Drug · FAERS side-effect profile with label screen

Ampicillin and Sulbactam side effects: what 859 FDA adverse event reports show

Ampicillin And Sulbactam · 36 reaction terms · 346 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Label matched

Ampicillin (Ampicillin)

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

Who reports

859 reports · 95% serious · 187 with death outcome · 44% female

openFDA FAERS counts, all years, deduplication not applied

Used for

To reduce the development of drug-resistant bacteria and maintain the effectiveness of ampicillin capsules, ampicillin for oral suspension and other antibacterial drugs, ampicillin capsules and ampicillin for oral suspension should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

FDA label, Indications and Usage

What it is

DESCRIPTION Ampicillin trihydrate is a semisynthetic penicillin derived from the basic penicillin nucleus, 6- aminopenicillanic acid. Ampicillin is designated chemically as (2S, 5 R , 6 R )-6-[( R )-2-Amino-2-phenylacetamido]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo [3.2.0] heptane-2- carboxylic acid.

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 31 strongest signals

Labeled adverse reaction 6Labeled (related wording) 4Likely indication confounding 3Reporting / coding artifact 2Not in label — unassessed 16

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.
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. 5 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
Multiple organ dysfunction syndrome	31	27.1 19.2–38.4ROR 28.1 · χ² 755 / p 2e-166	26.7 EB05 19.7 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.4 · 100% clinician	no trial data cached
Candida infection (yeast infection)	18	26.4 16.7–41.6ROR 26.9 · χ² 414 / p 2e-92	25.7 EB05 17.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.9	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	14	22.7 13.5–38.1ROR 23.0 · χ² 269 / p 1e-60	21.9 EB05 13.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.7	no trial data cached
Pneumocystis jirovecii pneumonia	8	19.6 9.8–39.0ROR 19.7 · χ² 123 / p 8e-29	17.7 EB05 8.1 · IC025 +2.0 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 11.9	no trial data cached
Bacteraemia	9	18.7 9.7–35.8ROR 18.9 · χ² 133 / p 4e-31	17.1 EB05 8.3 · IC025 +2.1 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 11.4	no trial data cached
Drug eruption	13	18.0 10.5–30.9ROR 18.3 · χ² 192 / p 5e-44	17.2 EB05 10.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.6	no trial data cached
Generalised oedema	9	17.9 9.3–34.2ROR 18.0 · χ² 127 / p 1e-29	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0	no trial data cached
Septic shock	29	16.4 11.5–23.4ROR 16.9 · χ² 404 / p 3e-90	16.1 EB05 11.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 96% clinician	no trial data cached
Erythema multiforme	6	15.7 7.1–34.9ROR 15.8 · χ² 69 / p 6e-17	12.2 EB05 4.6 · IC025 +1.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.8	no trial data cached
Pneumonia aspiration	16	15.7 9.6–25.5ROR 16.0 · χ² 206 / p 6e-47	14.9 EB05 9.2 · IC025 +2.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 9.5	no trial data cached
Acute respiratory distress syndrome	11	15.2 8.4–27.3ROR 15.4 · χ² 132 / p 8e-31	13.7 EB05 7.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Status epilepticus	7	15.1 7.2–31.6ROR 15.2 · χ² 79 / p 4e-19	12.2 EB05 5.0 · IC025 +1.7 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Cytomegalovirus infection	10	14.7 7.9–27.2ROR 14.8 · χ² 114 / p 6e-27	12.9 EB05 6.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Drug resistance	14	13.3 7.9–22.4ROR 13.5 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Nephropathy toxic	6	13.2 5.9–29.2ROR 13.2 · χ² 56 / p 4e-14	9.5 EB05 3.8 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Vasculitis	6	12.6 5.7–27.9ROR 12.6 · χ² 53 / p 2e-13	9.0 EB05 3.7 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 8.2	no trial data cached
Rebound effect	5	10.8 4.5–25.8ROR 10.8 · χ² 35 / p 2e-9	6.9 EB05 2.8 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 10.5	no trial data cached
Premature delivery	7	10.7 5.1–22.3ROR 10.8 · χ² 52 / p 3e-13	7.7 EB05 3.6 · IC025 +1.4 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	11	10.5 5.8–18.9ROR 10.6 · χ² 85 / p 1e-20	8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Hemiparesis	7	10.0 4.8–21.0ROR 10.1 · χ² 48 / p 2e-12	7.2 EB05 3.4 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.6	no trial data cached
Premature baby	12	9.7 5.5–17.0ROR 9.8 · χ² 85 / p 1e-20	8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Jaundice (yellowing of skin/eyes)	10	9.0 4.9–16.8ROR 9.1 · χ² 64 / p 7e-16	7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2	no trial data cached
Acute hepatic failure	5	9.0 3.7–21.5ROR 9.0 · χ² 28 / p 6e-8	5.7 EB05 2.5 · IC025 +0.8 3/3 methods agree	Not in label — unassessed	serious PRR 5.4	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	8	8.8 4.4–17.5ROR 8.8 · χ² 48 / p 3e-12	6.5 EB05 3.3 · IC025 +1.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.4	no trial data cached
Paranoia	6	8.5 3.8–18.8ROR 8.5 · χ² 32 / p 6e-9	5.7 EB05 2.7 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Rash generalised	9	8.4 4.4–16.0ROR 8.4 · χ² 51 / p 4e-13	6.4 EB05 3.4 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.7	no trial data cached
Osteonecrosis of jaw (jawbone death)	8	7.8 3.9–15.6ROR 7.9 · χ² 41 / p 7e-11	5.8 EB05 3.1 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Cholestasis (bile flow blockage)	6	7.7 3.5–17.0ROR 7.7 · χ² 28 / p 5e-8	5.3 EB05 2.5 · IC025 +0.9 3/3 methods agree	Not in label — unassessed	serious PRR 4.7	no trial data cached
Agranulocytosis (severe loss of white cells)	5	6.6 2.8–15.8ROR 6.6 · χ² 19 / p 8e-6	4.4 EB05 2.1 · IC025 +0.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.0	no trial data cached
Peritonitis	5	5.9 2.5–14.1ROR 5.9 · χ² 16 / p 4e-5	4.1 EB05 1.9 · IC025 +0.5	Not in label — unassessed	serious PRR 3.6	no trial data cached
Foetal exposure during pregnancy	17	5.1 3.2–8.2ROR 5.2 · χ² 52 / p 2e-13	4.5 EB05 3.0 · IC025 +1.4 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
Multiple organ dysfunction syndrome	31	27.1 19.2–38.4ROR 28.1 · χ² 755 / p 2e-166	26.7 EB05 19.7 · IC025 +3.7 3/3 methods agree	Labeled (related wording) related wording	serious PRR 16.4 · 100% clinician	no trial data cached
Septic shock	29	16.4 11.5–23.4ROR 16.9 · χ² 404 / p 3e-90	16.1 EB05 11.6 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.9 · 96% clinician	no trial data cached
Candida infection (yeast infection)	18	26.4 16.7–41.6ROR 26.9 · χ² 414 / p 2e-92	25.7 EB05 17.2 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 22.9	no trial data cached
Foetal exposure during pregnancy	17	5.1 3.2–8.2ROR 5.2 · χ² 52 / p 2e-13	4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree	Reporting / coding artifact	serious PRR 3.2	no trial data cached
Pneumonia aspiration	16	15.7 9.6–25.5ROR 16.0 · χ² 206 / p 6e-47	14.9 EB05 9.2 · IC025 +2.6 3/3 methods agree	Likely indication confounding shares a disease stem with the indications wording	serious PRR 9.5	no trial data cached
Drug resistance	14	13.3 7.9–22.4ROR 13.5 · χ² 147 / p 3e-34	12.1 EB05 6.9 · IC025 +2.3 3/3 methods agree	Reporting / coding artifact	serious PRR 9.1	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	14	22.7 13.5–38.1ROR 23.0 · χ² 269 / p 1e-60	21.9 EB05 13.7 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.7	no trial data cached
Drug eruption	13	18.0 10.5–30.9ROR 18.3 · χ² 192 / p 5e-44	17.2 EB05 10.0 · IC025 +2.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 11.6	no trial data cached
Premature baby	12	9.7 5.5–17.0ROR 9.8 · χ² 85 / p 1e-20	8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	11	10.5 5.8–18.9ROR 10.6 · χ² 85 / p 1e-20	8.6 EB05 4.7 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.4	no trial data cached
Acute respiratory distress syndrome	11	15.2 8.4–27.3ROR 15.4 · χ² 132 / p 8e-31	13.7 EB05 7.2 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.2	no trial data cached
Jaundice (yellowing of skin/eyes)	10	9.0 4.9–16.8ROR 9.1 · χ² 64 / p 7e-16	7.1 EB05 3.9 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.2	no trial data cached
Cytomegalovirus infection	10	14.7 7.9–27.2ROR 14.8 · χ² 114 / p 6e-27	12.9 EB05 6.4 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.0	no trial data cached
Rash generalised	9	8.4 4.4–16.0ROR 8.4 · χ² 51 / p 4e-13	6.4 EB05 3.4 · IC025 +1.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 6.7	no trial data cached
Generalised oedema	9	17.9 9.3–34.2ROR 18.0 · χ² 127 / p 1e-29	16.2 EB05 7.8 · IC025 +2.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 12.0	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.

Septic shock — n=29, PRR 16.4

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 Ampicillin and Sulbactam?

In FDA FAERS, the most frequently co-reported reaction terms for Ampicillin and Sulbactam are multiple organ dysfunction syndrome, septic shock, candida infection, pneumonia aspiration, toxic epidermal necrolysis, drug eruption. 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 Ampicillin and Sulbactam have an FDA boxed warning?

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

Do FAERS signals prove that Ampicillin and Sulbactam 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 0a66c5c3-63bf-46e3-835e-26b555ab6954, effective 20250717; matched on openfda.generic_name.exact:"AMPICILLIN")
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, 36 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.