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The safety of SKELID (tiludronate) has been studied in more than 1100 patients, and the adverse experience profile is similar between controlled and uncontrolled clinical trials. Adverse events occurring in placebo-controlled trials of pagetic patients treated with SKELID (tiludronate) 400 mg/day are presented in the table below.

The most frequently occurring adverse events in patients who received SKELID (tiludronate) 400 mg/day were in the gastrointestinal body system: nausea (9.3%), diarrhea (9.3%), and dyspepsia (5.3%).

Adverse events associated with SKELID (tiludronate) usually have been mild, and generally have not required discontinuation of therapy. In two placebo-controlled trials, 1.3% of patients receiving 400 mg SKELID (tiludronate) and 5.4% of patients receiving placebo discontinued therapy due to any clinical adverse event.

Adverse Events^a (%) Reported^b in > 2% of Pagetic Patients from Placebo-Controlled Studies

Other adverse events not listed in the table above but reported in ≥ 1% of pagetic patients treated with SKELID (tiludronate) in all clinical trials of at least one month duration, regardless of dose and causality assessment, are listed below. The adverse event terms within each body system are listed in the order of decreasing frequency occurring in the population.

Body as a Whole: Asthenia, syncope, fatigue

Cardiovascular: Hypertension

Central and Peripheral Nervous Systems: Vertigo, involuntary muscle contractions

Gastrointestinal: Abdominal pain, constipation, dry mouth, gastritis

Musculoskeletal: Fracture pathological

Psychiatric: Anorexia, somnolence, anxiety, nervousness, insomnia

Respiratory System: Bronchitis

Skin and Appendages: Pruritus, increased sweating

Urinary System: Urinary tract infection

Vascular (extracardiac): Flushing

Stevens-Johnson type syndrome has been observed rarely; the causality relationship of this to SKELID (tiludronate) has not been established.

The bioavailability of SKELID (tiludronate) is decreased 80% by calcium, when calcium and SKELID (tiludronate) are administered at the same time, and 60% by some aluminum- or magnesium-containing antacids, when administered 1 hour before SKELID (tiludronate) . Aspirin may decrease bioavailability of SKELID (tiludronate) by up to 50% when taken 2 hours after SKELID (tiludronate) . The bioavailability of SKELID (tiludronate) is increased 2-4 fold by indomethacin but is not significantly altered by coadministration of diclofenac. The pharmacokinetic parameters of digoxin are not significantly modified by SKELID (tiludronate) coadministration. In vitro studies show that tiludronate does not displace warfarin from its binding site on protein.

Last reviewed on RxList: 4/14/2010
This monograph has been modified to include the generic and brand name in many instances.