Skelid Side Effects

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

Skelid

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 Skelid:

Abnormal skin sensations; diarrhea; gas; nausea; stomach upset; stuffy nose; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black or bloody stools; chest pain; difficulty swallowing; new, worsening, or severe heartburn; pain upon swallowing; red, swollen, blistered, or peeling skin; severe bone, muscle, or joint pain; severe or persistent stomach pain; swelling of the hands or feet; swelling or pain in the jaw; throat pain or irritation; vision changes; vomit that looks like coffee grounds.

Skelid Side Effects - for the Professional

Skelid

The safety of Skelid 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 400 mg/day are presented in the table below.

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

Adverse events associated with Skelid 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 and 5.4% of patients receiving placebo discontinued therapy due to any clinical adverse event.

Other adverse events not listed in the table above but reported in ≥1% of pagetic patients treated with Skelid 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 has not been established.

Side Effects by Body System

General

During clinical trials, symptoms such as general body pain, flu-like symptoms, headaches, dizziness, and arthralgias were reported more frequently in the placebo groups than in patients receiving tiludronate.

Adverse effects generally have been mild and have not required discontinuation of tiludronate therapy. Gastrointestinal side effects including nausea (9%), diarrhea (9%) and dyspepsia ((5%) have occurred most frequently.

Gastrointestinal

Gastrointestinal (GI) side effects have been the most frequent side effects noted during tiludronate therapy. (GI) side effects have included diarrhea and nausea (9%), dyspepsia (5%), vomiting (4%), flatulence and tooth disorder (3%). Abdominal pain, constipation, dry mouth, and gastritis have also been reported.

Renal

Tiludronate is not recommended for patients with severe renal impairment (creatinine clearance <30 mL/min). A single oral dose of 400 mg of tiludronate administered to patients with creatinine clearance between 11 and 18 mL/min resulted in an elimination half-life of 205 hours.

Cardiovascular

Cardiovascular side effects have included edema (3%)and chest pain (3%). Hypertension and flushing have been reported occasionally.

Nervous system

Nervous system side effects such as paresthesia (4%), vertigo, and involuntary muscle contraction have occurred. Nervous system side effects of headache and dizziness occurred less often in patients receiving tiludronate when compared to patients in the placebo group (7% and 4% versus 12% and 7% respectively).

Endocrine

Endocrine side effects of hyperparathyroidism have occurred in 3% of patients receiving tiludronate.

Metabolic

Metabolic side effects are uncommon. Vitamin D deficiency has occurred at a rate of 3% in treatment and placebo groups.

Musculoskeletal

Musculoskeletal symptoms of arthralgia were reported less frequently in tiludronate treatment groups than were reported in placebo groups (3% versus 5%).

Musculoskeletal side effects such as arthrosis occurred in 3% of patients receiving tiludronate. Pathological fractures have been reported.

Immunologic

Unspecified infections have been reported in 3% of patients receiving tiludronate.

Respiratory

Upper respiratory infections occurred at a frequency of 15% in patients in placebo groups compared to 5% in patients treated with tiludronate.

Respiratory side effects including rhinitis and sinusitis (5%), coughing and pharyngitis (3%) have occurred. Bronchitis has also been reported.

Dermatologic

Dermatologic side effects have included rash and unspecified skin disorders in 3% of patients receiving tiludronate. Pruritus and diaphoresis have been reported.

Ocular

Ocular side effects have included cataracts, conjunctivitis, or glaucoma in 3% of patients receiving tiludronate.

Genitourinary

Genitourinary side effects have been uncommon. Urinary tract infections occasionally have been reported.

Hypersensitivity

Hypersensivity reactions have been rare. Stevens-Johnson Syndrome has been reported, however, causality has not been established.

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