Drug · FAERS side-effect profile with label screen
Tetracycline side effects: what 767 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Tetracycline Hydrochloride (Tetracycline Hydrochloride)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
767 reports · 65% serious · 208 with death outcome · 80% female
openFDA FAERS counts, all years, deduplication not applied
Used for
To reduce the development of drug-resistant bacteria and maintain the effectiveness of tetracycline hydrochloride and other antibacterial drugs, tetracycline hydrochloride should be used only to treat infections that are proven or strongly suspected to be caused by susceptible bacteria.
FDA label, Indications and Usage
What it is
DESCRIPTION Tetracycline is a yellow, crystalline powder. Tetracycline is stable in air but exposure to strong sunlight causes it to darken. Its potency is affected in solutions of pH below 2 and is rapidly destroyed by alkali hydroxide solutions.
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 2Labeled (related wording) 2Reporting / coding artifact 5Not in label — unassessed 31
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.
- 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. 32 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 |
|---|---|---|---|---|---|---|
| Folliculitis | 76 | 202.6 163.5–251.0ROR 224.8 · χ² 14,942 / p <1e-300 | 191.5 EB05 158.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 209.2 · 97% clinician | no trial data cached |
| Bursitis | 75 | 171.0 137.8–212.2ROR 189.4 · χ² 12,434 / p <1e-300 | 162.9 EB05 134.3 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 177.0 · 97% clinician | no trial data cached |
| Back injury | 66 | 167.7 133.0–211.3ROR 183.3 · χ² 10,707 / p <1e-300 | 159.0 EB05 129.4 · IC025 +5.8 3/3 methods agree | Not in label — unassessed | serious PRR 195.2 · 100% clinician | no trial data cached |
| Helicobacter infection | 55 | 148.3 114.9–191.4ROR 159.7 · χ² 7,859 / p <1e-300 | 140.4 EB05 111.9 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 135.4 · 93% clinician | no trial data cached |
| Wound infection | 58 | 146.7 114.4–188.0ROR 158.6 · χ² 8,205 / p <1e-300 | 139.3 EB05 111.7 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 138.5 · 100% clinician | no trial data cached |
| Hypercholesterolaemia | 49 | 140.7 107.2–184.6ROR 150.3 · χ² 6,627 / p <1e-300 | 132.8 EB05 104.5 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious PRR 131.7 · 100% clinician | no trial data cached |
| Liver function test increased | 77 | 99.1 80.1–122.5ROR 110.0 · χ² 7,357 / p <1e-300 | 96.4 EB05 79.6 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 136.4 · 97% clinician | no trial data cached |
| Obesity | 55 | 94.6 73.3–122.0ROR 101.8 · χ² 4,984 / p <1e-300 | 91.3 EB05 72.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 96.8 · 100% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 86 | 92.2 75.5–112.5ROR 103.7 · χ² 7,647 / p <1e-300 | 90.1 EB05 75.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 82.7 · 98% clinician | no trial data cached |
| Taste disorder | 61 | 83.5 65.6–106.2ROR 90.6 · χ² 4,878 / p <1e-300 | 81.2 EB05 65.5 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 147.9 · 100% clinician | no trial data cached |
| Synovitis | 50 | 75.9 58.1–99.3ROR 81.2 · χ² 3,616 / p <1e-300 | 73.7 EB05 58.1 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 70.2 · 100% clinician | no trial data cached |
| Pemphigus | 32 | 70.5 50.2–99.1ROR 73.6 · χ² 2,121 / p <1e-300 | 67.6 EB05 50.2 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 62.4 · 100% clinician | no trial data cached |
| Coeliac disease | 25 | 69.8 47.4–102.7ROR 72.1 · χ² 1,624 / p <1e-300 | 66.3 EB05 47.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 76.7 · 100% clinician | no trial data cached |
| Incorrect product administration duration | 50 | 67.5 51.6–88.3ROR 72.2 · χ² 3,206 / p <1e-300 | 65.7 EB05 51.8 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=49 · 94% clinician | no trial data cached |
| Adverse reaction | 29 | 59.9 41.9–85.6ROR 62.2 · χ² 1,618 / p <1e-300 | 57.6 EB05 42.1 · IC025 +4.3 3/3 methods agree | Reporting / coding artifact | serious n=29 · 100% clinician | no trial data cached |
| Hand deformity | 27 | 56.5 39.0–81.9ROR 58.6 · χ² 1,416 / p <1e-300 | 54.4 EB05 39.2 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 54.3 · 100% clinician | no trial data cached |
| Pericarditis | 34 | 55.9 40.2–77.7ROR 58.4 · χ² 1,776 / p <1e-300 | 54.2 EB05 40.5 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 49.8 · 100% clinician | no trial data cached |
| Fibromyalgia | 48 | 54.1 41.2–71.2ROR 57.7 · χ² 2,448 / p <1e-300 | 53.0 EB05 41.5 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 61.6 · 100% clinician | no trial data cached |
| Gait inability | 59 | 48.8 38.2–62.4ROR 52.8 · χ² 2,715 / p <1e-300 | 48.0 EB05 38.6 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 53.7 · 100% clinician | no trial data cached |
| Neck pain | 90 | 44.0 36.3–53.5ROR 49.8 · χ² 3,746 / p <1e-300 | 43.6 EB05 36.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 62.5 · 97% clinician | no trial data cached |
| Inflammation | 79 | 42.1 34.2–51.9ROR 46.9 · χ² 3,134 / p <1e-300 | 41.7 EB05 34.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 49.7 · 96% clinician | no trial data cached |
| Wound | 42 | 41.4 30.8–55.5ROR 43.7 · χ² 1,614 / p <1e-300 | 40.6 EB05 31.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 43.5 · 90% clinician | no trial data cached |
| Osteoarthritis | 64 | 41.3 32.6–52.2ROR 44.9 · χ² 2,475 / p <1e-300 | 40.7 EB05 33.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 40.9 · 100% clinician | no trial data cached |
| Joint range of motion decreased | 20 | 41.0 26.6–63.1ROR 42.0 · χ² 740 / p 4e-163 | 39.5 EB05 27.0 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 46.1 · 100% clinician | no trial data cached |
| Irritable bowel syndrome | 30 | 38.4 27.1–54.6ROR 40.0 · χ² 1,056 / p 5e-232 | 37.5 EB05 27.6 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 43.1 · 100% clinician | no trial data cached |
| Type 2 diabetes mellitus | 46 | 37.3 28.2–49.4ROR 39.6 · χ² 1,589 / p <1e-300 | 36.7 EB05 28.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 34.7 · 98% clinician | no trial data cached |
| Epilepsy | 41 | 36.8 27.3–49.5ROR 38.8 · χ² 1,392 / p <1e-300 | 36.2 EB05 27.8 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 · 100% clinician | no trial data cached |
| Glossodynia (burning tongue/mouth pain) | 30 | 36.7 25.9–52.2ROR 38.2 · χ² 1,007 / p 3e-221 | 35.9 EB05 26.4 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 47.0 · 100% clinician | no trial data cached |
| Systemic lupus erythematosus | 45 | 34.8 26.2–46.2ROR 36.9 · χ² 1,445 / p <1e-300 | 34.3 EB05 26.7 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 31.6 · 100% clinician | no trial data cached |
| Mobility decreased | 91 | 34.8 28.7–42.2ROR 39.3 · χ² 2,958 / p <1e-300 | 34.5 EB05 29.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · 98% clinician | no trial data cached |
| Wheezing | 70 | 32.4 25.9–40.5ROR 35.5 · χ² 2,101 / p <1e-300 | 32.1 EB05 26.3 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · 100% clinician | no trial data cached |
| Injury | 83 | 32.1 26.2–39.4ROR 35.9 · χ² 2,479 / p <1e-300 | 31.9 EB05 26.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.8 · 95% clinician | no trial data cached |
| Intentional product use issue | 101 | 31.4 26.2–37.7ROR 36.0 · χ² 2,954 / p <1e-300 | 31.2 EB05 26.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 40.9 · 98% clinician | no trial data cached |
| Stomatitis (mouth sores) | 63 | 28.4 22.4–36.0ROR 30.9 · χ² 1,642 / p <1e-300 | 28.2 EB05 22.8 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 37.1 · 100% clinician | no trial data cached |
| Drug-induced liver injury | 32 | 28.4 20.2–39.9ROR 29.6 · χ² 819 / p 2e-180 | 27.9 EB05 20.7 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · 100% clinician | no trial data cached |
| Blister | 58 | 28.3 22.1–36.3ROR 30.6 · χ² 1,504 / p <1e-300 | 28.1 EB05 22.5 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 41.5 · 98% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 82 | 28.0 22.8–34.3ROR 31.2 · χ² 2,113 / p <1e-300 | 27.8 EB05 23.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · 95% clinician | no trial data cached |
| Contraindicated product administered | 30 | 27.2 19.2–38.7ROR 28.3 · χ² 732 / p 2e-161 | 26.8 EB05 19.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 30.0 · 97% clinician | no trial data cached |
| Impaired healing | 30 | 25.0 17.6–35.5ROR 26.0 · χ² 668 / p 2e-147 | 24.6 EB05 18.1 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 26.7 · 100% clinician | no trial data cached |
| Liver injury | 22 | 24.9 16.5–37.6ROR 25.6 · χ² 481 / p 6e-107 | 24.4 EB05 17.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 22.8 · 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 |
|---|---|---|---|---|---|---|
| Drug hypersensitivity | 152 | 21.4 18.6–24.7ROR 26.5 · χ² 2,963 / p <1e-300 | 21.3 EB05 18.6 · IC025 +4.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 29.2 | no trial data cached |
| Hypersensitivity (allergic reaction) | 125 | 18.4 15.7–21.7ROR 21.8 · χ² 2,062 / p <1e-300 | 18.4 EB05 15.8 · IC025 +3.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.3 | no trial data cached |
| Intentional product use issue | 101 | 31.4 26.2–37.7ROR 36.0 · χ² 2,954 / p <1e-300 | 31.2 EB05 26.4 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 40.9 · 98% clinician | no trial data cached |
| Mobility decreased | 91 | 34.8 28.7–42.2ROR 39.3 · χ² 2,958 / p <1e-300 | 34.5 EB05 29.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 45.4 · 98% clinician | no trial data cached |
| Neck pain | 90 | 44.0 36.3–53.5ROR 49.8 · χ² 3,746 / p <1e-300 | 43.6 EB05 36.5 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 62.5 · 97% clinician | no trial data cached |
| Hepatitis (liver inflammation) | 86 | 92.2 75.5–112.5ROR 103.7 · χ² 7,647 / p <1e-300 | 90.1 EB05 75.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious PRR 82.7 · 98% clinician | no trial data cached |
| Urticaria (hives) | 85 | 14.0 11.4–17.1ROR 15.6 · χ² 1,018 / p 1e-223 | 13.9 EB05 11.5 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 21.7 | no trial data cached |
| Muscular weakness | 83 | 20.0 16.3–24.5ROR 22.3 · χ² 1,485 / p <1e-300 | 19.9 EB05 16.5 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 25.3 · 95% clinician | no trial data cached |
| Injury | 83 | 32.1 26.2–39.4ROR 35.9 · χ² 2,479 / p <1e-300 | 31.9 EB05 26.5 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious PRR 34.8 · 95% clinician | no trial data cached |
| Gastrooesophageal reflux disease (acid reflux) | 82 | 28.0 22.8–34.3ROR 31.2 · χ² 2,113 / p <1e-300 | 27.8 EB05 23.1 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious PRR 39.5 · 95% clinician | no trial data cached |
| Inflammation | 79 | 42.1 34.2–51.9ROR 46.9 · χ² 3,134 / p <1e-300 | 41.7 EB05 34.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 49.7 · 96% clinician | no trial data cached |
| Hypoaesthesia (numbness) | 77 | 14.1 11.4–17.4ROR 15.5 · χ² 927 / p 7e-204 | 13.9 EB05 11.5 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 20.1 · 96% clinician | no trial data cached |
| Joint swelling | 77 | 17.5 14.1–21.6ROR 19.3 · χ² 1,186 / p 3e-260 | 17.4 EB05 14.4 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.0 · 94% clinician | no trial data cached |
| Liver function test increased | 77 | 99.1 80.1–122.5ROR 110.0 · χ² 7,357 / p <1e-300 | 96.4 EB05 79.6 · IC025 +5.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 136.4 · 97% clinician | no trial data cached |
| Folliculitis | 76 | 202.6 163.5–251.0ROR 224.8 · χ² 14,942 / p <1e-300 | 191.5 EB05 158.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 209.2 · 97% clinician | 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.
- Folliculitis — n=76, PRR 202.6
- Bursitis — n=75, PRR 171.0
- Back injury — n=66, PRR 167.7
- Helicobacter infection — n=55, PRR 148.3
- Wound infection — n=58, PRR 146.7
- Hypercholesterolaemia — n=49, PRR 140.7
- Obesity — n=55, PRR 94.6
- Hepatitis — n=86, PRR 92.2
- Taste disorder — n=61, PRR 83.5
- Synovitis — n=50, PRR 75.9
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 Tetracycline?
In FDA FAERS, the most frequently co-reported reaction terms for Tetracycline are drug hypersensitivity, hypersensitivity, mobility decreased, neck pain, hepatitis, urticaria. 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 Tetracycline have an FDA boxed warning?
No. The FDA label retrieved for Tetracycline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Tetracycline 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 00acf413-c5d2-4a54-9d0d-56266cbc9edc, effective 20260522; matched on
openfda.generic_name.exact:"TETRACYCLINE HYDROCHLORIDE") - 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, 72 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.