Paricalcitol Side Effects

Brand Names: Zemplar

Please note - some side effects for Paricalcitol 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 Paricalcitol - for the Consumer

Paricalcitol

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 Paricalcitol:

Diarrhea; dizziness; light-headedness; nausea

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.

Paricalcitol 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 Paricalcitol Capsules:

Diarrhea; dizziness; light-headedness; nausea.

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.

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.

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