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Risedronate Side Effects

Medically reviewed by Drugs.com. Last updated on Apr 20, 2023.

Applies to risedronate: oral tablet, oral tablet delayed release.

Serious side effects of Risedronate

Along with its needed effects, risedronate may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking risedronate:

More common

Less common

Rare

Incidence not known

Get emergency help immediately if any of the following symptoms of overdose occur while taking risedronate:

Symptoms of overdose

Other side effects of Risedronate

Some side effects of risedronate may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Rare

Incidence not known

For Healthcare Professionals

Applies to risedronate: oral delayed release tablet, oral tablet.

General

Abdominal and musculoskeletal pain were commonly reported adverse effects.[Ref]

Cardiovascular

Very common (10% or more): Hypertension (up to 10.5%)

Common (1% to 10%): Arrhythmia (2%) in men with osteoporosis

Frequency not reported: Syncope, vasodilation[Ref]

Gastrointestinal

Very common (10% or more): Constipation (up to 12.9%), diarrhea (up to 10.8%), dyspepsia (up to 10.8%), nausea (up to 10.5%)

Common (1% to 10%): Abdominal pain, vomiting, abdominal upper pain, gastritis, gastroesophageal reflux disease, gastroenteritis

Uncommon (0.1% to 1%): Duodenitis, glossitis

Rare (less than 0.1%): Esophageal stricture

Postmarketing reports: Esophagitis, esophageal or gastric ulcers[Ref]

Genitourinary

Very common (10% or more): Urinary tract infection (up to 11.1%)

Common (1% to 10%): Nocturia (1.6%), cystitis, hemorrhoids, Hiatus hernia, urinary disorders, reproductive system and breast disorders[Ref]

Musculoskeletal

Very common (10% or more): Arthralgia (up to 23.7%)

Common (1% to 10%): Back pain, pain in extremity, musculoskeletal pain, bone pain, muscle spasms, myalgia, neck pain, arthritis, traumatic bone fracture, join disorder, leg cramps, myasthenia (1.6%), osteoarthritis, tendonitis

Rare (less than 0.1%): Severe or incapacitating bone, join, or muscle pain; osteonecrosis of the jaw (ONJ); atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)

Frequency not reported: Muscle spasms[Ref]

Other

Very common (10% or more): Accidental injury (up to 16.9%), pain (up to 14.1%), flu syndrome (up to 11.6%)

Common (1% to 10%): Tinnitus (1.6%), asthenia, peripheral edema, contusion, herpes zoster (1% to 2.6%), ear and labyrinth disorders, vertigo[Ref]

Respiratory

Very common (10% or more): Bronchitis (up to 10%)

Common (1% to 10%): Influenza, upper respiratory infection, chest pain, sinusitis, rhinitis, pharyngitis, increased cough, apnea (1.6%)

Postmarketing reports: Asthma exacerbations[Ref]

Dermatologic

Common (1% to 10%): Rash

Frequency not reported: Pruritus[Ref]

Endocrine

Common (1% to 10%): Elevated levels of parathyroid hormone (PTH), endocrine disorders[Ref]

Hematologic

Common (1% to 10%): Anemia (1% to 2.6%), blood and lymphatic system disorders[Ref]

Hepatic

In most of the postmarketing reported cases the patients were also treated with other products known to cause hepatic disorders.[Ref]

Common (1% to 10%): Colitis (1.6%), hepatobiliary disorders

Rare (less than 0.1%): Abnormal liver function test

Postmarketing reports: Serious hepatic disorders[Ref]

Hypersensitivity

Common (1% to 10%): Allergic reactions

Postmarketing reports: Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, anaphylactic reactions[Ref]

Immunologic

Common (1% to 10%): Immune system disorders[Ref]

Metabolic

Transient decreases from baseline in serum calcium (less than 1%) and serum phosphate (less than 3%) were observed within 6 months in patients in osteoporosis clinical trials treated with doses of 5 mg daily immediate-release.[Ref]

Common (1% to 10%): Decreased weight, hypocalcemia (1.6%), transient decreases from baseline of serum calcium and phosphate, hypercholesterolemia[Ref]

Nervous system

Common (1% to 10%): Dizziness, headache, insomnia, sciatica (0.6% to 2.3%)[Ref]

Ocular

Common (1% to 10%): Cataract; amblyopia, corneal lesion and dry eye (1.6%)

Uncommon (0.1% to 1%): Iritis

Rare (less than 0.1%): Eye inflammation including uveitis[Ref]

Oncologic

Common (1% to 10%): Benign prostatic hyperplasia (5%) in men with osteoporosis; neoplasms benign, malignant and unspecified (including cysts and polyps)[Ref]

Psychiatric

Common (1% to 10%): Depression, psychiatric disorders[Ref]

Renal

Common (1% to 10%): Nephrolithiasis (3%) in men with osteoporosis, renal disorders[Ref]

References

1. Product Information. Actonel (risedronate). Procter and Gamble Pharmaceuticals. 2001;PROD.

2. Delmas PD, Balena R, Confravreux E, Hardouin C, Hardy P, Bremond A. Bisphosphonate risedronate prevents bone loss in women with artificial menopause due to chemotherapy of breast cancer: a double blind, placebo-controlled study. J Clin Oncol. 1997;15:955-62.

3. Lourwood DL. The pharmacology and therapeutic utility of bisphosphonates. Pharmacotherapy. 1998;18:779-89.

4. Cerner Multum, Inc. UK Summary of Product Characteristics.

5. Cerner Multum, Inc. Australian Product Information.

6. Reginster JY, Colson F, Morlock G, Combe B, Ethgen D, Geusens P. Evaluation of the efficacy and safety of oral tiludronate in Paget's disease of bone. A double-blind, multiple-dosage, placebo-controlled study [published erratum appears in Arthritis Rheum 199 Jan;36(1):134]. Arthritis Rheum. 1992;35:967-74.

7. Taggart H, Bolognese MA, Lindsay R, et al. Upper gastrointestinal tract safety of risedronate: a pooled analysis of 9 clinical trials. Mayo Clin Proc. 2002;77:262-70.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.