Actonel Side Effects
Generic Name: risedronate
Note: This document contains side effect information about risedronate. Some of the dosage forms listed on this page may not apply to the brand name Actonel.
Some side effects of Actonel may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to risedronate: oral tablet, oral tablet delayed release
Along with its needed effects, risedronate (the active ingredient contained in Actonel) 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
- Abdominal or stomach pain
- skin rash
- Abdominal or stomach pain (severe)
- bone pain
- cramping of the stomach
- trouble swallowing
- Red, sore eyes
- Bone, joint, or muscle pain, severe and occasionally incapacitating
- chest pain
- pain or burning in the throat
- sores, ulcers, or white spots on the lips or tongue or inside the mouth
Get emergency help immediately if any of the following symptoms of overdose occur while taking risedronate:Symptoms of overdose
- 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
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
- Back pain
- cough or hoarseness
- fever or chills
- joint pain
- lower back or side pain
- painful or difficult urination
- Acid or sour stomach
- bladder pain
- bloody or cloudy urine
- blurred vision or change in vision
- body aches or pains
- difficult, burning, or painful urination
- difficulty with moving
- dry eyes
- dryness or soreness of the throat
- frequent urge to urinate
- general feeling of discomfort or illness
- leg cramps
- muscle pain or stiffness
- 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
- itching skin
- loss of appetite
- pale skin
- passing of gas
- redness, swelling, or soreness of the tongue
- stomach fullness
- tightness in the chest
- troubled breathing
- troubled breathing with exertion
- unusual bleeding or bruising
- unusual tiredness or weakness
- 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
For Healthcare Professionals
Applies to risedronate: oral delayed release tablet, oral tablet
Adverse effects reported with risedronate (the active ingredient contained in Actonel) have been mild to moderate and have seldom required discontinuation of therapy. General body symptoms have included flu-like symptoms (10%) and asthenia (5%).
There were no deaths in a 1 year, double-blind, placebo-controlled study of risedronate 35 mg once a week for prevention of bone loss in 278 postmenopausal women without osteoporosis. More treated subjects on risedronate experienced arthralgia (risedronate 13.9%; placebo 7.8%), myalgia (risedronate 5.1%; placebo 2.1%), and nausea (risedronate 7.3%; placebo 4.3%) than subjects on placebo.
During phase 3 clinical studies, patients with a history of upper gastrointestinal (GI) disease or abnormalities were not excluded. Severe upper GI side effects were not noted. Patients using NSAIDs or aspirin were also included in phase 3 clinical studies. GI side effects in patient using concomitant NSAIDs or aspirin were higher than in non users.
Gastrointestinal side effects have included diarrhea (20%), nausea (10%), abdominal pain (12%), constipation (6%), belching or colitis (3%). Dyspepsia, diarrhea, gastrointestinal disorder, flatulence, gastroenteritis, vomiting, and dry mouth have also been reported.
Nervous system side effects have included headache (18%), dizziness (7%), and tinnitus (3%). Dizziness, anxiety, depression, and vertigo have also been reported.
Musculoskeletal side effects have included arthralgias (33%), bone pain (5%), and leg cramps or myasthenia (3%). Postmarketing experience has included reports of bone, joint, or muscle pain, rarely described as severe or incapacitating. Myalgia, arthritis, bursitis, and traumatic bone fracture have also been reported. Additional postmarketing experience has included cases of osteonecrosis (primarily involving the jaw), predominantly in cancer patients treated with intravenous bisphosphonates, including pamidronate disodium. Many of these patients were also receiving chemotherapy and corticosteroids which may be risk factors for ONJ. Data suggest a greater frequency of reports of ONJ in certain cancers, such as advanced breast cancer and multiple myeloma. The majority of the reported cases are in cancer patients following invasive dental procedures, such as tooth extraction.
Dermatologic side effects have included rash and pruritus.
Cardiovascular side effects have included peripheral edema (8%) and chest pain (7%). Hypertension, syncope, and vasodilation have also been reported.
Respiratory side effects have included bronchitis (3%) and sinusitis (5%). Sinusitis, pharyngitis, increased cough, pneumonia, and rhinitis have also been reported. Postmarketing side effects have included exacerbations of asthma.
Iritis occurred in 3 patients in one supportive study. Treatment with topical steroids was effective in all cases. Iritis has not been observed in other clinical studies.
Ocular side effects have included amblyopia or dry eyes (3%) and iritis. Cataracts have also been reported.
Oncologic side effects have included neoplasms, which have occurred in 3% of patients receiving risedronate (the active ingredient contained in Actonel) therapy.
Hypersensitivity side effects have included angioedema, generalized rash, and bullous skin reactions.
Genitourinary side effects have included urinary tract infections.
More about Actonel (risedronate)
- Other brands: Atelvia
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