POSACONAZOLE

N/A

Manufactured by Merck Sharp & Dohme LLC

26,750 FDA adverse event reports analyzed

Last updated: 2026-04-14

About POSACONAZOLE

POSACONAZOLE is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Merck Sharp & Dohme LLC. The most commonly reported adverse reactions for POSACONAZOLE include OFF LABEL USE, DRUG INEFFECTIVE, FEBRILE NEUTROPENIA, DRUG INTERACTION, DEATH. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for POSACONAZOLE.

Top Adverse Reactions

OFF LABEL USE1,542 reports
DRUG INEFFECTIVE1,433 reports
FEBRILE NEUTROPENIA1,017 reports
DRUG INTERACTION930 reports
DEATH928 reports
PRODUCT USE IN UNAPPROVED INDICATION926 reports
PYREXIA851 reports
NEUTROPENIA705 reports
PNEUMONIA653 reports
THROMBOCYTOPENIA505 reports
DIARRHOEA498 reports
NAUSEA478 reports
SEPTIC SHOCK441 reports
CONDITION AGGRAVATED422 reports
SEPSIS416 reports
ACUTE KIDNEY INJURY408 reports
FATIGUE387 reports
PANCYTOPENIA361 reports
VOMITING321 reports
DYSPNOEA314 reports
ACUTE MYELOID LEUKAEMIA300 reports
ANAEMIA286 reports
HYPOKALAEMIA284 reports
INFECTION283 reports
ASTHENIA281 reports
RESPIRATORY FAILURE272 reports
PRODUCT USE ISSUE270 reports
DISEASE PROGRESSION266 reports
RENAL FAILURE266 reports
PLATELET COUNT DECREASED265 reports
HEADACHE259 reports
GRAFT VERSUS HOST DISEASE244 reports
ASPERGILLUS INFECTION243 reports
BRONCHOPULMONARY ASPERGILLOSIS238 reports
HYPOTENSION223 reports
FUNGAL INFECTION212 reports
RASH202 reports
ELECTROCARDIOGRAM QT PROLONGED201 reports
TOXICITY TO VARIOUS AGENTS200 reports
MULTIPLE ORGAN DYSFUNCTION SYNDROME195 reports
DECREASED APPETITE190 reports
COUGH184 reports
MUCORMYCOSIS184 reports
PNEUMONIA FUNGAL180 reports
WHITE BLOOD CELL COUNT DECREASED180 reports
CHOLESTASIS178 reports
ABDOMINAL PAIN174 reports
DRUG RESISTANCE173 reports
CYTOKINE RELEASE SYNDROME170 reports
HYPERTENSION170 reports
PLEURAL EFFUSION160 reports
PAIN158 reports
CONSTIPATION156 reports
HAEMOGLOBIN DECREASED155 reports
BACTERAEMIA154 reports
TREATMENT FAILURE154 reports
GENERAL PHYSICAL HEALTH DETERIORATION153 reports
ACUTE MYELOID LEUKAEMIA RECURRENT151 reports
COVID 19151 reports
RENAL IMPAIRMENT148 reports
HYPOXIA141 reports
CYTOMEGALOVIRUS INFECTION140 reports
DIZZINESS140 reports
URINARY TRACT INFECTION135 reports
DRUG INEFFECTIVE FOR UNAPPROVED INDICATION134 reports
FALL134 reports
HEPATIC CYTOLYSIS134 reports
CYTOMEGALOVIRUS INFECTION REACTIVATION132 reports
STAPHYLOCOCCAL INFECTION131 reports
CYTOPENIA130 reports
ADVERSE EVENT129 reports
CARDIAC ARREST129 reports
HEPATOTOXICITY129 reports
MALAISE129 reports
BONE MARROW FAILURE128 reports
WEIGHT DECREASED128 reports
MYELOSUPPRESSION126 reports
PRODUCT DOSE OMISSION ISSUE126 reports
MUCOSAL INFLAMMATION125 reports
DEVICE RELATED INFECTION123 reports
NEUTROPHIL COUNT DECREASED123 reports
NEUROPATHY PERIPHERAL122 reports
OEDEMA PERIPHERAL121 reports
TACHYCARDIA121 reports
CONFUSIONAL STATE119 reports
ALANINE AMINOTRANSFERASE INCREASED118 reports
PSEUDOMONAS INFECTION118 reports
MUSCULAR WEAKNESS116 reports
ENCEPHALOPATHY115 reports
HYPERBILIRUBINAEMIA115 reports
FUSARIUM INFECTION113 reports
HAEMORRHAGE113 reports
ATRIAL FIBRILLATION112 reports
DRUG INDUCED LIVER INJURY110 reports
CANDIDA INFECTION109 reports
NEUROTOXICITY108 reports
HYPONATRAEMIA107 reports
BLOOD CREATININE INCREASED106 reports
DRUG LEVEL BELOW THERAPEUTIC106 reports
NO ADVERSE EVENT106 reports

Report Outcomes

Out of 15,328 classified reports for POSACONAZOLE:

Serious 86.6%Non-Serious 13.4%

The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.

Demographics Breakdown

Reports by Sex

Male7,962 (59.0%)
Female5,456 (40.5%)
Unknown70 (0.5%)

Reports by Age

Age 65309 reports
Age 68309 reports
Age 70307 reports
Age 67282 reports
Age 59277 reports
Age 63272 reports
Age 56264 reports
Age 58263 reports
Age 64254 reports
Age 62247 reports
Age 60246 reports
Age 71243 reports
Age 72243 reports
Age 66239 reports
Age 49237 reports
Age 73229 reports
Age 69224 reports
Age 61218 reports
Age 57216 reports
Age 74215 reports

Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.

Frequently Asked Questions

How many FDA adverse event reports are associated with POSACONAZOLE?

This profile reflects 26,750 FDA FAERS reports that mention POSACONAZOLE. Reporting is voluntary and does not prove that the drug caused any listed event.

Which adverse reactions are most often listed for POSACONAZOLE?

Frequently reported terms in FAERS include OFF LABEL USE, DRUG INEFFECTIVE, FEBRILE NEUTROPENIA, DRUG INTERACTION, DEATH, PRODUCT USE IN UNAPPROVED INDICATION. Rankings reflect reporting volume in this dataset, not confirmed side effect rates in the general population.

Who manufactures POSACONAZOLE?

Labeling and FAERS entries often list Merck Sharp & Dohme LLC in connection with POSACONAZOLE. Always verify the specific product and NDC with your pharmacist.

Important Disclaimer: This content is generated by AI analysis of FDA adverse event reports and is provided for informational purposes only. It is not medical advice. Adverse event reports submitted to the FDA do not prove that a medication caused the reported side effect. Always consult your healthcare provider before starting, stopping, or changing any medication. If you experience a serious side effect, contact your doctor or call 911 immediately.