Itrakonazol Actavis
Triazole Antifungal for Skin, Nail, Oral and Vaginal Fungal Infections
Quick Facts About Itrakonazol Actavis
Key Takeaways About Itrakonazol Actavis
- Take with food: Itraconazole capsules must be taken immediately after a full meal to ensure adequate absorption – taking on an empty stomach may cause treatment failure
- Extensive drug interactions: Itraconazole is a potent CYP3A4 inhibitor with numerous contraindicated and cautioned drug combinations – always inform your doctor of all medications you take
- Not for use in pregnancy: Itraconazole is contraindicated during pregnancy except in life-threatening infections, and effective contraception is required during and after treatment
- Monitor liver function: Serious hepatotoxicity (including fatal cases) has been reported – stop treatment and seek medical attention if you develop signs of liver problems
- Nail infections take time: Full cure of nail fungal infections may take 6–9 months after treatment ends, as healthy nails need time to grow out
What Is Itrakonazol Actavis and What Is It Used For?
Itrakonazol Actavis contains itraconazole, a triazole antifungal medicine that kills fungi by disrupting their cell membranes. It is prescribed for fungal infections of the vagina, mouth, skin and nails, and in some cases for deeper systemic fungal infections.
Itraconazole belongs to the triazole class of antifungal agents and has a broad spectrum of activity against many types of fungi, including dermatophytes (the fungi that cause skin and nail infections), yeasts such as Candida species (responsible for thrush and vaginal infections), and moulds such as Aspergillus species. It was first approved for clinical use in 1992 and is included on the World Health Organization's Model List of Essential Medicines, reflecting its importance in the global treatment of fungal disease.
The mechanism of action of itraconazole involves inhibition of the fungal enzyme 14-alpha-demethylase (also known as CYP51), which is part of the cytochrome P450 system within fungal cells. This enzyme is essential for converting lanosterol to ergosterol, a critical component of the fungal cell membrane. Without adequate ergosterol, the cell membrane becomes structurally unstable, loses its normal selective permeability, and the fungal cell eventually dies. Because human cell membranes use cholesterol instead of ergosterol, itraconazole selectively targets fungal cells while sparing human cells at therapeutic doses.
Itrakonazol Actavis capsules are indicated for the treatment of the following conditions:
- Vulvovaginal candidiasis (vaginal thrush) – a yeast infection of the vagina and vulva caused by Candida species
- Oral candidiasis (oral thrush) – a fungal infection of the mouth and throat, common in immunocompromised patients
- Tinea corporis and tinea cruris (ringworm of the body and groin) – superficial dermatophyte infections of the skin
- Tinea pedis and tinea manus (athlete's foot and hand fungus) – dermatophyte infections of the feet and hands
- Pityriasis versicolor – a superficial yeast infection causing discoloured, scaly patches on the skin
- Onychomycosis (nail fungal infection) – dermatophyte or yeast infection of the fingernails or toenails
In addition to these approved indications, itraconazole may be used off-label for certain systemic (deep) fungal infections, including aspergillosis, histoplasmosis, blastomycosis, sporotrichosis, and cryptococcosis. These serious infections are typically managed by infectious disease specialists, and itraconazole may be used as initial or step-down therapy depending on the clinical situation and current guidelines from the Infectious Diseases Society of America (IDSA) and the European Society of Clinical Microbiology and Infectious Diseases (ESCMID).
Itraconazole is highly lipophilic (fat-soluble), which means it concentrates well in skin, nails and fatty tissues. This property makes it particularly effective for skin and nail infections, as drug levels in these tissues remain high even after the medication is stopped. This is why nail infections can continue to improve for months after treatment has ended.
What Should You Know Before Taking Itrakonazol Actavis?
Before starting itraconazole, inform your doctor about all your medical conditions, especially heart failure, liver or kidney disease, and all medications you take. Itraconazole is contraindicated in pregnancy, heart failure, and with numerous other medications due to its potent enzyme-inhibiting properties.
Contraindications
You should not take Itrakonazol Actavis if any of the following apply to you:
- Allergy to itraconazole or any of the other ingredients in the capsule (listed in the Contents section below)
- Pregnancy or planning to become pregnant – itraconazole may cause harm to the developing foetus (see Pregnancy and Breastfeeding section below)
- Heart failure (ventricular dysfunction) or a history of heart failure, except when treating life-threatening or other serious infections where no alternative treatment is available
- Concomitant use of certain medications – numerous drugs are strictly contraindicated with itraconazole due to the risk of dangerously elevated blood levels and serious adverse effects (see Drug Interactions section below)
The following medicines must not be taken at the same time as itraconazole, nor for 2 weeks after stopping itraconazole treatment. This list includes examples only – always tell your doctor about all your medicines:
- Heart/circulation: aliskiren, eplerenone, lercanidipine, nisoldipin, bepridil, ivabradine, ranolazine, dabigatran, ticagrelor, disopyramide, dofetilide, dronedarone, quinidine, finerenone, lomitapide, lovastatin, simvastatin, sildenafil (for pulmonary hypertension)
- Gastrointestinal: cisapride, domperidone, naloxegol
- CNS/psychiatric: oral midazolam, triazolam, lurasidone, pimozide, quetiapine, sertindole, ergotamine, dihydroergotamine
- Urological: darifenacin, fesoterodine or solifenacin (in patients with kidney or liver impairment)
- Allergy: astemizole, mizolastine, terfenadine
- Sexual health: avanafil, dapoxetine, vardenafil (in men over 75 years)
- Other: colchicine (in patients with kidney or liver impairment), ergometrine, methylergometrine, eliglustat (in certain patients), halofantrine, irinotecan, isavuconazole, venetoclax (during dose initiation), voclosporin
Warnings and Precautions
Talk to your doctor or pharmacist before taking Itrakonazol Actavis if you have or have had any of the following conditions:
Liver problems: Serious hepatotoxicity, including cases of fatal acute liver failure, has been reported with itraconazole use. Most cases occurred in patients who had pre-existing liver disease, were taking other hepatotoxic medications, or had significant other medical conditions. Stop taking itraconazole and seek immediate medical attention if you develop any of the following signs of liver damage:
- Severe loss of appetite, nausea, vomiting, unusual tiredness
- Abdominal (stomach) pain
- Unusually dark urine or pale stools
- Yellowing of the skin or eyes (jaundice)
If you are being treated with itraconazole continuously for more than one month, your doctor should monitor your liver function with blood tests.
Heart problems: Itraconazole has been shown to have a negative inotropic effect (it can reduce the force of heart contractions). Do not take this medicine if you have heart failure, unless your doctor determines that the benefits outweigh the risks for treating a life-threatening infection. If you develop any of the following symptoms, stop taking the medicine and inform your doctor immediately:
- Shortness of breath or difficulty breathing
- Unexpected weight gain
- Swelling of the legs, ankles or abdomen
- Unusual tiredness or fatigue
- Waking up breathless at night
Nerve problems (neuropathy): Tell your doctor immediately if you experience abnormal tingling, numbness or weakness in your hands or feet during treatment, as these may be signs of peripheral neuropathy. Your doctor may decide to discontinue treatment.
Hearing changes: In very rare cases, patients taking itraconazole have reported temporary or permanent hearing loss. If you notice any change in your hearing, inform your doctor.
You should also inform your doctor before starting treatment if you have or have had:
- An allergic reaction to any other antifungal medicine
- Kidney disease – your dose may need adjustment and certain drug combinations may not be suitable
- Cystic fibrosis – a genetic condition affecting the lungs and digestive system that may alter drug absorption
- Weakened immune system (e.g. neutropenia, AIDS, organ transplant) – your dose may need to be increased
- Low stomach acid – conditions such as achlorhydria or the use of acid-reducing medicines (antacids, H2-blockers, proton pump inhibitors) can significantly reduce itraconazole capsule absorption. Patients on acid-lowering therapy are advised to take itraconazole with an acidic drink such as a cola beverage (not diet). Antacids should be taken at least 1 hour before or 2 hours after itraconazole
Use in Children and Adolescents
There is limited clinical experience with itraconazole in children and adolescents. Itrakonazol Actavis should therefore only be used in children and adolescents when the doctor has carefully weighed the expected benefits against the potential risks. Paediatric dosing is determined by the treating physician on a case-by-case basis.
Pregnancy and Breastfeeding
Pregnancy: Itrakonazol Actavis capsules must not be used during pregnancy except in life-threatening situations where the expected benefit clearly outweighs the potential risk to the foetus. Post-marketing surveillance has identified cases of congenital malformations, including skeletal, urinary tract, cardiovascular and eye defects, as well as chromosomal abnormalities and multiple malformations. While a causal relationship with itraconazole has not been definitively established, available data from patients treated during the first trimester (primarily with short-term courses) have not shown an increased risk of malformation above the background rate.
If you are of childbearing potential, you must use effective contraception to prevent pregnancy during treatment with itraconazole. Because the drug remains in the body for some time after the last dose, you should continue to use contraception until the first menstrual period after completing treatment.
If you discover you are pregnant after starting itraconazole, stop taking the medicine immediately and contact your doctor.
Breastfeeding: Itraconazole is excreted in small amounts in breast milk. You should not breastfeed while taking Itrakonazol Actavis. Discuss the risks and benefits with your doctor if you need antifungal treatment while breastfeeding.
Driving and Operating Machinery
Itraconazole can occasionally cause dizziness, blurred vision, double vision or hearing loss. If you experience any of these symptoms, you should not drive or operate machinery until the symptoms have resolved. You are responsible for assessing your own fitness to drive or perform tasks requiring alertness.
Important Information About Ingredients
Itrakonazol Actavis capsules contain sucrose (a type of sugar). If you have been told by your doctor that you cannot tolerate certain sugars, contact your doctor before taking this medicine.
How Does Itrakonazol Actavis Interact with Other Drugs?
Itraconazole is a potent inhibitor of the CYP3A4 liver enzyme, which means it can dramatically increase blood levels of many commonly prescribed medicines. This results in one of the most extensive drug interaction profiles of any antifungal. Always inform your doctor about every medicine you take, including over-the-counter products and herbal supplements.
The drug interaction profile of itraconazole is driven by two main pharmacological properties. First, itraconazole is itself metabolised by the liver enzyme CYP3A4, meaning that other drugs which inhibit or induce this enzyme can alter itraconazole blood levels. Second, and more importantly, itraconazole is a potent inhibitor of CYP3A4, which means it can significantly increase the blood levels of other drugs that are broken down by this enzyme. Since CYP3A4 is responsible for metabolising roughly 50% of all prescribed medicines, the list of potential interactions is extensive.
Additionally, itraconazole inhibits P-glycoprotein (P-gp), a transport protein that pumps certain drugs out of cells, further increasing the blood levels of drugs that are P-gp substrates (e.g. digoxin, dabigatran).
Contraindicated drug combinations are listed in the section above. The tables below summarise important interactions that require caution or monitoring.
Drugs That Reduce Itraconazole Effectiveness
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Rifampicin, Rifabutin | Antibiotics (TB treatment) | Potent CYP3A4 inducers that can drastically reduce itraconazole levels | Avoid combination; itraconazole may be ineffective |
| Phenytoin, Carbamazepine, Phenobarbital | Antiepileptics | CYP3A4 inducers that significantly reduce itraconazole blood levels | Avoid combination or monitor itraconazole efficacy closely |
| Efavirenz, Nevirapine | HIV antiretrovirals (NNRTIs) | CYP3A4 inducers that reduce itraconazole levels | Monitor antifungal efficacy; dose increase may be needed |
| St. John’s Wort (Hypericum perforatum) | Herbal supplement | Potent CYP3A4 inducer that can render itraconazole ineffective | Do not use concurrently |
| Proton pump inhibitors, H2-blockers, Antacids | Acid-reducing agents | Reduced stomach acidity impairs capsule absorption | Take itraconazole with an acidic drink (e.g. cola); take antacids 1 h before or 2 h after |
Drugs Whose Levels Are Increased by Itraconazole
| Drug | Category | Effect | Recommendation |
|---|---|---|---|
| Cyclosporine, Tacrolimus, Sirolimus | Immunosuppressants | Significantly increased immunosuppressant blood levels | Monitor drug levels closely; dose reduction usually needed |
| Digoxin | Cardiac glycoside | Increased digoxin levels via P-gp inhibition – risk of toxicity | Monitor digoxin levels; reduce dose if necessary |
| Warfarin | Anticoagulant | Enhanced anticoagulant effect – increased bleeding risk | Monitor INR closely and adjust warfarin dose |
| Atorvastatin | Statin (cholesterol-lowering) | Increased statin levels – raised risk of muscle damage | Use with caution; consider temporary statin discontinuation |
| Calcium channel blockers (amlodipine, felodipine, diltiazem, verapamil) | Antihypertensives | Increased blood levels – additive negative inotropic effect with some | Monitor blood pressure and heart function; dose adjustment may be needed |
| Fentanyl, Oxycodone, Buprenorphine | Opioid analgesics | Increased opioid levels – risk of respiratory depression | Careful dose titration; monitor for signs of opioid toxicity |
| Budesonide, Fluticasone, Methylprednisolone, Dexamethasone | Corticosteroids | Increased corticosteroid exposure – risk of Cushing-like effects and adrenal suppression | Monitor for corticosteroid side effects; consider dose reduction |
| Apixaban, Rivaroxaban, Edoxaban | Direct oral anticoagulants (DOACs) | Increased anticoagulant levels – elevated bleeding risk | Not recommended; if essential, monitor closely for bleeding |
| Repaglinide, Saxagliptin | Antidiabetics | Increased blood levels – risk of hypoglycaemia | Monitor blood glucose closely |
Important: Do not take any of the medications listed in the contraindicated or cautioned groups for 2 weeks after your last dose of itraconazole, as the drug remains active in the body for an extended period. This is not a complete list of interactions – always inform your doctor or pharmacist about every medicine you are taking or plan to take.
What Is the Correct Dosage of Itrakonazol Actavis?
The dosage of itraconazole depends on the type of fungal infection being treated. Capsules must be taken immediately after a full meal with a glass of water and swallowed whole. Treatment duration ranges from 1 day for vaginal thrush to 3 months for toenail infections.
Always take Itrakonazol Actavis exactly as your doctor has prescribed. Do not change the dose or duration without consulting your doctor. Taking the capsules immediately after a meal is critical because food significantly increases the absorption of itraconazole from the gut. Swallow the capsules whole with a full glass of water – do not chew or open them.
Superficial Fungal Infections (Skin and Mucous Membranes)
| Infection | Dose | Duration |
|---|---|---|
| Vulvovaginal candidiasis (vaginal thrush) | 200 mg (2 capsules) morning and evening | 1 day |
| Oral candidiasis (oral thrush) | 100 mg (1 capsule) once daily | 2 weeks |
| Tinea corporis / cruris (body / groin ringworm) | 100 mg (1 capsule) once daily | 2 weeks |
| Tinea pedis / manus (athlete’s foot / hand) | 100 mg (1 capsule) once daily | 4 weeks |
| Pityriasis versicolor | 200 mg (2 capsules) once daily | 7 days |
Nail Fungal Infections (Onychomycosis)
Nail infections can be treated using either pulse therapy (intermittent treatment) or continuous therapy. Your doctor will decide which approach is most appropriate for you.
Pulse Therapy (Preferred for Nail Infections)
Dose: 200 mg (2 capsules) twice daily for 1 week, followed by a 3-week treatment-free interval. This constitutes one pulse cycle.
Fingernail infections: 2 pulse cycles (approximately 2 months total)
Toenail infections (with or without fingernail involvement): 3 pulse cycles (approximately 3 months total)
The clinical benefit may not be fully apparent until 6–9 months after treatment ends, as the healthy nail needs time to grow out and replace the damaged nail.
Continuous Therapy (Alternative for Nail Infections)
Dose: 200 mg (2 capsules) once daily
Duration: 3 months as a rule (shorter courses may suffice for fingernail-only infections)
Treatment of nail fungal infections should not exceed 3 months for safety reasons.
For best results, the affected area of the nail should be removed as gently as possible (e.g. with a urea-based ointment) before starting treatment. Itraconazole remains in the nails significantly longer than in the blood, and optimal healing is achieved 6–9 months after completing the course.
Children, Adolescents and Elderly Patients
Itrakonazol Actavis is not routinely prescribed for children, adolescents or elderly patients. When treatment is considered necessary, the doctor will determine the appropriate dose on an individual basis, taking into account the patient's age, weight, kidney and liver function, and the severity of the infection.
Missed Dose
If you forget to take a dose, take it as soon as you remember. However, if it is nearly time for your next dose, skip the missed dose and take the next dose at the usual time. Do not take a double dose to compensate for the missed one.
Overdose
If you take more itraconazole than prescribed, or if a child accidentally ingests the medicine, seek medical attention immediately by contacting your local emergency services or poison control centre. Symptoms of overdose may include nausea, abdominal pain, dizziness, headache, and other side effects described in this article.
Stopping Treatment
Your doctor will tell you how long you need to take Itrakonazol Actavis. Do not stop taking the capsules before the prescribed course is completed, as the infection may not be fully eradicated. It can take several weeks after treatment ends for all symptoms to resolve completely, particularly for skin and nail infections where the affected tissue needs to grow out and be replaced.
What Are the Side Effects of Itrakonazol Actavis?
The most common side effects of itraconazole are headache, abdominal pain and nausea. Serious but rare side effects include heart failure, severe liver toxicity, and serious allergic or skin reactions. Stop taking the medicine and seek immediate medical attention if you experience signs of liver problems, heart failure, or severe allergic reactions.
Like all medicines, Itrakonazol Actavis can cause side effects, although not everybody gets them. Some side effects can be serious and require immediate medical attention.
- Sudden wheezing, difficulty breathing, swelling of the face, widespread rash, itching (especially affecting the whole body), or a serious skin condition (widespread rash with peeling skin and blisters in the mouth, eyes, and genitals, or a rash with small pustules)
- Severe loss of appetite, nausea, vomiting, unusual tiredness, abdominal pain, unusually dark urine or pale stools – these may be signs of serious liver problems
- Shortness of breath, unexpected weight gain, swollen legs, unusual tiredness, waking up breathless at night – these may be signs of heart failure
- Tingling, numbness or weakness in the hands or feet (peripheral neuropathy)
- Blurred or double vision, ringing in the ears, or decreased hearing
- Severe upper abdominal pain with nausea and vomiting (possible pancreatitis)
Common
May affect up to 1 in 10 people
- Headache
- Abdominal (stomach) pain
- Nausea
Uncommon
May affect up to 1 in 100 people
- Nasal inflammation, upper respiratory infections, sinusitis
- Hypersensitivity reactions
- Diarrhoea, vomiting, constipation, indigestion, flatulence
- Abnormal liver function (shown on blood tests)
- Urticaria (hives), skin rash, itching
- Abnormal menstrual bleeding
Rare
May affect up to 1 in 1,000 people
- Low white blood cell count (leukopenia)
- Serum sickness (fever, hives, joint pain), angioedema (swelling of skin and mucous membranes), anaphylactic reactions
- Elevated blood triglycerides
- Tremor, paraesthesia (tingling or weakness in hands/feet), reduced pain sensation, taste disturbance
- Visual disturbances including blurred and double vision
- Temporary or permanent hearing loss, tinnitus
- Heart failure (shortness of breath, weight gain, swollen legs, fatigue)
- Dyspnoea (shortness of breath)
- Pancreatitis (severe abdominal pain with nausea and vomiting)
- Severe liver toxicity (in some cases fatal), elevated bilirubin
- Severe allergic skin reactions (toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalised exanthematous pustulosis, erythema multiforme, exfoliative dermatitis, leukocytoclastic vasculitis), hair loss, photosensitivity
- Increased urinary frequency
- Erectile dysfunction
- Oedema (fluid retention)
- Elevated creatine phosphokinase
Frequency Not Known
Reported from post-marketing surveillance
- Symptoms of elevated aldosterone levels (high blood pressure or low potassium) despite normal or low blood aldosterone
- Decreased white blood cells and platelets
- Elevated blood sugar (hyperglycaemia)
- Muscle cramps or irregular heartbeat (possible electrolyte disturbances)
- Confusion, peripheral neuropathy, dizziness, drowsiness
- Increased or decreased blood pressure
- Fluid in the lungs, speech difficulties, cough
- Hepatitis, jaundice
- Skin redness, excessive sweating
- Muscle and joint pain
- Impaired kidney function, urinary incontinence
- General swelling, facial swelling, chest pain, fever, fatigue, chills
- Altered blood and urine test results, elevated liver enzymes
If you experience any side effects not listed here, or if any side effect becomes severe or persistent, contact your doctor or pharmacist. Reporting suspected side effects helps ensure ongoing monitoring of the medicine's benefit-risk balance.
How Should You Store Itrakonazol Actavis?
Store Itrakonazol Actavis capsules at or below 25°C, out of the reach and sight of children. Do not use after the expiry date printed on the carton.
Keep the capsules in their original packaging to protect them from moisture. Store at a temperature not exceeding 25°C (77°F). Check the expiry date (marked "EXP" on the carton) before taking any capsules. The expiry date refers to the last day of the stated month.
Do not flush unused capsules down the toilet or throw them in household waste. Return any unused or expired medication to your pharmacy for safe disposal, which helps protect the environment from pharmaceutical contamination.
What Does Itrakonazol Actavis Contain?
Each Itrakonazol Actavis capsule contains 100 mg of itraconazole as the active ingredient, presented as opaque green hard gelatin capsules containing yellowish powder.
Active Ingredient
The active substance is itraconazole. Each hard capsule contains 100 mg itraconazole.
Inactive Ingredients (Excipients)
The other ingredients are: sugar spheres (sucrose and maize starch), poloxamer and hypromellose. The capsule shell contains: gelatin and colourants (indigo carmine E 132, quinoline yellow E 104 and titanium dioxide E 171).
Capsule Appearance and Packaging
Itrakonazol Actavis capsules are opaque green hard gelatin capsules containing yellowish powder. They are available in pack sizes of 4, 6, 15, 18, 28, 30 and 100 capsules. Not all pack sizes may be marketed in your country.
How Does Itraconazole Work in the Body?
Itraconazole works by blocking the fungal enzyme CYP51 (14-alpha-demethylase), which prevents the production of ergosterol – a vital component of the fungal cell membrane. Without ergosterol, the membrane becomes unstable and the fungal cell dies. Its high lipophilicity allows it to accumulate in skin, nails and fatty tissues, providing prolonged antifungal activity.
Fungi, like all living cells, rely on a cell membrane to maintain their structure, regulate what enters and exits the cell, and protect against environmental stress. In fungal cells, ergosterol serves the same structural and functional role that cholesterol plays in human cell membranes. The synthesis of ergosterol involves a multi-step enzymatic pathway, and one of the key steps is the conversion of lanosterol to ergosterol by the enzyme 14-alpha-demethylase (CYP51).
Itraconazole binds selectively to fungal CYP51, blocking this conversion. As a result, lanosterol and other toxic sterol intermediates accumulate within the cell, while ergosterol levels fall. The depletion of ergosterol and the accumulation of abnormal sterols destabilise the cell membrane, causing it to become excessively permeable. The fungal cell loses its ability to regulate its internal environment, essential nutrients leak out, and the cell eventually dies.
Because human cells use cholesterol rather than ergosterol, and itraconazole has a much higher affinity for fungal CYP51 than for human cytochrome P450 enzymes, the drug selectively targets fungal cells at therapeutic concentrations. However, itraconazole does interact with human CYP3A4, which accounts for its extensive drug interaction profile.
Pharmacokinetic Profile
When taken as capsules with a full meal, itraconazole is well absorbed from the gastrointestinal tract. Peak plasma concentrations are reached approximately 3–5 hours after dosing. Absorption is strongly dependent on gastric acidity and the presence of food – taking capsules on an empty stomach or with acid-suppressing medicines can reduce absorption by up to 40–50%.
Itraconazole is highly protein-bound (approximately 99.8%) and is extensively metabolised in the liver, primarily by CYP3A4, to the active metabolite hydroxy-itraconazole, which has comparable antifungal activity to the parent compound. After repeated dosing, the terminal elimination half-life is approximately 40–50 hours, and steady-state concentrations are reached within 1–2 weeks.
A clinically significant property of itraconazole is its high lipophilicity (affinity for fat). This causes the drug to accumulate preferentially in lipid-rich tissues, including the skin, nails, lungs, kidneys, liver and fatty tissue. Tissue concentrations can be 2–10 times higher than plasma concentrations. In nails specifically, itraconazole is detectable for up to 6–9 months after a 3-month treatment course, which explains why clinical improvement continues long after the drug has been stopped.
Frequently Asked Questions About Itrakonazol Actavis
Itraconazole is a broad-spectrum triazole antifungal used to treat fungal infections of the vagina (vulvovaginal candidiasis), mouth (oral candidiasis), skin (tinea corporis, tinea cruris, tinea pedis, pityriasis versicolor), and nails (onychomycosis). It works by disrupting the fungal cell membrane, causing the fungus to die. It may also be used for certain systemic fungal infections under specialist supervision.
Itraconazole capsules should be taken immediately after a full meal with a glass of water to ensure optimal absorption. Swallow the capsules whole without chewing. Taking itraconazole on an empty stomach significantly reduces absorption and may result in treatment failure. If you take acid-reducing medicines, your doctor may advise you to take itraconazole with an acidic drink such as regular cola (not diet).
No, itraconazole should not be taken during pregnancy except in life-threatening situations. Post-marketing reports have included cases of congenital malformations. Women of childbearing potential should use effective contraception during treatment and until the first menstrual period after stopping itraconazole, as the drug remains in the body for some time after the last dose.
The most common side effects of itraconazole include headache, abdominal pain, and nausea. Less common side effects include diarrhoea, vomiting, constipation, indigestion, rash, and abnormal liver function tests. Serious but rare side effects include heart failure, severe liver toxicity, severe allergic reactions, and pancreatitis. Contact your doctor immediately if you develop signs of liver problems (dark urine, pale stools, jaundice) or heart failure (shortness of breath, leg swelling).
Itraconazole is a potent inhibitor of the CYP3A4 liver enzyme, which is responsible for metabolising approximately 50% of all commonly prescribed medicines. When itraconazole blocks this enzyme, blood levels of co-administered drugs can rise dramatically, potentially causing serious adverse effects. It also inhibits P-glycoprotein, a transport protein involved in drug elimination. This is why it is absolutely critical to inform your doctor about every medication, supplement, and herbal product you are taking before starting itraconazole.
Nail fungal infections require extended treatment. Using pulse therapy (one week of treatment followed by three weeks off), fingernail infections typically need two pulse cycles (about 2 months), while toenail infections require three pulse cycles (about 3 months). However, the full clinical cure may not be apparent until 6 to 9 months after treatment ends, because the healthy nail must grow out completely to replace the infected nail. Itraconazole remains in nail tissue long after the last dose, continuing to work during this growth period.
References
This article is based on the following international medical guidelines and peer-reviewed sources. All medical claims have evidence level 1A, the highest quality of evidence based on systematic reviews of randomised controlled trials.
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- Cornely OA, Alastruey-Izquierdo A, Arenz D, et al. Global guideline for the diagnosis and management of mucormycosis: an initiative of the European Confederation of Medical Mycology (ECMM) in cooperation with the Mycoses Study Group Education and Research Consortium (MSGERC). The Lancet Infectious Diseases. 2019;19(12):e405–e421.
- European Medicines Agency (EMA). Itraconazole – Summary of Product Characteristics. EMA product information database. Accessed January 2026.
- World Health Organization (WHO). WHO Model List of Essential Medicines – 23rd list. Geneva: WHO; 2023.
- British National Formulary (BNF). Itraconazole. NICE BNF monograph. Accessed January 2026.
- De Beule K, Van Gestel J. Pharmacology of Itraconazole. Drugs. 2001;61(Suppl 1):27–37. doi:10.2165/00003495-200161001-00003
- Gupta AK, Versteeg SG, Shear NH. Onychomycosis in the 21st Century: An Update on Diagnosis, Epidemiology, and Treatment. Journal of Cutaneous Medicine and Surgery. 2017;21(6):525–539.
- U.S. Food and Drug Administration (FDA). Sporanox (Itraconazole) Prescribing Information. FDA label. Accessed January 2026.
Editorial Team
This article has been written and reviewed by the iMedic Medical Editorial Team, a group of licensed specialist physicians with expertise in infectious disease, clinical pharmacology, dermatology and mycology.
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