Zoledronic acid Side Effects
Some side effects of zoledronic acid 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 zoledronic acid: intravenous powder for solution, intravenous solution
Along with its needed effects, zoledronic acid 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 or nurse immediately if any of the following side effects occur while taking zoledronic acid:More common
- black, tarry stools
- blurred vision
- chest pain
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- irregular heartbeat
- lack or loss of strength
- lower back or side pain
- muscle pain or cramps
- muscle trembling or twitching
- nausea or vomiting
- numbness and tingling around the mouth, fingertips, or feet
- painful or difficult urination
- pale skin
- rapid weight gain
- shaking of the hands, arms, feet, legs, or face
- skin rash, cracks in the skin at the corners of the mouth, or soreness or redness around the fingernails and toenails
- sore throat
- sores, ulcers, or white spots on the lips or mouth
- sudden sweating
- swollen glands
- tightness in the chest
- trouble breathing with exercise
- unusual bleeding or bruising
- unusual tiredness or weakness
- Feeling of constant movement of self or surroundings
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms
- neck pain
- pounding in the ears
- rapid breathing
- sensation of spinning
- slow or fast heartbeat
- sunken eyes
- tingling of the hands or feet
- Blurred vision or other change in vision
- decreased frequency or amount of urine
- decreased vision
- eye pain
- eye tenderness
- heavy jaw feeling
- increased blood pressure
- increased tearing
- increased thirst
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- loosening of a tooth
- pain, swelling, or numbness in the mouth or jaw
- redness of the eye
- sensitivity of the eye to light
- severe eye pain
- swelling of the face, hands, fingers, lower legs, or ankles
- weight gain
Some side effects of zoledronic acid 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
- Abdominal or stomach pain
- back pain
- bad, unusual, or unpleasant (after) taste
- bladder pain
- blistering, crusting, irritation, itching, or reddening of the skin
- bloody or cloudy urine
- bone pain
- burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
- change in taste
- cracked lips
- cracked, dry, or scaly skin
- difficulty with swallowing
- dry mouth
- ear congestion
- feeling sad or empty
- frequent urge to urinate
- hair loss or thinning hair
- joint pain or swollen joints
- loss of appetite
- loss of interest or pleasure
- loss of voice
- muscle stiffness or difficulty with moving
- nasal congestion or runny nose
- pain, swelling, or redness in the joints
- partial loss of feeling
- seeing, hearing, or feeling things that are not there
- sleepiness or unusual drowsiness
- sleeplessness, trouble sleeping, or unable to sleep
- swelling or inflammation of the mouth
- trouble with concentrating
- unusually cold, shivering
- weight loss
- Acid or sour stomach
- red streaks on the skin
- stomach discomfort or upset
- swelling, tenderness, or pain at the injection site
- unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
- wrinkled skin
- Burning, dry, or itching eyes
- discharge or excessive tearing
- redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid
- throbbing pain
For Healthcare Professionals
Applies to zoledronic acid: intravenous powder for injection, intravenous solution
In general, side effects have been mild and transient and similar to other bisphosphonates. Postmarketing reports have included weight gain.
Metabolic side effects have included hypomagnesemia (10.5%), hypokalemia (11.6%), hypophosphatemia (12.8%), and dehydration and hypocalcemia have been reported in 5% to 10% of patients. Grade 3 and 4 laboratory abnormalities have included hypophosphatemia (51.4%, grade 3; 1.4%, grade 4) and hypocalcemia (1.2%, grade 3).
Renal side effects have included renal toxicity (deterioration of renal function or renal failure). Grade 3 increases (more than 3 times upper limit of normal) in serum creatinine have been reported in 2.3% of patients. Postmarketing reports have included hematuria, proteinuria, hyperkalemia, and hypernatremia.
Hematologic side effects have included anemia (22.1% to 33%) and neutropenia (12%). Granulocytopenia, thrombocytopenia, and pancytopenia have been reported in 5% to 10% of patients.
Gastrointestinal side effects have included nausea (46% to 29.1%), vomiting (14% to 32%), constipation (26.7% to 31%), diarrhea (17.4% to 24%), abdominal pain (14% to 16.3%), dyspepsia (10%), anorexia (9.3%), stomatitis (8%), sore throat (8%), and dysphagia (5% to 10%). Postmarketing reports have included reports of dry mouth.
Ocular side effects have included conjunctivitis. Cases of uveitis and episcleritis have been reported during post approval use. Postmarketing reports have included blurred vision. Cases of uveitis, scleritis, episcleritis, conjunctivitis, iritis, and orbital inflammation including orbital edema have been reported during postmarketing use. In some cases, symptoms resolved with topical steroids.
Cardiovascular side effects have included hypotension (10.5%). Postmarketing reports have included atrial fibrillation, hypertension, bradycardia, and hypotension.
In the postmenopausal osteoporosis trial, adjudicated serious adverse events of atrial fibrillation in the zoledronic acid treatment group occurred in 1.3% of patients (50 out of 3862) compared to 0.4% (17 out of 3852) in the placebo group. The overall incidence of all atrial fibrillation adverse events in the zoledronic acid treatment group was, reported in 2.5% of patients (96 out of 3862) in the Reclast group vs. 1.9% of patients (75 out of 3852) in the placebo group.
Musculoskeletal side effects have included bone pain (55%), myalgia (23%), arthralgia (21%), back pain (15%), and limb pain (14%). Postmarketing reports have included muscle cramps. Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported with bisphosphonate use. Cases of osteonecrosis (primarily involving the jaws) have been reported predominantly in cancer patients treated with intravenous bisphosphonates including zoledronic acid
Nervous system side effects have included headache (19%), dizziness (18%), insomnia (15.1%), paresthesia (15%), anxiety (14%), confusion (12.8%), agitation (12.8%), hypoesthesia (12%), and somnolence (5% to 10%). Postmarketing reports have included taste disturbance, hyperesthesia, tremor, and vertigo.
Respiratory side effects have included dyspnea (27% to 22.1%), coughing (22% to 11.6%), upper respiratory infection (10%), and pleural effusion (5% to 10%). Postmarketing reports have included bronchoconstriction and asthma exacerbations.
Genitourinary side effects have included urinary tract infection (14%).
Oncologic side effects have included aggravation of malignant neoplasm and progression of cancer.
Fever is the most common adverse effect associated with zoledronic acid infusion.
Flu-like syndromes including fever, chills, bone pain, and/or arthralgias and myalgias have also occasionally been reported. These symptoms generally did not require treatment and resolved within 24 to 48 hours.
Other side effects have included fever (44.2%) and moniliasis (11.6%). Nonspecific infections, asthenia, chest pain, leg edema, and mucositis have been reported in 5% to 10% of patients. Flu-like syndromes have also been reported.
Local side effects have infrequently included redness or swelling at the injection site. Postmarketing reports have included itching and pain at the injection site.
Dermatologic side effects have included alopecia (12%) and dermatitis (11%). Rash and pruritus have been reported rarely. Postmarketing reports have included increased sweating and urticaria.
Psychiatric side effects have included depression (14%), anxiety (11%), and confusion (7%).
Hypersensitivity side effects have included rare cases of urticaria, bronchoconstriction, bronchospasms, interstitial lung disease (ILD) with positive re-challenge, angioedema and very rare cases of anaphylactic reaction/shock.
Other side effects have included postmarketing reports of pyrexia, asthenia, fatigue, or malaise persisting for greater than 30 days.
Postmarketing reports of Acute Phase Reaction have occurred within three days after Zometa administration with symptoms of pyrexia, fatigue, bone pain and/or arthralgias, myalgias, chills, and influenza-like illness. Symptoms usually resolve within three days of onset, but resolution can take up to 7 to 14 days, and some symptoms have persisted for a longer duration.
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