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

• intravenous solution

Serious side effects of Doxercalciferol

Along with its needed effects, doxercalciferol 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 doxercalciferol:

More common

• Arm, back, or jaw pain
• black, tarry stools
• bladder pain
• chest pain, discomfort, tightness, or heaviness
• confusion
• cough or hoarseness
• decreased urination
• fast or irregular heartbeat
• fever or chills
• frequent urge to urinate
• increase in heart rate
• lightheadedness, dizziness, or fainting
• lower back or side pain
• nausea
• painful, burning, or difficult urination
• pale skin
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• sunken eyes
• sweating
• swollen glands
• thirst
• trouble breathing
• unusual bleeding or bruising
• unusual tiredness or weakness
• wrinkled skin

Incidence not known

• Blurred vision
• constipation
• cough
• depression
• difficulty swallowing
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• dry mouth
• heart stops
• hives, itching, skin rash
• incoherent speech
• increased urination
• large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• low bone turnover
• metallic taste
• muscle weakness
• no breathing
• no pulse or blood pressure
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• stomach pain
• thirst
• unconscious
• vomiting
• weight loss

Other side effects of Doxercalciferol

Some side effects of doxercalciferol 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:

More common

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• difficulty in moving
• excessive muscle tone
• heartburn
• indigestion
• muscle pain, stiffness, tension, or tightness
• pain in the joints
• pain or tenderness around the eyes and cheekbones
• stomach discomfort or upset
• stuffy or runny nose
• swelling
• trouble sleeping
• weight loss

For Healthcare Professionals

Applies to doxercalciferol: intravenous solution, oral capsule.

Metabolic

Very common (10% or more): Edema (34.4%)

Common (1% to 10%): Anorexia, weight increase, dehydration

Frequency not reported: Hypercalcemia, hyperphosphatemia, hypercalciuria^[Ref]

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

Prolonged hypercalcemia may result in polyuria, polydipsia, anorexia, weight loss, nocturia conjunctivitis (calcific), pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, elevated blood urea nitrogen (BUN), albuminuria, hypercholesterolemia, elevated serum aspartate transaminase (AST) and alanine transaminase (ALT), ectopic calcification, hypertension, cardiac arrhythmias, sensory disturbances, dehydration, apathy, arrested growth, urinary tract infections, and, rarely, overt psychosis.

Hyperphosphatemia may exacerbate hyperparathyroidism.

Hypercalciuria may accelerate the onset of renal failure.^[Ref]

Endocrine

Oversuppression of iPTH may result in adynamic bone syndrome.^[Ref]

Frequency not reported: Oversuppression of parathyroid hormone^[Ref]

Cardiovascular

Common (1% to 10%): Bradycardia, chest pain^[Ref]

Gastrointestinal

Very common (10% or more): Nausea/vomiting (21.3%)

Common (1% to 10%): Dyspepsia, constipation^[Ref]

Musculoskeletal

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

Nervous system

Very common (10% or more): Headache (27.9%), dizziness (11.5%)

Common (1% to 10%): Hypertonia, paresthesia^[Ref]

Dermatologic

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

Respiratory

Very common (10% or more): Dyspnea (11.5%)

Common (1% to 10%): Cough increased, rhinitis^[Ref]

Other

Very common (10% or more): Malaise (27.9%)

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

Psychiatric

Common (1% to 10%): Sleep disorder, depression

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

Immunologic

Common (1% to 10%): Infection

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions (including fatal outcome)

Hypersensitivity reactions include anaphylaxis with symptoms of angioedema (involving face, lips, tongue, and airway), hypotension, unresponsiveness, chest discomfort, shortness of breath, cardiopulmonary arrest, pruritus, and skin burning sensation. These reactions may occur separately or together.

Hematologic

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