Drug · FAERS side-effect profile with label screen
Tigecycline side effects: what 6,097 FDA adverse event reports show
Drug class
Tetracycline-class Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
6,097 reports · 93% serious · 1,633 with death outcome · 43% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Tigecycline for injection is a tetracycline class antibacterial indicated in patients 18 years of age and older for: Complicated skin and skin structure infections ( 1.1 ) Complicated intra-abdominal infections ( 1.2 ) Community-acquired bacterial pneu.
FDA label, Indications and Usage
What it is
Tigecycline for Injection, USP is a tetracycline class antibacterial for intravenous infusion.
FDA label, Description section
Boxed warning
ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established.
FDA 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 — boxed warning 2Labeled adverse reaction 8Labeled (related wording) 6Likely indication confounding 2Reporting / coding artifact 3Lab value / disease marker 5Not in label — unassessed 14
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- 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.
- 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. 155 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 |
|---|---|---|---|---|---|---|
| Coagulopathy | 207 | 43.4 37.9–49.6ROR 44.9 · χ² 8,427 / p <1e-300 | 42.7 EB05 38.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 | no trial data cached |
| Drug resistance | 218 | 29.4 25.8–33.6ROR 30.5 · χ² 5,915 / p <1e-300 | 29.1 EB05 26.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.0 · 97% clinician | no trial data cached |
| Pancreatitis acute | 151 | 23.4 20.0–27.4ROR 24.0 · χ² 3,201 / p <1e-300 | 23.2 EB05 20.3 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.5 · 99% clinician | no trial data cached |
| Septic shock | 232 | 18.6 16.4–21.1ROR 19.3 · χ² 3,823 / p <1e-300 | 18.4 EB05 16.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · 93% clinician | no trial data cached |
| Clostridium difficile colitis | 55 | 17.9 13.7–23.3ROR 18.1 · χ² 857 / p 1e-188 | 17.7 EB05 14.1 · IC025 +3.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 11.3 · 96% clinician | no trial data cached |
| Bacteraemia | 59 | 17.3 13.4–22.3ROR 17.5 · χ² 887 / p 3e-195 | 17.1 EB05 13.7 · IC025 +3.5 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 10.6 · 94% clinician | no trial data cached |
| Multi-organ failure | 80 | 15.7 12.7–19.6ROR 15.9 · χ² 1,086 / p 2e-238 | 15.6 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 9.8 · 99% clinician | no trial data cached |
| Blood bilirubin increased | 110 | 14.0 11.6–16.9ROR 14.3 · χ² 1,313 / p 7e-288 | 13.9 EB05 11.8 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 9.5 | no trial data cached |
| Candida infection (yeast infection) | 62 | 12.8 10.0–16.4ROR 12.9 · χ² 662 / p 3e-146 | 12.6 EB05 10.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Bacterial infection | 69 | 12.8 10.1–16.2ROR 13.0 · χ² 738 / p 8e-163 | 12.6 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.4 · ♀ 23% (drug 43%) | no trial data cached |
| Multiple organ dysfunction syndrome | 103 | 12.7 10.5–15.4ROR 12.9 · χ² 1,100 / p 2e-241 | 12.6 EB05 10.6 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 94% clinician | no trial data cached |
| Nephropathy toxic | 41 | 12.7 9.4–17.2ROR 12.8 · χ² 429 / p 1e-95 | 12.3 EB05 9.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 98% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 92 | 12.4 10.1–15.2ROR 12.6 · χ² 953 / p 2e-209 | 12.3 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 · 99% clinician | no trial data cached |
| Blood urea increased | 58 | 11.9 9.2–15.4ROR 12.0 · χ² 566 / p 2e-125 | 11.6 EB05 9.2 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 7.6 · 96% clinician | no trial data cached |
| Liver injury | 77 | 11.0 8.8–13.7ROR 11.1 · χ² 687 / p 9e-152 | 10.7 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Transaminases increased | 67 | 10.4 8.2–13.2ROR 10.5 · χ² 559 / p 8e-124 | 10.1 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.7 | no trial data cached |
| Cholestasis (bile flow blockage) | 57 | 10.3 7.9–13.3ROR 10.4 · χ² 468 / p 5e-104 | 9.9 EB05 7.9 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.5 · 91% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 66 | 10.3 8.1–13.1ROR 10.4 · χ² 542 / p 4e-120 | 10.0 EB05 8.0 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.5 · 97% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 151 | 9.8 8.4–11.5ROR 10.1 · χ² 1,190 / p 5e-261 | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 96% clinician | no trial data cached |
| Hyperbilirubinaemia | 27 | 9.0 6.2–13.2ROR 9.1 · χ² 185 / p 2e-42 | 8.2 EB05 5.8 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 92% clinician | no trial data cached |
| Hepatic failure | 77 | 8.8 7.0–11.0ROR 8.9 · χ² 523 / p 6e-116 | 8.5 EB05 7.0 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 · 92% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 62 | 8.6 6.7–11.0ROR 8.7 · χ² 408 / p 6e-91 | 8.2 EB05 6.6 · IC025 +2.6 3/3 methods agree | Lab value / disease marker | serious PRR 5.8 | no trial data cached |
| Sepsis (blood infection) | 268 | 8.3 7.4–9.3ROR 8.6 · χ² 1,712 / p <1e-300 | 8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 91% clinician | no trial data cached |
| Drug-induced liver injury | 74 | 8.3 6.6–10.4ROR 8.4 · χ² 465 / p 2e-103 | 8.0 EB05 6.5 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Abscess | 38 | 8.2 6.0–11.3ROR 8.3 · χ² 233 / p 6e-53 | 7.7 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · ♀ 70% (drug 43%) · 95% clinician | no trial data cached |
| Acute hepatic failure | 32 | 8.1 5.7–11.5ROR 8.1 · χ² 192 / p 6e-44 | 7.5 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.0 · 90% clinician | no trial data cached |
| Neutrophil count increased | 24 | 8.0 5.4–12.0ROR 8.1 · χ² 141 / p 9e-33 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 5.3 · 100% clinician | no trial data cached |
| Staphylococcal infection | 77 | 8.0 6.4–10.0ROR 8.1 · χ² 465 / p 2e-103 | 7.7 EB05 6.4 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 5.4 | no trial data cached |
| Thrombocytopenia (low platelets) | 256 | 7.9 7.0–8.9ROR 8.2 · χ² 1,544 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 93% clinician | no trial data cached |
| Agranulocytosis (severe loss of white cells) | 40 | 7.5 5.5–10.2ROR 7.5 · χ² 217 / p 2e-49 | 7.0 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 · 100% clinician | no trial data cached |
| Hepatic function abnormal | 77 | 7.2 5.7–8.9ROR 7.2 · χ² 402 / p 1e-89 | 6.9 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 30 | 6.9 4.8–9.8ROR 6.9 · χ² 144 / p 2e-33 | 6.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 96% clinician | no trial data cached |
| Device related infection | 29 | 6.5 4.5–9.3ROR 6.5 · χ² 129 / p 4e-30 | 5.9 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.1 | no trial data cached |
| Gamma-glutamyltransferase increased | 41 | 6.4 4.7–8.6ROR 6.4 · χ² 180 / p 2e-41 | 6.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 100% clinician | no trial data cached |
| Disseminated intravascular coagulation | 26 | 6.3 4.3–9.3ROR 6.4 · χ² 112 / p 2e-26 | 5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 96% clinician | no trial data cached |
| Acute respiratory distress syndrome | 32 | 6.2 4.4–8.8ROR 6.3 · χ² 135 / p 2e-31 | 5.7 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.9 · 94% clinician | no trial data cached |
| Generalised oedema | 22 | 6.2 4.1–9.3ROR 6.2 · χ² 90 / p 1e-21 | 5.5 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Bone marrow failure | 36 | 6.1 4.4–8.4ROR 6.1 · χ² 147 / p 4e-34 | 5.6 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 · 94% clinician | no trial data cached |
| Cytomegalovirus infection | 29 | 6.0 4.2–8.6ROR 6.0 · χ² 116 / p 3e-27 | 5.5 EB05 4.0 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.8 · 100% clinician | no trial data cached |
| Treatment failure | 141 | 5.9 5.0–7.0ROR 6.0 · χ² 572 / p 9e-127 | 5.8 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 6.5 · 92% 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 ineffective (drug did not work) | 743 | 1.9 1.8–2.1ROR 2.1 · χ² 361 / p 1e-80 | 1.9 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 3.3 · 92% clinician | no trial data cached |
| Off label use (used outside approved label) | 689 | 2.7 2.5–2.9ROR 3.0 · χ² 787 / p 2e-173 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 92% clinician | no trial data cached |
| Nausea | 414 | 1.8 1.6–2.0ROR 1.9 · χ² 154 / p 1e-35 | 1.8 EB05 1.7 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 · 92% clinician | no trial data cached |
| Vomiting | 280 | 2.1 1.8–2.3ROR 2.1 · χ² 154 / p 1e-35 | 2.1 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.7 | no trial data cached |
| Sepsis (blood infection) | 268 | 8.3 7.4–9.3ROR 8.6 · χ² 1,712 / p <1e-300 | 8.2 EB05 7.4 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 91% clinician | no trial data cached |
| Death | 259 | 1.0 0.9–1.2ROR 1.0 · χ² 0 / p 0.301 | 1.0 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.6 | no trial data cached |
| Thrombocytopenia (low platelets) | 256 | 7.9 7.0–8.9ROR 8.2 · χ² 1,544 / p <1e-300 | 7.8 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.0 · 93% clinician | no trial data cached |
| Septic shock | 232 | 18.6 16.4–21.1ROR 19.3 · χ² 3,823 / p <1e-300 | 18.4 EB05 16.5 · IC025 +3.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 11.4 · 93% clinician | no trial data cached |
| Drug resistance | 218 | 29.4 25.8–33.6ROR 30.5 · χ² 5,915 / p <1e-300 | 29.1 EB05 26.0 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.0 · 97% clinician | no trial data cached |
| Coagulopathy | 207 | 43.4 37.9–49.6ROR 44.9 · χ² 8,427 / p <1e-300 | 42.7 EB05 38.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 27.8 | no trial data cached |
| Condition aggravated | 203 | 2.3 2.0–2.6ROR 2.4 · χ² 152 / p 3e-35 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.2 | no trial data cached |
| Product use in unapproved indication | 172 | 2.4 2.1–2.8ROR 2.5 · χ² 144 / p 2e-33 | 2.4 EB05 2.1 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 · 91% clinician | no trial data cached |
| Platelet count decreased | 172 | 5.6 4.8–6.4ROR 5.7 · χ² 641 / p 1e-141 | 5.5 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 91% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 162 | 3.7 3.1–4.3ROR 3.7 · χ² 313 / p 3e-70 | 3.6 EB05 3.2 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 92% clinician | no trial data cached |
| Pancreatitis (pancreas inflammation) | 151 | 9.8 8.4–11.5ROR 10.1 · χ² 1,190 / p 5e-261 | 9.7 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.2 · 96% 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.
- Coagulopathy — n=207, PRR 43.4
- Multi-organ failure — n=80, PRR 15.7
- Candida infection — n=62, PRR 12.8
- Nephropathy toxic — n=41, PRR 12.7
- Liver injury — n=77, PRR 11.0
- Hyperbilirubinaemia — n=27, PRR 9.0
- Drug-induced liver injury — n=74, PRR 8.3
- Agranulocytosis — n=40, PRR 7.5
- Toxic epidermal necrolysis — n=30, PRR 6.9
- Disseminated intravascular coagulation — n=26, PRR 6.3
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 Tigecycline?
In FDA FAERS, the most frequently co-reported reaction terms for Tigecycline are nausea, vomiting, sepsis, thrombocytopenia, septic shock, coagulopathy. 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 Tigecycline have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ALL-CAUSE MORTALITY An increase in all-cause mortality has been observed in a meta-analysis of Phase 3 and 4 clinical trials in tigecycline-treated patients versus comparator. The cause of this mortality risk difference of 0.6% (95% CI 0.1, 1.2) has not been established.
Do FAERS signals prove that Tigecycline 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 230484a8-408c-dcc1-d0c4-d9dd9a46831b, effective 20260106; matched on
openfda.generic_name.exact:"TIGECYCLINE") - 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, 195 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.