Drug · FAERS side-effect profile with label screen
Pyridostigmine Bromide Oral side effects: what 3,412 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Pyridostigmine Bromide Oral (Pyridostigmine)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
3,412 reports · 78% serious · 297 with death outcome · 56% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Pyridostigmine Bromide Oral Solution, USP is useful in the treatment of myasthenia gravis.
FDA label, Indications and Usage
What it is
DESCRIPTION Pyridostigmine Bromide Oral Solution, USP is an orally active cholinesterase inhibitor.
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 40 strongest signals
Reporting / coding artifact 6Not in label — unassessed 34
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.
- 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. 104 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Eyelid ptosis | 63 | 38.3 30.0–48.9ROR 39.0 · χ² 2,237 / p <1e-300 | 37.7 EB05 30.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=51 | no trial data cached |
| Diplopia (double vision) | 65 | 15.4 12.1–19.6ROR 15.7 · χ² 860 / p 2e-189 | 15.3 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Rebound effect | 28 | 15.2 10.5–22.0ROR 15.3 · χ² 357 / p 7e-80 | 14.8 EB05 10.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 · 100% clinician | no trial data cached |
| Therapy partial responder | 35 | 14.3 10.3–19.9ROR 14.4 · χ² 419 / p 2e-93 | 14.0 EB05 10.3 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 · 100% clinician | no trial data cached |
| Osteopenia | 25 | 10.1 6.8–14.9ROR 10.1 · χ² 195 / p 1e-44 | 9.3 EB05 6.4 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 · 100% clinician | no trial data cached |
| Therapy non-responder | 72 | 9.9 7.9–12.5ROR 10.1 · χ² 570 / p 3e-126 | 9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 97% clinician | no trial data cached |
| Covid-19 pneumonia | 17 | 8.8 5.5–14.1ROR 8.8 · χ² 110 / p 6e-26 | 7.6 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Paraesthesia oral | 18 | 7.7 4.9–12.2ROR 7.7 · χ² 98 / p 2e-23 | 6.7 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Drug ineffective for unapproved indication | 68 | 7.5 5.9–9.5ROR 7.6 · χ² 377 / p 2e-84 | 7.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 · 94% clinician | no trial data cached |
| Respiratory failure | 89 | 7.5 6.1–9.2ROR 7.7 · χ² 496 / p 3e-110 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 35% (drug 56%) · 92% clinician | no trial data cached |
| Tachypnoea | 15 | 6.8 4.1–11.3ROR 6.8 · χ² 69 / p 6e-17 | 5.8 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | no trial data cached |
| Intestinal perforation | 12 | 6.6 3.7–11.6ROR 6.6 · χ² 51 / p 4e-13 | 5.4 EB05 3.3 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Ventricular extrasystoles | 11 | 6.5 3.6–11.7ROR 6.5 · χ² 46 / p 6e-12 | 5.3 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 5.3 | no trial data cached |
| Acute respiratory failure | 20 | 6.4 4.1–9.9ROR 6.5 · χ² 86 / p 8e-21 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.8 · 95% clinician | no trial data cached |
| Insurance issue | 15 | 6.2 3.7–10.3ROR 6.2 · χ² 60 / p 4e-15 | 5.3 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Salivary hypersecretion | 10 | 6.2 3.3–11.4ROR 6.2 · χ² 38 / p 3e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pneumocystis jirovecii pneumonia | 10 | 6.2 3.3–11.4ROR 6.2 · χ² 38 / p 3e-10 | 4.9 EB05 2.9 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Lymphopenia | 14 | 6.1 3.6–10.3ROR 6.1 · χ² 55 / p 6e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Multiple organ dysfunction syndrome | 27 | 5.9 4.1–8.7ROR 6.0 · χ² 106 / p 3e-25 | 5.4 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Dysarthria (slurred speech) | 36 | 5.9 4.3–8.1ROR 5.9 · χ² 141 / p 7e-33 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Muscular weakness | 104 | 5.6 4.7–6.8ROR 5.8 · χ² 393 / p 1e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Orthostatic hypotension (dizziness on standing) | 15 | 5.3 3.2–8.8ROR 5.3 · χ² 48 / p 2e-12 | 4.6 EB05 3.0 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Drug-induced liver injury | 26 | 5.2 3.5–7.6ROR 5.2 · χ² 84 / p 3e-20 | 4.8 EB05 3.4 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · ♀ 29% (drug 56%) · 100% clinician | no trial data cached |
| Mental status changes | 23 | 5.1 3.4–7.6ROR 5.1 · χ² 72 / p 1e-17 | 4.6 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Dysphagia (difficulty swallowing) | 77 | 5.0 4.0–6.2ROR 5.1 · χ² 243 / p 4e-55 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Cytokine release syndrome | 15 | 4.8 2.9–8.0ROR 4.9 · χ² 42 / p 5e-11 | 4.3 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Therapeutic response shortened | 25 | 4.8 3.3–7.1ROR 4.9 · χ² 72 / p 1e-17 | 4.5 EB05 3.2 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 8.0 | no trial data cached |
| Rib fracture | 16 | 4.8 2.9–7.8ROR 4.8 · χ² 44 / p 1e-11 | 4.3 EB05 2.8 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 | no trial data cached |
| Respiratory distress | 21 | 4.7 3.1–7.2ROR 4.7 · χ² 57 / p 2e-14 | 4.3 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 · 100% clinician | no trial data cached |
| Syringe issue | 13 | 4.6 2.6–7.8ROR 4.6 · χ² 33 / p 6e-9 | 4.0 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Choking | 14 | 4.4 2.6–7.5ROR 4.4 · χ² 34 / p 3e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Bradycardia (slow heart rate) | 37 | 4.3 3.1–5.9ROR 4.3 · χ² 90 / p 1e-21 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 97% clinician | no trial data cached |
| Drug effective for unapproved indication | 20 | 4.2 2.7–6.5ROR 4.2 · χ² 46 / p 7e-12 | 3.9 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=9 | no trial data cached |
| Pneumonia aspiration | 17 | 4.2 2.6–6.7ROR 4.2 · χ² 38 / p 3e-10 | 3.8 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Ventricular tachycardia | 11 | 4.1 2.3–7.4ROR 4.1 · χ² 23 / p 1e-6 | 3.6 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 | no trial data cached |
| Osteoporosis | 27 | 4.0 2.8–5.9ROR 4.1 · χ² 59 / p 1e-14 | 3.8 EB05 2.7 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 · ♀ 22% (drug 56%) | no trial data cached |
| Intentional product use issue | 57 | 4.0 3.1–5.2ROR 4.0 · χ² 125 / p 3e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Delusion | 10 | 4.0 2.1–7.4ROR 4.0 · χ² 19 / p 5e-6 | 3.4 EB05 2.0 · IC025 +0.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Photophobia (light sensitivity) | 12 | 4.0 2.2–7.0ROR 4.0 · χ² 24 / p 6e-7 | 3.5 EB05 2.2 · IC025 +0.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Drug resistance | 16 | 3.8 2.3–6.2ROR 3.8 · χ² 31 / p 2e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.2 | 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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 465 | 3.3 3.0–3.6ROR 3.7 · χ² 772 / p 4e-170 | 3.3 EB05 3.0 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Product dose omission issue | 105 | 2.3 1.9–2.7ROR 2.3 · χ² 74 / p 4e-18 | 2.3 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 5.0 · 83% consumer | no trial data cached |
| Muscular weakness | 104 | 5.6 4.7–6.8ROR 5.8 · χ² 393 / p 1e-87 | 5.5 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 4.9 | no trial data cached |
| Respiratory failure | 89 | 7.5 6.1–9.2ROR 7.7 · χ² 496 / p 3e-110 | 7.3 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 · ♀ 35% (drug 56%) · 92% clinician | no trial data cached |
| Covid-19 | 83 | 2.9 2.3–3.6ROR 2.9 · χ² 101 / p 5e-24 | 2.8 EB05 2.4 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Dysphagia (difficulty swallowing) | 77 | 5.0 4.0–6.2ROR 5.1 · χ² 243 / p 4e-55 | 4.9 EB05 4.0 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Therapy non-responder | 72 | 9.9 7.9–12.5ROR 10.1 · χ² 570 / p 3e-126 | 9.7 EB05 7.9 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 97% clinician | no trial data cached |
| Drug ineffective for unapproved indication | 68 | 7.5 5.9–9.5ROR 7.6 · χ² 377 / p 2e-84 | 7.2 EB05 5.9 · IC025 +2.4 3/3 methods agree | Reporting / coding artifact | serious PRR 11.3 · 94% clinician | no trial data cached |
| Diplopia (double vision) | 65 | 15.4 12.1–19.6ROR 15.7 · χ² 860 / p 2e-189 | 15.3 EB05 12.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 | no trial data cached |
| Eyelid ptosis | 63 | 38.3 30.0–48.9ROR 39.0 · χ² 2,237 / p <1e-300 | 37.7 EB05 30.5 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=51 | no trial data cached |
| Intentional product use issue | 57 | 4.0 3.1–5.2ROR 4.0 · χ² 125 / p 3e-29 | 3.9 EB05 3.1 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 2.7 | no trial data cached |
| Hospitalisation | 49 | 2.0 1.5–2.6ROR 2.0 · χ² 23 / p 9e-7 | 2.0 EB05 1.5 · IC025 +0.5 | Reporting / coding artifact | serious PRR 1.5 · 74% consumer | no trial data cached |
| Therapeutic product effect incomplete | 43 | 3.7 2.8–5.0ROR 3.8 · χ² 84 / p 3e-20 | 3.6 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Bradycardia (slow heart rate) | 37 | 4.3 3.1–5.9ROR 4.3 · χ² 90 / p 1e-21 | 4.1 EB05 3.1 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 · 97% clinician | no trial data cached |
| Dysarthria (slurred speech) | 36 | 5.9 4.3–8.1ROR 5.9 · χ² 141 / p 7e-33 | 5.5 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | 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.
- Eyelid ptosis — n=63, PRR 38.3
- Diplopia — n=65, PRR 15.4
- Rebound effect — n=28, PRR 15.2
- Osteopenia — n=25, PRR 10.1
- Respiratory failure — n=89, PRR 7.5
- Acute respiratory failure — n=20, PRR 6.4
- Multiple organ dysfunction syndrome — n=27, PRR 5.9
- Dysarthria — n=36, PRR 5.9
- Muscular weakness — n=104, PRR 5.6
- Drug-induced liver injury — n=26, PRR 5.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Minoxidil (oral) ↔ Pericardial effusion.
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 Pyridostigmine?
In FDA FAERS, the most frequently co-reported reaction terms for Pyridostigmine are muscular weakness, respiratory failure, covid-19, dysphagia, diplopia, eyelid ptosis. 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 Pyridostigmine have an FDA boxed warning?
No. The FDA label retrieved for Pyridostigmine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Pyridostigmine 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 ef78ff05-8e0f-463a-88cd-ca9a01aed76a, effective 20190311; matched on
openfda.generic_name.exact:"PYRIDOSTIGMINE BROMIDE ORAL") - 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, 144 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.