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 solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking zoledronic acid: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

• urinating less than usual or not at all;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• swelling, weight gain, feeling short of breath;

• muscle spasms, numb or tingly feeling (especially around your mouth);

• fever, chills, body aches, flu symptoms;

• pale skin, easy bruising, unusual weakness;

• feeling like you might pass out;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip; or

• bronchospasm (wheezing, chest tightness, trouble breathing).

Less serious side effects of zoledronic acid may include:

• cough;

• vision problems;

• diarrhea, constipation;

• headache, tired feeling;

• mild joint or muscle pain; or

• redness or swelling where the needle was placed.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to zoledronic acid: intravenous powder for injection, intravenous solution

General

In general, side effects have been mild and transient and similar to other bisphosphonates. Postmarketing reports have included weight gain.

Metabolic

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

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

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

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

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

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

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

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

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.

Genitourinary

Genitourinary side effects have included urinary tract infection (14%).

Oncologic

Oncologic side effects have included aggravation of malignant neoplasm and progression of cancer.

Other

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

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

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

Psychiatric side effects have included depression (14%), anxiety (11%), and confusion (7%).

Hypersensitivity

Hypersensitivity side effects have included rare cases of urticaria, bronchoconstriction, angioedema and very rare cases of anaphylactic reaction/shock.

Other

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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