Sporanox Side Effects
Generic name: itraconazole
Note: This document contains side effect information about itraconazole. Some of the dosage forms listed on this page may not apply to the brand name Sporanox.
Some side effects of Sporanox may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.
For the Consumer
Applies to itraconazole: oral capsule, oral solution, oral tablet
Along with its needed effects, itraconazole (the active ingredient contained in Sporanox) 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
- dry mouth
- 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
- shortness of breath
- unusual tiredness or weakness
- Abdominal or stomach cramps or pain
- blurred vision
- chest pain
- clay-colored stools
- cloudy urine
- cold sweats
- dark urine
- decrease in urine output or decrease in urine-concentrating ability
- difficult or labored breathing
- dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
- feeling unusually cold
- light-colored stools
- mental changes
- muscle cramps in the hands, arms, feet, legs, or face
- muscle spasms (tetany) or twitching
- noisy, rattling breathing
- numbness and tingling around the mouth or fingertips
- pounding in the ears
- slow, fast, or pounding heartbeat or pulse
- sore throat
- swelling of the fingers, hands, feet, or lower legs
- tightness in the chest
- 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:Less common
- Decreased interest in sexual intercourse
- difficulty having a bowel movement (stool)
- difficulty with moving
- feeling of constant movement of self or surroundings
- feeling sad or empty
- inability to have or keep an erection
- 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
- Acid or sour stomach
- change in taste
- hair loss or thinning of the hair
- 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: intravenous kit, oral capsule, oral solution, oral tablet
In general, pooled data involving 15,000 patients suggest that adverse effects occur in approximately 7% of patients treated with itraconazole (the active ingredient contained in Sporanox) for 4 weeks or less, and up to 18% in patients treated for more than one month. Most reported adverse effects are transient and considered mild to moderate in nature.
Gastrointestinal side effects have included nausea (up to 11%), diarrhea (up to 11%), vomiting (7%), abdominal pain or discomfort (up to 6%), dyspepsia (up to 4%), flatulence (up to 4%), gingivitis (3%), constipation (up to 3%), ulcerative stomatitis (up to 3%), gastritis (2%), increased appetite (2%), gastroenteritis (2%), dysphagia (less than 2%), hemorrhoids (less than 2%), dysgeusia (less than 2%), and anorexia (1%). Cholestasis has been reported. Abdominal pain, pancreatitis, vomiting, dyspepsia, nausea, diarrhea, constipation, and dysgeusia have also been reported during postmarketing experience.
Metabolic side effects have included hypertriglyceridemia (up to 11%), hypokalemia (up to 9%), increased alkaline phosphatase (up to 2%), hypomagnesemia (up to 2%), increased lactate dehydrogenase (up to 2%), hypophosphatemia (1% to 2%), hyperglycemia (less than 2%), dehydration (less than 2%), decreased weight (less than 2%), fluid overload (1%), and hypocalcemia (1%). Hypertriglyceridemia and hypokalemia have also been reported during postmarketing experience.
Nervous system side effects have included headache (up to 10%), dizziness (up to 4%), hypoacusis (3.3%), tremor (1% to 2%), insomnia (less than 2%), tinnitus (less than 2%), vertigo (1%), and somnolence (1%). An elderly patient experienced visual hallucinations, confusion, and weakness after receiving itraconazole (the active ingredient contained in Sporanox) The symptoms reappeared following accidental itraconazole doses 7 and 10 days later. Transient or permanent hearing loss, tinnitus, peripheral neuropathy, paresthesia, headache, dizziness, and hypoesthesia have been reported during postmarketing experience.
Respiratory side effects have included rhinitis (up to 9%), upper respiratory tract infection (up to 8%), sinusitis (up to 7%), coughing (up to 4%), pneumonia (2%), increased sputum (2%), dyspnea (up to 2%), pharyngitis (up to 2%), pulmonary infiltration (1% to 2%), and pharyngolaryngeal pain (1%). Pulmonary edema and dyspnea have been reported during postmarketing experience.
Other side effects have included fever (up to 7%), injury (up to 7%), edema (up to 4%), chest pain (3%), fatigue (up to 3%), malaise (up to 3%), pain (up to 3%), asthenia (up to 2%), rigors (less than 2%), back pain (less than 2%), hot flushes (less than 2%), and implantation complication (less than 2%). Peripheral edema and pyrexia have been reported during postmarketing experience.
Dermatologic side effects have included rash (up to 9%), pruritus (up to 5%), increased sweating (up to 3%), unspecified skin disorder (2.3%), and erythematous rash (1% to 2%). Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, exfoliative dermatitis, leukocytoclastic vasculitis, erythema multiforme, photosensitivity, rash, urticaria, pruritus, and alopecia have been reported during postmarketing experience.
Hepatic side effects have included bilirubinemia (up to 6%), abnormal liver function (up to 3%), increased SGPT/ALT (up to 3%), jaundice (up to 2%), increased SGOT/AST (up to 2%), increased gamma-glutamyltransferase (1% to 2%), and hepatitis (less than 2%). Mild, transient elevations in liver function tests have occurred in 1% to 7% of patients receiving continuous therapy. Rare cases of serious hepatotoxicity (including liver failure and death) and rare cases of reversible hepatitis (4 to 6 weeks after initiating itraconazole (the active ingredient contained in Sporanox) therapy) have been reported. Isolated cases of cholestatic jaundice have also been reported. Serious hepatotoxicity (including some cases of fatal acute liver failure), hepatitis, and reversible increases in hepatic enzymes have also been reported during postmarketing experience.
Hypersensitivity side effects have included rash and pruritus in up to 5% of treated patients (may be more likely in immunocompromised patients). Anaphylaxis; anaphylactic, anaphylactoid, and allergic reactions; serum sickness; and angioneurotic edema have been reported during postmarketing experience. At least one case of anaphylactic shock following long-term intravenous therapy has been reported.
Cardiovascular side effects have included hypertension (up to 3.2%), vein disorder (3%), abnormal electrocardiogram (1.4%), hypotension (1%), orthostatic hypotension (1%), vasculitis (1%), sinus bradycardia (1%), and tachycardia (up to 1%). Premature ventricular contractions have been reported. Congestive heart failure has been reported during postmarketing experience.
Local side effects associated with the intravenous formulation have included application site reaction (4%).
Renal side effects have included increased serum creatinine (up to 3%), abnormal renal function (1%), and increased blood urea nitrogen (up to 1%).
Psychiatric side effects have included depression (up to 3%), anxiety (3%), abnormal dreaming (2%), and decreased libido (up to 2%).
Genitourinary side effects have included cystitis (3%), urinary tract infection (up to 3%), albuminuria (less than 2%), hematuria (less than 2%), gynecomastia (less than 2%), male breast pain (less than 2%), bacteriuria (1.4%), impotence (1%), and menstrual disorders (infrequent). Urinary incontinence, pollakiuria, menstrual disorders, and erectile dysfunction have been reported during postmarketing experience.
Musculoskeletal side effects have included myalgia (up to 3%), bursitis (3%), and back pain (1.2%). Arthralgia and myalgia have been reported during postmarketing experience.
Hematologic side effects have included neutropenia, leukopenia, and thrombocytopenia during postmarketing experience.
Immunologic side effects have included Pneumocystis carinii infection (2%), herpes zoster (2%), and unspecified infection (less than 2%).
Endocrine side effects have included adrenal insufficiency (less than 2%).
Ocular side effects have included abnormal vision (less than 2%). Visual disturbances (including blurred vision and diplopia) have been reported during postmarketing experience.
More Sporanox resources
- Sporanox Monograph (AHFS DI)
- Sporanox Prescribing Information (FDA)
- Sporanox Consumer Overview
- Sporanox Advanced Consumer (Micromedex) - Includes Dosage Information
- Sporanox MedFacts Consumer Leaflet (Wolters Kluwer)
- Itraconazole Prescribing Information (FDA)
- Itraconazole Professional Patient Advice (Wolters Kluwer)
- Onmel MedFacts Consumer Leaflet (Wolters Kluwer)
- Onmel Prescribing Information (FDA)
- Sporanox PulsePak MedFacts Consumer Leaflet (Wolters Kluwer)
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