Amphotericin b liposome: adverse event reports filed with FDA

2,092

reports as suspect product

0% of all reports · about 142 a year

0

reports, 12 months to June 2026

0 in the 12 months before

99.1%

marked serious by the reporter

97.9% across the class

56.8%

record death among outcomes, as reported

1,189 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

Reactions recorded in the reports

share of Amphotericin b liposome reports recording the termmedian drug in lipid-based polyene antifungal

1. Drug ineffectivethe medicine did not work as expected48.6%1,017
2. Off label useused for a purpose or in a way not on the label16.5%346
3. Deaththe patient died; cause not stated by this term5.2%108
4. Acute kidney injurysudden loss of kidney function4.1%86
5. Hypokalaemialow blood potassium3.9%81
6. Pyrexiafever3.3%70
7. Treatment failurethe treatment did not work2.9%60
8. Multiple organ dysfunction syndromeseveral organs failing2.7%56
9. Pancytopenialow counts of all blood cells2.6%54
10. Renal impairmentreduced kidney function2.4%51
11. Renal failurekidney failure2.2%45
12. Blood creatinine increasedraised creatinine, a kidney test2.1%44
13. Fungal infectiona fungal infection1.9%39
14. Septic shockshock arising from infection1.8%38
15. Respiratory failurethe lungs could not supply enough oxygen1.7%35
16. Pneumonialung infection1.5%32
17. Vomitingbeing sick1.5%32
18. Dyspnoeashortness of breath1.5%31
19. Condition aggravatedthe condition being treated got worse1.4%29
20. Aspergillus infection1.3%28
21. Blood potassium decreased1.3%28
22. Bronchopulmonary aspergillosis1.3%28
23. Drug ineffective for unapproved indication1.3%28
24. Drug interactionan interaction between medicines1.2%26
25. Mucormycosis1.2%26
26. Immune reconstitution inflammatory syndrome1.2%25
27. Nauseafeeling sick1.2%25
28. Product use in unapproved indicationused for a purpose not on the label1.2%25
29. Product use issuea problem in how the product was used1.2%25
30. Sepsisa severe body-wide response to infection1.2%25

Top 30 of 343 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the lipid-based polyene antifungal class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 8,609 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 11.4% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 2,092 reports.

Drugs most often listed in the same reports

Other products listed in reports where Amphotericin b liposome is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the lipid-based polyene antifungal class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Amphotericin b liposome as a suspect or interacting product; reports listing it only as a concomitant medication (272) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.