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Zemplar Capsules

Last reviewed on RxList: 8/2/2017
Zemplar Capsules Side Effects Center

Last reviewed on RxList 8/02/2017

Zemplar Capsules (paricalcitol) is a man-made form of vitamin D used to treat hyperparathyroidism (overactive parathyroid gland) in people with chronic kidney failure. Many people using Zemplar do not have serious side effects. Tell your doctor if unlikely but serious side effects of Zemplar occur: fast/slow/irregular heartbeat, seizures, weakness, loss of appetite, back/bone/joint/muscle pain, constipation, diarrhea, dry mouth, eye pain or redness, eye sensitivity to light, headache, nausea/, vomiting, drowsiness, stomach or abdominal pain, indigestion, increased thirst, change in the amount of urine, dizziness, spinning sensation, sore throat, cough, runny or stuffy nose, or itching or skin rash.

Zemplar Capsules may be taken daily in doses of 1 or 2 mcg, or taken three times a week in 2 or 4 mcg doses. Other drugs may interact with Zemplar. Tell your doctor all prescription and over-the-counter medications and supplements you use. During pregnancy, Zemplar should be used only when prescribed. This drug may pass into breast milk and could have undesirable effects on a nursing infant. Breastfeeding is not recommended while using this drug.

Our Zemplar Capsules (paricalcitol) 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.

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Zemplar Capsules Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • fast, slow, or pounding heartbeats;
  • fever, flu symptoms, mouth and throat ulcers;
  • new or worsening cough, fever, trouble breathing;
  • a seizure; or
  • high calcium levels--nausea, vomiting, loss of appetite, constipation, increased thirst or urination, confusion, weight loss, tiredness.

You may be more likely to have a broken bone if your parathyroid hormone levels get too low. Talk with your doctor about how to avoid the risk of fractures.

Common side effects may include:

  • nausea, vomiting;
  • swelling in your hands or feet;
  • dizziness or spinning sensation;
  • joint pain; or
  • runny nose.

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.

Read the entire detailed patient monograph for Zemplar Capsules (Paricalcitol)

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Zemplar Capsules Professional Information

SIDE EFFECTS

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Clinical Trials Experience

CKD Stages 3 and 4

Adults

The safety of ZEMPLAR capsules has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stages 3 and 4 patients. Six percent (6%) of ZEMPLAR capsules treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. Adverse events occurring in the ZEMPLAR capsules group at a frequency of 2% or greater and more frequently than in the placebo group are presented in Table 3:

Table 3: Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the ZEMPLAR-Treated Group of Three, Double-Blind, Placebo-Controlled CKD Stages 3 and 4 Studies

Adverse Eventa Number (%) of Subjects
ZEMPLAR Capsules
(n = 107)
Placebo
(n = 113)
Overall 88 (82%) 86 (76%)
Ear and Labyrinth Disorders
  Vertigo 5 (5%) 0 (0%)
Gastrointestinal Disorders
  Abdominal Discomfort 4 (4%) 1 (1%)
  Constipation 4 (4%) 4 (4%)
  Diarrhea 7 (7%) 5 (4%)
  Nausea 6 (6%) 4 (4%)
  Vomiting 5 (5%) 5 (4%)
General Disorders and Administration Site Conditions
  Chest Pain 3 (3%) 1 (1%)
  Edema 6 (6%) 5 (4%)
  Pain 4 (4%) 4 (4%)
Immune System Disorders
  Hypersensitivity 6 (6%) 2 (2%)
Infections and Infestations
  Fungal Infection 3 (3%) 0 (0%)
  Gastroenteritis 3 (3%) 3 (3%)
  Infection 3 (3%) 3 (3%)
  Sinusitis 3 (3%) 1 (1%)
  Urinary Tract Infection 3 (3%) 1 (1%)
  Viral Infection 8 (7%) 8 (7%)
Metabolism and Nutrition Disorders
  Dehydration 3 (3%) 1 (1%)
Musculoskeletal and Connective Tissue Disorders
  Arthritis 5 (5%) 0 (0%)
  Back Pain 3 (3%) 1 (1%)
  Muscle Spasms 3 (3%) 0 (0%)
Nervous System Disorders
  Dizziness 5 (5%) 5 (4%)
  Headache 5 (5%) 5 (4%)
  Syncope 3 (3%) 1 (1%)
Psychiatric Disorders
  Depression 3 (3%) 0 (0%)
Respiratory, Thoracic and Mediastinal Disorders
  Cough 3 (3%) 2 (2%)
  Oropharyngeal Pain 4 (4%) 0 (0%)
Skin and Subcutaneous Tissue Disorders
  Pruritus 3 (3%) 3 (3%)
  Rash 4 (4%) 1 (1%)
  Skin Ulcer 3 (3%) 0 (0%)
Vascular Disorders
  Hypertension 7 (7%) 4 (4%)
  Hypotension 5 (5%) 3 (3%)
a. Includes only events more common in the ZEMPLAR treatment group.

Additional Adverse Reactions

The following additional adverse reactions occurred in < 2% of the ZEMPLAR-treated patients in the above double-blind, placebo-controlled clinical trial.

Gastrointestinal Disorders: Dry mouth

Investigations: Hepatic enzyme abnormal

Nervous System Disorders: Dysgeusia

Skin and Subcutaneous Tissue Disorders: Urticaria

Pediatric Patients 10 To 16 Years Of Age

The safety of ZEMPLAR capsules has been evaluated in one multicenter clinical study involving CKD Stages 3 and 4 patients ages 10 to 16 years. A 12-week double-blind, placebo-controlled phase was followed by an open-label phase during which all patients received ZEMPLAR capsules.

During the 12-week blinded phase, a total of 18 patients received ZEMPLAR capsules and 18 patients received placebo. Adverse events occurring more frequently in the ZEMPLAR capsules group than in the placebo group are presented in Table 4.

Table 4: Adverse Reactions by Body System Occurring in the Double-Blind, Placebo-Controlled, CKD Stages 3 and 4 Study in Patients Ages 10 to 16 Years

Adverse Eventa Number (%)of Subjects
ZEMPLAR Capsules
(n = 18)
Placebo
(n = 18)
Overall 7 (39%) 16 (89%)
Gastrointestinal Disorders
  Nausea 1 (6%) 0 (0%)
Infections and Infestations
  Conjunctivitis 1 (6%) 0 (0%)
  Rhinitis 3 (17%) 0 (0%)
Renal and Urinary Disorders
  Micturition Urgency 1 (6%) 0 (0%)
Respiratory, Thoracic and Mediastinal Disorders
  Asthma 1 (6%) 0 (0%)
a. Includes only events more common in the ZEMPLAR treatment group.

Additional Adverse Reactions

The following adverse reactions have occurred in ZEMPLAR-treated patients:

Gastrointestinal Disorders: Abdominal pain, constipation, vomiting

Metabolism and Nutrition Disorders: Hypercalcemia and hyperphosphatemia

Nervous System Disorders: Headache

CKD Stage 5

Adults

The safety of ZEMPLAR capsules has been evaluated in one 12-week, double-blind, placebo-controlled, multicenter clinical study involving 88 CKD Stage 5 patients. Sixty-one patients received ZEMPLAR capsules and 27 patients received placebo.

The proportion of patients who terminated prematurely from the study due to adverse events was 7% for ZEMPLAR capsules treated patients and 7% for placebo patients.

Adverse events occurring in the ZEMPLAR capsules group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:

Table 5: Adverse Reactions by Body System Occurring in ≥ 2% of Subjects in the ZEMPLAR-Treated Group, Double-Blind, Placebo-Controlled CKD Stage 5 Study

Adverse Eventsa Number (%) of Subjects
ZEMPLAR Capsules
(n=61)
Placebo
(n = 27)
Overall 43 (70%) 19 (70%)
Gastrointestinal Disorders
  Constipation 3 (5%) 0 (0%)
  Diarrhea 7 (11%) 3 (11%)
  Vomiting 4 (7%) 0 (0%)
General Disorders and Administration Site Conditions
  Fatigue 2 (3%) 0 (0%)
  Edema Peripheral 2 (3%) 0 (0%)
Infections and Infestations
  Nasopharyngitis 5 (8%) 2 (7%)
  Peritonitis 3 (5%) 0 (0%)
  Sinusitis 2 (3%) 0 (0%)
  Urinary Tract Infection 2 (3%) 0 (0%)
Metabolism and Nutrition Disorders
  Fluid Overload 3 (5%) 0 (0%)
  Hypoglycemia 2 (3%) 0 (0%)
Nervous System Disorders  
  Dizziness 4 (7%) 0 (0%)
  Headache 2 (3%) 0 (0%)
Psychiatric Disorders
  Anxiety 2 (3%) 0 (0%)
  Insomnia 3 (5%) 0 (0%)
Renal and Urinary Disorders
  Renal Failure Chronic 2 (3%) 0 (0%)
a. Includes only events more common in the ZEMPLAR treatment group.

Additional Adverse Reactions

The following adverse reactions occurred in < 2% of the ZEMPLAR-treated patients in the above double-blind, placebo-controlled clinical trial.

Gastrointestinal Disorders: Gastroesophageal reflux disease

Metabolism and Nutrition Disorders: Decreased appetite, hypercalcemia, hypocalcemia

Reproductive System and Breast Disorders: Breast tenderness

Skin and Subcutaneous Tissue Disorders: Acne

Pediatric patients 10 to 16 years of age

The safety of ZEMPLAR capsules has been evaluated in one 12-week, open-label, single-arm, multicenter clinical studies involving 13 CKD Stage 5 patients ages 10 to 16 years of age receiving peritoneal dialysis or hemodialysis.

The following adverse reactions were reported:

Gastrointestinal Disorders: Abdominal pain, diarrhea, nausea, vomiting

Metabolism and Nutrition Disorders: Hypercalcemia, hyperphosphatemia

Three of 13 patients (23%) had hypercalcemia defined as at least 2 consecutive serum calcium values > 10.2 mg/dL (2.55 mmol/L).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of ZEMPLAR capsules. 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.

Immune System Disorders: Angioedema (including laryngeal edema)

Investigations: Blood creatinine increased

Read the entire FDA prescribing information for Zemplar Capsules (Paricalcitol)

Related Resources for Zemplar Capsules

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Read the Zemplar Capsules User Reviews »

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

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