Itraconazole Side Effects

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:

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

• Abdominal or stomach cramps or pain
• blurred vision
• chest pain
• chills
• clay-colored stools
• cloudy urine
• cold sweats
• confusion
• cough
• dark urine
• decrease in urine output or decrease in urine-concentrating ability
• diarrhea
• dizziness
• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
• 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
• 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

• Abdominal or stomach tenderness
• 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 fatigue
• 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
• swollen lymph glands
• tingling of the hands or feet
• 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:

• Decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• 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
• tiredness
• trouble concentrating
• trouble sleeping

• Acid or sour stomach
• 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
• stomach fullness, discomfort, or upset

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.^[Ref]

Gastrointestinal

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

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^[Ref]

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^[Ref]

Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.^[Ref]

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^[Ref]

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

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^[Ref]

Pulmonary edema and dyspnea have also been reported during postmarketing experience.^[Ref]

Other

Edema and pyrexia have also been reported during postmarketing experience.^[Ref]

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^[Ref]

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.^[Ref]

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^[Ref]

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^[Ref]

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.^[Ref]

Cardiovascular

Congestive heart failure has also been reported during postmarketing experience.^[Ref]

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^[Ref]

Renal

Common (1% to 10%): Increased serum creatinine
Uncommon (0.1% to 1%): Abnormal renal function, increased blood urea
Frequency not reported: Renal impairment^[Ref]

Psychiatric

Common (1% to 10%): Depression, anxiety, abnormal dreaming
Frequency not reported: Insomnia, decreased libido, visual hallucinations, confusional state^[Ref]

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

Genitourinary

Pollakiuria, menstrual disorders, and erectile dysfunction have also been reported during postmarketing experience.^[Ref]

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^[Ref]

Musculoskeletal

Common (1% to 10%): Myalgia, bursitis, back pain
Rare (less than 0.1%): Increased blood creatine phosphokinase
Postmarketing reports: Arthralgia^[Ref]

Increased blood creatine phosphokinase and myalgia have also been reported during postmarketing experience.^[Ref]

Local

IV:
Common (1% to 10%): Application site reaction
Frequency not reported: Injection site inflammation^[Ref]

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^[Ref]

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.^[Ref]

Ocular

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

Uncommon (0.1% to 1%): Visual disturbances (including blurred vision, diplopia)
Frequency not reported: Abnormal vision^[Ref]

Hematologic

Rare (less than 0.1%): Leukopenia
Frequency not reported: Granulocytopenia
Postmarketing reports: Neutropenia, thrombocytopenia^[Ref]

Leukopenia has also been reported during postmarketing experience.^[Ref]

Endocrine

Frequency not reported: Adrenal insufficiency^[Ref]

Some side effects of itraconazole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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