What the label lists and what reports show
Fluconazole side effects
Fluconazole's FDA label: “The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%).” FAERS holds 69,671 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 (4,204 reports).
- Generic listed
Check it at the source: the fluconazole FDA label on DailyMed (effective April 7, 2026, Zydus Pharmaceuticals (USA) 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 fluconazole tablets?Fluconazole tablets may cause serious side effects including: serious liver problems. Some people with serious medical problems have developed serious liver problems that became life-threatening or caused death while taking fluconazole tablets. Sometimes these liver problems can be reversed when you stop taking fluconazole tablets. Tell your healthcare provider right away if you have symptoms of serious liver problems including: dark colored urine light-colored stools vomiting severe skin itching tiredness loss of appetite yellowing of the skin and eyes (jaundice) serious allergic reactions: Serious allergic reactions (anaphylaxis) have happened while taking fluconazole tablets. […]
Source: FDA drug label (Fluconazole), Aurobindo Pharma Limited, effective November 14, 2024 (SPL set 6ebf24fd-41cd-4b3c-8176-a1436253ba2d), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%).
PercentageofPatientsWithTreatment-RelatedSideEffects
| Reaction | Fluconazole (N=577) | Comparative Agents (N=451) |
|---|---|---|
| With any side effect | 13 | 9.3 |
| Vomiting | 5.4 | 5.1 |
| Abdominal pain | 2.8 | 1.6 |
| Nausea | 2.3 | 1.6 |
| Diarrhea | 2.1 | 2.2 |
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.
From the label: adverse reactions, continuedFluconazole is generally well tolerated. In some patients, particularly those with serious underlying diseases such as AIDS and cancer, changes in renal and hematological function test results and hepatic abnormalities have been observed during treatment with fluconazole and comparative agents, but the clinical significance and relationship to treatment is uncertain. In Patients Receiving a Single Dose for Vaginal Candidiasis: During comparative clinical studies conducted in the United States, 448 patients with vaginal candidiasis were treated with fluconazole, 150 mg single dose. The overall incidence of side effects possibly related to fluconazole was 26%. In 422 patients receiving active comparative agents, the incidence was 16%. The most common treatment-related adverse events reported in the patients who received 150 mg single dose fluconazole for vaginitis were headache (13%), nausea (7%), and abdominal pain (6%). Other side effects reported with an incidence equal to or greater than 1% included diarrhea (3%), dyspepsia (1%), dizziness (1%), and taste perversion (1%). Most of the reported side effects were mild to moderate in severity. Rarely, angioedema and anaphylactic reaction have been reported in marketing experience. …
Source: FDA drug label, Zydus Pharmaceuticals (USA) Inc., effective April 7, 2026 (SPL set d1364455-1537-46d4-b093-38cca3be778f), via openFDA; the full label on DailyMed
What do FAERS reports show?
69,671 reports list fluconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 12,476 are coded as a death and 30,560 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 20 reactions below, 12 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?
- Fluconazole: 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