What the label lists and what reports show
Pentamidine diisethionate side effects
Pentamidine diisethionate'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
Check it at the source: the pentamidine diisethionate FDA label on DailyMed (effective May 7, 2026, PAI Holdings, LLC dba PAI Pharma); 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) […]
From the label: adverse reactions, continuedCAUTION : 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. 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): Cardiovascular: Hypotension 5.0% Gastrointestinal: Anorexia/Nausea 5.9% Hematologic: Anemia Leukopenia Thrombocytopenia 1.2% 10.4% 2.6% Hepatic: Elevated liver function tests 8.7% Metabolic: Hypoglycemia 5.9% Neurologic: Confusion/hallucinations 1.7% Skin: Sterile abscess and/or necrosis, pain, or induration at the site of IM injection Rash 11.1% 3.3% Special Senses: Bad taste 1.7% Urogenital: Azotemia Elevated serum creatinine Elevated blood urea nitrogen Impaired renal function 8.5% 23.6% 6.6% 28.8% Adverse events with a frequency of less than 1% incidence were as follows (No causal relationship to treatment has been established for these adverse events): Body as a whole: Allergic reaction (i.e. …
Source: FDA drug label, PAI Holdings, LLC dba PAI Pharma, effective May 7, 2026 (SPL set d46aea4f-8f3f-4ce0-93d6-94e147f5a31a), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,232 reports list pentamidine diisethionate 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 diisethionate: 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