Zemplar Side Effects

Generic Name: paricalcitol

Please note - some side effects for Zemplar may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zemplar - for the Consumer

Zemplar

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zemplar:

Back or joint pain; diarrhea; feeling unwell; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black tarry or bloody stools; chest pain; depression; fever or chills; irregular heartbeat; muscle cramps or spasms; pounding in the chest; stomach pain; swelling of the hands or feet; trouble breathing.

Zemplar Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zemplar Capsules:

Back or joint pain; diarrhea; feeling unwell; lightheadedness; nausea; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); black tarry or bloody stools; chest pain; depression; fever or chills; irregular heartbeat; muscle cramps or spasms; pounding in the chest; stomach pain; swelling of the hands or feet; trouble breathing.

Zemplar Side Effects - for the Professional

Zemplar

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 Stage 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. All reported adverse events occurring in at least 2% in either treatment group are presented in Table 3.

Potential adverse effects of Zemplar Capsules are, in general, similar to those encountered with excessive vitamin D intake. The early and late signs and symptoms of hypercalcemia associated with vitamin D overdoses include:

Early

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, and metallic taste.

Late

Anorexia, weight loss, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, hypercholesterolemia, elevated AST and ALT, ectopic calcification, hypertension, cardiac arrhythmias, somnolence, death, and, rarely, overt psychosis.

Zemplar Injection

Zemplar has been evaluated for safety in clinical studies in 454 CKD Stage 5 patients. In four, placebo-controlled, 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 PHARMACOLOGY - Clinical Studies) and 2.0% of 51 patients treated with placebo for 1 to 3 months. Adverse events occurring with greater frequency in the Zemplar group at a frequency of 2% or greater, regardless of causality, are presented in the following table:

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.

Potential adverse events of Zemplar Injection are, in general, similar to those encountered with excessive vitamin D intake. Signs and symptoms of vitamin D intoxication associated with hypercalcemia include:

Early

Weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, and metallic taste.

Late

Anorexia, weight loss, conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, hypercholesterolemia, elevated AST and ALT, ectopic calcification, hypertension, cardiac arrhythmias, somnolence, death, and rarely, overt psychosis.

Adverse Events During Post-marketing Experience

Taste perversion, such as metallic taste, and allergic reactions, such as rash, urticaria, pruritus, angioedema and laryngeal edema rarely have been reported.

Side Effects by Body System

Gastrointestinal

Gastrointestinal side effects associated with paricalcitol injection have included nausea (13%), vomiting (8%), gastrointestinal bleeding (5%), and dry mouth (3%). Taste perversion has been reported rarely.

Gastrointestinal side effects associated with paricalcitol oral have included diarrhea (7%), nausea (6%), vomiting (6%), constipation (4%), abdominal pain (4%), gastroenteritis (3%), dyspepsia (2%), gastritis (2%), and rectal disorder (2%).

Cardiovascular

Cardiovascular side effects associated with paricalcitol injection have included edema (7%) and palpitations (3%).

Cardiovascular side effects associated with paricalcitol oral have included hypertension (7%), hypotension (5%), syncope (3%), cardiomyopathy (2%), congestive heart failure (2%), myocardial infarct (2%), and postural hypotension (2%).

Nervous system

Nervous system side effects associated with paricalcitol injection have included light-headedness (5%).

Nervous system side effects associated with paricalcitol oral have included dizziness (5%), vertigo (5%), depression (3%), insomnia (2%), and neuropathy (2%).

Respiratory

Respiratory side effects associated with paricalcitol injection have included pneumonia (5%).

Respiratory side effects associated with paricalcitol oral have included pharyngitis (10%), rhinitis (5%), bronchitis (3%), increased cough (3%), sinusitis (3%), epistaxis (2%), and pneumonia (2%).

Other

Other side effects associated with paricalcitol injection have included fever (5%), chills (5%), flu (5%), sepsis (5%), and feeling unwell (3%). In addition, side effects associated with paricalcitol injection may resemble those seen with excessive vitamin D intake.

Other side effects associated with paricalcitol oral have included accidental injury (9%), pain (7%), edema (7%), viral infection (7%), headache (5%), back pain (4%), infection (4%), fungal infection (3%), asthenia (3%), chest pain (3%), fever (3%), bacterial infection (2%), cyst (2%), flu syndrome (2%), and hypervolemia (2%).

Other side effects associated with paricalcitol oral and injection have included hypercalcemia, elevated Ca x P product, and metastatic calcification. Vitamin D intoxication may be associated with hypercalcemia.

Early signs and symptoms of vitamin D intoxication have included weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain, and metallic taste.

Late signs and symptoms of vitamin D intoxication have included anorexia, weight loss, calcific conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated BUN, hypercholesterolemia, elevated AST and ALT, ectopic calcification, hypertension, cardiac arrhythmias, somnolence, and death. Overt psychosis occurs rarely.

Hypersensitivity

Hypersensitivity side effects associated with paricalcitol injection have rarely included pruritus, rash, urticaria, and facial and oral edema.

Hypersensitivity side effects associated with paricalcitol oral have included allergic reaction in 6% of patients.

Dermatologic

Dermatologic side effects associated with paricalcitol oral have included rash (6%), pruritus (3%), skin ulcer (3%), skin hypertrophy (2%), and vesiculobullous rash (2%).

Endocrine

Endocrine side effects associated with paricalcitol oral have included hypoglycemia in 2% of patients.

Genitourinary

Genitourinary side effects associated with paricalcitol oral have included urinary tract infection in 3% of patients.

Metabolic

Metabolic side effects associated with paricalcitol oral have included uremia (7%), gout (4%), dehydration (3%), acidosis (2%), hyperkalemia (2%), hyperphosphatemia (2%), and hypokalemia (2%).

Musculoskeletal

Musculoskeletal side effects associated with paricalcitol oral have included arthritis (5%), leg cramps (3%), and myalgia (2%).

Ocular

Ocular side effects associated with paricalcitol oral have included amblyopia and retinal disorder in 2% of patients.

Renal

Renal side effects associated with paricalcitol oral have included abnormal kidney function in 2% of patients.

Hematologic

Hematologic side effects associated with paricalcitol oral have included ecchymosis in 2% of patients.

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