Zometa Side Effects

Generic Name: zoledronic acid

Please note - some side effects for Zometa may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zometa - for the Consumer

Zometa

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zometa:

Back pain; constipation; cough; decreased appetite; diarrhea; dizziness; fatigue; headache; mild muscle or joint aches; mild pain, swelling, or redness at the injection site; nausea; sore throat; stomach pain or upset; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); blurred vision or other vision changes; change in the amount of urine produced; chest pain; fainting; fever or chills; irregular or slow heartbeat; jaw pain or swelling; mental or mood changes (eg, agitation, anxiety, depression); muscle cramps or spasms; numbness or tingling of the lips, tongue, fingers, or feet; redness, pain, or swelling of the eyes; severe bone, joint, or muscle pain; severe dizziness; shortness of breath; swelling of the ankles or feet; unusual bruising or bleeding; unusual tiredness or weakness.

Zometa Side Effects - for the Professional

Zometa

The most common adverse events (>25%) were nausea, fatigue, anemia, bone pain, constipation, fever, vomiting, and dyspnea (6.1)

Side Effects by Body System

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.

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%0, 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 (20%), progression of cancer (16.3%) and metastases (5% to 10%).

Other

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.

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.

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 and angioedema and very rare cases of anaphylactic shock.

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