Drug · FAERS side-effect profile with label screen
Escherichia Coli side effects: what 393 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Colibacillinum
openFDA label
Who reports
393 reports · 99% serious · 288 with death outcome · 58% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Rx Only
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 33 strongest signals
Reporting / coding artifact 1Lab value / disease marker 1No label text to screen 31
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.
- 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. 0 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 |
|---|---|---|---|---|---|---|
| Ocular discomfort | 220 | 1,103.4 1,008.7–1,207.0ROR 2,505.3 · χ² 236,378 / p <1e-300 | 987.2 EB05 882.4 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=220 · 92% clinician | no trial data cached |
| Generalised oedema | 196 | 863.1 780.4–954.5ROR 1,720.8 · χ² 165,300 / p <1e-300 | 783.7 EB05 695.8 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 546.7 · 95% clinician | no trial data cached |
| Head discomfort | 218 | 668.7 611.2–731.5ROR 1,500.4 · χ² 142,971 / p <1e-300 | 623.9 EB05 557.4 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 681.3 · 93% clinician | no trial data cached |
| Altered state of consciousness | 218 | 545.3 498.5–596.4ROR 1,223.3 · χ² 116,804 / p <1e-300 | 515.2 EB05 460.3 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 316.1 · 93% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 219 | 463.6 424.2–506.8ROR 1,045.9 · χ² 99,881 / p <1e-300 | 441.8 EB05 394.8 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 273.0 · 93% clinician | no trial data cached |
| Photophobia (light sensitivity) | 159 | 458.3 406.1–517.1ROR 769.0 · χ² 71,536 / p <1e-300 | 430.7 EB05 377.4 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 427.2 · 94% clinician | no trial data cached |
| Presyncope (near-fainting) | 185 | 411.1 369.9–456.9ROR 775.8 · χ² 74,772 / p <1e-300 | 391.3 EB05 346.2 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 303.1 · 95% clinician | no trial data cached |
| Diplopia (double vision) | 185 | 382.7 344.4–425.3ROR 722.3 · χ² 69,636 / p <1e-300 | 365.6 EB05 323.5 · IC025 +7.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 301.8 · 95% clinician | no trial data cached |
| Ascites | 208 | 380.0 345.9–417.4ROR 806.1 · χ² 77,789 / p <1e-300 | 364.6 EB05 324.9 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 222.0 · 93% clinician | no trial data cached |
| Haematuria (blood in urine) | 190 | 297.2 268.2–329.4ROR 574.4 · χ² 55,570 / p <1e-300 | 287.0 EB05 254.3 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 189.1 · 95% clinician | no trial data cached |
| Blindness | 218 | 287.2 262.7–314.0ROR 643.8 · χ² 61,680 / p <1e-300 | 278.7 EB05 249.0 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.9 · 93% clinician | no trial data cached |
| Cardio-respiratory arrest | 211 | 268.8 245.1–294.8ROR 579.3 · χ² 55,863 / p <1e-300 | 261.2 EB05 232.9 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.5 · 92% clinician | no trial data cached |
| Coma | 214 | 240.6 219.7–263.5ROR 527.0 · χ² 50,704 / p <1e-300 | 234.5 EB05 209.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.2 · 92% clinician | no trial data cached |
| Tinnitus (ringing in the ears) | 187 | 217.7 196.2–241.6ROR 414.4 · χ² 40,045 / p <1e-300 | 212.1 EB05 187.8 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 193.9 · 95% clinician | no trial data cached |
| Eye pain | 217 | 210.5 192.5–230.2ROR 468.8 · χ² 44,970 / p <1e-300 | 205.9 EB05 183.9 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 281.1 · 93% clinician | no trial data cached |
| Tachycardia (fast heart rate) | 226 | 136.1 124.9–148.2ROR 318.8 · χ² 30,216 / p <1e-300 | 134.2 EB05 120.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.3 · 92% clinician | no trial data cached |
| Sepsis (blood infection) | 210 | 100.6 91.7–110.3ROR 214.9 · χ² 20,678 / p <1e-300 | 99.5 EB05 88.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.6 · 93% clinician | no trial data cached |
| Chills | 220 | 100.2 91.7–109.4ROR 226.3 · χ² 21,578 / p <1e-300 | 99.1 EB05 88.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.4 · 93% clinician | no trial data cached |
| Syncope (fainting) | 186 | 99.3 89.5–110.3ROR 187.7 · χ² 18,057 / p <1e-300 | 98.2 EB05 86.9 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 61.3 · 95% clinician | no trial data cached |
| Blood pressure increased | 190 | 66.2 59.8–73.4ROR 127.3 · χ² 12,219 / p <1e-300 | 65.7 EB05 58.3 · IC025 +5.6 3/3 methods agree | Lab value / disease marker | serious PRR 55.8 · 95% clinician | no trial data cached |
| Vision blurred (blurred vision) | 157 | 61.4 54.4–69.3ROR 101.6 · χ² 9,317 / p <1e-300 | 60.9 EB05 53.3 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 68.0 · 94% clinician | no trial data cached |
| Myalgia (muscle pain) | 188 | 59.1 53.3–65.5ROR 112.3 · χ² 10,751 / p <1e-300 | 58.7 EB05 52.0 · IC025 +5.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.8 · 95% clinician | no trial data cached |
| Somnolence (drowsiness) | 190 | 50.5 45.6–55.9ROR 96.8 · χ² 9,244 / p <1e-300 | 50.2 EB05 44.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 50.7 · 95% clinician | no trial data cached |
| Abdominal pain upper | 173 | 45.0 40.2–50.3ROR 79.5 · χ² 7,461 / p <1e-300 | 44.7 EB05 39.4 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 48.9 · 95% clinician | no trial data cached |
| Abdominal pain | 194 | 44.6 40.3–49.3ROR 87.0 · χ² 8,303 / p <1e-300 | 44.3 EB05 39.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 34.4 · 93% clinician | no trial data cached |
| Decreased appetite (loss of appetite) | 187 | 43.1 38.9–47.8ROR 81.3 · χ² 7,730 / p <1e-300 | 42.9 EB05 38.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 38.4 · 95% clinician | no trial data cached |
| Insomnia (trouble sleeping) | 203 | 40.6 36.9–44.7ROR 83.0 · χ² 7,903 / p <1e-300 | 40.5 EB05 36.0 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 44.5 · 93% clinician | no trial data cached |
| Cough | 191 | 36.4 32.9–40.4ROR 70.0 · χ² 6,633 / p <1e-300 | 36.3 EB05 32.2 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 37.6 · 95% clinician | no trial data cached |
| Fall | 223 | 35.8 32.8–39.0ROR 81.5 · χ² 7,628 / p <1e-300 | 35.7 EB05 31.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · 93% clinician | no trial data cached |
| Drug interaction | 93 | 31.3 26.2–37.4ROR 40.7 · χ² 2,716 / p <1e-300 | 31.1 EB05 26.1 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 20.4 · 98% clinician | no trial data cached |
| Pruritus (itching) | 215 | 30.4 27.8–33.2ROR 65.8 · χ² 6,185 / p <1e-300 | 30.3 EB05 27.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.2 · 93% clinician | no trial data cached |
| Arthralgia (joint pain) | 217 | 28.0 25.6–30.6ROR 61.2 · χ² 5,724 / p <1e-300 | 27.9 EB05 24.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.6 · 93% clinician | no trial data cached |
| Asthenia (weakness) | 190 | 27.0 24.4–29.9ROR 51.3 · χ² 4,810 / p <1e-300 | 26.9 EB05 23.8 · IC025 +4.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 22.3 · 95% clinician | 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 |
|---|---|---|---|---|---|---|
| Tachycardia (fast heart rate) | 226 | 136.1 124.9–148.2ROR 318.8 · χ² 30,216 / p <1e-300 | 134.2 EB05 120.1 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 87.3 · 92% clinician | no trial data cached |
| Fall | 223 | 35.8 32.8–39.0ROR 81.5 · χ² 7,628 / p <1e-300 | 35.7 EB05 31.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 25.0 · 93% clinician | no trial data cached |
| Chills | 220 | 100.2 91.7–109.4ROR 226.3 · χ² 21,578 / p <1e-300 | 99.1 EB05 88.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 91.4 · 93% clinician | no trial data cached |
| Ocular discomfort | 220 | 1,103.4 1,008.7–1,207.0ROR 2,505.3 · χ² 236,378 / p <1e-300 | 987.2 EB05 882.4 · IC025 +8.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=220 · 92% clinician | no trial data cached |
| Haematemesis (vomiting blood) | 219 | 463.6 424.2–506.8ROR 1,045.9 · χ² 99,881 / p <1e-300 | 441.8 EB05 394.8 · IC025 +7.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 273.0 · 93% clinician | no trial data cached |
| Blindness | 218 | 287.2 262.7–314.0ROR 643.8 · χ² 61,680 / p <1e-300 | 278.7 EB05 249.0 · IC025 +7.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 169.9 · 93% clinician | no trial data cached |
| Altered state of consciousness | 218 | 545.3 498.5–596.4ROR 1,223.3 · χ² 116,804 / p <1e-300 | 515.2 EB05 460.3 · IC025 +7.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 316.1 · 93% clinician | no trial data cached |
| Head discomfort | 218 | 668.7 611.2–731.5ROR 1,500.4 · χ² 142,971 / p <1e-300 | 623.9 EB05 557.4 · IC025 +7.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 681.3 · 93% clinician | no trial data cached |
| Arthralgia (joint pain) | 217 | 28.0 25.6–30.6ROR 61.2 · χ² 5,724 / p <1e-300 | 27.9 EB05 24.9 · IC025 +4.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 29.6 · 93% clinician | no trial data cached |
| Eye pain | 217 | 210.5 192.5–230.2ROR 468.8 · χ² 44,970 / p <1e-300 | 205.9 EB05 183.9 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 281.1 · 93% clinician | no trial data cached |
| Pruritus (itching) | 215 | 30.4 27.8–33.2ROR 65.8 · χ² 6,185 / p <1e-300 | 30.3 EB05 27.0 · IC025 +4.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 43.2 · 93% clinician | no trial data cached |
| Coma | 214 | 240.6 219.7–263.5ROR 527.0 · χ² 50,704 / p <1e-300 | 234.5 EB05 209.3 · IC025 +7.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.2 · 92% clinician | no trial data cached |
| Cardio-respiratory arrest | 211 | 268.8 245.1–294.8ROR 579.3 · χ² 55,863 / p <1e-300 | 261.2 EB05 232.9 · IC025 +7.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 155.5 · 92% clinician | no trial data cached |
| Sepsis (blood infection) | 210 | 100.6 91.7–110.3ROR 214.9 · χ² 20,678 / p <1e-300 | 99.5 EB05 88.7 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 58.6 · 93% clinician | no trial data cached |
| Ascites | 208 | 380.0 345.9–417.4ROR 806.1 · χ² 77,789 / p <1e-300 | 364.6 EB05 324.9 · IC025 +7.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 222.0 · 93% clinician | 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 Escherichia Coli?
In FDA FAERS, the most frequently co-reported reaction terms for Escherichia Coli are tachycardia, fall, chills, ocular discomfort, haematemesis, blindness. 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 Escherichia Coli have an FDA boxed warning?
No. The FDA label retrieved for Escherichia Coli has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Escherichia Coli 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 85411aca-0ef1-9d48-e053-2991aa0a0790, effective 20231115; matched on
openfda.generic_name.exact:"ESCHERICHIA COLI" AND openfda.product_type:"HUMAN PRESCRIPTION DRUG") - 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, 33 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.