Drug · FAERS side-effect profile with label screen

Nitroprusside side effects: what 382 FDA adverse event reports show

Sodium Nitroprusside · 16 reaction terms · 539 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Sodium Nitroprusside (Sodium Nitroprusside)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

382 reports · 93% serious · 84 with death outcome · 51% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Sodium nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. Concomitant longer-acting antihypertensive medication should be administered so that the duration of treatment with sodium nitroprusside can be minimized. Sodium nitroprusside is also indicated for producing controlled hypotension in order to reduce bleeding during surgery.

FDA label, Indications and Usage

What it is

DESCRIPTION Sodium nitroprusside is disodium pentacyanonitrosylferrate(2-) dihydrate, a hypotensive agent whose structural formula is whose molecular formula is Na 2 [Fe(CN) 5 NO] 2H 2 O, and whose molecular weight is 297.95.

FDA label, Description section

Boxed warning

Sodium nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside injection can cause precipitous decreases in blood pressure (see DOSAGE AND ADMINISTRATION ).

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 15 strongest signals

Labeled (related wording) 1Likely indication confounding 1Reporting / coding artifact 1Not in label — unassessed 12

What the badges mean

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.
Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fear	53	107.5 83.7–138.1ROR 124.7 · χ² 5,485 / p <1e-300	103.4 EB05 82.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 90.3	no trial data cached
Multi-organ failure	32	100.3 72.0–139.8ROR 109.4 · χ² 3,044 / p <1e-300	94.6 EB05 70.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 62.1	no trial data cached
Anhedonia	41	85.1 63.7–113.7ROR 95.2 · χ² 3,323 / p <1e-300	81.8 EB05 62.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 58.2	no trial data cached
Renal injury	44	80.6 61.0–106.4ROR 90.9 · χ² 3,378 / p <1e-300	77.8 EB05 60.4 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 49.9	no trial data cached
Injury	59	45.9 36.3–58.0ROR 54.1 · χ² 2,551 / p <1e-300	45.2 EB05 36.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 35.2	no trial data cached
Unevaluable event	55	39.9 31.3–51.0ROR 46.5 · χ² 2,055 / p <1e-300	39.4 EB05 31.4 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 43.7	no trial data cached
Posterior reversible encephalopathy syndrome	6	34.6 15.6–76.6ROR 35.2 · χ² 164 / p 9e-38	31.0 EB05 14.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	no trial data cached
Ventricular fibrillation	7	34.5 16.6–71.9ROR 35.1 · χ² 196 / p 1e-44	31.5 EB05 16.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 18.3	no trial data cached
Hypertensive crisis	7	34.4 16.5–71.8ROR 35.1 · χ² 195 / p 1e-44	31.5 EB05 16.0 · IC025 +2.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 21.4	no trial data cached
Mental status changes	17	33.6 21.1–53.5ROR 35.1 · χ² 506 / p 3e-112	32.5 EB05 21.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Renal failure (kidney failure)	74	30.4 24.8–37.3ROR 37.4 · χ² 2,086 / p <1e-300	30.2 EB05 24.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Stress	38	29.0 21.5–39.2ROR 32.1 · χ² 1,003 / p 2e-220	28.6 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.8	no trial data cached
Emotional distress	43	19.4 14.7–25.8ROR 21.8 · χ² 738 / p 1e-162	19.3 EB05 14.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Lactic acidosis	11	18.8 10.5–33.7ROR 19.3 · χ² 168 / p 8e-39	17.7 EB05 9.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.7	no trial data cached
Toxicity to various agents	49	16.0 12.3–20.8ROR 18.2 · χ² 681 / p 2e-150	15.9 EB05 12.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.2 · ♀ 71% (drug 51%) · 98% clinician	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Renal failure (kidney failure)	74	30.4 24.8–37.3ROR 37.4 · χ² 2,086 / p <1e-300	30.2 EB05 24.8 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 18.9	no trial data cached
Injury	59	45.9 36.3–58.0ROR 54.1 · χ² 2,551 / p <1e-300	45.2 EB05 36.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 35.2	no trial data cached
Unevaluable event	55	39.9 31.3–51.0ROR 46.5 · χ² 2,055 / p <1e-300	39.4 EB05 31.4 · IC025 +4.4 3/3 methods agree	Reporting / coding artifact	serious PRR 43.7	no trial data cached
Fear	53	107.5 83.7–138.1ROR 124.7 · χ² 5,485 / p <1e-300	103.4 EB05 82.1 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 90.3	no trial data cached
Toxicity to various agents	49	16.0 12.3–20.8ROR 18.2 · χ² 681 / p 2e-150	15.9 EB05 12.4 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.2 · ♀ 71% (drug 51%) · 98% clinician	no trial data cached
Renal injury	44	80.6 61.0–106.4ROR 90.9 · χ² 3,378 / p <1e-300	77.8 EB05 60.4 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 49.9	no trial data cached
Emotional distress	43	19.4 14.7–25.8ROR 21.8 · χ² 738 / p 1e-162	19.3 EB05 14.9 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Anhedonia	41	85.1 63.7–113.7ROR 95.2 · χ² 3,323 / p <1e-300	81.8 EB05 62.9 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 58.2	no trial data cached
Stress	38	29.0 21.5–39.2ROR 32.1 · χ² 1,003 / p 2e-220	28.6 EB05 21.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 29.8	no trial data cached
Multi-organ failure	32	100.3 72.0–139.8ROR 109.4 · χ² 3,044 / p <1e-300	94.6 EB05 70.2 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 62.1	no trial data cached
Mental status changes	17	33.6 21.1–53.5ROR 35.1 · χ² 506 / p 3e-112	32.5 EB05 21.5 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 23.0	no trial data cached
Lactic acidosis	11	18.8 10.5–33.7ROR 19.3 · χ² 168 / p 8e-39	17.7 EB05 9.7 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.7	no trial data cached
Hypertensive crisis	7	34.4 16.5–71.8ROR 35.1 · χ² 195 / p 1e-44	31.5 EB05 16.0 · IC025 +2.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 21.4	no trial data cached
Ventricular fibrillation	7	34.5 16.6–71.9ROR 35.1 · χ² 196 / p 1e-44	31.5 EB05 16.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 18.3	no trial data cached
Posterior reversible encephalopathy syndrome	6	34.6 15.6–76.6ROR 35.2 · χ² 164 / p 9e-38	31.0 EB05 14.5 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 21.4	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.

Fear — n=53, PRR 107.5
Multi-organ failure — n=32, PRR 100.3
Anhedonia — n=41, PRR 85.1
Renal injury — n=44, PRR 80.6
Injury — n=59, PRR 45.9
Renal failure — n=74, PRR 30.4
Stress — n=38, PRR 29.0
Emotional distress — n=43, PRR 19.4
Toxicity to various agents — n=49, PRR 16.0

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 Nitroprusside?

In FDA FAERS, the most frequently co-reported reaction terms for Nitroprusside are renal failure, injury, fear, toxicity to various agents, renal injury, emotional distress. 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 Nitroprusside have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: Sodium nitroprusside injection is not suitable for direct injection. The solution must be further diluted in sterile 5% dextrose injection before infusion. Sodium nitroprusside injection can cause precipitous decreases in blood pressure (see DOSAGE AND ADMINISTRATION ).

Do FAERS signals prove that Nitroprusside 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 01841345-bed3-458f-8e99-911fbd286512, effective 20210722; matched on openfda.generic_name.exact:"SODIUM NITROPRUSSIDE")
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, field patient.drug.openfda.generic_name.exact, 16 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.