What the label lists and what reports show
Itraconazole side effects
Itraconazole's FDA label lists its adverse reactions in its own words. FAERS holds 11,610 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (589 reports).
- Generic listed
- A presentation discontinued
- Boxed warning
Check it at the source: the itraconazole FDA label on DailyMed (effective July 13, 2026, Janssen Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SPORANOX?SPORANOX may cause serious side effects, including: See " What is the most important information I should know about SPORANOX? " New or worsening high blood pressure and low potassium levels in your blood (pseudoaldosteronism). Your healthcare provider should check your blood pressure and potassium levels. Nerve problems (neuropathy). Call your healthcare provider right away if you have tingling or numbness in your hands or feet. Your healthcare provider may stop your treatment with SPORANOX if you have nerve problems. Hearing loss. Hearing loss can happen for a short time or permanently in some people who take SPORANOX. Stop taking SPORANOX and call your healthcare provider right away if you have any changes in your hearing. The most common side effects of SPORANOX include: headache, rash, digestive system problems (such as nausea and vomiting), and edema. […]
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. SPORANOX ® has been associated with rare cases of serious hepatotoxicity, including liver failure and death. Some of these cases had neither pre-existing liver disease nor a serious underlying medical condition. If clinical signs or symptoms develop that are consistent with liver disease, treatment should be discontinued and liver function testing performed. The risks and benefits of SPORANOX ® use should be reassessed. …
Table 3: Clinical Trials of Systemic Fungal Infections: Adverse Events Occurring with an Incidence of Greater than or Equal to 1%
| Body System/Adverse Event | Incidence (%) (N=602) Gastrointestinal |
|---|---|
| Nausea | 11 |
| Vomiting | 5 |
| Diarrhea | 3 |
| Abdominal Pain | 2 |
| Anorexia | 1 |
| Edema | 4 |
| Fatigue | 3 |
| Fever | 3 |
| Malaise | 1 |
| Rash Rash tends to occur more frequently in immunocompromised patients receiving… | 9 |
| Pruritus | 3 |
| Headache | 4 |
| Dizziness | 2 |
| Libido Decreased | 1 |
| Somnolence | 1 |
| Hypertension | 3 |
| Hypokalemia | 2 |
| Albuminuria | 1 |
| Hepatic Function Abnormal | 3 |
| Impotence | 1 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Janssen Pharmaceuticals, Inc., effective July 13, 2026 (SPL set a4d555fa-787c-40fb-bb7d-b0d4f7318fd0), via openFDA; the full label on DailyMed
What do FAERS reports show?
11,610 reports list itraconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,259 are coded as a death and 4,411 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 19 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Itraconazole: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions