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Skelid

Last reviewed on RxList: 4/14/2010
Skelid Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 5/26/2016

Skelid (tiludronate disodium) is a bisphosphonate used to treat Paget's disease of bone. The brand name Skelid is discontinued, but generic versions may be available. Common side effects of Skelid (tiludronate disodium) include:

A single 400-mg daily oral dose of Skelid, taken with 6 to 8 ounces of plain water only, should be administered for a period of 3 months. Skelid may interact with other drugs. Tell your doctor all medications and supplements you use. Caution is advised if you are pregnant or planning to become pregnant in the future. Skelid may stay in your body for many years. Its effects on a fetus are unknown. Consult your doctor before starting treatment with Skelid. It is unknown if this drug passes into breast milk, and the effect on a nursing infant is unknown. Consult your doctor before breastfeeding.

Our Skelid (tiludronate disodium) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skelid Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using tiludronate 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 may include:

  • nausea, vomiting, upset stomach;
  • mild diarrhea; or
  • runny or stuffy nose.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Skelid (Tiludronate)

Skelid Professional Information

SIDE EFFECTS

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 Eventsa (%) Reportedb in > 2% of Pagetic Patients from Placebo-Controlled Studies

  SKELID (tiludronate)
400 mg/day
(n=75)
Placebo
(n=74)
BODY AS A WHOLE
  Pain 21.3 23.0
  Back Pain 8.0 8.1
  Accidental Injury 4.0 2.7
  Influenza-like Symptoms 4.0 5.4
  Chest Pain 2.7 0
  Peripheral Edema 2.7 1.4
CARDIOVASCULAR, GENERAL
  Dependent Edema 2.7 0
Central and Peripheral Nervous Systems
  Headache 6.7 12.2
  Dizziness 4.0 6.8
  Paresthesia 4.0 0
  Hyperparathyroidism 2.7 0
GASTROINTESTINAL
  Diarrhea 9.3 4.1
  Nausea 9.3 5.4
  Dyspepsia 5.3 8.1
  Vomiting 4.0 0
  Flatulence 2.7 0
  Tooth Disorder 2.7 1.4
Metabolic and Nutritional
  Vitamin D Deficiency 2.7 2.7
Musculoskeletal System
  Arthralgia 2.7 5.4
  Arthrosis 2.7 0
Resistance Mechanism
  Infection 2.7 0
Respiratory System
  Rhinitis 5.3 0
  Sinusitis 5.3 1.4
  Upper Respiratory Tract Infection 5.3 14.9
  Coughing 2.7 2.7
  Pharyngitis 2.7 1.4
Skin and Appendage
  Rash 2.7 1.4
  Skin Disorder 2.7 1.4
Vision
  Cataract 2.7 0
  Conjunctivitis 2.7 0
  Glaucoma 2.7 0
a Reported using WHO terminology
b All events reported, irrespective of causality

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.

Read the entire FDA prescribing information for Skelid (Tiludronate)

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© Skelid Patient Information is supplied by Cerner Multum, Inc. and Skelid Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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