Aredia Side Effects

Generic name: pamidronate

Note: This document contains side effect information about pamidronate. Some of the dosage forms listed on this page may not apply to the brand name Aredia.

Some side effects of Aredia 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 pamidronate: intravenous powder for injection, intravenous solution

Get emergency medical help if you have any of these signs of an allergic reaction while taking pamidronate (the active ingredient contained in Aredia) 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:

• high fever;

• severe joint, bone, or muscle pain;

• new or unusual pain in your thigh or hip;

• urinating less than usual or not at all;

• swelling, rapid weight gain;

• pain or burning when you urinate;

• seizure (convulsions);

• eye pain, vision changes;

• pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or

• confusion, uneven heart rate, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling, or jerking muscle movements.

Less serious side effects of pamidronate may include:

• low fever;

• stomach pain, loss of appetite, nausea, vomiting;

• constipation; or

• pain, redness, swelling or a hard painful lump under your skin around the IV needle.

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 pamidronate: intravenous powder for injection, intravenous solution

General

Pamidronate has been generally well tolerated and many adverse effects that occurred during treatment may have been related to the underlying disease state. Adverse effects have been most often associated with larger (90 mg) doses of pamidronate (the active ingredient contained in Aredia) The most common adverse effect has been fever, occurring in up to 41% of patients. The fever was generally mild and transient. Onset was typically within the first 48 hours after infusion and resolution was within another 48 hours.

In patients with osteolytic bone involvement associated with breast cancer and multiple myeloma, the most commonly reported (>15%) adverse effects occurred with similar frequency in pamidronate and placebo treatment groups.

Five pamidronate associated serious and unexpected adverse events occurred in multiple myeloma patients during clinical trials. Symptoms included worsening renal function or multiple myeloma associated amyloidosis (3), adult respiratory distress syndrome (1), and an allergic reaction after the sixth infusion (1).

Four breast cancer patients discontinued pamidronate because of serious adverse events including interstitial pneumonitis, malaise, dyspnea, symptomatic hypocalcemia, and severe bone pain.

Local

Local side effects associated with intravenous infusion have been reported in up to 18% of patients and included phlebitis as well as redness, swelling, and pain at the injection site.

Metabolic

Metabolic side effects have included hypophosphatemia (18%), hypokalemia (18%), hypocalcemia (12%), and hypomagnesemia (12%). While usually asymptomatic, rare cases of symptomatic hypocalcemia have been reported.

Presentation of hypocalcemia may be delayed. In one case report, the patient presented with fingertip paresthesias and a serum calcium of 6.8 mEq/L (7.8 mEq/mL, corrected) 13 days after a single infusion of pamidronate.

Hematologic

Leukopenia was generally mild and transient. In one study, granulocytopenia occurred in 4.2% of patients but completely resolved after discontinuation of pamidronate (the active ingredient contained in Aredia) therapy. Patients with anemia, leukopenia, or thrombocytopenia prior to initiation of pamidronate should be carefully monitored during the first 2 weeks of therapy.

Hematologic side effects have included anemia, mild leukopenia, and granulocytopenia. Chronic idiopathic thrombocytopenic purpura has also been cited in a case report.

Renal

Renal side effects have included postmarketing reports of focal segmental glomerulosclerosis including the collapsing variant and nephrotic syndrome. Monitoring of renal function during and following pamidronate (the active ingredient contained in Aredia) therapy is recommended.

Ocular

Uveitis generally occurs within 24 to 48 hours after administration of pamidronate (the active ingredient contained in Aredia) The uveitis may be bilateral, and reversible, partial 3rd and 4th nerve palsies have been reported with the uveitis. Recurrences have occurred with rechallenge of the drug. Therapy with pamidronate should be discontinued if uveitis occurs. Although severe cases have been reported, most symptoms have resolved on discontinuation of pamidronate with minimal or no intervention.

A nonspecific conjunctivitis has been reported with pamidronate use. The conjunctivitis may consist of any or all of the following symptoms: conjunctival hyperemia, irritation, epiphora, discharge, and blurred vision. These symptoms may appear within the first 6 to 48 hours after administration of the drug and generally resolve within a few days after drug discontinuation.

Ocular side effects have included abnormal vision as well as uveitis, iritis, episcleritis, scleritis, and nonspecific transitory conjunctivitis. Post marketing reports have included orbital inflammation.

Musculoskeletal

Musculoskeletal side effects have included worsening of bone pain, arthralgias, and myalgias. In addition, cases of osteomalacia and mineralization defects have been reported. Post marketing reports have included cases of osteonecrosis, primarily of the jaws.

Nervous system

Nervous system side effects have included headache in 15% of patients with Paget's disease receiving pamidronate (the active ingredient contained in Aredia) Insomnia, somnolence, and psychoses have also been reported. Seizures have been reported although causality has not been established. Postmarketing reports have included confusion and visual hallucinations, sometimes in the presence of electrolyte imbalance.

Gastrointestinal

In one study, 4.7% of patients taking oral pamidronate (the active ingredient contained in Aredia) required interruption of therapy due to gastrointestinal side effects.

Gastrointestinal side effects have been more frequently reported with oral pamidronate (not available in the United States) than with the IV formulation and have included abdominal pain, anorexia, constipation, diarrhea, stomatitis, gastrointestinal hemorrhage, nausea, and vomiting.

Other

Other side effects have included rigors (3% to 8%) and general malaise (9% to 12%).

Cardiovascular

Cardiovascular side effects such as fluid overload and hypertension have occurred in at least 15% of patients treated with pamidronate (the active ingredient contained in Aredia) during clinical trials. Rare cases of atrial fibrillation, atrial flutter, tachycardia, syncope, and cardiac failure have been reported.

Genitourinary

Genitourinary side effects have included urinary tract infections (15%) and moniliasis (6%).

Respiratory

Respiratory side effects including dyspnea, rales, rhinitis, and upper respiratory infections have been uncommon and occurred more frequently with larger doses of pamidronate (the active ingredient contained in Aredia)

Endocrine

Endocrine side effects have been uncommon. Hypothyroidism has been reported in patients receiving 90 mg of pamidronate (the active ingredient contained in Aredia) .

Other

Other side effects have included postmarketing reports of reactivation of Herpes simplex and Herpes zoster and influenza-like symptoms.

Dermatologic

Dermatologic side effects have included postmarketing reports of rash and pruritus.

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 information does not endorse drugs, diagnose patients, or recommend therapy. This drug 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 drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information 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 drugs you are taking, check with your doctor, nurse, or pharmacist.