Etidronate Side Effects

Brand Names: Didronel

Please note - some side effects for Etidronate 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 Etidronate - for the Consumer

Etidronate

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 Etidronate:

Bloating; bone, muscle, or joint pain; constipation; diarrhea; gas; headache; indigestion; nausea; stomach pain; vomiting.

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black or bloody stools; chest pain; difficulty swallowing; fever, chills, or persistent sore throat; mental or mood changes; new, worsening, or severe heartburn; pain upon swallowing; severe bone, muscle, or joint pain; severe or persistent stomach pain; swelling or pain in your jaw.

Etidronate Side Effects - for the Professional

Etidronate

The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for Etidronate disodium at 5 mg/kg/day as for placebo, about 1 patient in 15. At 10 to 20 mg/kg/day the incidence may increase to 2 or 3 in 10. These complaints are often alleviated by dividing the total daily dose.

Paget’s Disease

In Paget’s patients, increased or recurrent bone pain at pagetic sites, and/or the onset of pain at previously asymptomatic sites has been reported. At 5 mg/kg/day about 1 patient in 10 (versus 1 in 15 in the placebo group) report these phenomena. At higher doses the incidence rises to about 2 in 10. When therapy continues, pain resolves in some patients but persists in others.

Heterotopic Ossification

No specific adverse reactions.

Worldwide Postmarketing Experience

The worldwide postmarketing experience for Etidronate disodium reflects its use in the following approved indications: Paget’s disease, heterotopic ossification, and hypercalcemia of malignancy. It also reflects the use of Etidronate disodium for osteoporosis where approved in countries outside the US. Other adverse events that have been reported and were thought to be possibly related to Etidronate disodium include the following: alopecia; arthropathies, including arthralgia and arthritis; bone fracture; esophagitis; glossitis; hypersensitivity reactions, including angioedema, follicular eruption, macular rash, maculopapular rash, pruritus, a single case of Stevens-Johnson syndrome, and urticaria; osteomalacia; neuropsychiatric events, including amnesia, confusion, depression and hallucination; and paresthesias.

In patients receiving Etidronate disodium, there have been rare reports of agranulocytosis, pancytopenia, and a report of leukopenia with recurrence on rechallenge. In addition, there have been rare reports of exacerbation of asthma. Exacerbation of existing peptic ulcer disease has been reported in a few patients. In one patient, perforation also occurred.

In osteoporosis clinical trials, headache, gastritis, leg cramps, and arthralgia occurred at a significantly greater incidence in patients who received Etidronate as compared with those who received placebo.

Side Effects by Body System

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 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. 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 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.

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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