Summary

More frequently reported side effects include: arthritis, hypersensitivity reaction, and vertigo. Continue reading for a comprehensive list of adverse effects.

Applies to paricalcitol: oral capsule liquid filled. Other dosage forms:

• intravenous solution

Serious side effects of Paricalcitol

Along with its needed effects, paricalcitol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking paricalcitol:

More common

• Blurred vision
• cough or hoarseness
• difficulty with swallowing
• dizziness
• fever or chills
• headache
• hives
• itching
• lower back or side pain
• nervousness
• pain
• painful or difficult urination
• pounding in the ears
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• slow or fast heartbeat
• swelling
• tightness in the chest
• unusual tiredness or weakness

Less common

• Abdominal or stomach pain
• abnormal growth filled with fluid or semisolid material
• ammonia-like breath odor
• anxiety
• bladder pain
• bloating or swelling of the face, arms, hands, lower legs, or feet
• bloody or cloudy urine
• burning, tingling, numbness or pain in the hands, arms, feet, or legs
• chest pain or discomfort
• cold sweats
• coma
• confusion
• convulsions
• cool, pale skin
• decreased urine
• depression
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• dry mouth
• fainting
• frequent urge to urinate
• general feeling of discomfort or illness
• increase in heart rate
• increased hunger
• increased thirst
• irregular heartbeat
• joint pain
• lightheadedness
• loss of appetite
• muscle aches and pains
• nausea or vomiting
• nightmares
• numbness or tingling in the hands, feet, or lips
• pain or discomfort in the arms, jaw, back, or neck
• rapid breathing
• rapid weight gain
• runny nose
• sensation of pins and needles
• shakiness
• shivering
• slurred speech
• sneezing
• sore throat
• stabbing pain
• sunken eyes
• sweating
• thirst
• trouble sleeping
• troubled breathing
• unusual weight gain or loss
• weight loss
• wrinkled skin

Incidence not known

• Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• slow or irregular breathing

Get emergency help immediately if any of the following symptoms of overdose occur while taking paricalcitol:

Symptoms of overdose

• Abdominal or stomach cramps
• constipation
• depression
• high urine levels of calcium
• incoherent speech
• increased urination
• metallic taste
• muscle cramps in the hands, arms, feet, legs, or face
• muscle weakness
• tremor

Other side effects of Paricalcitol

Some side effects of paricalcitol may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach
• back pain
• belching
• bloody nose
• bruising
• change in vision
• cough producing mucus
• difficulty with moving
• feeling of constant movement of self or surroundings
• heartburn
• impaired vision
• indigestion
• lack or loss of strength
• large, flat, blue, or purplish patches in the skin
• leg cramps
• muscle pain or stiffness
• pain or tenderness around the eyes and cheekbones
• pain, swelling, or redness in the joints
• sensation of spinning
• sores on the skin
• stomach discomfort, upset, or pain
• stuffy nose

For Healthcare Professionals

Applies to paricalcitol: intravenous solution, oral capsule.

General

The most common adverse events were nausea, diarrhea, and elevated calcium phosphate product.^[Ref]

Gastrointestinal

Very common (10% or more): Nausea (12.9%), diarrhea (11.5%)

Common (1% to 10%): Vomiting, constipation, gastrointestinal hemorrhage, abdominal discomfort, dry mouth, gastroenteritis, stomach discomfort, gastroesophageal reflux disease

Uncommon (0.1% to 1%): Rectal hemorrhage, colitis, gastritis, dyspepsia, dysphagia, abdominal pain, gastrointestinal disorder

Frequency not reported: Intestinal ischemia, gastrointestinal hemorrhage^[Ref]

Metabolic

Very common (10% or more): Elevated calcium phosphate product (12%)

Common (1% to 10%): Fluid overload, hypoglycemia, dehydration, hypercalcemia, hypocalcemia, decreased appetite, hyperphosphatemia

Uncommon (0.1% to 1%): Hyperkalemia, anorexia, thirst^[Ref]

Cardiovascular

Common (1% to 10%): Hypertension, hypotension, palpitations

Uncommon (0.1% to 1%): Cardiac arrest, arrhythmia, atrial flutter

Frequency not reported: Irregular heart rate^[Ref]

Nervous system

Common (1% to 10%): Vertigo, dizziness, headache, syncope, dysgeusia

Uncommon (0.1% to 1%): Coma, cerebrovascular accident, transient ischemic attack, myoclonus, hypoesthesia, paresthesia, gait disturbance

Frequency not reported: Unresponsive to stimuli^[Ref]

Respiratory

Common (1% to 10%): Nasopharyngitis, pneumonia, influenza, oropharyngeal pain, sinusitis, cough

Uncommon (0.1% to 1%): Pulmonary edema, asthma, dyspnea, epistaxis, pharyngitis

Frequency not reported: Upper respiratory tract infection, orthopnea, wheezing^[Ref]

Other

Common (1% to 10%): Viral infection, edema, peritonitis, chills, pyrexia, pain, fatigue, peripheral edema, malaise, chest pain, fungal infection, infection

Uncommon (0.1% to 1%): Laboratory test abnormal, decreased weight, ear disorder, condition aggravated, asthenia

Frequency not reported: Phosphorous increased, ear discomfort, chest discomfort, feeling abnormal, swelling^[Ref]

Hypersensitivity

Common (1% to 10%): Hypersensitivity

Postmarketing reports: Allergic reactions including rash, urticaria, and angioedema (including laryngeal edema)^[Ref]

Dermatologic

Common (1% to 10%): Rash, pruritus, skin ulcer, acne

Uncommon (0.1% to 1%): Urticaria, bullous dermatitis, alopecia, hirsutism, hyperhidrosis

Frequency not reported: Blister, night sweats, rash pruritic, skin burning sensation^[Ref]

Endocrine

Common (1% to 10%): Hypoparathyroidism

Uncommon (0.1% to 1%): Hyperparathyroidism^[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection, breast tenderness

Uncommon (0.1% to 1%): Vaginal infection, breast pain, erectile dysfunction^[Ref]

Musculoskeletal

Common (1% to 10%): Chills, arthralgia, arthritis, back pain, muscle spasms

Uncommon (0.1% to 1%): Joint stiffness, muscle twitching, myalgia^[Ref]

Renal

Common (1% to 10%): Renal failure chronic

Uncommon (0.1% to 1%): Blood creatinine increased^[Ref]

Immunologic

Common (1% to 10%): Sepsis^[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression

Uncommon (0.1% to 1%): Confusional state, delirium, depersonalization, agitation, nervousness

Frequency not reported: Restlessness^[Ref]

Hematologic

Uncommon (0.1% to 1%): Bleeding time prolonged, anemia, leukopenia, lymphadenopathy^[Ref]

Hepatic

Uncommon (0.1% to 1%): Hepatic enzyme abnormal, increased aspartate aminotransferase

Frequency not reported: Alkaline phosphatase decreased^[Ref]

Ocular

Uncommon (0.1% to 1%): Conjunctivitis, glaucoma

Frequency not reported: Ocular hyperemia^[Ref]

Oncologic

Uncommon (0.1% to 1%): Breast cancer^[Ref]

Local

Uncommon (0.1% to 1%): Injection site pain

Frequency not reported: Injection site extravasation^[Ref]