Drug · FAERS side-effect profile with label screen
Ampicillin and Sulbactam side effects: what 2,550 FDA adverse event reports show
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
2,550 reports · 94% serious · 520 with death outcome · 48% 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 40 strongest signals
Labeled adverse reaction 3Labeled (related wording) 7Likely indication confounding 2Lab value / disease marker 4Not in label — unassessed 24
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.
- 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. 186 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 |
|---|---|---|---|---|---|---|
| Drug eruption | 46 | 21.5 16.2–28.7ROR 21.9 · χ² 878 / p 3e-193 | 21.3 EB05 16.6 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.5 | no trial data cached |
| Pneumonia aspiration | 58 | 19.2 14.9–24.8ROR 19.6 · χ² 981 / p 1e-215 | 19.0 EB05 15.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.8 · 91% clinician | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 35 | 19.1 13.8–26.6ROR 19.4 · χ² 583 / p 5e-129 | 18.9 EB05 14.2 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.7 | no trial data cached |
| Disseminated intravascular coagulation | 32 | 18.7 13.2–26.4ROR 18.9 · χ² 517 / p 9e-115 | 18.4 EB05 13.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 11.5 · 90% clinician | no trial data cached |
| Acute respiratory distress syndrome | 34 | 15.8 11.3–22.1ROR 16.0 · χ² 457 / p 9e-102 | 15.6 EB05 11.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Atelectasis | 18 | 15.3 9.6–24.2ROR 15.4 · χ² 226 / p 2e-51 | 14.6 EB05 9.3 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Hepatic function abnormal | 64 | 14.2 11.2–18.1ROR 14.6 · χ² 774 / p 1e-170 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 · 97% clinician | no trial data cached |
| Blood lactate dehydrogenase increased | 27 | 13.9 9.6–20.3ROR 14.1 · χ² 311 / p 5e-70 | 13.5 EB05 9.4 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious PRR 8.8 | no trial data cached |
| Clostridium difficile colitis | 17 | 13.2 8.2–21.2ROR 13.3 · χ² 179 / p 3e-41 | 12.2 EB05 7.5 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.2 | no trial data cached |
| Deformity | 15 | 13.2 8.0–21.8ROR 13.3 · χ² 157 / p 3e-36 | 12.1 EB05 7.1 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.2 | no trial data cached |
| Osteonecrosis of jaw (jawbone death) | 36 | 11.9 8.6–16.5ROR 12.1 · χ² 348 / p 5e-78 | 11.5 EB05 8.4 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Bacteraemia | 17 | 11.9 7.4–19.1ROR 12.0 · χ² 159 / p 1e-36 | 10.8 EB05 6.6 · IC025 +2.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.3 | no trial data cached |
| Sinus tachycardia | 20 | 11.6 7.5–18.0ROR 11.7 · χ² 184 / p 4e-42 | 10.7 EB05 6.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Erythema multiforme | 13 | 11.5 6.7–19.8ROR 11.5 · χ² 114 / p 6e-27 | 9.9 EB05 5.6 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Multi-organ failure | 24 | 11.3 7.6–16.8ROR 11.4 · χ² 214 / p 8e-49 | 10.5 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 | no trial data cached |
| Gamma-glutamyltransferase increased | 30 | 11.1 7.8–15.9ROR 11.3 · χ² 267 / p 3e-60 | 10.5 EB05 7.5 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 7.3 · 93% clinician | no trial data cached |
| Osteomyelitis | 24 | 10.9 7.3–16.3ROR 11.0 · χ² 206 / p 4e-47 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Multiple organ dysfunction syndrome | 37 | 10.9 7.9–15.0ROR 11.1 · χ² 324 / p 1e-72 | 10.4 EB05 7.7 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 · 100% clinician | no trial data cached |
| Interstitial lung disease | 64 | 10.9 8.6–13.9ROR 11.2 · χ² 567 / p 1e-125 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Septic shock | 56 | 10.7 8.2–13.8ROR 10.9 · χ² 482 / p 5e-107 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 100% clinician | no trial data cached |
| C-reactive protein increased | 47 | 10.6 8.0–14.1ROR 10.8 · χ² 401 / p 1e-89 | 10.2 EB05 7.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 | no trial data cached |
| Intervertebral disc degeneration | 12 | 10.6 6.0–18.7ROR 10.7 · χ² 95 / p 9e-23 | 8.9 EB05 5.0 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Toxic skin eruption | 13 | 10.6 6.2–18.2ROR 10.6 · χ² 103 / p 1e-24 | 9.0 EB05 5.2 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 | no trial data cached |
| Cholecystitis | 15 | 10.4 6.3–17.2ROR 10.5 · χ² 118 / p 8e-28 | 9.0 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Candida infection (yeast infection) | 21 | 10.4 6.8–15.9ROR 10.4 · χ² 168 / p 8e-39 | 9.4 EB05 6.2 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 28 | 10.3 7.2–15.0ROR 10.5 · χ² 227 / p 1e-51 | 9.6 EB05 6.8 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.4 · 92% clinician | no trial data cached |
| Aspiration | 13 | 9.9 5.7–17.0ROR 9.9 · χ² 95 / p 9e-23 | 8.3 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Anaphylactic shock | 30 | 9.6 6.8–13.8ROR 9.7 · χ² 224 / p 7e-51 | 8.9 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 100% clinician | no trial data cached |
| Malnutrition | 13 | 9.6 5.6–16.6ROR 9.7 · χ² 92 / p 4e-22 | 8.0 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 | no trial data cached |
| Blood urea increased | 19 | 9.3 5.9–14.5ROR 9.4 · χ² 132 / p 6e-31 | 8.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Lab value / disease marker | serious PRR 6.3 | no trial data cached |
| Renal failure acute | 48 | 9.2 6.9–12.2ROR 9.3 · χ² 342 / p 1e-76 | 8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Leukocytosis | 20 | 9.1 5.9–14.1ROR 9.2 · χ² 136 / p 9e-32 | 8.1 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Iron deficiency anaemia | 10 | 9.0 4.8–16.6ROR 9.0 · χ² 63 / p 1e-15 | 7.0 EB05 3.9 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Dental caries | 12 | 8.9 5.1–15.7ROR 9.0 · χ² 77 / p 9e-19 | 7.3 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 8.5 | no trial data cached |
| Cellulitis (skin infection) | 54 | 8.8 6.8–11.5ROR 9.0 · χ² 367 / p 5e-82 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Arteriosclerosis | 10 | 8.7 4.7–16.2ROR 8.8 · χ² 61 / p 3e-15 | 6.8 EB05 3.8 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Generalised oedema | 13 | 8.7 5.1–15.0ROR 8.7 · χ² 81 / p 1e-19 | 7.2 EB05 4.3 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.9 | no trial data cached |
| Bone disorder | 19 | 8.5 5.4–13.3ROR 8.6 · χ² 119 / p 7e-28 | 7.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Aspartate aminotransferase increased | 54 | 8.4 6.4–10.9ROR 8.5 · χ² 344 / p 5e-77 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 98% clinician | no trial data cached |
| Renal tubular necrosis | 10 | 8.4 4.5–15.5ROR 8.4 · χ² 58 / p 2e-14 | 6.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 | 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 |
|---|---|---|---|---|---|---|
| Sepsis (blood infection) | 92 | 6.8 5.6–8.3ROR 7.0 · χ² 450 / p 3e-100 | 6.6 EB05 5.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 | no trial data cached |
| Respiratory failure | 67 | 7.6 6.0–9.6ROR 7.7 · χ² 376 / p 5e-84 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 92% clinician | no trial data cached |
| Interstitial lung disease | 64 | 10.9 8.6–13.9ROR 11.2 · χ² 567 / p 1e-125 | 10.6 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Hepatic function abnormal | 64 | 14.2 11.2–18.1ROR 14.6 · χ² 774 / p 1e-170 | 14.1 EB05 11.3 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.5 · 97% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 60 | 4.4 3.4–5.7ROR 4.5 · χ² 157 / p 3e-36 | 4.3 EB05 3.5 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 · 91% clinician | no trial data cached |
| Platelet count decreased | 60 | 4.6 3.6–6.0ROR 4.7 · χ² 168 / p 9e-39 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.5 · 95% clinician | no trial data cached |
| Alanine aminotransferase increased | 58 | 7.8 6.0–10.0ROR 7.9 · χ² 336 / p 2e-75 | 7.4 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.1 · 93% clinician | no trial data cached |
| Pneumonia aspiration | 58 | 19.2 14.9–24.8ROR 19.6 · χ² 981 / p 1e-215 | 19.0 EB05 15.2 · IC025 +3.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 11.8 · 91% clinician | no trial data cached |
| Septic shock | 56 | 10.7 8.2–13.8ROR 10.9 · χ² 482 / p 5e-107 | 10.3 EB05 8.2 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 · 100% clinician | no trial data cached |
| Aspartate aminotransferase increased | 54 | 8.4 6.4–10.9ROR 8.5 · χ² 344 / p 5e-77 | 8.0 EB05 6.3 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.4 · 98% clinician | no trial data cached |
| Cellulitis (skin infection) | 54 | 8.8 6.8–11.5ROR 9.0 · χ² 367 / p 5e-82 | 8.4 EB05 6.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pleural effusion | 51 | 6.9 5.3–9.0ROR 7.0 · χ² 252 / p 6e-57 | 6.5 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Renal impairment | 48 | 4.7 3.6–6.2ROR 4.8 · χ² 138 / p 5e-32 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 92% clinician | no trial data cached |
| Renal failure acute | 48 | 9.2 6.9–12.2ROR 9.3 · χ² 342 / p 1e-76 | 8.7 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| C-reactive protein increased | 47 | 10.6 8.0–14.1ROR 10.8 · χ² 401 / p 1e-89 | 10.2 EB05 7.9 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 6.6 | 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.
- Disseminated intravascular coagulation — n=32, PRR 18.7
- Acute respiratory distress syndrome — n=34, PRR 15.8
- Osteonecrosis of jaw — n=36, PRR 11.9
- Sinus tachycardia — n=20, PRR 11.6
- Multi-organ failure — n=24, PRR 11.3
- Osteomyelitis — n=24, PRR 10.9
- Interstitial lung disease — n=64, PRR 10.9
- Septic shock — n=56, PRR 10.7
- Candida infection — n=21, PRR 10.4
- Anaphylactic shock — n=30, PRR 9.6
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 sepsis, respiratory failure, interstitial lung disease, hepatic function abnormal, thrombocytopenia, platelet count decreased. 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, fieldpatient.drug.openfda.generic_name.exact, 226 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.