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
Zemplar Side Effects, and Drug Interactions - Paricalcitol
Zemplar Side Effects, and Drug Interactions - Paricalcitol
SIDE EFFECTS
Zemplar™ has been evaluated for safety in clinical studies in 454 CRF patients.
In four, placebo-controlled, double-blind, multicenter studies, discontinuation
of therapy due to any adverse event occurred in 6.5% of 62 patients treated
with Zemplar™ (dosage titrated as tolerated, see CLINICAL PHARMACOLOGY,
Clinical Studies ) and 2.0% of 51 patients treated with placebo for one
to three months. Adverse events occurring with greater frequency in theZemplar™
group at a frequency of 2% or greater, regardless of causality, are presented
in the following table:
Adverse Event Incidence Rates for All Treated Patients
In All Placebo-Controlled Studies
|
Adverse Event
|
Zemplar™ (n=62)% |
Placebo (n=51)% |
|
Overall
|
71 |
78 |
|
Body as a Whole
|
|
Chills
|
5 |
0 |
|
Feeling unwell
|
3 |
0 |
|
Fever
|
5 |
2 |
|
Flu
|
5 |
4 |
|
Sepsis
|
5 |
2 |
|
Cardiovascular System
|
|
Palpitation
|
3 |
0 |
|
Digestive System
|
|
Dry mouth
|
3 |
2 |
|
Gastrointestinal bleeding
|
5 |
2 |
|
Nausea
|
13 |
8 |
|
Vomiting
|
8 |
4 |
|
Metabolic and Nutritional Disorders
|
|
Edema
|
7 |
0 |
|
Nervous System
|
|
Light-headedness
|
5 |
2 |
|
Respiratory System
|
|
Pneumonia
|
5 |
0 |
A patient who reported the same medical term more than once was counted only
once for that medical term.
Safety parameters (changes in mean Ca, P, Ca × P) in an open-label safety study
up to 13 months in duration support the long-term safety of Zemplar™ in this
patient population.
Adverse Events during post-marketing experience: Taste perversion, such as metallic taste, and allergic reactions, such as rash, urticaria and pruritus rarely have been reported.
DRUG INTERACTIONS
Specific interaction studies were not performed. Digitalis toxicity is potentiated by hypercalcemia of any cause,
so caution should be applied when digitalis compounds are prescribed concomitantly
withZemplar™.
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