Drug · FAERS side-effect profile with label screen
Erythromycin side effects: what 18,647 FDA adverse event reports show
Drug class
Macrolide, Macrolide Antimicrobial
FDA label (Established Pharmacologic Class)
Who reports
18,647 reports · 62% serious · 1,666 with death outcome · 70% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of erythromycin tablets, USP and other antibacterial drugs, erythromycin tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA label, Indications and Usage
What it is
DESCRIPTION Erythromycin tablets, USP are an antibacterial product containing erythromycin, USP, in a unique, nonenteric film coating for oral administration. Erythromycin tablets are available in two strengths containing either 250 mg or 500 mg of erythromycin base.
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
Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 10Not in label — unassessed 24
What the badges mean
- 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.
- 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, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,166 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 |
|---|---|---|---|---|---|---|
| Anti factor v antibody | 14 | 1,940.2 814.0–4,624.5ROR 1,941.7 · calibrated p 1e-15 ✓ | 359.0 EB05 227.3 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=14 | no trial data cached |
| Grip strength | 123 | 1,286.5 992.6–1,667.5ROR 1,295.1 · calibrated p 4e-18 ✓ | 545.2 EB05 469.0 · IC025 +7.2 3/3 methods agree | Not in label — unassessed | serious n=123 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Umbilical erythema | 17 | 438.3 250.0–768.4ROR 438.7 · calibrated p 9e-12 ✓ | 232.5 EB05 153.7 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Swollen joint count | 57 | 339.8 252.6–457.0ROR 340.8 · calibrated p 8e-12 ✓ | 239.4 EB05 191.7 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=57 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Lupus vulgaris | 168 | 185.0 157.2–217.7ROR 186.6 · calibrated p 9e-10 ✓ | 155.9 EB05 137.1 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=168 · ♀ 100% (drug 70%) · 93% clinician | no trial data cached |
| Anti-cyclic citrullinated peptide antibody | 75 | 142.4 112.0–181.0ROR 143.0 · calibrated p 1e-8 ✓ | 122.4 EB05 100.9 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=75 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Porphyria acute | 134 | 120.9 101.2–144.4ROR 121.8 · calibrated p 3e-8 ✓ | 107.5 EB05 93.0 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=134 · 100% clinician | no trial data cached |
| Adjustment disorder with depressed mood | 187 | 115.0 99.0–133.6ROR 116.1 · calibrated p 4e-8 ✓ | 103.2 EB05 91.4 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=187 · ♀ 100% (drug 70%) · 96% clinician | no trial data cached |
| Dislocation of vertebra | 206 | 114.8 99.5–132.4ROR 116.0 · calibrated p 4e-8 ✓ | 103.1 EB05 91.8 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=206 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Bloody discharge | 101 | 108.2 88.2–132.7ROR 108.8 · calibrated p 8e-8 ✓ | 96.9 EB05 82.0 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=101 · ♀ 100% (drug 70%) · 90% clinician | no trial data cached |
| Deep vein thrombosis postoperative | 171 | 107.4 91.9–125.6ROR 108.4 · calibrated p 7e-8 ✓ | 97.0 EB05 85.4 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=171 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Seronegative arthritis | 96 | 105.2 85.4–129.6ROR 105.7 · calibrated p 1e-7 ✓ | 94.4 EB05 79.6 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=96 · ♀ 100% (drug 70%) | no trial data cached |
| X-ray abnormal | 149 | 102.4 86.6–121.1ROR 103.2 · calibrated p 1e-7 ✓ | 92.8 EB05 80.9 · IC025 +5.9 3/3 methods agree | Lab value / disease marker | serious n=149 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Retinitis | 130 | 94.9 79.4–113.5ROR 95.6 · calibrated p 2e-7 ✓ | 86.5 EB05 74.7 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=130 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Deafness permanent | 15 | 92.4 54.6–156.4ROR 92.5 · calibrated p 1e-6 ✓ | 77.3 EB05 49.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| International normalised ratio fluctuation | 148 | 85.4 72.3–100.9ROR 86.1 · calibrated p 4e-7 ✓ | 78.6 EB05 68.5 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=146 · ♀ 100% (drug 70%) · 91% clinician | no trial data cached |
| Swollen joint count increased | 170 | 64.8 55.5–75.6ROR 65.4 · calibrated p 3e-6 ✓ | 60.9 EB05 53.6 · IC025 +5.4 3/3 methods agree | Lab value / disease marker | serious n=170 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Rheumatic fever | 219 | 59.3 51.8–67.9ROR 60.0 · calibrated p 5e-6 ✓ | 56.1 EB05 50.1 · IC025 +5.4 3/3 methods agree | Likely indication confounding term in indications | serious n=219 · ♀ 100% (drug 70%) · 95% clinician | no trial data cached |
| Drug tolerance decreased | 139 | 58.7 49.5–69.6ROR 59.1 · calibrated p 5e-6 ✓ | 55.4 EB05 48.1 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=138 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Hyphaema | 26 | 58.6 39.5–86.9ROR 58.7 · calibrated p 1e-5 ✓ | 53.6 EB05 38.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 70%) · 100% clinician | no trial data cached |
| Facet joint syndrome | 155 | 58.1 49.5–68.3ROR 58.6 · calibrated p 6e-6 ✓ | 54.9 EB05 48.0 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=155 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Bone erosion | 160 | 53.2 45.4–62.3ROR 53.6 · calibrated p 1e-5 ✓ | 50.5 EB05 44.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=159 · ♀ 100% (drug 70%) · 98% clinician | no trial data cached |
| Monocytosis | 27 | 51.3 34.9–75.4ROR 51.3 · calibrated p 2e-5 ✓ | 47.5 EB05 34.3 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=27 · ♀ 100% (drug 70%) · 100% clinician | no trial data cached |
| Necrosis ischaemic | 20 | 50.7 32.4–79.4ROR 50.8 · calibrated p 3e-5 ✓ | 46.6 EB05 31.8 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=20 · ♀ 100% (drug 70%) | no trial data cached |
| Pneumococcal infection | 23 | 45.9 30.2–69.6ROR 45.9 · calibrated p 5e-5 ✓ | 42.6 EB05 29.9 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=23 | no trial data cached |
| Rheumatoid factor positive | 222 | 45.0 39.4–51.4ROR 45.5 · calibrated p 3e-5 ✓ | 43.1 EB05 38.6 · IC025 +5.1 3/3 methods agree | Lab value / disease marker | serious n=222 · ♀ 100% (drug 70%) · 96% clinician | no trial data cached |
| Breast cancer stage iii | 245 | 44.5 39.2–50.5ROR 45.1 · calibrated p 3e-5 ✓ | 42.7 EB05 38.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=245 · ♀ 100% (drug 70%) · 96% clinician | no trial data cached |
| Peripheral venous disease | 145 | 42.3 35.9–49.9ROR 42.7 · calibrated p 4e-5 ✓ | 40.6 EB05 35.4 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=144 · ♀ 100% (drug 70%) · 92% clinician | no trial data cached |
| Periorbital pain | 29 | 42.1 29.1–61.0ROR 42.2 · calibrated p 7e-5 ✓ | 39.7 EB05 29.0 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | ♀ 100% (drug 70%) · 100% consumer | no trial data cached |
| Faecal volume decreased | 17 | 41.0 25.3–66.5ROR 41.0 · calibrated p 1e-4 ✓ | 38.0 EB05 25.1 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Duodenal ulcer perforation | 255 | 40.4 35.7–45.8ROR 41.0 · calibrated p 5e-5 ✓ | 38.9 EB05 35.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 36.2 · ♀ 100% (drug 70%) · 94% clinician | no trial data cached |
| C-reactive protein | 30 | 38.4 26.7–55.3ROR 38.5 · calibrated p 1e-4 ✓ | 36.4 EB05 26.7 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=30 · ♀ 100% (drug 70%) | no trial data cached |
| C-reactive protein abnormal | 204 | 37.0 32.2–42.5ROR 37.4 · calibrated p 8e-5 ✓ | 35.7 EB05 31.8 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=204 · ♀ 100% (drug 70%) · 97% clinician | no trial data cached |
| Anti-cyclic citrullinated peptide antibody positive | 221 | 36.1 31.6–41.2ROR 36.5 · calibrated p 9e-5 ✓ | 34.9 EB05 31.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious PRR 32.6 · ♀ 100% (drug 70%) · 97% clinician | no trial data cached |
| Lyme disease | 99 | 34.5 28.3–42.2ROR 34.7 · calibrated p 1e-4 ✓ | 33.3 EB05 28.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=99 · ♀ 100% (drug 70%) | no trial data cached |
| Subcutaneous drug absorption impaired | 16 | 34.0 20.7–55.9ROR 34.0 · calibrated p 3e-4 ✓ | 31.9 EB05 20.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Allergic oedema | 19 | 33.8 21.4–53.4ROR 33.8 · calibrated p 3e-4 ✓ | 31.9 EB05 21.6 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=19 | no trial data cached |
| Chronic kidney disease-mineral and bone disorder | 31 | 33.3 23.3–47.6ROR 33.4 · calibrated p 2e-4 ✓ | 31.8 EB05 23.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Measles | 15 | 32.2 19.3–53.7ROR 32.2 · calibrated p 4e-4 ✓ | 30.2 EB05 19.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Maternal exposure timing unspecified | 98 | 30.4 24.9–37.1ROR 30.6 · calibrated p 3e-4 ✓ | 29.5 EB05 24.9 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=97 · ♀ 100% (drug 70%) · 100% 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 4,114 | 24.3 23.7–25.0ROR 30.9 · calibrated p 2e-4 ✓ | 23.8 EB05 23.2 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.9 | no trial data cached |
| Nausea | 1,308 | 1.9 1.8–2.0ROR 1.9 · calibrated p 0.906 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Vomiting | 1,142 | 2.7 2.6–2.9ROR 2.9 · calibrated p 0.675 | 2.7 EB05 2.6 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.0 | no trial data cached |
| Diarrhoea (diarrhea) | 1,098 | 1.9 1.8–2.0ROR 2.0 · calibrated p 0.933 | 1.9 EB05 1.8 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 2.5 | no trial data cached |
| Drug ineffective (drug did not work) | 1,091 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.260 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.9 | no trial data cached |
| Dyspnoea (shortness of breath) | 1,067 | 2.1 2.0–2.3ROR 2.2 · calibrated p 0.956 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Fatigue (tiredness) | 1,056 | 1.5 1.4–1.6ROR 1.6 · calibrated p 0.682 | 1.5 EB05 1.5 · IC025 +0.5 | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Rash | 1,034 | 2.7 2.5–2.8ROR 2.8 · calibrated p 0.701 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Not in label — unassessed | serious PRR 3.3 | no trial data cached |
| Off label use (used outside approved label) | 956 | 1.2 1.2–1.3ROR 1.3 · calibrated p 0.476 | 1.2 EB05 1.2 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.7 | no trial data cached |
| Headache | 885 | 1.6 1.5–1.7ROR 1.6 · calibrated p 0.719 | 1.6 EB05 1.5 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.4 | no trial data cached |
| Pain | 800 | 1.5 1.4–1.6ROR 1.5 · calibrated p 0.631 | 1.5 EB05 1.4 · IC025 +0.4 | Labeled adverse reaction exact term | serious PRR 1.9 | no trial data cached |
| Dizziness | 799 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.855 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Pyrexia (fever) | 717 | 2.3 2.2–2.5ROR 2.4 · calibrated p 0.864 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.6 | no trial data cached |
| Malaise (feeling unwell) | 706 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.853 | 1.8 EB05 1.7 · IC025 +0.7 | Not in label — unassessed | serious PRR 2.5 | no trial data cached |
| Hypersensitivity (allergic reaction) | 694 | 4.2 3.9–4.5ROR 4.3 · calibrated p 0.319 | 4.2 EB05 3.9 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | 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.
- Grip strength — n=123, PRR 1,286.5
- Swollen joint count — n=57, PRR 339.8
- Lupus vulgaris — n=168, PRR 185.0
- Porphyria acute — n=134, PRR 120.9
- Adjustment disorder with depressed mood — n=187, PRR 115.0
- Dislocation of vertebra — n=206, PRR 114.8
- Bloody discharge — n=101, PRR 108.2
- Deep vein thrombosis postoperative — n=171, PRR 107.4
- Seronegative arthritis — n=96, PRR 105.2
- Retinitis — n=130, PRR 94.9
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 Erythromycin?
In FDA FAERS, the most frequently co-reported reaction terms for Erythromycin are drug hypersensitivity, nausea, vomiting, diarrhoea, dyspnoea, fatigue. 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 Erythromycin have an FDA boxed warning?
No. The FDA label retrieved for Erythromycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Erythromycin 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 0277341c-8513-4317-9334-c242f97630c1, effective 20240320; matched on
openfda.generic_name.exact:"ERYTHROMYCIN") - 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, 1,206 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 2026-10-14. 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.