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Risedronate Side Effects

Report Risedronate Side Effects

If you experienced any harmful or unwanted effects of Risedronate, please share your experience. This could help to raise awareness about Risedronate side effects, identify uknown risks and inform health professionals and patients taking Risedronate.

Examples: headache, dizziness


The most commonly reported Risedronate side effects are:
CHONDRITIS (1 reports)
High Blood Pressure (1 reports)

If you have experienced a side effect listed above, you can check a box to report it.


View a complete list of Risedronate side effects or compare Risedronate side effects

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 (eg, physician, pharmacist). Your health care provider can provide additional clinical information and complete a copy of the side effect reporting form.

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.

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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.
Skin Cancer, Eczema
on Apr 27, 2012 Female from JAPAN , 75 years of age, was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: skin cancer, eczema. Risedronate Sodium dosage: N/A.
Associated medications used:
  • Forteo (Unk)
Patient was hospitalized.

Oedema Peripheral, Aldolase Increased, Liver Disorder, Anxiety, Polymyositis, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Blood Albumin Decreased, Pleural Effusion
Patient was taking Risedronate Sodium (risedronate Sodium) N/a. Patient felt the following Risedronate side effects: oedema peripheral, aldolase increased, liver disorder, anxiety, polymyositis, alanine aminotransferase increased, aspartate aminotransferase increased, blood albumin decreased, pleural effusion on Apr 24, 2012 from Additional patient health information: Female , 58 years of age, weighting 125.7 lb, . Risedronate Sodium (risedronate Sodium) N/a dosage: N/A.
Multiple prescriptions taken:
  • Rheumatrex (Unk, Oral)
  • Benet (ridsedronate Sodium)
  • Enbrel (25 Mg, Unk, Subcutaneous)
  • Foliamin (folic Acid) N/a
Patient was hospitalized.

Nausea, Blood Fibrinogen Increased, Red Blood Cell Sedimentation Rate Increased, Chills, Delusion, Urticaria
Adverse event was reported on Apr 19, 2012 by a Female taking Risedronate Sodium (Dosage: 75 Mg, 2 Cd/month, Oral) was diagnosed with and. Location: ITALY , 72 years of age, After Risedronate was administered, patient encountered several Risedronate side effects: nausea, blood fibrinogen increased, red blood cell sedimentation rate increased, chills, delusion, urticaria.

Fall, Femur Fracture
on Apr 10, 2012 Female from JAPAN , 76 years of age, was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: fall, femur fracture. Risedronate Sodium dosage: Oral.
Associated medications used:
  • Alendronate Sodium (Oral)



Dysphagia, Red Blood Cell Count Decreased, White Blood Cell Count Increased, Foreign Body, Blood Urea Increased, Oesophagitis, Oesophageal Stenosis, Blood Iron Decreased
on Apr 09, 2012 Female from JAPAN , 82 years of age, was diagnosed with and was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: dysphagia, red blood cell count decreased, white blood cell count increased, foreign body, blood urea increased, oesophagitis, oesophageal stenosis, blood iron decreased. Risedronate Sodium dosage: 17.5mg Once Weekly, Oral.
Multiple prescriptions taken:
  • Rebamipide (rebamipide)
  • Falken (flurbiprofen)
  • Blopress (candesartan Cilexetil)
  • Mobic
  • Rheumatrex
  • Loxoprofen (loxoprofen)
  • Predonine /000161201/ (prednisolone)
  • Prednisolone
Patient was hospitalized.

Feeling Abnormal, Asthenia, Myalgia, Mobility Decreased
Patient was taking Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: feeling abnormal, asthenia, myalgia, mobility decreased on Apr 11, 2012 from UNITED STATES Additional patient health information: Female , 73 years of age, weighting 168.0 lb, was diagnosed with and. Risedronate Sodium dosage: 150 Mg 1-month Oral.

Polymyalgia Rheumatica
Adverse event was reported on Apr 04, 2012 by a Patient taking Risedronate Sodium (Dosage: 17.5 Mg, Weekly) was diagnosed with and. Location: JAPAN , weighting 105.8 lb, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: polymyalgia rheumatica.
Associated medications used:
  • Hirudoid
  • Candesartan Cilexetil (4 Mg, Uid/qd)
  • Beclomethasone Dipropionate
  • Mucosta (100 Mg, Qid)
  • Epinastine Hydrochloride (20 Mg, Uid/qd)
  • Heparin
  • Loxoprofen (60 Mg, Qid)
  • Diazepam (2 Mg, Uid/qd)
Patient was hospitalized.

Hallucination, Confusional State, Hallucination, Visual, Dyskinesia, Insomnia
on Mar 30, 2012 Female from CANADA , 89 years of age, weighting 216.1 lb, was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: hallucination, confusional state, hallucination, visual, dyskinesia, insomnia. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Enteric Coated Acetylsalicyclic Acid, Delayed Release
  • Lorazepam (0.5 Milligram Once Daily As Needed At Hs)
  • Metoprolol Tartrate
  • Biaxin
  • Betahistine (Once Every 8 Hrs As Needed)
Patient was hospitalized.

Osteonecrosis
on Mar 23, 2012 Female from CANADA , weighting 154.1 lb, was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: osteonecrosis. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Actemra
  • Sulfasalazine
  • Plaquenil
  • Pantoprazole Sodium
  • Calcium Carbonate
  • Prednisone
  • Vitamin D
  • Naproxen
Patient was hospitalized.

Myalgia, Atrial Fibrillation, Haematocrit Decreased, Haemoglobin Decreased, Pulse Abnormal, Pain In Jaw, Angina Pectoris
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: myalgia, atrial fibrillation, haematocrit decreased, haemoglobin decreased, pulse abnormal, pain in jaw, angina pectoris on Mar 26, 2012 from JAPAN Additional patient health information: Male , 74 years of age, was diagnosed with and. Risedronate Sodium dosage: 2.5 Mg Once Daily, Oral.
Associated medications used:
  • Magnesium Oxide (magnesium Oxide)
  • Mobic
  • Pansoporin (cefotiam Hydrochloride)
  • Methycobal (mecobalamin)
  • Berizym /00517401/ (enzymes Nos)
  • Methylprednisolone Sodium Succinate
  • Foipan (camostat Mesilate)
  • Veen D (calcium Chloride Dihydrate, Glucose, Potassium Chloride, Sodiu


Injury, Femur Fracture, Fall
Adverse event was reported on Mar 29, 2012 by a Female taking Risedronate Sodium (Dosage: N/A) was diagnosed with and. Location: UNITED STATES , 85 years of age, Patient felt the following Risedronate side effects: injury, femur fracture, fall.
Multiple prescriptions taken:
  • Methotrexate
  • Prednisone Tab


Injection Site Pain, Blood Triglycerides Abnormal, Anaemia, Limb Deformity, Pain In Extremity
on Mar 12, 2012 Female from UNITED STATES , 55 years of age, weighting 114.6 lb, was diagnosed with and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: injection site pain, blood triglycerides abnormal, anaemia, limb deformity, pain in extremity. Risedronate Sodium dosage: 35 Mg, Once Weekly.
Multiple concurrent drugs taken:
  • Oscal /00751519/ (500 Mg, Unk)
  • Enbrel (50 Mg, Weekly)


Sciatica, Pain, Pain In Extremity, Pseudarthrosis, Femur Fracture, Device Breakage, Fracture Delayed Union, Bone Disorder
on Mar 02, 2012 Female from JAPAN , 73 years of age, was diagnosed with and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: sciatica, pain, pain in extremity, pseudarthrosis, femur fracture, device breakage, fracture delayed union, bone disorder. Risedronate Sodium dosage: 17.5mg Once Weekly, Oral. Patient was hospitalized.

Anaphylactic Shock
Patient was taking Risedronate Sodium. Patient felt the following Risedronate side effects: anaphylactic shock on Mar 13, 2012 from JAPAN Additional patient health information: Male , 32 years of age, weighting 160.9 lb, . Risedronate Sodium dosage: Unk.
Multiple prescriptions taken:
  • Famotidine (20 Mg, Unk)
  • Celecoxib (200 Mg, 1x/day)
  • Prednisolone (Unk)
  • Celecoxib (200 Mg, 2x/day)
Patient was hospitalized.

Balance Disorder, Hypoaesthesia, Dizziness, Amnesia, Thinking Abnormal, Malaise, Urinary Incontinence, Investigation, Motor Dysfunction
Adverse event was reported on Mar 05, 2012 by a Female taking Risedronate Sodium (Dosage: Unk Unk, Qwk) was diagnosed with and. Location: SWEDEN , 73 years of age, After Risedronate was administered, patient encountered several Risedronate side effects: balance disorder, hypoaesthesia, dizziness, amnesia, thinking abnormal, malaise, urinary incontinence, investigation, motor dysfunction.
Multiple concurrent drugs taken:
  • Vitamin B-12 (1 Df, Q2mo)
  • Prolia (Unk)
  • Cortisone Acetate
  • Kalcipos-d
  • Eye Q
  • Prolia
  • Atacand
  • Cortisone Acetate
Patient was hospitalized.

Cerebral Haemorrhage, Hemiplegia, Altered State Of Consciousness
on Mar 02, 2012 Female from JAPAN , weighting 74.96 lb, was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: cerebral haemorrhage, hemiplegia, altered state of consciousness. Risedronate Sodium dosage: 2.5 Mg.
Associated medications used:
  • Aspenon (20 Mg)
  • Livalo (1 Mg)
  • Aspirin (100 Mg)
  • Micardis (20 Mg)
  • Seroquel (100 Mg)
  • Aricept (1.5 Mg)
  • Pramipexole Dihydrochloride (0.5 Mg)
  • Metoprolol Tartrate (60 Mg)
Patient was hospitalized.

Fall, Hip Fracture, Stress Fracture, Bone Formation Decreased, Fracture Delayed Union, Low Turnover Osteopathy, Femur Fracture
on Feb 08, 2012 Female from FINLAND , 53 years of age, was diagnosed with and was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: fall, hip fracture, stress fracture, bone formation decreased, fracture delayed union, low turnover osteopathy, femur fracture. Risedronate Sodium dosage: 35 Mg Once Weekly, Oral.
Multiple prescriptions taken:
  • Prednisolon /00016201/ (prednisolone)
Patient was hospitalized and became disabled.

Gastric Cancer
Patient was taking Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: gastric cancer on Feb 15, 2012 from JAPAN Additional patient health information: Female , 94 years of age, was diagnosed with and. Risedronate Sodium dosage: Oral.

Cough, Dyspnoea, Bronchiectasis
Adverse event was reported on Feb 10, 2012 by a Male taking Risedronate Sodium (Dosage: N/A) . Location: TURKEY , weighting 176.4 lb, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: cough, dyspnoea, bronchiectasis.
Associated medications used:
  • Peginterferon Alfa-2a
  • Tenofovir Disoproxil Fumarate
  • Peginterferon Alfa-2a
Patient was hospitalized.

Electrocardiogram Qt Prolonged, Electrocardiogram Qt Interval Abnormal
on Feb 09, 2012 Female from JAPAN , 80 years of age, was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: electrocardiogram qt prolonged, electrocardiogram qt interval abnormal. Risedronate Sodium dosage: 17.5 Mg, Once Per Week.
Multiple prescriptions taken:
  • Donepezil Hcl (5 Mg Daily)
  • Atorvastatin Calcium (10 Mg Daily)
  • Benidipine (8 Mg Daily)
  • Alfacalcidol (0.5 Ug Daily)


Femur Fracture, Femoral Neck Fracture, Fall, Low Turnover Osteopathy, Bone Callus Excessive
on Feb 06, 2012 Female from JAPAN , 83 years of age, was diagnosed with and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: femur fracture, femoral neck fracture, fall, low turnover osteopathy, bone callus excessive. Risedronate Sodium dosage: 17.5 Mg Once A Week, Oral. Patient was hospitalized.

Restlessness
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: restlessness on Jan 23, 2012 from Additional patient health information: Male , 74 years of age, weighting 154.3 lb, . Risedronate Sodium dosage: N/A.
Associated medications used:
  • Ramipril (Oral)
  • Acetaminophen
  • Aspirin
  • Levothyroxine Sodium
  • Influenza Virus (influenza Vaccine)
  • Diltiazem Hydrochloride
  • Tramadol Hcl
  • Hydroxocobalamin


Fall, Femur Fracture
Adverse event was reported on Jan 18, 2012 by a Female taking Risedronate Sodium (Dosage: N/A) . Location: JAPAN , 76 years of age, Patient felt the following Risedronate side effects: fall, femur fracture.
Multiple prescriptions taken:
  • Fosamax


Femur Fracture
on Jan 10, 2012 Female from JAPAN , 81 years of age, weighting 79.37 lb, was diagnosed with and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: femur fracture. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Fosamax
  • Cholecalciferol And Vitamin A
Patient was hospitalized.

Interstitial Lung Disease, Pyrexia, Lymphocyte Stimulation Test Positive, Back Pain
on Dec 28, 2011 Female from JAPAN , 80 years of age, was diagnosed with and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: interstitial lung disease, pyrexia, lymphocyte stimulation test positive, back pain. Risedronate Sodium dosage: 17.5 Mg Once Weekly, Oral. Patient was hospitalized.

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Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    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.

    Medicine Name and Dosage:

     

    Side Effects

    Scale

    Date & Time

    Other Medicine(s) or Treatment(s)

     

     

     

     

    Scale: 1 = very mild to 10 = very bad


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  • 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.

    Discuss Risedronate Side Effects

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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