Pentamidine Isethionate side effects: what 1,230 FDA adverse event reports show
Drug class
Not stated in label
Who reports
1,230 reports · 89% serious · 219 with death outcome · 40% female
Used for
Pentamidine isethionate for injection is indicated for the treatment of pneumonia due to Pneumocystis carinii .
What it is
DESCRIPTION Pentamidine isethionate for injection, an anti-protozoal agent, is a sterile, nonpyrogenic, lyophilized product. After reconstitution, it should be administered by intramuscular (IM) or intravenous (IV) routes (see DOSAGE AND ADMINISTRATION ).
Boxed warning
None in the current label
Causality screen of the 27 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 18 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Haematotoxicity | 31 | 57.1 40.3–80.9ROR 58.6 · χ² 1,649 / p <1e-300 | 55.1 EB05 40.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 · 100% clinician | no trial data cached |
| Mucosal inflammation | 57 | 37.3 29.0–48.1ROR 39.1 · χ² 1,977 / p <1e-300 | 36.8 EB05 29.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 96% clinician | no trial data cached |
| Febrile neutropenia | 134 | 34.5 29.4–40.5ROR 38.6 · χ² 4,335 / p <1e-300 | 34.3 EB05 29.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.5 · 96% clinician | no trial data cached |
| Pneumocystis jirovecii pneumonia | 20 | 34.1 22.1–52.8ROR 34.7 · χ² 610 / p 6e-135 | 33.1 EB05 22.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 22.2 | no trial data cached |
| Multi-organ failure | 31 | 30.1 21.3–42.7ROR 30.9 · χ² 844 / p 8e-186 | 29.6 EB05 21.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 | no trial data cached |
| Transfusion | 18 | 29.2 18.5–46.2ROR 29.6 · χ² 462 / p 9e-103 | 28.4 EB05 19.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 19.9 | no trial data cached |
| Bacteraemia | 15 | 21.7 13.1–36.0ROR 22.0 · χ² 276 / p 3e-62 | 21.1 EB05 13.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 14.2 | no trial data cached |
| Cytomegalovirus infection | 18 | 18.5 11.7–29.2ROR 18.7 · χ² 280 / p 4e-63 | 17.9 EB05 11.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
| Bone marrow failure | 22 | 18.3 12.1–27.7ROR 18.7 · χ² 343 / p 6e-77 | 18.0 EB05 12.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Pancytopenia (all blood cells low) | 55 | 16.8 13.0–21.8ROR 17.6 · χ² 804 / p 3e-177 | 16.7 EB05 13.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Ileus | 12 | 16.6 9.5–29.2ROR 16.8 · χ² 161 / p 4e-37 | 15.5 EB05 8.6 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Hyperlipidaemia | 11 | 15.6 8.7–28.2ROR 15.8 · χ² 136 / p 8e-32 | 14.3 EB05 7.5 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 11.2 | no trial data cached |
| Bronchospasm (airway tightening) | 13 | 15.5 9.0–26.6ROR 15.6 · χ² 162 / p 2e-37 | 14.4 EB05 8.1 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.6 | no trial data cached |
| Blood lactate dehydrogenase increased | 12 | 12.8 7.3–22.5ROR 12.9 · χ² 119 / p 5e-28 | 11.3 EB05 6.1 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 | no trial data cached |
| Disseminated intravascular coagulation | 10 | 12.1 6.5–22.4ROR 12.2 · χ² 91 / p 8e-22 | 10.0 EB05 5.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Acute respiratory distress syndrome | 12 | 11.6 6.6–20.3ROR 11.7 · χ² 105 / p 5e-25 | 9.9 EB05 5.4 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.5 | no trial data cached |
| Blood triglycerides increased | 12 | 11.5 6.6–20.3ROR 11.6 · χ² 105 / p 6e-25 | 9.8 EB05 5.4 · IC025 +2.0 3/3 methods agree | Lab value / disease marker | serious PRR 11.8 | no trial data cached |
| Gamma-glutamyltransferase increased | 14 | 10.8 6.4–18.1ROR 10.9 · χ² 114 / p 5e-27 | 9.3 EB05 5.4 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 | no trial data cached |
| Pneumothorax | 10 | 10.8 5.8–19.9ROR 10.8 · χ² 79 / p 3e-19 | 8.6 EB05 4.5 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | no trial data cached |
| Blood bilirubin increased | 17 | 10.7 6.7–17.2ROR 10.8 · χ² 140 / p 1e-32 | 9.5 EB05 5.9 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 8.0 | no trial data cached |
| Neutrophil count decreased | 24 | 10.1 6.8–15.0ROR 10.3 · χ² 188 / p 4e-43 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Herpes zoster (shingles) | 34 | 10.1 7.2–14.0ROR 10.3 · χ² 269 / p 8e-61 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 94% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 31 | 10.0 7.1–14.1ROR 10.2 · χ² 242 / p 7e-55 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 78 | 9.8 7.9–12.2ROR 10.4 · χ² 612 / p 2e-135 | 9.6 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 91% clinician | no trial data cached |
| Renal failure acute | 24 | 9.5 6.4–14.1ROR 9.7 · χ² 174 / p 4e-40 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 52 | 7.9 6.1–10.4ROR 8.3 · χ² 310 / p 9e-70 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Platelet count decreased | 46 | 7.4 5.5–9.8ROR 7.6 · χ² 248 / p 4e-56 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Febrile neutropenia | 134 | 34.5 29.4–40.5ROR 38.6 · χ² 4,335 / p <1e-300 | 34.3 EB05 29.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.5 · 96% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 78 | 9.8 7.9–12.2ROR 10.4 · χ² 612 / p 2e-135 | 9.6 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 · 91% clinician | no trial data cached |
| Mucosal inflammation | 57 | 37.3 29.0–48.1ROR 39.1 · χ² 1,977 / p <1e-300 | 36.8 EB05 29.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 25.8 · 96% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 55 | 16.8 13.0–21.8ROR 17.6 · χ² 804 / p 3e-177 | 16.7 EB05 13.3 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.0 | no trial data cached |
| Thrombocytopenia (low platelets) | 52 | 7.9 6.1–10.4ROR 8.3 · χ² 310 / p 9e-70 | 7.5 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.3 | no trial data cached |
| Platelet count decreased | 46 | 7.4 5.5–9.8ROR 7.6 · χ² 248 / p 4e-56 | 6.9 EB05 5.4 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.8 | no trial data cached |
| Herpes zoster (shingles) | 34 | 10.1 7.2–14.0ROR 10.3 · χ² 269 / p 8e-61 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.4 · 94% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 31 | 10.0 7.1–14.1ROR 10.2 · χ² 242 / p 7e-55 | 9.3 EB05 6.7 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Multi-organ failure | 31 | 30.1 21.3–42.7ROR 30.9 · χ² 844 / p 8e-186 | 29.6 EB05 21.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 19.6 | no trial data cached |
| Haematotoxicity | 31 | 57.1 40.3–80.9ROR 58.6 · χ² 1,649 / p <1e-300 | 55.1 EB05 40.7 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 38.1 · 100% clinician | no trial data cached |
| Renal failure acute | 24 | 9.5 6.4–14.1ROR 9.7 · χ² 174 / p 4e-40 | 8.6 EB05 5.9 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.2 · 100% clinician | no trial data cached |
| Neutrophil count decreased | 24 | 10.1 6.8–15.0ROR 10.3 · χ² 188 / p 4e-43 | 9.2 EB05 6.3 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.6 | no trial data cached |
| Bone marrow failure | 22 | 18.3 12.1–27.7ROR 18.7 · χ² 343 / p 6e-77 | 18.0 EB05 12.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.0 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 20 | 34.1 22.1–52.8ROR 34.7 · χ² 610 / p 6e-135 | 33.1 EB05 22.6 · IC025 +3.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 22.2 | no trial data cached |
| Cytomegalovirus infection | 18 | 18.5 11.7–29.2ROR 18.7 · χ² 280 / p 4e-63 | 17.9 EB05 11.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 12.1 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Haematotoxicity — n=31, PRR 57.1
- Mucosal inflammation — n=57, PRR 37.3
- Multi-organ failure — n=31, PRR 30.1
- Bone marrow failure — n=22, PRR 18.3
- Herpes zoster — n=34, PRR 10.1
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Pentamidine Isethionate?
In FDA FAERS, the most frequently co-reported reaction terms for Pentamidine Isethionate are febrile neutropenia, neutropenia, mucosal inflammation, pancytopenia, thrombocytopenia, platelet count decreased. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Pentamidine Isethionate have an FDA boxed warning?
No. The FDA label retrieved for Pentamidine Isethionate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pentamidine Isethionate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 5c14fbf2-e21f-44b3-b35c-06919d40d7e0, effective 20251031; matched on
openfda.generic_name.exact:"PENTAMIDINE ISETHIONATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 45 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.