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Risedronate Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 268 

Fall, Hip Fracture, Stress Fracture, Bone Formation Decreased, Fracture Delayed Union, Low Turnover Osteopathy, Femur Fracture (8174135-4)
on Feb 08, 2012 Female from FINLAND , 53 years of age, was diagnosed with
  • osteoporosis
and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected 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.
Associated medications used:
  • Prednisolon /00016201/ (prednisolone)
Patient was hospitalized and became disabled.

Gastric Cancer (8173735-5)
Patient was taking Risedronate Sodium. Patient felt the following Risedronate side effects: gastric cancer on Feb 15, 2012 from JAPAN Additional patient health information: Female , 94 years of age, was diagnosed with
  • osteoporosis
and. Risedronate Sodium dosage: Oral.

Cough, Dyspnoea, Bronchiectasis (8160635-X)
Adverse event was reported on Feb 10, 2012 by a Male taking Risedronate Sodium (Dosage: N/A) . Location: TURKEY , weighting 176.4 lb, After Risedronate was administered, patient encountered several Risedronate side effects: cough, dyspnoea, bronchiectasis.
Multiple concurrent drugs taken:
  • Peginterferon Alfa-2a
  • Tenofovir Disoproxil Fumarate
  • Peginterferon Alfa-2a
Patient was hospitalized.

Electrocardiogram Qt Prolonged, Electrocardiogram Qt Interval Abnormal (8139217-1)
on Feb 09, 2012 Female from JAPAN , 80 years of age, was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: electrocardiogram qt prolonged, electrocardiogram qt interval abnormal. Risedronate Sodium dosage: 17.5 Mg, Once Per Week.
Associated medications used:
  • 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 (8138699-9)
on Feb 06, 2012 Female from JAPAN , 83 years of age, was diagnosed with
  • osteoporosis prophylaxis
and was treated with Risedronate Sodium. Patient felt the following 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 (8118287-0)
Patient was taking Risedronate Sodium. After Risedronate was administered, patient encountered several 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.
Multiple concurrent drugs taken:
  • Ramipril (Oral)
  • Acetaminophen
  • Aspirin
  • Levothyroxine Sodium
  • Influenza Virus (influenza Vaccine)
  • Diltiazem Hydrochloride
  • Tramadol Hcl
  • Hydroxocobalamin


Fall, Femur Fracture (8090703-2)
Adverse event was reported on Jan 18, 2012 by a Female taking Risedronate Sodium (Dosage: N/A) . Location: JAPAN , 76 years of age, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: fall, femur fracture.
Associated medications used:
  • Fosamax


Femur Fracture (8063857-1)
on Jan 10, 2012 Female from JAPAN , 81 years of age, weighting 79.37 lb, was diagnosed with
  • osteoporosis
and was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: femur fracture. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Fosamax
  • Cholecalciferol And Vitamin A
Patient was hospitalized.

Interstitial Lung Disease, Pyrexia, Lymphocyte Stimulation Test Positive, Back Pain (8058030-7)
on Dec 28, 2011 Female from JAPAN , 80 years of age, was diagnosed with
  • osteoporosis
and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several 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.

Skin Haemorrhage, Asthenia, Occult Blood Positive, Gastrointestinal Haemorrhage, Organ Failure (8045420-1)
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: skin haemorrhage, asthenia, occult blood positive, gastrointestinal haemorrhage, organ failure on Jan 11, 2012 from AUSTRALIA Additional patient health information: Female , weighting 163.1 lb, . Risedronate Sodium dosage: N/A.
Associated medications used:
  • Pradaxa (220 Mg)
  • Furosemide
  • Carvedilol
  • Moviprep
  • Ramipril
  • Celecoxib
Patient was hospitalized.

Abdominal Pain Upper, Abdominal Distension, Insomnia, Nervousness (8033349-4)
Adverse event was reported on Jan 10, 2012 by a Female taking Risedronate Sodium (Dosage: Unk) was diagnosed with
  • osteoporosis
and. Location: UNITED STATES , weighting 152.0 lb, Patient felt the following Risedronate side effects: abdominal pain upper, abdominal distension, insomnia, nervousness.
Multiple prescriptions taken:
  • Chantix (0.5 Mg, 1x/day)
  • Prevacid (Unk)
  • Chantix (Unk)


Pneumonia Chlamydial, Hypogammaglobulinaemia, Pneumocystis Jiroveci Pneumonia (8017702-0)
on Dec 21, 2011 Male from JAPAN , weighting 114.6 lb, was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: pneumonia chlamydial, hypogammaglobulinaemia, pneumocystis jiroveci pneumonia. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Pydoxal
  • Remicade
  • Rheumatrex
  • Folic Acid
  • Isoniazid
  • Rheumatrex
  • Prednisolone
  • Rheumatrex
Patient was hospitalized.

Lymphocyte Stimulation Test Positive, Interstitial Lung Disease (8004575-5)
on Dec 01, 2011 Female from JAPAN , 80 years of age, was diagnosed with
  • osteoporosis
and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: lymphocyte stimulation test positive, interstitial lung disease. Risedronate Sodium dosage: 17.5 Mg Once Weekly, Oral. Patient was hospitalized.

Wound Infection (8002639-3)
Patient was taking Risedronate Sodium. Patient felt the following Risedronate side effects: wound infection on Dec 15, 2011 from JAPAN Additional patient health information: Female , weighting 119.0 lb, was diagnosed with
  • osteoporosis
  • breast cancer
  • dyspepsia
and. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Tykerb (1250mg Per Day)
  • Miya Bm
  • Meloxicam
Patient was hospitalized.

Haemoglobin Decreased, Erythema, Pain In Jaw, Swelling, Pyrexia, Red Blood Cell Sedimentation Rate Increased, Trismus, Osteonecrosis Of Jaw, White Blood Cell Count Decreased (7997913-0)
Adverse event was reported on Dec 14, 2011 by a Female taking Risedronate Sodium (Dosage: Unk) was diagnosed with
  • spinal fracture
and. Location: INDIA , 77 years of age, After Risedronate was administered, patient encountered several Risedronate side effects: haemoglobin decreased, erythema, pain in jaw, swelling, pyrexia, red blood cell sedimentation rate increased, trismus, osteonecrosis of jaw, white blood cell count decreased.
Multiple concurrent drugs taken:
  • Zoledronic Acid (4 Mg)
Patient was hospitalized.

Femur Fracture (7980075-3)
on Dec 12, 2011 Female from SPAIN , 83 years of age, was diagnosed with
  • osteoporosis postmenopausal
and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: femur fracture. Risedronate Sodium dosage: N/A.

Radius Fracture (7978617-7)
on Nov 29, 2011 Female from CANADA , 55 years of age, was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: radius fracture. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Ibuprofen
  • Vitamin K /00032401/ (phytomenadione)
  • Calcium /00060701/ (calcium Gluconate)
  • Modafinil
  • Fampridine-sr (fampridine) Tablet (10 Mg, Qd, Oral)
  • Acetaminophen
  • Fluoxetine Hydrochloride
  • Ergocalciferol
Patient was hospitalized.

Pathological Fracture, Femur Fracture (7964808-8)
Patient was taking Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: pathological fracture, femur fracture on Nov 28, 2011 from SPAIN Additional patient health information: Female , 83 years of age, was diagnosed with
  • osteoporosis postmenopausal
and. Risedronate Sodium dosage: 75 Mg, 2 Cd/month, Oral.
Multiple concurrent drugs taken:
  • Alendronate Sodium/cholecalciferol (70 Mg, 1/month)
  • Actonel (75 Mg, 2 Cd/month, Oral)


Bone Graft, Femur Fracture, Bone Disorder, Device Breakage (7957421-X)
Adverse event was reported on Nov 17, 2011 by a Female taking Risedronate Sodium (Dosage: 17.5 Mg Once Weekly, Oral) was diagnosed with
  • osteoporosis
and. Location: JAPAN , 73 years of age, Directly after, patient experienced the unwanted or unexpected Risedronate side effects: bone graft, femur fracture, bone disorder, device breakage. Patient was hospitalized.

Chest Pain, Cold Sweat (7945773-6)
on Nov 22, 2011 Male from UNITED KINGDOM , weighting 158.7 lb, was treated with Risedronate Sodium. Patient felt the following Risedronate side effects: chest pain, cold sweat. Risedronate Sodium dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
  • Bisoprolol Fumarate
  • Lansoprazole
  • Rituximab
Patient was hospitalized.

Pyrexia, Osteonecrosis Of Jaw, Swelling, Red Blood Cell Sedimentation Rate Increased, Pain In Jaw, Trismus, Haemoglobin Decreased, Decreased Appetite, Erythema (7931644-8)
on Nov 11, 2011 Female from INDIA , 77 years of age, was diagnosed with
  • spinal fracture
and was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: pyrexia, osteonecrosis of jaw, swelling, red blood cell sedimentation rate increased, pain in jaw, trismus, haemoglobin decreased, decreased appetite, erythema. Risedronate Sodium dosage: Unk Ukn, Unk.
Multiple concurrent drugs taken:
  • Zoledronic Acid (4 Mg, Once-weekly)
Patient was hospitalized.

Femur Fracture, Impaired Healing (7832894-1)
Patient was taking Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: femur fracture, impaired healing on Oct 03, 2011 from BRAZIL Additional patient health information: Female , 63 years of age, was diagnosed with
  • osteoporosis
  • femur fracture
and. Risedronate Sodium dosage: 35 Mg Per Week, Oral. Patient was hospitalized.

Hepatic Function Abnormal, Thrombocytopenia (7824331-8)
Adverse event was reported on Oct 12, 2011 by a Female taking Risedronate Sodium (Dosage: N/A) was diagnosed with
  • osteoporosis prophylaxis
  • peripheral vascular disorder
  • ileus paralytic
  • gastrooesophageal reflux disease
  • interstitial lung disease
  • scleroderma
and. Location: JAPAN , 61 years of age, Patient felt the following Risedronate side effects: hepatic function abnormal, thrombocytopenia.
Multiple prescriptions taken:
  • Procylin
  • Gasmotin
  • Famotidine
  • Cyclophosphamide
  • Cyclophosphamide
Patient was hospitalized.

Tibia Fracture, Femur Fracture (7808175-9)
on Sep 27, 2011 Female from BRAZIL , 77 years of age, was treated with Risedronate Sodium. After Risedronate was administered, patient encountered several Risedronate side effects: tibia fracture, femur fracture. Risedronate Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Fosamax
  • Cholecalciferol
  • Calcium Carbonate


Thrombocytopenia, Hepatic Function Abnormal (7795941-1)
on Sep 26, 2011 Female from JAPAN , 61 years of age, was diagnosed with
  • osteoporosis prophylaxis
  • interstitial lung disease
  • ileus paralytic
  • scleroderma
  • gastrooesophageal reflux disease
  • peripheral vascular disorder
and was treated with Risedronate Sodium. Directly after, patient experienced the unwanted or unexpected Risedronate side effects: thrombocytopenia, hepatic function abnormal. Risedronate Sodium dosage: N/A.
Associated medications used:
  • Cyclophosphamide
  • Gasmotin
  • Cyclophosphamide
  • Famotidine
  • Procylin
Patient was hospitalized.

Showing 1-25 of 268 

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

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 Information

More About Risedronate

Side Effects reported to FDA: 268. View Risedronate Adverse Reports

Risedronate safety alerts: 2007

Reported deaths: 13

Reported hospitalizations: 160

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]

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