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Zemplar

Last reviewed on RxList: 11/9/2016
Zemplar Side Effects Center

Last reviewed on RxList 7/18/2016

Zemplar (paricalcitol) Injection is a form of vitamin D indicated for the prevention and treatment of secondary hyperparathyroidism associated with chronic kidney disease Stage 5. Common side effects of Zemplar Injection include:

The recommended initial dose of Zemplar is 0.04 mcg/kg to 0.1 mcg/kg (2.8 - 7 mcg) administered as a bolus dose no more frequently than every other day at any time during dialysis. Zemplar Injection may interact with azole antifungals, antiviral medications, macrolide antibiotics, nefazodone, and digitalis. Tell your doctor all medications and supplements you use. During pregnancy, Zemplar should be used only if prescribed. It is unknown if Zemplar passes into breast milk. Breastfeeding while taking Zemplar is not recommended.

Our Zemplar (paricalcitol) Injection Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Zemplar Consumer Information
SIDE EFFECTS: Headache, nausea, chills, or fever may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may raise your vitamin D and calcium levels too high. Tell your doctor immediately if any of these unlikely but serious effects of too much vitamin D/calcium occur: constipation, drowsiness, dry mouth, muscle/bone/joint pain, metallic taste in mouth, weakness, vomiting.

Tell your doctor immediately if any of these rare but serious side effects of very high vitamin D levels occur: loss of appetite, unusual weight loss, eye pain/redness/sensitivity to light, severe runny nose, stomach/abdominal pain.

Tell your doctor right away if you have any serious side effects, including: dizziness, fast/irregular/pounding heartbeat, swelling hands/ankles/feet, severe mental/mood changes (e.g., agitation, confusion), easy bleeding/bruising, bloody/tarry stool, vomit that looks like coffee grounds.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Zemplar (Paricalcitol Tablets)

Zemplar Professional Information

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) %
Placebo
(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

Investigations:

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 entire FDA prescribing information for Zemplar (Paricalcitol Tablets)

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© Zemplar Patient Information is supplied by Cerner Multum, Inc. and Zemplar Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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