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Risedronate Side Effects

It is possible that some side effects of risedronate may not have been reported. These can be reported to the FDA here. Always consult a healthcare professional for medical advice.

For the Consumer

Applies to risedronate: oral tablet, oral tablet delayed release

As well as its needed effects, risedronate may cause unwanted side effects that require medical attention.

If any of the following side effects occur while taking risedronate, check with your doctor immediately:

More common
  • Abdominal or stomach pain
  • skin rash
Less common
  • Abdominal or stomach pain (severe)
  • belching
  • bone pain
  • cramping of the stomach
  • trouble swallowing
  • Red, sore eyes
Incidence not known
  • Bone, joint, or muscle pain, severe and occasionally incapacitating
  • chest pain
  • heartburn
  • pain or burning in the throat
  • sores, ulcers, or white spots on the lips or tongue or inside the mouth
  • vomiting

If any of the following symptoms of overdose occur while taking risedronate, get emergency help immediately:

Symptoms of overdose
  • Confusion
  • convulsions
  • difficulty with breathing
  • irregular heartbeats
  • muscle cramps in the hands, arms, feet, legs, or face
  • numbness and tingling around the mouth, fingertips, or feet
  • shortness of breath
  • tremor

Some risedronate side effects may not need any medical attention. As your body gets used to the medicine these side effects may disappear. Your health care professional may be able to help you prevent or reduce these side effects, but do check with them if any of the following side effects continue, or if you are concerned about them:

More common
  • Back pain
  • cough or hoarseness
  • diarrhea
  • fever or chills
  • headache
  • joint pain
  • lower back or side pain
  • painful or difficult urination
Less common
  • Acid or sour stomach
  • bladder pain
  • bloody or cloudy urine
  • blurred vision or change in vision
  • body aches or pains
  • congestion
  • constipation
  • difficult, burning, or painful urination
  • difficulty with moving
  • dizziness
  • dry eyes
  • dryness or soreness of the throat
  • frequent urge to urinate
  • general feeling of discomfort or illness
  • indigestion
  • leg cramps
  • muscle pain or stiffness
  • nausea
  • nervousness
  • pain, swelling, or redness in the joints
  • pounding in the ears
  • ringing in the ears
  • runny nose
  • slow or fast heartbeat
  • stomach discomfort or upset
  • swelling of the feet or lower legs
  • tender swollen glands in the neck
  • voice changes
  • weakness
  • Fainting
  • fear
  • itching skin
  • loss of appetite
  • pale skin
  • passing of gas
  • redness, swelling, or soreness of the tongue
  • sneezing
  • stomach fullness
  • tightness in the chest
  • troubled breathing
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • wheezing
Incidence not known
  • Eye pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • muscle pain
  • redness of the eye
  • sensitivity of the eye to light
  • skin blisters
  • tearing

For Healthcare Professionals

Applies to risedronate: oral delayed release tablet, oral tablet


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


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]


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]


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]


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, joint, or muscle pain; osteonecrosis of the jaw (ONJ); atypical subtrochanteric and diaphyseal femoral fractures (bisphosphonate class adverse reaction)
Frequency not reported: Muscle spasms[Ref]


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]


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]


Common (1% to 10%): Rash
Frequency not reported: Pruritus[Ref]


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


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


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]


Common (1% to 10%): Allergic reactions
Postmarketing reports: Angioedema, generalized rash, bullous skin reactions, Stevens-Johnson syndrome and toxic epidermal necrolysis, anaphylactic reactions[Ref]


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


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

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]

Nervous system

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


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]


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


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


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


1. Lourwood DL "The pharmacology and therapeutic utility of bisphosphonates." Pharmacotherapy 18 (1998): 779-89

2. "Product Information. Actonel (risedronate)." Procter and Gamble Pharmaceuticals, Cincinnati, OH.

3. 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 15 (1997): 955-62

4. Cerner Multum, Inc. "Australian Product Information." O 0

5. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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 35 (1992): 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 77 (2002): 262-70

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