What the label lists and what reports show
Posaconazole side effects
Posaconazole's FDA label: “The most frequently reported adverse reactions (>25%) in patients treated with posaconazole delayed-release tablets 300 mg once daily were diarrhea, pyrexia, and nausea.” FAERS holds 16,154 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 febrile neutropenia (1,072 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the posaconazole FDA label on DailyMed (effective August 3, 2026, Aurobindo Pharma Limited); 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 posaconazole delayed-release tablets?Posaconazole delayed-release tablets may cause serious side effects, including: drug interactions with cyclosporine or tacrolimus. If you take posaconazole delayed-release tablets with cyclosporine or tacrolimus, your blood levels of cyclosporine or tacrolimus may increase. Serious side effects can happen in your kidney or brain if you have high levels of cyclosporine or tacrolimus in your blood. Your healthcare provider should do blood tests to check your levels of cyclosporine or tacrolimus if you are taking these medicines while taking posaconazole delayed-release tablets. Tell your healthcare provider right away if you have swelling in your arm or leg or shortness of breath. problems with the electrical system of your heart (arrhythmias and QTc prolongation). […]
Source: FDA drug label, Aurobindo Pharma Limited, effective August 3, 2026 (SPL set f8a26673-261c-4e8e-b1e1-9e23aaf7f285), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported adverse reactions (>25%) in patients treated with posaconazole delayed-release tablets 300 mg once daily were diarrhea, pyrexia, and nausea.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reactions | Posaconazole delayed-release tablet (300 mg) n=210 (%) |
|---|---|
| Percentage of Patients Reporting any Adverse Reaction | 99 |
| Diarrhea | 29 |
| Pyrexia | 28 |
| Nausea | 27 |
| Hypokalemia | 22 |
| Cough | 17 |
| Edema Peripheral | 16 |
| Rash | 16 |
| Epistaxis | 14 |
| Headache | 14 |
| Mucosal Inflammation | 14 |
| Thrombocytopenia | 14 |
| Vomiting | 13 |
| Abdominal Pain | 11 |
| Hypertension | 11 |
| Anemia | 10 |
| Asthenia | 10 |
| Chills | 10 |
| Constipation | 10 |
| Hypomagnesemia | 10 |
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, continuedThe following serious and otherwise important adverse reactions are discussed in detail in another section of the labeling: Arrhythmias and QT Prolongation [see Warnings and Precautions (5.2) ] Electrolyte Disturbances [see Warnings and Precautions (5.3) ] Pseudoaldosteronism [see Warnings and Precautions (5.4) ] Hepatic Toxicity [see Warnings and Precautions (5.5) ] Adult Patients: Common adverse reactions in studies with posaconazole in adults are diarrhea, nausea, fever, vomiting, headache, coughing, and hypokalemia. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of posaconazole cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Clinical Trial Experience with Posaconazole Delayed-Release Tablets for Prophylaxis of Invasive Aspergillus and Candida Infections The safety of posaconazole delayed-release tablets has been assessed in 230 patients in clinical trials. …
Source: FDA drug label, Aurobindo Pharma Limited, effective August 3, 2026 (SPL set f8a26673-261c-4e8e-b1e1-9e23aaf7f285), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,154 reports list posaconazole among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,855 are coded as a death and 7,189 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 16 reactions below, 7 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?
- Posaconazole: 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