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.

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:

Diarrhea; dizziness; light-headedness; nausea

Seek medical attention right away if any of these SEVERE side effects occur when using Zemplar:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; depression; fainting; fever, chills, or persistent sore throat; irregular heartbeat; muscle cramps or spasms; painful urination; pounding in the chest; seizures; severe or persistent dizziness or headache; stomach pain; swelling of the hands or feet; symptoms of high blood calcium levels (eg, constipation, increased thirst or urination, loss of appetite, nausea, tiredness, trouble thinking, vomiting, weight loss); trouble breathing; unusual or severe dry eyes, mouth, or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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:

Diarrhea; dizziness; light-headedness; nausea.

Seek medical attention right away if any of these SEVERE side effects occur when using Zemplar Capsules:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); black, tarry, or bloody stools; chest pain; depression; fainting; fever, chills, or persistent sore throat; irregular heartbeat; muscle cramps or spasms; painful urination; pounding in the chest; seizures; severe or persistent dizziness or headache; stomach pain; swelling of the hands or feet; symptoms of high blood calcium levels (eg, confusion, constipation, increased thirst or urination, loss of appetite, nausea, tiredness, trouble thinking, vomiting, weight loss); trouble breathing; unusual or severe dry eyes, mouth, or skin.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Top

Zemplar Side Effects - for the Professional

Zemplar

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

	Number (%) of Subjects
Adverse Eventa	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

	Number (%) of Subjects
Adverse Eventsa	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 with the active ingredient in Zemplar capsules: angioedema (including laryngeal edema).

Top

Side Effects by Body System - for Healthcare Professionals

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%), palpitations (3%), and angioedema (including laryngeal edema).

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 lightheadedness (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 injection have included rash and urticaria.

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 injection have included arthralgia (5%).

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.

Top

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.