Drug · FAERS side-effect profile with label screen
Daptomycin side effects: what 9,171 FDA adverse event reports show
Drug class
Lipopeptide Antibacterial
FDA label (Established Pharmacologic Class)
Who reports
9,171 reports · 93% serious · 1,268 with death outcome · 39% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Daptomycin for injection is a lipopeptide antibacterial indicated for the treatment of: Complicated skin and skin structure infections (cSSSI) in adult and pediatric patients (1 to 17 years of age) ( 1.1 ) and, Staphylococcus aureus bloodstream infections (bacteremia), in adult patients including those with right-sided infective endocarditis.
FDA label, Indications and Usage
What it is
Daptomycin for injection contains daptomycin, a cyclic lipopeptide antibacterial agent derived from the fermentation of Streptomyces roseosporus .
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 5Labeled (related wording) 7Likely indication confounding 7Reporting / coding artifact 2Lab value / disease marker 1Not in label — unassessed 18
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.
- 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. 960 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 |
|---|---|---|---|---|---|---|
| Minimum inhibitory concentration | 24 | 6,013.5 2,796.0–12,933.7ROR 6,029.3 · χ² 37,725 / p <1e-300 | 708.0 EB05 500.7 · IC025 +4.9 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 · ♀ 0% (drug 39%) · 96% clinician | no trial data cached |
| Protothecosis | 24 | 784.4 493.2–1,247.5ROR 786.4 · χ² 13,356 / p <1e-300 | 397.3 EB05 281.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 100% (drug 39%) | no trial data cached |
| Aortoenteric fistula | 13 | 666.3 359.0–1,236.5ROR 667.2 · χ² 6,162 / p <1e-300 | 292.9 EB05 182.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Eosinophilic pneumonia acute | 144 | 459.3 384.4–548.8ROR 466.6 · χ² 54,331 / p <1e-300 | 363.3 EB05 316.2 · IC025 +7.1 3/3 methods agree | Labeled (related wording) related wording | serious n=144 · 97% clinician | no trial data cached |
| Antimicrobial susceptibility test resistant | 47 | 406.1 297.9–553.6ROR 408.2 · χ² 15,753 / p <1e-300 | 302.0 EB05 236.2 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | serious n=47 · ♀ 2% (drug 39%) | no trial data cached |
| Eosinophilic pneumonia | 463 | 398.4 361.7–438.8ROR 419.5 · χ² 155,650 / p <1e-300 | 334.0 EB05 309.3 · IC025 +7.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=455 · ♀ 19% (drug 39%) · 96% clinician | no trial data cached |
| Intracranial infection | 13 | 271.4 152.7–482.4ROR 271.8 · χ² 2,890 / p <1e-300 | 179.1 EB05 111.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Pulmonary interstitial emphysema syndrome | 15 | 268.5 157.2–458.4ROR 268.9 · χ² 3,337 / p <1e-300 | 184.1 EB05 118.4 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Osteomyelitis fungal | 15 | 241.6 141.9–411.3ROR 242.0 · χ² 3,033 / p <1e-300 | 171.2 EB05 110.1 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious n=15 | no trial data cached |
| Alveolar lung disease | 15 | 194.4 114.8–329.3ROR 194.7 · χ² 2,482 / p <1e-300 | 146.1 EB05 94.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Hyperoxaluria | 11 | 154.1 83.7–283.7ROR 154.3 · χ² 1,426 / p <1e-300 | 115.8 EB05 69.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Enterobacter pneumonia | 10 | 153.4 80.9–291.0ROR 153.6 · χ² 1,279 / p 3e-280 | 113.3 EB05 65.8 · IC025 +3.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=10 | no trial data cached |
| Geotrichum infection | 10 | 112.8 59.8–212.7ROR 112.9 · χ² 951 / p 4e-209 | 89.6 EB05 52.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Hypersensitivity pneumonitis | 53 | 112.3 85.3–147.9ROR 113.0 · χ² 5,465 / p <1e-300 | 103.2 EB05 81.9 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=51 · ♀ 17% (drug 39%) · 100% clinician | no trial data cached |
| Vancomycin infusion reaction | 16 | 105.2 63.7–173.6ROR 105.4 · χ² 1,480 / p <1e-300 | 90.1 EB05 58.8 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=16 | no trial data cached |
| Eosinophilic pleural effusion | 12 | 95.6 53.7–170.3ROR 95.7 · χ² 989 / p 2e-217 | 80.4 EB05 49.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Creatine kinase increased | 17 | 93.5 57.6–151.8ROR 93.7 · χ² 1,406 / p <1e-300 | 81.8 EB05 54.1 · IC025 +3.8 3/3 methods agree | Lab value / disease marker | serious n=17 | no trial data cached |
| Drug dispensed to wrong patient | 33 | 82.9 58.6–117.2ROR 83.2 · χ² 2,496 / p <1e-300 | 76.6 EB05 57.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 0% (drug 39%) · 97% clinician | no trial data cached |
| Device related bacteraemia | 10 | 78.6 41.8–147.6ROR 78.7 · χ² 667 / p 2e-147 | 66.7 EB05 38.7 · IC025 +3.0 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Hypoprothrombinaemia | 10 | 78.0 41.6–146.5ROR 78.1 · χ² 662 / p 2e-146 | 66.3 EB05 38.5 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Acute interstitial pneumonitis | 17 | 76.7 47.3–124.3ROR 76.8 · χ² 1,156 / p 1e-253 | 68.7 EB05 45.4 · IC025 +3.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Fusarium infection | 18 | 61.8 38.7–98.6ROR 61.9 · χ² 989 / p 2e-217 | 56.7 EB05 38.0 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Pulmonary eosinophilia | 12 | 60.9 34.4–108.1ROR 61.0 · χ² 632 / p 1e-139 | 54.5 EB05 33.2 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious n=10 | no trial data cached |
| Staphylococcal bacteraemia | 112 | 60.6 50.3–73.1ROR 61.4 · χ² 6,339 / p <1e-300 | 58.5 EB05 50.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=112 · 93% clinician | no trial data cached |
| Disseminated aspergillosis | 12 | 60.0 33.8–106.4ROR 60.1 · χ² 622 / p 1e-137 | 53.8 EB05 32.8 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Rectal perforation | 13 | 56.4 32.5–97.7ROR 56.5 · χ² 637 / p 8e-141 | 51.2 EB05 31.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Systemic candida | 55 | 52.1 39.9–68.0ROR 52.4 · χ² 2,644 / p <1e-300 | 50.1 EB05 39.9 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=55 · 91% clinician | no trial data cached |
| Crystalluria | 12 | 51.3 28.9–90.8ROR 51.3 · χ² 530 / p 1e-117 | 46.7 EB05 28.4 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Diffuse alveolar damage | 25 | 50.6 34.1–75.2ROR 50.7 · χ² 1,141 / p 2e-250 | 47.8 EB05 34.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 0% (drug 39%) · 96% clinician | no trial data cached |
| Eosinophilia | 364 | 48.6 43.9–53.8ROR 50.6 · χ² 16,590 / p <1e-300 | 47.5 EB05 43.6 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.6 · 96% clinician | no trial data cached |
| Mediastinitis | 12 | 48.2 27.2–85.3ROR 48.2 · χ² 497 / p 2e-110 | 44.1 EB05 26.9 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=12 | no trial data cached |
| Urticarial vasculitis | 10 | 44.8 24.0–83.8ROR 44.9 · χ² 378 / p 1e-84 | 40.8 EB05 23.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Symmetrical drug-related intertriginous and flexural exanthema | 14 | 41.1 24.2–69.6ROR 41.1 · χ² 499 / p 9e-111 | 38.4 EB05 24.3 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious n=14 | no trial data cached |
| Chorioretinitis | 11 | 39.8 21.9–72.1ROR 39.8 · χ² 371 / p 5e-83 | 36.8 EB05 21.9 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Hepatic cytolysis | 201 | 38.2 33.3–43.9ROR 39.1 · χ² 7,132 / p <1e-300 | 37.5 EB05 33.3 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 23.4 · 100% clinician | no trial data cached |
| Enterococcal infection | 79 | 37.9 30.4–47.3ROR 38.2 · χ² 2,756 / p <1e-300 | 37.0 EB05 30.6 · IC025 +4.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=75 · 95% clinician | no trial data cached |
| Enterococcal bacteraemia | 17 | 37.4 23.2–60.4ROR 37.5 · χ² 557 / p 2e-123 | 35.5 EB05 23.5 · IC025 +3.4 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | no trial data cached |
| Enterococcal sepsis | 13 | 37.0 21.4–63.9ROR 37.0 · χ² 413 / p 4e-92 | 34.7 EB05 21.6 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=13 | no trial data cached |
| Pathogen resistance | 141 | 36.0 30.5–42.4ROR 36.5 · χ² 4,685 / p <1e-300 | 35.3 EB05 30.6 · IC025 +4.7 3/3 methods agree | Reporting / coding artifact | serious PRR 22.5 · 94% clinician | no trial data cached |
| Alveolitis allergic | 15 | 33.2 20.0–55.3ROR 33.3 · χ² 431 / p 5e-96 | 31.6 EB05 20.3 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=15 | 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) | 753 | 1.3 1.2–1.4ROR 1.3 · χ² 58 / p 1e-14 | 1.3 EB05 1.2 · IC025 +0.3 | Reporting / coding artifact | serious PRR 2.2 · 92% clinician | no trial data cached |
| Off label use (used outside approved label) | 694 | 1.8 1.7–2.0ROR 1.9 · χ² 271 / p 4e-61 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 2.0 · 93% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 599 | 9.0 8.3–9.8ROR 9.6 · χ² 4,279 / p <1e-300 | 9.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 · 94% clinician | no trial data cached |
| Pyrexia (fever) | 477 | 3.2 2.9–3.4ROR 3.3 · χ² 710 / p 1e-156 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Eosinophilic pneumonia | 463 | 398.4 361.7–438.8ROR 419.5 · χ² 155,650 / p <1e-300 | 334.0 EB05 309.3 · IC025 +7.8 3/3 methods agree | Labeled adverse reaction exact term | serious n=455 · ♀ 19% (drug 39%) · 96% clinician | no trial data cached |
| Rhabdomyolysis (muscle breakdown) | 370 | 20.5 18.5–22.7ROR 21.3 · χ² 6,794 / p <1e-300 | 20.3 EB05 18.6 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.4 · 95% clinician | no trial data cached |
| Eosinophilia | 364 | 48.6 43.9–53.8ROR 50.6 · χ² 16,590 / p <1e-300 | 47.5 EB05 43.6 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.6 · 96% clinician | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 334 | 30.3 27.2–33.7ROR 31.4 · χ² 9,310 / p <1e-300 | 29.8 EB05 27.2 · IC025 +4.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.6 · 98% clinician | no trial data cached |
| Blood creatine phosphokinase increased | 331 | 26.2 23.5–29.1ROR 27.1 · χ² 7,903 / p <1e-300 | 25.8 EB05 23.6 · IC025 +4.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 15.2 · 91% clinician | no trial data cached |
| Product use in unapproved indication | 301 | 2.8 2.5–3.2ROR 2.9 · χ² 355 / p 2e-79 | 2.8 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 96% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 294 | 5.0 4.4–5.6ROR 5.1 · χ² 932 / p 5e-205 | 4.9 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 · 95% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 276 | 5.7 5.0–6.4ROR 5.8 · χ² 1,060 / p 8e-233 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.6 · 93% clinician | no trial data cached |
| Interstitial lung disease | 270 | 12.8 11.4–14.4ROR 13.2 · χ² 2,927 / p <1e-300 | 12.7 EB05 11.5 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.9 · 96% clinician | no trial data cached |
| Rash | 267 | 1.4 1.3–1.6ROR 1.4 · χ² 32 / p 9e-9 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 · 92% clinician | no trial data cached |
| Pneumonitis | 257 | 21.9 19.4–24.8ROR 22.5 · χ² 5,070 / p <1e-300 | 21.7 EB05 19.6 · IC025 +4.2 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 14.1 · 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.
- Protothecosis — n=24, PRR 784.4
- Drug dispensed to wrong patient — n=33, PRR 82.9
- Diffuse alveolar damage — n=25, PRR 50.6
- Hepatic cytolysis — n=201, PRR 38.2
✓ A hand-written Bradford Hill causality assessment exists for this drug: Daptomycin ↔ Myopathy / rhabdomyolysis.
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 Daptomycin?
In FDA FAERS, the most frequently co-reported reaction terms for Daptomycin are acute kidney injury, pyrexia, eosinophilic pneumonia, rhabdomyolysis, eosinophilia, drug reaction with eosinophilia and systemic symptoms. 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 Daptomycin have an FDA boxed warning?
No. The FDA label retrieved for Daptomycin has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Daptomycin 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 0e55bfa7-7dbf-4fa1-8aee-eac3fe4e05e3, effective 20250207; matched on
openfda.generic_name.exact:"DAPTOMYCIN") - 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, 1,000 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.