Drug · FAERS side-effect profile with label screen

Acetylcholine and Helicobacter Pylori Dna side effects: what 65 FDA adverse event reports show

Acetylcholine Chloride, Helicobacter Pylori Dna · 14 reaction terms · 350 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Acetylcholine Chloride, Helicobacter Pylori Dna (Acetylcholine Chloride)

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

Who reports

65 reports · 86% serious · 0 with death outcome · 76% female

openFDA FAERS counts, all years, deduplication not applied

Used for

• For the temporary relief of symptoms including: • dizziness • chest congestion • cough • fatigue • rash • itching • headache • poor memory These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.

FDA label, Indications and Usage

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 13 strongest signals

Lab value / disease marker 1No label text to screen 12

What the badges mean

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.
No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.

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
Full blood count abnormal	24	735.9 535.3–1,011.8ROR 1,166.1 · χ² 16,856 / p <1e-300	462.4 EB05 327.0 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious PRR 651.7 · ♀ 100% (drug 76%)	no trial data cached
Sleep disorder due to a general medical condition	28	559.5 422.9–740.2ROR 982.1 · χ² 15,041 / p <1e-300	403.9 EB05 293.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 739.0 · ♀ 100% (drug 76%)	no trial data cached
Eosinophilia	27	499.3 374.0–666.4ROR 853.3 · χ² 12,923 / p <1e-300	368.1 EB05 265.7 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 348.6 · ♀ 100% (drug 76%)	no trial data cached
Sinus disorder	27	439.8 329.5–587.0ROR 751.5 · χ² 11,380 / p <1e-300	334.8 EB05 241.7 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 632.8 · ♀ 100% (drug 76%)	no trial data cached
Mental impairment	27	359.3 269.2–479.5ROR 613.8 · χ² 9,292 / p <1e-300	286.2 EB05 206.5 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 302.2 · ♀ 100% (drug 76%)	no trial data cached
Respiratory disorder	27	290.6 217.7–387.8ROR 496.4 · χ² 7,509 / p <1e-300	240.9 EB05 173.9 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 240.4 · ♀ 100% (drug 76%)	no trial data cached
Mental disorder	27	199.9 149.8–266.8ROR 341.3 · χ² 5,155 / p <1e-300	175.2 EB05 126.5 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 162.3 · ♀ 100% (drug 76%)	no trial data cached
Productive cough (cough with phlegm)	27	184.1 138.0–245.7ROR 314.2 · χ² 4,743 / p <1e-300	163.0 EB05 117.6 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 183.0 · ♀ 100% (drug 76%)	no trial data cached
Loss of personal independence in daily activities	25	169.7 124.7–230.8ROR 275.1 · χ² 4,032 / p <1e-300	150.3 EB05 107.1 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 149.3 · ♀ 100% (drug 76%)	no trial data cached
Chronic obstructive pulmonary disease	27	167.1 125.3–223.1ROR 285.2 · χ² 4,303 / p <1e-300	149.6 EB05 108.0 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 130.3 · ♀ 100% (drug 76%)	no trial data cached
Nasal congestion (stuffy nose)	27	148.9 111.6–198.7ROR 253.9 · χ² 3,828 / p <1e-300	134.8 EB05 97.3 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 231.2 · ♀ 100% (drug 76%)	no trial data cached
Rhinorrhoea (runny nose)	27	135.2 101.3–180.4ROR 230.6 · χ² 3,473 / p <1e-300	123.5 EB05 89.2 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 217.5 · ♀ 100% (drug 76%)	no trial data cached
Breast cancer	27	92.6 69.4–123.6ROR 157.7 · χ² 2,367 / p <1e-300	87.1 EB05 62.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 62.2 · ♀ 100% (drug 76%)	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
Sleep disorder due to a general medical condition	28	559.5 422.9–740.2ROR 982.1 · χ² 15,041 / p <1e-300	403.9 EB05 293.3 · IC025 +5.1 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 739.0 · ♀ 100% (drug 76%)	no trial data cached
Breast cancer	27	92.6 69.4–123.6ROR 157.7 · χ² 2,367 / p <1e-300	87.1 EB05 62.8 · IC025 +4.5 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 62.2 · ♀ 100% (drug 76%)	no trial data cached
Rhinorrhoea (runny nose)	27	135.2 101.3–180.4ROR 230.6 · χ² 3,473 / p <1e-300	123.5 EB05 89.2 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 217.5 · ♀ 100% (drug 76%)	no trial data cached
Nasal congestion (stuffy nose)	27	148.9 111.6–198.7ROR 253.9 · χ² 3,828 / p <1e-300	134.8 EB05 97.3 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 231.2 · ♀ 100% (drug 76%)	no trial data cached
Chronic obstructive pulmonary disease	27	167.1 125.3–223.1ROR 285.2 · χ² 4,303 / p <1e-300	149.6 EB05 108.0 · IC025 +4.7 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 130.3 · ♀ 100% (drug 76%)	no trial data cached
Productive cough (cough with phlegm)	27	184.1 138.0–245.7ROR 314.2 · χ² 4,743 / p <1e-300	163.0 EB05 117.6 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 183.0 · ♀ 100% (drug 76%)	no trial data cached
Mental disorder	27	199.9 149.8–266.8ROR 341.3 · χ² 5,155 / p <1e-300	175.2 EB05 126.5 · IC025 +4.8 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 162.3 · ♀ 100% (drug 76%)	no trial data cached
Respiratory disorder	27	290.6 217.7–387.8ROR 496.4 · χ² 7,509 / p <1e-300	240.9 EB05 173.9 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 240.4 · ♀ 100% (drug 76%)	no trial data cached
Mental impairment	27	359.3 269.2–479.5ROR 613.8 · χ² 9,292 / p <1e-300	286.2 EB05 206.5 · IC025 +4.9 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 302.2 · ♀ 100% (drug 76%)	no trial data cached
Sinus disorder	27	439.8 329.5–587.0ROR 751.5 · χ² 11,380 / p <1e-300	334.8 EB05 241.7 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 632.8 · ♀ 100% (drug 76%)	no trial data cached
Eosinophilia	27	499.3 374.0–666.4ROR 853.3 · χ² 12,923 / p <1e-300	368.1 EB05 265.7 · IC025 +5.0 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 348.6 · ♀ 100% (drug 76%)	no trial data cached
Loss of personal independence in daily activities	25	169.7 124.7–230.8ROR 275.1 · χ² 4,032 / p <1e-300	150.3 EB05 107.1 · IC025 +4.6 3/3 methods agree	No label text to screen label has no adverse-reaction text	serious PRR 149.3 · ♀ 100% (drug 76%)	no trial data cached
Full blood count abnormal	24	735.9 535.3–1,011.8ROR 1,166.1 · χ² 16,856 / p <1e-300	462.4 EB05 327.0 · IC025 +4.8 3/3 methods agree	Lab value / disease marker	serious PRR 651.7 · ♀ 100% (drug 76%)	no trial data cached
Blood count abnormal	3	62.9 20.8–190.1ROR 65.9 · χ² 126 / p 1e-29	42.9 EB05 12.0 · IC025 +0.6 3/3 methods agree	Lab value / disease marker	serious PRR 58.9	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 Acetylcholine and Helicobacter Pylori Dna?

In FDA FAERS, the most frequently co-reported reaction terms for Acetylcholine and Helicobacter Pylori Dna are sleep disorder due to a general medical condition, breast cancer, rhinorrhoea, nasal congestion, chronic obstructive pulmonary disease, productive cough. 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 Acetylcholine and Helicobacter Pylori Dna have an FDA boxed warning?

No. The FDA label retrieved for Acetylcholine and Helicobacter Pylori Dna has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Acetylcholine and Helicobacter Pylori Dna 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 8586b46c-4853-4b26-ac39-88e701930081, effective 20240312; matched on openfda.generic_name.exact:"ACETYLCHOLINE CHLORIDE, HELICOBACTER PYLORI DNA")
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, 14 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.