A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Skelid Side Effects, and Drug Interactions - Tiludronate
Skelid Side Effects, and Drug Interactions - Tiludronate
SIDE EFFECTS
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.
Adverse Events a (%) Reported b
in > 2% of Pagetic
Patients from Placebo-Controlled Studies
|
|
SKELID
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 System
|
|
Headache
|
6.7 |
12.2 |
|
Dizziness
|
4.0 |
6.8 |
|
Paresthesia
|
4.0 |
0 |
|
Endocrine
|
|
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 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.
DRUG INTERACTIONS
The bioavailability of SKELID is decreased 80% by calcium, when calcium and
SKELID are administered at the same time, and 60% by some aluminum- or magnesium-containing
antacids, when administered 1 hour before SKELID. Aspirin may decrease bioavailability
of SKELID by up to 50% when taken 2 hours after SKELID. The bioavailability
of SKELID 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 coadministration. In vitro studies
show that tiludronate does not displace warfarin from its binding site on protein.
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