In Summary

Commonly reported side effects of itraconazole include: nausea. Other side effects include: vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to itraconazole: oral capsule, oral solution, oral tablet

Along with its needed effects, itraconazole 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 itraconazole:

More common

• Decreased urine output
• dry mouth
• fever
• increased thirst
• irregular heartbeat
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea
• numbness or tingling in the hands, feet, or lips
• seizures
• trouble breathing
• unusual tiredness or weakness
• vomiting

Less common

• Blurred vision
• chest pain
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• confusion
• cough
• dark urine
• decrease in urine-concentrating ability
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• feeling unusually cold
• headache
• itching or rash
• light-colored stools
• mental changes
• muscle cramps in the hands, arms, feet, legs, or face
• muscle spasms (tetany) or twitching
• nervousness
• noisy, rattling breathing
• numbness and tingling around the mouth or fingertips
• pounding in the ears
• shivering
• slow, fast, or pounding heartbeat or pulse
• sneezing
• sore throat
• stomach cramps or pain
• sweating
• swelling of the fingers, hands, feet, or lower legs
• tightness in the chest
• trembling
• troubled breathing at rest
• unpleasant breath odor
• vomiting of blood
• weight gain
• yellow eyes or skin

Rare

• Black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the urine or stools
• blue lips and fingernails
• burning, crawling, itching, numbness, painful, prickling, "pins and needles", or tingling feelings
• continuing ringing or buzzing or other unexplained noise in the ears
• coughing that sometimes produces a pink frothy sputum
• cracks in the skin
• decreased appetite
• difficulty with swallowing
• dilated neck veins
• disturbed color perception
• double vision
• extreme tiredness or weakness
• fast or irregular breathing
• feeling of discomfort
• general feeling of tiredness or weakness
• halos around lights
• hearing loss
• hives or welts
• inflammation of the joints
• joint pain
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of heat from the body
• loss of vision
• lower back or side pain
• night blindness
• overbright appearance of lights
• painful or difficult urination
• pale skin
• pinpoint red spots on the skin
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• rapid weight gain
• red skin lesions, often with a purple center
• red, irritated eyes
• red, swollen skin
• scaly skin
• sores, ulcers, or white spots on the lips or in the mouth
• stomach pain, continuing
• stomach tenderness
• swollen lymph glands
• tunnel vision
• unsteadiness or awkwardness
• unusual bleeding or bruising
• unusual weight gain or loss
• upper right abdominal or stomach pain
• weakness in the arms, hands, legs, or feet

Some side effects of itraconazole 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

• Decreased interest in sexual intercourse
• difficulty having a bowel movement
• difficulty with moving
• discouragement
• feeling of constant movement of self or surroundings
• feeling sad or empty
• inability to have or keep an erection
• indigestion
• irritability
• loss in sexual ability, desire, drive, or performance
• loss of interest or pleasure
• muscle aching or stiffness
• pain or tenderness around the eyes and cheekbones
• passing of gas
• sensation of spinning
• sleepiness or unusual drowsiness
• soreness of the skin
• stomach fullness or discomfort
• stuffy or runny nose
• swollen joints
• trouble concentrating
• trouble sleeping

Rare

• Belching
• change in taste
• hair loss or thinning of the hair
• heartburn
• increased need to urinate
• increased sensitivity of the eyes to sunlight
• increased sensitivity of the skin to sunlight
• loss of bladder control
• loss of taste
• menstrual changes
• passing urine more often
• redness or other discoloration of the skin
• severe sunburn

For Healthcare Professionals

Applies to itraconazole: compounding powder, intravenous kit, oral capsule, oral solution, oral tablet

General

In clinical trials, side effects were reported in about 7% to 9% of patients receiving short-term therapy and about 15% of patients receiving prolonged (about 1 month) continuous therapy.

Gastrointestinal

Pancreatitis, abdominal pain, vomiting, dyspepsia, nausea, diarrhea, and constipation have also been reported during postmarketing experience.

Very common (10% or more): Nausea (up to 11%), diarrhea (up to 11%)

Common (1% to 10%): Vomiting, abdominal pain or discomfort, dyspepsia, flatulence, gingivitis, constipation, ulcerative stomatitis, gastritis, gastroenteritis

Rare (less than 0.1%): Pancreatitis

Frequency not reported: Dysphagia, hemorrhoids, gastrointestinal disorder

Metabolic

Very common (10% or more): Hypertriglyceridemia (up to 11%)

Common (1% to 10%): Hypokalemia, increased blood alkaline phosphatase, hypomagnesemia, increased blood lactate dehydrogenase, hypophosphatemia, increased appetite

Uncommon (0.1% to 1%): Fluid overload, hypocalcemia, anorexia, hyperglycemia

Frequency not reported: Dehydration, decreased weight, hyperkalemia

Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.

Nervous system

Common (1% to 10%): Headache, dizziness, hypoacusis, tremor, dysgeusia

Uncommon (0.1% to 1%): Vertigo, somnolence, hypoesthesia, transient or permanent hearing loss, peripheral neuropathy

Rare (less than 0.1%): Paresthesia, tinnitus

Peripheral neuropathy, paresthesia, hypoesthesia, headache, dizziness, tinnitus, transient or permanent hearing loss, dysgeusia, and tremor have also been reported during postmarketing experience.

Respiratory

Common (1% to 10%): Rhinitis, upper respiratory tract infection, sinusitis, cough, pneumonia, increased sputum, dyspnea, pharyngitis, pulmonary infiltration

Uncommon (0.1% to 1%): Pulmonary edema, pharyngolaryngeal pain

Frequency not reported: Dysphonia

Pulmonary edema and dyspnea have also been reported during postmarketing experience.

Other

Edema and pyrexia have also been reported during postmarketing experience.

Common (1% to 10%): Pyrexia, injury, edema, chest pain, fatigue, malaise, pain, asthenia, Pneumocystis carinii infection, herpes zoster

Frequency not reported: Unspecified infection, rigors, back pain, hot flushes, implantation complication, face edema, chills, generalized edema

Postmarketing reports: Peripheral edema

Dermatologic

Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis, alopecia, photosensitivity, rash, pruritus, and urticaria have also been reported during postmarketing experience.

Common (1% to 10%): Rash, pruritus, hyperhidrosis, unspecified skin disorder, erythematous rash

Uncommon (0.1% to 1%): Urticaria

Rare (less than 0.1%): Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, alopecia

Hepatic

Common (1% to 10%): Increased hepatic enzymes (including reversible increases), bilirubinemia, abnormal liver function, increased ALT, jaundice, increased AST, increased GGT, hepatitis, hyperbilirubinemia

Rare (less than 0.1%): Serious hepatotoxicity (including some cases of fatal acute liver failure)

Frequency not reported: Cholestasis, cholestatic jaundice, hepatic failure

Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy.

Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.

Cardiovascular

Congestive heart failure has also been reported during postmarketing experience.

Common (1% to 10%): Hypertension, vein disorder, abnormal electrocardiogram

Uncommon (0.1% to 1%): Hypotension, orthostatic hypotension, vasculitis, sinus bradycardia, tachycardia

Rare (less than 0.1%): Congestive heart failure

Frequency not reported: Premature ventricular contractions, cardiac failure, left ventricular failure

Renal

Common (1% to 10%): Increased serum creatinine

Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea

Frequency not reported: Renal impairment

Psychiatric

Common (1% to 10%): Depression, anxiety, abnormal dreaming

Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state

An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole. The symptoms reappeared following accidental itraconazole doses 7 and 10 days later.

Genitourinary

Pollakiuria, menstrual disorders, and erectile dysfunction have also been reported during postmarketing experience.

Common (1% to 10%): Cystitis, urinary tract infection

Uncommon (0.1% to 1%): Impotence, menstrual disorders, abnormal urine analysis

Rare (less than 0.1%): Pollakiuria, erectile dysfunction

Frequency not reported: Albuminuria, hematuria, gynecomastia, male breast pain, bacteriuria

Postmarketing reports: Urinary incontinence

Musculoskeletal

Common (1% to 10%): Myalgia, bursitis, back pain

Rare (less than 0.1%): Increased blood creatine phosphokinase

Postmarketing reports: Arthralgia

Increased blood creatine phosphokinase and myalgia have also been reported during postmarketing experience.

Local

IV:

Common (1% to 10%): Application site reaction

Frequency not reported: Injection site inflammation

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity

Rare (less than 0.1%): Allergic reactions (e.g., pruritus, rash, urticaria, angioedema), serum sickness, angioneurotic edema, anaphylactic reaction

Frequency not reported: Anaphylactic shock

Postmarketing reports: Anaphylaxis, anaphylactoid reaction

At least 1 case of anaphylactic shock after long-term IV therapy has been reported.

Anaphylactic reactions, allergic reactions, serum sickness, and angioneurotic edema have also been reported during postmarketing experience.

Ocular

Visual disturbances (including blurred vision, diplopia) have also been reported during postmarketing experience.

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)

Frequency not reported: Abnormal vision

Hematologic

Rare (less than 0.1%): Leukopenia

Frequency not reported: Granulocytopenia

Postmarketing reports: Neutropenia, thrombocytopenia

Leukopenia has also been reported during postmarketing experience.

Endocrine

Frequency not reported: Adrenal insufficiency