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Zemplar Capsules

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Zemplar Capsules

Zemplar Capsules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

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

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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Zemplar Capsules in Detail - Patient Information: Side Effects

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

Stop taking paricalcitol and call your doctor at once if you have a serious side effect such as:

  • fever, chills, body aches, flu symptoms;
  • chest pain, feeling short of breath;
  • feeling like you might pass out;
  • swelling, rapid weight gain;
  • pain or burning when you urinate;
  • dry mouth, drowsiness, increased urination, fast heart rate, feeling light-headed, fainting, or seizure (convulsions);
  • nausea, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless;
  • early signs of vitamin D overdose (weakness, metallic taste in your mouth, weight loss, muscle or bone pain, constipation, nausea, and vomiting).

Less serious side effects may include:

  • dizziness, spinning sensation;
  • back pain, mild muscle or joint pain;
  • stomach pain, indigestion;
  • diarrhea;
  • sore throat, cough, runny or stuffy nose; or
  • mild itching or skin rash.

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) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Zemplar Capsules Overview - Patient Information: Side Effects

SIDE EFFECTS: 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.

Tell your doctor immediately if any of these unlikely but serious side effects occur: fast/slow/irregular heartbeat, seizures, weakness, loss of appetite, back/bone/joint/muscle pain, constipation, dry mouth, eye pain/redness/sensitivity to light, headache, nausea/vomiting, drowsiness, stomach/abdominal pain, increased thirst, change in the amount of urine.

Tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., psychosis).

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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 Capsules (Paricalcitol)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Zemplar Capsules FDA Prescribing Information: Side Effects
(Adverse Reactions)

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

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 1:

Table 1: Treatment-Emergent Adverse Events by Body System Occurring in ≥ 2% of Subjects in the Zemplar-Treated Group of Three, Double-Blind, Placebo-Controlled, Phase 3, CKD Stages 3 and 4 Studies; All Treated Patients

Adverse Eventa Number (%) of Subjects
Zemplar Capsules
(n = 107)
Placebo
(n = 113)
Overall 88 (82%) 86 (76%)
Ear and Labyrinth Disorders
  Vertigo 5 (4.7%) 0 (0.0%)
Gastrointestinal Disorders
  Abdominal Discomfort 4 (3.7%) 1 (0.9%)
  Constipation 4 (3.7%) 4 (3.5%)
  Diarrhea 7 (6.5%) 5 (4.4%)
  Nausea 6 (5.6%) 4 (3.5%)
  Vomiting 5 (4.7%) 5 (4.4%)
General Disorders and Administration Site Conditions
  Chest Pain 3 (2.8%) 1 (0.9%)
  Edema 6 (5.6%) 5 (4.4%)
  Pain 4 (3.7%) 4 (3.5%)
Immune System Disorders
  Hypersensitivity 6 (5.6%) 2 (1.8%)
Infections and Infestations
  Fungal Infection 3 (2.8%) 0 (0.0%)
  Gastroenteritis 3 (2.8%) 3 (2.7%)
  Infection 3 (2.8%) 3 (2.7%)
  Sinusitis 3 (2.8%) 1 (0.9%)
  Urinary Tract Infection 3 (2.8%) 1 (0.9%)
  Viral Infection 8 (7.5%) 8 (7.1%)
Metabolism and Nutrition Disorders
  Dehydration 3 (2.8%) 1 (0.9%)
Musculoskeletal and Connective Tissue Disorders
  Arthritis 5 (4.7%) 0 (0.0%)
  Back Pain 3 (2.8%) 1 (0.9%)
  Muscle Spasms 3 (2.8%) 0 (0.0%)
Nervous System Disorders
  Dizziness 5 (4.7%) 5 (4.4%)
  Headache 5 (4.7%) 5 (4.4%)
  Syncope 3 (2.8%) 1 (0.9%)
Psychiatric Disorders
  Depression 3 (2.8%) 0 (0.0%)
Respiratory, Thoracic and Mediastinal Disorders
  Cough 3 (2.8%) 2 (1.8%)
  Oropharyngeal Pain 4 (3.7%) 0 (0.0%)
Skin and Subcutaneous Tissue Disorders
  Pruritus 3 (2.8%) 3 (2.7%)
  Rash 4 (3.7%) 1 (0.9%)
  Skin Ulcer 3 (2.8%) 0 (0.0%)
Vascular Disorders
  Hypertension 7 (6.5%) 4 (3.5%)
  Hypotension 5 (4.7%) 3 (2.7%)
a Includes only events more common in the Zemplar treatment group.

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.

Gastrointestinal Disorders: Dry mouth

Investigations: Hepatic enzyme abnormal

Nervous System Disorders: Dysgeusia

Skin and Subcutaneous Tissue Disorders: Urticaria

CKD Stage 5

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 2: Treatment-Emergent Adverse Events by Body System Occurring in ≥ 2% of Subjects in the Zemplar-Treated Group, Double-Blind, Placebo-Controlled, Phase 3, CKD Stage 5 Study; All Treated Patients

Adverse Eventsa Number (%) of Subjects
Zemplar Capsules
(n=61)
Placebo
(n = 27)
Overall 43 (70%) 19 (70%)
Gastrointestinal Disorders
  Constipation 3 (4.9%) 0 (0.0%)
  Diarrhea 7 (11.5%) 3 (11.1%)
  Vomiting 4 (6.6%) 0 (0.0%)
General Disorders and Administration Site Conditions
  Fatigue 2 (3.3%) 0 (0.0%)
  Edema Peripheral 2 (3.3%) 0 (0.0%)
Infections and Infestations
  Nasopharyngitis 5 (8.2%) 2 (7.4%)
  Peritonitis 3 (4.9%) 0 (0.0%)
  Sinusitis 2 (3.3%) 0 (0.0%)
  Urinary Tract Infection 2 (3.3%) 0 (0.0%)
Metabolism and Nutrition Disorders
  Fluid Overload 3 (4.9%) 0 (0.0%)
  Hypoglycemia 2 (3.3%) 0 (0.0%)
Nervous System Disorders
  Dizziness 4 (6.6%) 0 (0.0%)
  Headache 2 (3.3%) 0 (0.0%)
Psychiatric Disorders
  Anxiety 2 (3.3%) 0 (0.0%)
  Insomnia 3 (4.9%) 0 (0.0%)
Renal and Urinary Disorders
  Renal Failure Chronic 2 (3.3%) 0 (0.0%)
a Includes only events more common in the Zemplar treatment group.

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.

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

Postmarketing Experience

The following additional adverse reactions have been reported during post-approval use and post-approval clinical trials with the active ingredient in Zemplar capsules:

Immune System Disorders: Angioedema (including laryngeal edema)

Metabolism and Nutrition Disorders: Hypercalcemia

Investigations: Blood creatinine increased

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

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Zemplar Capsules - User Reviews

Zemplar Capsules User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Zemplar Capsules sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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