What the label lists and what reports show
Pentamidine isethionate side effects
Pentamidine isethionate's FDA label: “The most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424) […]” FAERS holds 1,232 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 (135 reports).
- Generic listed
- A presentation discontinued
Check it at the source: the pentamidine isethionate FDA label on DailyMed (effective September 13, 2022, Fresenius Kabi USA, LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most frequently reported spontaneous adverse events (1 to 30%) reported in clinical trials, regardless of their relation to pentamidine isethionate therapy were as follows (n=424) […]
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
This table is printed in the pentamidine isethionate label published by Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc. of October 31, 2025; the label quoted above does not print one.
| Reaction | Cardiovascular: |
|---|---|
| Hypotension | 5.0% |
| Anorexia/Nausea | 5.9% |
| Anemia | 1.2% |
| Leukopenia | 10.4% |
| Thrombocytopenia | 2.6% |
| Elevated liver function tests | 8.7% |
| Hypoglycemia | 5.9% |
| Confusion/hallucinations | 1.7% |
| Sterile abscess and/or necrosis, pain, or induration at the site of IM injection | 11.1% |
| Rash | 3.3% |
| Bad taste | 1.7% |
| Azotemia | 8.5% |
| Elevated serum creatinine | 23.6% |
| Elevated blood urea nitrogen | 6.6% |
| Impaired renal function | 28.8% |
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, continuedTo report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. CAUTION : Fatalities due to severe hypotension, hypoglycemia, acute pancreatitis and cardiac arrhythmias have been reported in patients treated with pentamidine isethionate, both by the IM and IV routes. Nephrotoxic events (increased creatinine, impaired renal function, azotemia, and renal failure) are common with the parenteral administration of pentamidine isethionate. The administration of the drug should, therefore, be limited to the patients in whom Pneumocystis carinii has been demonstrated.
Source: FDA drug label, Fresenius Kabi USA, LLC, effective September 13, 2022 (SPL set cc2b635e-4840-4dc3-a177-5484371680e8), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,232 reports list pentamidine isethionate among the medicines taken, each a report of something that happened, not proof the medicine caused it; 219 are coded as a death and 606 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 23 reactions below, 11 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?
- Pentamidine isethionate: 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