Didronel (Etidronate Disodium) Drug Information: Side Effects and Drug Interactions

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May 26, 2012

Didronel

Osteoporosis »

Osteoporosis facts

Osteoporosis is a condition of increased susceptibility to fracture due to fragile bone.
Osteoporosis weakens bone and increases risk of bone fracture.
Bone mass (bone density) decreases after 35 years of age and decreases more rapidly in women after menopause.
Key risk factors for osteoporosis include genetics, lack of exercise, lack of calcium and vitamin D, personal history of fracture as an adult, cigarette smoking, excessive alcohol consumption, history of rheumatoid arthritis, low body weight, and family history of osteoporosis.
Patients with osteoporosis have no symptoms until bone fractures occur.
The diagnosis of osteoporosis can be suggested by X-rays and confirmed by tests to measure bone density.
Treatments for osteoporosis, in addition to prescription osteoporosis medications, include stopping use of alcohol and cigarettes, and assur...

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Didronel

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SIDE EFFECTS

The incidence of gastrointestinal complaints (diarrhea, nausea) is the same for Didronel (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, Procter & Gamble Pharmaceuticals 6 Didronel (etidronate disodium) 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, 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 including perforation has been reported rarely.

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.

DRUG INTERACTIONS

There have been isolated reports of patients experiencing increases in their prothrombin times when etidronate was added to warfarin therapy. The majority of these reports concerned variable elevations in prothrombin times without clinically significant sequelae. Although the relevance of these reports and any mechanism of coagulation alterations is unclear, patients on warfarin should have their prothrombin time monitored.

Last reviewed on RxList: 1/15/2010
This monograph has been modified to include the generic and brand name in many instances.