Neostigmine Methylsulfate side effects: what 426 FDA adverse event reports show

Neostigmine Methylsulfate · 12 reaction terms · 108 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Who reports

426 reports · 87% serious · 53 with death outcome · 57% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Neostigmine Methylsulfate Injection, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery. Neostigmine Methylsulfate, a cholinesterase inhibitor, is indicated for reversal of the effects of nondepolarizing neuromuscular blocking agents (NMBA) after surgery ( 1 ).

FDA label, Indications and Usage

What it is

Neostigmine Methylsulfate Injection, USP, a cholinesterase inhibitor, has an empirical formula of C 13 H 22 N 2 O 6 S, a molecular weight of 334.39 g/mol and the following structural formula: .

FDA label, Description section

Boxed warning

None in the current 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 11 strongest signals

Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 9

What the badges mean

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.
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. 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
Ileus	13	52.1 30.5–88.9ROR 53.7 · χ² 601 / p 6e-133	48.5 EB05 30.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 34.5	no trial data cached
Generalised tonic-clonic seizure	15	45.2 27.5–74.3ROR 46.8 · χ² 604 / p 1e-133	42.8 EB05 27.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.1	no trial data cached
Bladder disorder	9	44.6 23.3–85.1ROR 45.5 · χ² 341 / p 2e-76	40.9 EB05 23.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Sinus tachycardia	11	38.2 21.3–68.5ROR 39.2 · χ² 362 / p 4e-81	36.0 EB05 21.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Paralysis	10	34.3 18.6–63.3ROR 35.1 · χ² 291 / p 2e-65	32.3 EB05 18.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.4	no trial data cached
Blood test abnormal	9	31.6 16.5–60.3ROR 32.2 · χ² 237 / p 1e-53	29.7 EB05 16.5 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 31.8	no trial data cached
Abortion induced	6	31.3 14.2–69.4ROR 31.8 · χ² 147 / p 4e-34	28.1 EB05 12.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.6	no trial data cached
Neutrophil count increased	6	28.7 13.0–63.6ROR 29.1 · χ² 134 / p 3e-31	25.7 EB05 11.3 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 20.8	no trial data cached
Dementia	13	23.0 13.5–39.3ROR 23.7 · χ² 252 / p 5e-57	22.2 EB05 13.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.3	no trial data cached
Dystonia	7	17.7 8.5–36.9ROR 18.0 · χ² 94 / p 1e-22	15.1 EB05 6.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Circumstance or information capable of leading to medication error	6	8.8 4.0–19.5ROR 8.9 · χ² 34 / p 3e-9	6.0 EB05 2.8 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	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
Generalised tonic-clonic seizure	15	45.2 27.5–74.3ROR 46.8 · χ² 604 / p 1e-133	42.8 EB05 27.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 30.1	no trial data cached
Dementia	13	23.0 13.5–39.3ROR 23.7 · χ² 252 / p 5e-57	22.2 EB05 13.5 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 16.3	no trial data cached
Ileus	13	52.1 30.5–88.9ROR 53.7 · χ² 601 / p 6e-133	48.5 EB05 30.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 34.5	no trial data cached
Sinus tachycardia	11	38.2 21.3–68.5ROR 39.2 · χ² 362 / p 4e-81	36.0 EB05 21.4 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 25.7	no trial data cached
Paralysis	10	34.3 18.6–63.3ROR 35.1 · χ² 291 / p 2e-65	32.3 EB05 18.7 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 23.4	no trial data cached
Blood test abnormal	9	31.6 16.5–60.3ROR 32.2 · χ² 237 / p 1e-53	29.7 EB05 16.5 · IC025 +2.5 3/3 methods agree	Reporting / coding artifact	serious PRR 31.8	no trial data cached
Bladder disorder	9	44.6 23.3–85.1ROR 45.5 · χ² 341 / p 2e-76	40.9 EB05 23.0 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious n=9	no trial data cached
Dystonia	7	17.7 8.5–36.9ROR 18.0 · χ² 94 / p 1e-22	15.1 EB05 6.2 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 12.9	no trial data cached
Circumstance or information capable of leading to medication error	6	8.8 4.0–19.5ROR 8.9 · χ² 34 / p 3e-9	6.0 EB05 2.8 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	–	no trial data cached
Neutrophil count increased	6	28.7 13.0–63.6ROR 29.1 · χ² 134 / p 3e-31	25.7 EB05 11.3 · IC025 +1.8 3/3 methods agree	Lab value / disease marker	serious PRR 20.8	no trial data cached
Abortion induced	6	31.3 14.2–69.4ROR 31.8 · χ² 147 / p 4e-34	28.1 EB05 12.8 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 21.6	no trial data cached
Respiratory depression	3	12.0 3.9–37.2ROR 12.1 · χ² 20 / p 3e-6	6.1 EB05 2.0 · IC025 +0.2	Labeled adverse reaction exact term	serious PRR 8.2	no trial data cached

Unlabeled candidate signals

Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.

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 Neostigmine Methylsulfate?

In FDA FAERS, the most frequently co-reported reaction terms for Neostigmine Methylsulfate are generalised tonic-clonic seizure, dementia, ileus, sinus tachycardia, paralysis, bladder disorder. 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 Neostigmine Methylsulfate have an FDA boxed warning?

No. The FDA label retrieved for Neostigmine Methylsulfate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Neostigmine Methylsulfate 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 088f96eb-20b8-48f8-ac83-329f75a44ce1, effective 20240122; matched on openfda.generic_name.exact:"NEOSTIGMINE METHYLSULFATE")
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, 12 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.