Didronel Side Effects

Generic name: etidronate

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

Some side effects of Didronel 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 etidronate: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking etidronate (the active ingredient contained in Didronel) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using etidronate and call your doctor at once if you have any of these serious side effects:

• painful or difficult swallowing;

• severe heartburn, burning pain in your upper stomach, or coughing up blood;

• severe joint, bone, or muscle pain;

• jaw pain, numbness, or swelling;

• severe diarrhea;

• bone fracture; or

• a red, blistering, peeling skin rash.

Less serious side effects of etidronate may include:

• mild diarrhea;

• headache, confusion;

• muscle cramps, joint pain; or

• numbness or tingly feeling.

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 etidronate: intravenous solution, oral tablet

General

Etidronate has been generally well tolerated after both oral and intravenous administration. Side effects have been uncommon and appear to be dose related, usually occurring only with doses above 5 mg/kg per day. Because etidronate (the active ingredient contained in Didronel) undergoes renal elimination, patients with reduced renal function may accumulate drug and are, therefore, at increased risk for side effects.

Renal

Etidronate use is associated with elevations in serum creatinine and BUN in up to 10% of patients. Patients with preexisting renal disease or on concomitant potentially renal toxic agents may be at increased risk. In addition, the use of higher than recommended doses or rapid infusion rates may contribute to the potential renal toxicity of etidronate (the active ingredient contained in Didronel) In animal studies, etidronate produced proximal renal tubular damage when used in high doses.

The risk of renal side effects may be reduced by delaying etidronate therapy until the patient is adequately volume expanded.

Renal side effects have included mild to moderate increases in serum creatinine (0.5 mg/dl or more) as well as BUN in up to 10% of patients.

Gastrointestinal

Gastrointestinal side effects have included diarrhea, nausea, vomiting, abdominal discomfort, esophagitis, glossitis, and peptic ulcer. Loss of taste or metallic taste has been reported in up to 52% of patients receiving intravenous etidronate (the active ingredient contained in Didronel) and in 4% of patients receiving oral etidronate.

Gastrointestinal side effects are more common with higher doses (10 to 20 mg/kg) and may be alleviated by dividing the daily dose. While these effects are generally mild and transient, perforated peptic ulcers, with or without subsequent peritonitis, have occurred. At least one fatality has been reported. Patients on high doses or unusually prolonged therapy may be at greater risk for severe gastrointestinal side effects of etidronate.

Cardiovascular

Cardiovascular side effects have included a case report of mitral and aortic valve thickening; causality is unknown.

Dermatologic

Dermatologic side effects have included rash and pruritus. Alopecia has been reported in patients receiving etidronate (the active ingredient contained in Didronel)

Hypersensitivity

Hypersensitivity side effects have included rash, follicular eruptions, urticaria, and angioedema. A case of Stevens-Johnson Syndrome has been reported.

Musculoskeletal

Musculoskeletal side effects have included worsening of pagetic bone pain, arthralgias, fractures, and osteomalacia.

Worsening of pagetic bone pain as well as appearance of pain at sites which were previously asymptomatic is reported in 10 to 20% of patients. This generally resolves despite continued therapy in most patients.

In one study, 9/13 patients with Paget's disease had biopsy evidence of focal osteomalacia after treatment with etidronate. All 13 patients had evidence of a mineralization defect. Two patients suffered fissure fractures.

Worsening pagetic pain and a rapid decline in serum alkaline phosphatase levels were reported in a patient who experienced a fractured patella associated with the development of osteomalacia. The authors suggest that worsened pagetic pain in association with a rapid decline in alkaline phosphatase may be a predictor of osteomalacia risk.

Metabolic

Metabolic side effects have included hypocalcemia and hyperphosphatemia, although clinical manifestations are not noted.

Psychiatric

Psychiatric side effects have included amnesia, confusion, depression and hallucinations.

Nervous system

Nervous system side effects have included paresthesia.

Respiratory

Respiratory side effects have included rare exacerbation of asthma.

Hematologic

Hematologic side effects have been rare, but have included agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge.

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