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
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
CKD Stages 3 and 4
The safety of Zemplar Capsules (paricalcitol) has been evaluated in three 24-week (approximately six-month), double-blind, placebo-controlled, multicenter clinical studies involving 220 CKD Stage 3 and 4 patients. Six percent (6%) of Zemplar Capsules (paricalcitol) treated patients and 4% of placebo treated patients discontinued from clinical studies due to an adverse event. All reported adverse events occurring in at least 2% in either treatment group are presented in Table 4.
Table 4 : 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 Stage 3 and 4 Studies; All Treated Patients
| Body Systema COSTART V Term |
Number (%) of Subjects | |||
| Zemplar Capsules (n = 107) |
Placebo (n = 113) |
|||
| Overall | 88 | (82%) | 86 | (76%) |
| Body as a Whole | 49 | (46%) | 40 | (35%) |
| Accidental Injury | 10 | (9%) | 8 | (7%) |
| Pain | 8 | (7%) | 7 | (6%) |
| Viral Infection | 8 | (7%) | 8 | (7%) |
| Allergic Reaction | 6 | (6%) | 2 | (2%) |
| Headache | 5 | (5%) | 5 | (4%) |
| Abdominal Pain | 4 | (4%) | 2 | (2%) |
| Back Pain | 4 | (4%) | 1 | (1%) |
| Infection | 4 | (4%) | 4 | (4%) |
| Asthena | 3 | (3%) | 2 | (2%) |
| Chest Pain | 3 | (3%) | 1 | (1%) |
| Fever | 3 | (3%) | 1 | (1%) |
| Infection Fungal | 3 | (3%) | 0 | (0%) |
| Cyst | 2 | (2%) | 0 | (0%) |
| Flu Syndrome | 2 | (2%) | 1 | (1%) |
| Infection Bacterial | 2 | (2%) | 1 | (1%) |
| Cardiovascular | 27 | (25%) | 19 | (17%) |
| Hypertension | 7 | (7%) | 4 | (4%) |
| Hypotension | 5 | (5%) | 3 | (3%) |
| Syncope | 3 | (3%) | 1 | (1%) |
| Cardiomyopathy | 2 | (2%) | 0 | (0%) |
| Congestive Heart Failure | 2 | (2%) | 5 | (4%) |
| Myocardial Infarct | 2 | (2%) | 0 | (0%) |
| Postural Hypotension | 2 | (2%) | 0 | (0%) |
| Digestive | 29 | (27%) | 31 | (27%) |
| Diarrhea | 7 | (7%) | 5 | (4%) |
| Nausea | 6 | (6%) | 4 | (4%) |
| Vomiting | 6 | (6%) | 5 | (4%) |
| Constipation | 4 | (4%) | 4 | (4%) |
| Gastroenteritis | 3 | (3%) | 3 | (3%) |
| Dyspepsia | 2 | (2%) | 2 | (2%) |
| Gastritis | 2 | (2%) | 4 | (4%) |
| Rectal Disorder | 2 | (2%) | 0 | (0%) |
| Hemic and Lymphatic System | 4 | (4%) | 10 | (9%) |
| Hypervolemia | 2 | (2%) | 4 | (4%) |
| Ecchymosis | 2 | (2%) | 4 | (4%) |
| Metabolic and Nutritional Disorders | 24 | (22%) | 34 | (30%) |
| Edema | 7 | (7%) | 5 | (4%) |
| Uremia | 7 | (7%) | 9 | (8%) |
| Gout | 4 | (4%) | 6 | (5%) |
| Dehydration | 3 | (3%) | 1 | (1%) |
| Acidosis | 2 | (2%) | 1 | (1%) |
| Hyperkalemia | 2 | (2%) | 3 | (3%) |
| Hyperphosphatemia | 2 | (2%) | 4 | (4%) |
| Hypoglycemia | 2 | (2%) | 4 | (4%) |
| Hypokalemia | 2 | (2%) | 1 | (1%) |
| Musculoskeletal | 12 | (11%) | 9 | (8%) |
| Arthritis | 5 | (5%) | 1 | (1%) |
| Leg Cramps | 3 | (3%) | 0 | (0%) |
| Myalgia | 2 | (2%) | 5 | (4%) |
| Nervous | 18 | (17%) | 12 | (11%) |
| Dizziness | 5 | (5%) | 5 | (4%) |
| Vertigo | 5 | (5%) | 0 | (0%) |
| Depression | 3 | (3%) | 0 | (0%) |
| Insomnia | 2 | (2%) | 2 | (2%) |
| Neuropathy | 2 | (2%) | 1 | (1%) |
| Respiratory | 26 | (24%) | 25 | (22%) |
| Pharyngitis | 11 | (10%) | 12 | (11%) |
| Rhinitis | 5 | (5%) | 4 | (4%) |
| Bronchitis | 3 | (3%) | 1 | (1%) |
| Cough Increased | 3 | (3%) | 2 | (2%) |
| Sinusitis | 3 | (3%) | 1 | (1%) |
| Epistaxis | 2 | (2%) | 1 | (1%) |
| Pneumonia | 2 | (2%) | 0 | (0%) |
| Skin and Appendages | 17 | (16%) | 10 | (9%) |
| Rash | 6 | (6%) | 3 | (3%) |
| Pruritus | 3 | (3%) | 3 | (3%) |
| Skin Ulcer | 3 | (3%) | 0 | (0%) |
| Skin Hypertrophy | 2 | (2%) | 0 | (0%) |
| Vesiculobullous Rash | 2 | (2%) | 1 | (1%) |
| Special Senses | 9 | (8%) | 11 | (10%) |
| Amblyopia | 2 | (2%) | 0 | (0%) |
| Retinal Disorder | 2 | (2%) | 0 | (0%) |
| Urogenital System | 10 | (9%) | 10 | (9%) |
| Urinary Tract Infection | 3 | (3%) | 1 | (1%) |
| Kidney Function Abnormal | 2 | (2%) | 1 | (1%) |
| a Includes all patients with events in that body system. | ||||
CKD Stage 5
The safety of Zemplar Capsules (paricalcitol) 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 (paricalcitol) and 27 patients received placebo.
The proportion of patients who terminated prematurely from the study due to adverse events was 7% for Zemplar Capsules (paricalcitol) treated patients and 7% for placebo patients.
Adverse events occurring in the Zemplar Capsules (paricalcitol) group at a frequency of 2% or greater and more frequently than in the placebo group are as follows:
Table 5 : 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
| Body Systema COSTART V Term |
Number (%) of Subjects | |||
| Zemplar Capsules (n = 61) |
Placebo (n = 27) |
|||
| Overall | 43 | (70%) | 19 | (70%) |
| Body as a Whole | 27 | (44%) | 8 | (30%) |
| Infection | 9 | (15%) | 3 | (11%) |
| Asthenia | 3 | (5%) | 0 | (0%) |
| Peritonitis | 3 | (5%) | 0 | (0%) |
| Accidental Injury | 2 | (3%) | 0 | (0%) |
| Headache | 2 | (3%) | 0 | (0%) |
| Digestive | 18 | (30%) | 4 | (15%) |
| Diarrhea | 7 | (11%) | 3 | (11%) |
| Constipation | 3 | (5%) | 0 | (0%) |
| Nausea and Vomiting | 3 | (5%) | 0 | (0%) |
| Dyspepsia | 2 | (3%) | 0 | (0%) |
| Hemic and Lymphatic System | 6 | (10%) | 0 | (0%) |
| Hypervolemia | 3 | (5%) | 0 | (0%) |
| Ecchymosis | 2 | (3%) | 0 | (0%) |
| Metabolic and Nutritional Disorders | 7 | (11%) | 0 | (0%) |
| Hypoglycemia | 2 | (3%) | 0 | (0%) |
| Peripheral Edema | 2 | (3%) | 0 | (0%) |
| Uremia | 2 | (3%) | 0 | (0%) |
| Nervous | 12 | (20%) | 2 | (7%) |
| Dizziness | 4 | (7%) | 0 | (0%) |
| Insomnia | 3 | (5%) | 0 | (0%) |
| Anxiety | 2 | (3%) | 0 | (0%) |
| Respiratory | 8 | (13%) | 4 | (15%) |
| Sinusitis | 2 | (3%) | 0 | (0%) |
| Urogenital System | 6 | (10%) | 4 | (15%) |
| Urinary Tract Infection | 2 | (3%) | 0 | (0%) |
Read the entire FDA prescribing information for Zemplar Capsules (Paricalcitol) »
Additional Zemplar Capsules Information
Zemplar Capsules - User Reviews
Zemplar Capsules User Reviews
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