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Sensipar (Cinacalcet Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE EVENTS

Secondary Hyperparathyroidism in Patients with Chronic Kidney Disease on Dialysis

In 3 double-blind placebo-controlled clinical trials, 1126 CKD patients on dialysis received study drug (656 Sensipar®, 470 placebo) for up to 6 months. The most frequently reported adverse events (incidence of at least 5% in the Sensipar® group and greater than placebo) are provided in Table 2. The most frequently reported events in the Sensipar® group were nausea, vomiting, and diarrhea.

Table 2. Adverse Event Incidence (≥ 5%) in Patients on Dialysis
Event 1: Placebo
(n = 470)
(%)
Sensipar®
(n = 656)
(%)
Nausea 19 31
Vomiting 15 27
Diarrhea 20 21
Myalgia 14 15
Dizziness 8 10
Hypertension 5 7
Asthenia 4 7
Anorexia 4 6
Pain Chest, Non­Cardiac 4 6
Access Infection 4 5

1 Included are events that were reported at a greater incidence in the Sensipar® group than in the placebo group.

The incidence of serious adverse events (29% vs. 31%) was similar in the Sensipar® and placebo groups, respectively.

12-Month Experience with Sensipar®: Two hundred and sixty-six patients from 2 phase 3 studies continued to receive Sensipar® or placebo treatment in a 6-month double-blind extension study (12-month total treatment duration). The incidence and nature of adverse events in this study were similar in the two treatment groups, and comparable to those observed in the phase 3 studies.

Postmarketing Experience with Sensipar®: Rash, hypersensitivity reactions (including angioedema and urticaria), diarrhea and myalgia have been identified as adverse reactions during post-approval use of Sensipar®. Isolated, idiosyncratic cases of hypotension, worsening heart failure, and/ or arrhythmia have been reported in Sensipar®-treated patients with impaired cardiac function in postmarketing safety surveillance. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Parathyroid Carcinoma

The most frequent adverse events in this patient group were nausea and vomiting.

Laboratory values: Serum calcium levels should be closely monitored in patients receiving Sensipar® (see PRECAUTIONS and DOSAGE AND ADMINISTRATION).



REPORTS OF SUSPECTED SENSIPAR SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Sensipar. The information is not vetted and should not be considered as verified clinical evidence.

Possible Sensipar side effects / adverse reactions in 66 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-21

Patient: 66 year old female

Reactions: Blood Parathyroid Hormone Abnormal

Suspect drug(s):
Sensipar
    Dosage: 60 mg, qd
    Indication: Hyperparathyroidism Secondary
    Start date: 2011-05-26

Sensipar
    Dosage: 60 mg, 3 times/wk
    Start date: 2011-09-22

Other drugs received by patient: Atenolol; Keflex; Zemplar; Zemplar; Norvasc; Prednisone; Lipitor; Coumadin; Vital /00943602/



Possible Sensipar side effects / adverse reactions in 83 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-25

Patient: 83 year old female

Reactions: Blood Calcium Decreased, Osteitis Deformans, Blood Parathyroid Hormone Increased

Suspect drug(s):
Sensipar
    Dosage: unk
    Indication: Product Used FOR Unknown Indication

Prolia
    Dosage: 60 mg, unk
    Indication: Osteitis Deformans
    Start date: 2011-09-01

Other drugs received by patient: Hectorol



Possible Sensipar side effects / adverse reactions in 81 year old male

Reported by a physician from Australia on 2011-10-26

Patient: 81 year old male

Reactions: Vertigo, Dizziness

Adverse event resulted in: hospitalization

Suspect drug(s):
Sensipar



See index of all Sensipar side effect reports >>

Drug label data at the top of this Page last updated: 2010-06-08

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