Actonel Side Effects

Generic Name: risedronate

Note: This page contains information about the side effects of risedronate. Some of the dosage forms included on this document may not apply to the brand name Actonel.

Not all side effects for Actonel may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to risedronate: oral tablet, oral tablet delayed release

In addition to its needed effects, some unwanted effects may be caused by risedronate (the active ingredient contained in Actonel). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking risedronate:

More common
  • Abdominal or stomach pain
  • skin rash
Less common
  • Abdominal or stomach pain (severe)
  • belching
  • bone pain
  • cramping of the stomach
  • trouble swallowing
Rare
  • 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 of the side effects that can occur with risedronate may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

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
Rare
  • 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

General

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.

Gastrointestinal

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

Nervous system side effects have included headache (18%), dizziness (7%), and tinnitus (3%). Dizziness, anxiety, depression, and vertigo have also been reported.

Musculoskeletal

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

Dermatologic side effects have included rash and pruritus.

Cardiovascular

Cardiovascular side effects have included peripheral edema (8%) and chest pain (7%). Hypertension, syncope, and vasodilation have also been reported.

Respiratory

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.

Ocular

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

Oncologic side effects have included neoplasms, which have occurred in 3% of patients receiving risedronate (the active ingredient contained in Actonel) therapy.

Hypersensitivity

Hypersensitivity side effects have included angioedema, generalized rash, and bullous skin reactions.

Genitourinary

Genitourinary side effects have included urinary tract infections.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This material does not endorse drugs, diagnose patients, or recommend therapy. This information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate safety, effectiveness, or appropriateness for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of materials provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the substances you are taking, check with your doctor, nurse, or pharmacist.

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