalized.
Risedronate Side Effect Report#8427518-9
Gastrointestinal Disorder, Bronchopneumonia
This is a report of a 62-year-old female patient (weight: NA) from Japan, suffering from the following health symptoms/conditions: osteoporosis,rheumatoid arthritis, who was treated with Risedronate Sodium (dosage: NA, start time:
May 31, 2011), combined with:
  • Orencia
  • Prednisolone
  • Lansoprazole
  • Gasmotin
  • Neoral
and developed a serious reaction and side effect(s): Gastrointestinal Disorder, Bronchopneumonia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate Sodium treatment in female patients, resulting in Gastrointestinal Disorder side effect. The patient was hospitalized.
Risedronate Side Effect Report#8398663-1
Bone Callus Excessive, Injury, Atypical Femur Fracture
This report suggests a potential Risedronate Sodium Bone Callus Excessive side effect(s) that can have serious consequences. A 74-year-old female patient (weight: NA) from Japan was diagnosed with the following symptoms/conditions: NA and used Risedronate Sodium (dosage: 17.5 Mg Weekly) starting NS. After starting Risedronate Sodium the patient began experiencing various side effects, including: Bone Callus Excessive, Injury, Atypical Femur FractureAdditional drugs used concurrently: NA. Although Risedronate Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Bone Callus Excessive, may still occur.
Risedronate Side Effect Report#8398065-8
Atypical Femur Fracture, Fall, Bone Callus Excessive
This Atypical Femur Fracture problem was reported by a health professional from Japan. A 79-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Risedronate Sodium (dosage: 17.5 Mg Weekly). The following drugs were being taken at the same time: NA. When using Risedronate Sodium, the patient experienced the following unwanted symptoms/side effects: Atypical Femur Fracture, Fall, Bone Callus ExcessiveAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Atypical Femur Fracture, may become evident only after a product is in use by the general population.
Risedronate Side Effect Report#8375135-1
Dyspnoea, Dizziness, Swollen Tongue
This Dyspnoea side effect was reported by a physician from United Kingdom. A female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Risedronate Sodium (drug dosage: NA), which was initiated on
Apr 18, 2012. Concurrently used drugs:
  • Calcium Carbonate
  • Folic Acid
  • Bendrofluazide
  • Losartan Potassium
  • Methotrexate
  • Metformin Hcl
  • Bydureon (2 Mg, Weekly (1/w))
.After starting to take Risedronate Sodium the consumer reported adverse symptoms, such as: Dyspnoea, Dizziness, Swollen TongueThese side effects may potentially be related to Risedronate Sodium.
Risedronate Side Effect Report#8364261-9
Femur Fracture, Bone Scan Abnormal, Stress Fracture
This is a report of a 53-year-old female patient (weight: NA) from United States, suffering from the following health symptoms/conditions: osteoporosis, who was treated with Risedronate Sodium (dosage: NA, start time: NS), combined with:
  • Alendronic Acid (alendronic Acid)
and developed a serious reaction and side effect(s): Femur Fracture, Bone Scan Abnormal, Stress Fracture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Risedronate Sodium treatment in female patients, resulting in Femur Fracture side effect.


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The appearance of Risedronate on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

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    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

    Risedronate reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

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    Risedronate Safety Alerts, Active Ingredients, Usage Information

    NDC0378-4150
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameRisedronate Sodium
    Namerisedronate sodium
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20140610
    LabelerMylan Pharmaceuticals Inc.
    Active Ingredient(s)RISEDRONATE SODIUM ANHYDROUS
    Strength(s)150
    Unit(s)mg/1
    Pharma ClassBisphosphonate [EPC],Diphosphonates [Chemical/Ingredient]

    More About Risedronate

    Side Effects reported to FDA: 285

    Risedronate safety alerts: 2007

    Reported deaths: 16

    Reported hospitalizations: 172

    Bisphosphonates marketed as Alendronate (Fosamax, Fosamax Plus D), Etidronate (Didronel), Ibandronate (Boniva), Pamidronate (Aredia), Risedronate (Actonel, Actonel W/Calcium), Tiludronate (Skelid), and Zoledronic acid (Reclast, Zometa)

    Audience: Geriatricians, gynecologists, orthopedic surgeons, other healthcare professionals, consumers

    [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 Pagetā??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. 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.

    [October 2007 - Early Communication - FDA]

    Latest Risedronate clinical trials