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Risedronate Side Effects

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.

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.

Risedronate Side Effects Reported to FDA

The following 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.


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.
Rash Pruritic, Dysgeusia, Parosmia
on Nov 18, 2013 Female from US , 69 years of age, was diagnosed with and was treated with Risedronate. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: rash pruritic, dysgeusia, parosmia. Risedronate dosage: N/A.

Eye Disorder, Oral Mucosal Exfoliation, Melanocytic Naevus, Scab, Oral Pain, Conjunctivitis, Erythema
Patient was taking Risedronate Sodium. Patient felt the following Risedronate side effects: eye disorder, oral mucosal exfoliation, melanocytic naevus, scab, oral pain, conjunctivitis, erythema on Oct 09, 2013 from GB Additional patient health information: Male , 70 years of age, was diagnosed with and. Risedronate Sodium dosage: 35 Mg, Qw.
Multiple prescriptions taken:
  • Alendronic Acid
  • Bendroflumethiazide (2.5 Mg, Unk)
  • Adcal (2 Df, Qd)
  • Glucosamine Sulphate
  • Paracetamol (2 Df, Qhs)
  • Prednisolone (5 Mg, Bid)


Allergic Myocarditis
Adverse event was reported on Aug 06, 2013 by a Female taking Risedronate Sodium (Dosage: N/A) . Location: GB , 81 years of age, After Risedronate was administered, patient encountered several Risedronate side effects: allergic myocarditis.
Multiple concurrent drugs taken:
  • Calcichew D3
  • Glycerol
  • Glycerol
  • Co-codamol
  • Magnesium Citrate


Atypical Femur Fracture, Fracture Delayed Union, Pain In Extremity
on Mar 12, 2013 Female from GR , 65 years of age, was diagnosed with and was treated with Risedronate. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: atypical femur fracture, fracture delayed union, pain in extremity. Risedronate dosage: N/A.
Associated medications used:
  • Alendronate (alendronate Sodium)



Balance Disorder, Dizziness, Loss Of Control Of Legs, Ventricular Tachycardia
on Feb 20, 2013 Male from SE , 85 years of age, was diagnosed with and was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: balance disorder, dizziness, loss of control of legs, ventricular tachycardia. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • 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)
Patient was hospitalized.

Cardiac Failure Congestive, Aortic Stenosis, Mitral Valve Incompetence, Pulmonary Embolism, Clostridium Difficile Colitis, Urinary Tract Infection Pseudomonal, Anaemia, Suffocation Feeling, Dyspnoea
Patient was taking Risedronate. After Risedronate was administered, patient encountered several Risedronate side effects: cardiac failure congestive, aortic stenosis, mitral valve incompetence, pulmonary embolism, clostridium difficile colitis, urinary tract infection pseudomonal, anaemia, suffocation feeling, dyspnoea on Dec 14, 2012 from ES Additional patient health information: Female , 90 years of age, weighting 132.3 lb, was diagnosed with and. Risedronate dosage: N/A. Patient was hospitalized.

Arthralgia, Myalgia, Pain In Extremity
Adverse event was reported on Dec 06, 2012 by a Female taking Risedronate Sodium (Dosage: 1-35 Mg Tablet Weekly Po) was diagnosed with and. Location: US , 68 years of age, weighting 158.0 lb, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: arthralgia, myalgia, pain in extremity.

Atypical Femur Fracture, Fall
on Nov 15, 2012 Female from JP , 86 years of age, was diagnosed with and was treated with Risedronate. Patient felt the following Risedronate side effects: atypical femur fracture, fall. Risedronate dosage: N/A.
Multiple prescriptions taken:
  • Menatetrenone


Atypical Femur Fracture, Arthralgia, Tenderness, Impaired Healing
on Nov 07, 2012 Female from GB , 65 years of age, was diagnosed with and was treated with Risedronate. After Risedronate was administered, patient encountered several Risedronate side effects: atypical femur fracture, arthralgia, tenderness, impaired healing. Risedronate dosage: N/A. Patient was hospitalized.

Osteoarthritis
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: osteoarthritis on Sep 28, 2012 from ES Additional patient health information: Female , 46 years of age, . Risedronate Sodium dosage: N/A.
Associated medications used:
  • Lormetazepam
  • Glizolan (diacerein)


Atypical Femur Fracture, Fracture Delayed Union, Fall, Bone Pain
Adverse event was reported on Feb 08, 2013 by a Female taking Risedronate Sodium (Dosage: 17.5 Mg Weekly, Oral) was diagnosed with and. Location: JP , 74 years of age, Patient felt the following Risedronate side effects: atypical femur fracture, fracture delayed union, fall, bone pain.
Multiple prescriptions taken:
  • Loxonin (loxoprofen Sodium)
  • Stomatidin /00027901/ (hexetidine)
  • Lyrica
Patient was hospitalized.

Atypical Femur Fracture, Low Turnover Osteopathy, Osteoporosis, Calcium Metabolism Disorder
on Nov 05, 2013 Female from JP , 69 years of age, was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: atypical femur fracture, low turnover osteopathy, osteoporosis, calcium metabolism disorder. Risedronate Sodium dosage: Oral.

Oesophageal Stenosis, Dehydration, Pneumonia, Dysphagia, Oesophagitis, Decreased Appetite, Cough, Fatigue, Gastrooesophageal Reflux Disease
on Oct 04, 2012 Female from JP , 74 years of age, weighting 134.5 lb, was diagnosed with and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: oesophageal stenosis, dehydration, pneumonia, dysphagia, oesophagitis, decreased appetite, cough, fatigue, gastrooesophageal reflux disease. Risedronate Sodium dosage: N/A.
Associated medications used:
  • Fareston
  • Femara
Patient was hospitalized.

Atypical Femur Fracture, Bone Disorder, Impaired Healing, Disease Complication, Injury
Patient was taking Risedronate Sodium. Patient felt the following Risedronate side effects: atypical femur fracture, bone disorder, impaired healing, disease complication, injury on Feb 25, 2013 from JP Additional patient health information: Female , 79 years of age, . Risedronate Sodium dosage: , Oral.

Pleurisy
Adverse event was reported on Jun 13, 2012 by a Male taking Risedronate Sodium (Dosage: Unk) . Location: SWEDEN , 73 years of age, After Risedronate was administered, patient encountered several Risedronate side effects: pleurisy.
Multiple concurrent drugs taken:
  • Enbrel (50 Mg, Weekly)
  • Methotrexate Sodium (10 Mg/ml, Pre-filled Syring)
  • Prednisolone (Unk)
  • Methotrexate Sodium (10 Mg/ml, Unk)
Patient was hospitalized.

Blood Albumin Decreased, Exostosis, Dysstasia, Pain, Fall, Blood Creatine Phosphokinase Increased, White Blood Cell Count Decreased, Atypical Femur Fracture, Haemoglobin Decreased
on May 31, 2012 Female from JAPAN , 79 years of age, was diagnosed with and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: blood albumin decreased, exostosis, dysstasia, pain, fall, blood creatine phosphokinase increased, white blood cell count decreased, atypical femur fracture, haemoglobin decreased. Risedronate Sodium dosage: 2.5 Mg Daily, Oral. Patient was hospitalized.

Carotid Aneurysm Rupture
on Jun 13, 2012 Male from JAPAN , 68 years of age, was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: carotid aneurysm rupture. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Bucillamine
  • Lorcam
  • Voltaren
  • Orencia
  • Prednisolone
  • Selbex
  • Loxonin
Patient was hospitalized.

Pneumonia
Patient was taking Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: pneumonia on May 30, 2012 from JAPAN Additional patient health information: Male , 61 years of age, was diagnosed with and. Risedronate Sodium dosage: N/A. Patient was hospitalized.

Gastric Cancer
Adverse event was reported on Dec 17, 2012 by a Female taking Risedronate Sodium (Dosage: Oral) . Location: JP , 94 years of age, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: gastric cancer.

Femur Fracture, Bone Pain, Traumatic Fracture
on Jun 12, 2013 Female from JP , 79 years of age, was diagnosed with and was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: femur fracture, bone pain, traumatic fracture. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Norvasc
  • Myonal /00287502/ (epirizole Hydrochloride)
  • Celecoxib
  • Aspara-ca (aspartate Calcium)
  • Onealfa (alfacalcidol)
  • Blopress (candesartan Cilexetil)
  • Takepron (lansoprazole)
  • Benet (risedronate Sodium) Tablet
Patient was hospitalized.

Gastrointestinal Disorder, Bronchopneumonia
on Jun 04, 2012 Female from JAPAN , 62 years of age, weighting 119.0 lb, was diagnosed with and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: gastrointestinal disorder, bronchopneumonia. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Orencia
  • Prednisolone
  • Lansoprazole
  • Gasmotin
  • Neoral
Patient was hospitalized.

Bone Callus Excessive, Injury, Atypical Femur Fracture
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: bone callus excessive, injury, atypical femur fracture on May 14, 2012 from JAPAN Additional patient health information: Female , 74 years of age, . Risedronate Sodium dosage: 17.5 Mg Weekly.

Atypical Femur Fracture, Fall, Bone Callus Excessive
Adverse event was reported on May 14, 2012 by a Female taking Risedronate Sodium (Dosage: 17.5 Mg Weekly) . Location: JAPAN , 79 years of age, Patient felt the following Risedronate side effects: atypical femur fracture, fall, bone callus excessive.

Dyspnoea, Dizziness, Swollen Tongue
on May 14, 2012 Female from UNITED KINGDOM , weighting 246.9 lb, was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: dyspnoea, dizziness, swollen tongue. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Calcium Carbonate
  • Folic Acid
  • Bendrofluazide
  • Losartan Potassium
  • Methotrexate
  • Metformin Hcl
  • Bydureon (2 Mg, Weekly (1/w))


Femur Fracture, Bone Scan Abnormal, Stress Fracture
on May 03, 2012 Female from UNITED STATES , 53 years of age, was diagnosed with and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: femur fracture, bone scan abnormal, stress fracture. Risedronate Sodium dosage: N/A.
Associated medications used:
  • Alendronic Acid (alendronic Acid)


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Why Your Notes are Important

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    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

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    Scale: 1 = very mild to 10 = very bad


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    Discuss Risedronate Side Effects

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    How Effective is Risedronate for You?

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    Safety Alerts, Active Ingredients, Usage Information

    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