April 26, 2017
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Side Effects


Zemplar has been evaluated for safety in clinical studies in 609 CKD Stage 5 patients. In four, placebocontrolled, 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 Studies) and 2.0% of 51 patients treated with placebo for 1 to 3 months. Adverse events occurring in the Zemplar group at a frequency of 2% or greater and with an incidence greater than that in the placebo group, 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) %
(n = 51) %
Overall 71 78
Cardiac Disorders
  Palpitations 3.2 0.0
Gastrointestinal Disorders 
  Dry Mouth 3.2 2.0
  Gastrointestinal Hemorrhage 4.8 2.0
  Nausea 12.9 7.8
  Vomiting 8.1 5.9
General Disorders and Administration Site Conditions
  Chills 4.8 2.0
  Edema 6.5 0.0
  Malaise 3.2 0.0
  Pyrexia 4.8 2.0
Infections and Infestations
  Influenza 4.8 3.9
  Pneumonia 4.8 0.0
  Sepsis 4.8 2.0
Musculoskeletal and Connective Tissue Disorders
  Arthralgia 4.8 3.9

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 (see Clinical Studies).

Other Adverse Reactions Observed During Clinical Evaluation Of Zemplar Injection

The following adverse reactions, with a causal relationship to Zemplar, occurred in < 2% of the Zemplar treated patients in the above double-blind, placebo-controlled clinical trial data set. In addition,the following also includes adverse reactions reported in Zemplar-treated patients who participated in other studies (non placebo-controlled), including double-blind, active-controlled and open-label studies:

Blood and Lymphatic System Disorders:

Anemia, lymphadenopathy

Cardiac Disorders:

Arrhythmia, atrial flutter, cardiac arrest

Ear and Labyrinth Disorders:

Ear discomfort

Endocrine Disorders:

Hyperparathyroidism, hypoparathyroidism

Eye Disorders:

Conjunctivitis, glaucoma, ocular hyperemia

Gastrointestinal Disorders:

Abdominal discomfort, constipation, diarrhea, dysphagia, gastritis, intestinal ischemia, rectal hemorrhage

General Disorders and Administration Site Conditions:

Asthenia, chest discomfort, chest pain, condition aggravated, edema peripheral, fatigue, feeling abnormal, gait disturbance, injection site extravasation, injection site pain, pain, swelling, thirst

Infections and Infestations:

Nasopharyngitis, upper respiratory tract infection, vaginal infection


Aspartate aminotransferase increased, bleeding time prolonged, heart rate irregular, laboratory test abnormal, weight decreased

Metabolism and Nutrition Disorders:

Decreased appetite, hypercalcemia, hyperkalemia, hyperphosphatemia, hypocalcemia

Musculoskeletal and Connective Tissue Disorders:

Joint stiffness, muscle twitching, myalgia

Neoplasms Benign, Malignant and Unspecified:

Breast cancer

Nervous System Disorders:

Cerebrovascular accident, dizziness, dysgeusia, headache, hypoesthesia, myoclonus, paresthesia, syncope, unresponsive to stimuli

Psychiatric Disorders:

Agitation, confusional state, delirium, insomnia, nervousness, restlessness

Reproductive System and Breast Disorders:

Breast pain, erectile dysfunction

Respiratory, Thoracic and Mediastinal Disorders:

Cough, dyspnea, orthopnea, pulmonary edema, wheezing

Skin and Subcutaneous Tissue Disorders:

Alopecia, blister, hirsutism, night sweats, rash pruritic, pruritus, skin burning sensation

Vascular Disorders:

Hypertension, hypotension

Additional Adverse Events Reported During Post-marketing Experience

Allergic reactions, such as rash, urticaria, and angioedema (including laryngeal edema) have been reported.

Read the Zemplar (paricalcitol tablets) Side Effects Center for a complete guide to possible side effects


Specific interaction studies were not performed with Zemplar Injection. Paricalcitol is not expected to inhibit the clearance of drugs metabolized by cytochrome P450 enzymes CYP1A2, CYP2A6, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A nor induce the clearance of drug metabolized by CYP2B6, CYP2C9 or CYP3A.

A multiple dose drug-drug interaction study with ketoconazole and paricalcitol capsule demonstrated that ketoconazole approximately doubled paricalcitol AUC0-∞ (see CLINICAL PHARMACOLOGY). Since paricalcitol is partially metabolized by CYP3A and ketoconazole is known to be a strong inhibitor of cytochrome P450 3A enzyme, care should be taken while paricalcitol is co-administered with ketoconazole and other strong P450 3A inhibitors including the following drugs but not limited to: atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin or voriconazole.

Digitalis toxicity is potentiated by hypercalcemia of any cause, so caution should be applied when digitalis compounds are prescribed concomitantly with Zemplar.

Read the Zemplar Drug Interactions Center for a complete guide to possible interactions

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 11/9/2016

Side Effects

Zemplar Injection - User Reviews

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