Amikacin Sulfate side effects: what 1,714 FDA adverse event reports show
Drug class
Brand names
Arikayce
Who reports
1,714 reports · 94% serious · 423 with death outcome · 43% female
Used for
LIMITED POPULATION: ARIKAYCE ® is indicated in adults, who have limited or no alternative treatment options, for the treatment of Mycobacterium avium complex (MAC) lung disease as part of a combination antibacterial drug regimen in patients who do not achieve negative sputum cultures after a minimum of 6 consecutive months of a multidrug background regimen therapy.
What it is
The active ingredient in ARIKAYCE (amikacin liposome inhalation suspension) is amikacin sulfate USP, an aminoglycoside antibacterial.
Boxed warning
RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] .
Causality screen of the 40 strongest signals
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.
- 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. 68 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Drug resistance | 62 | 29.6 23.2–37.8ROR 30.7 · χ² 1,685 / p <1e-300 | 29.3 EB05 23.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.6 · 97% clinician | no trial data cached |
| Disseminated intravascular coagulation | 33 | 28.7 20.5–40.2ROR 29.2 · χ² 853 / p 9e-188 | 28.2 EB05 21.0 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 17.5 · 91% clinician | no trial data cached |
| Nephropathy toxic | 21 | 23.1 15.1–35.4ROR 23.4 · χ² 422 / p 4e-94 | 22.7 EB05 15.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 14.4 · 100% clinician | no trial data cached |
| Blood alkaline phosphatase increased | 43 | 21.2 15.8–28.5ROR 21.7 · χ² 807 / p 7e-178 | 21.0 EB05 16.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.5 | no trial data cached |
| Blood urea increased | 29 | 21.1 14.7–30.3ROR 21.5 · χ² 536 / p 8e-119 | 20.8 EB05 15.2 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 14.2 | no trial data cached |
| Toxic skin eruption | 17 | 20.6 12.9–33.1ROR 20.8 · χ² 298 / p 5e-67 | 20.1 EB05 13.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.6 | no trial data cached |
| Eosinophilia | 28 | 19.7 13.6–28.4ROR 20.0 · χ² 477 / p 5e-106 | 19.4 EB05 14.0 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 12.5 · 96% clinician | no trial data cached |
| Gamma-glutamyltransferase increased | 35 | 19.4 13.9–26.9ROR 19.7 · χ² 591 / p 9e-131 | 19.1 EB05 14.3 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious PRR 11.9 | no trial data cached |
| Ventricular fibrillation | 17 | 18.7 11.7–30.1ROR 18.9 · χ² 267 / p 2e-60 | 18.2 EB05 11.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Blood lactate dehydrogenase increased | 23 | 17.7 11.8–26.6ROR 17.9 · χ² 345 / p 2e-77 | 17.3 EB05 12.0 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 11.5 · ♀ 18% (drug 43%) | no trial data cached |
| Candida infection (yeast infection) | 22 | 16.2 10.7–24.5ROR 16.4 · χ² 298 / p 5e-67 | 15.7 EB05 10.7 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 · 95% clinician | no trial data cached |
| Vasculitis | 15 | 15.8 9.5–26.1ROR 15.9 · χ² 193 / p 4e-44 | 14.9 EB05 9.0 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 32 | 15.4 10.9–21.6ROR 15.6 · χ² 415 / p 1e-92 | 15.1 EB05 11.0 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · 94% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 44 | 15.0 11.2–20.1ROR 15.4 · χ² 561 / p 3e-124 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Multiple organ dysfunction syndrome | 34 | 14.9 10.7–20.8ROR 15.2 · χ² 428 / p 2e-95 | 14.7 EB05 10.8 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.1 · 97% clinician | no trial data cached |
| Septic shock | 52 | 14.8 11.3–19.3ROR 15.2 · χ² 654 / p 2e-144 | 14.6 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 90% clinician | no trial data cached |
| Hepatic function abnormal | 41 | 13.6 10.0–18.4ROR 13.9 · χ² 465 / p 2e-103 | 13.3 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| C-reactive protein increased | 40 | 13.5 9.9–18.3ROR 13.8 · χ² 450 / p 3e-100 | 13.2 EB05 9.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 · ♀ 21% (drug 43%) | no trial data cached |
| Status epilepticus | 12 | 13.0 7.4–22.9ROR 13.1 · χ² 121 / p 2e-28 | 11.5 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Deafness | 27 | 12.6 8.7–18.4ROR 12.8 · χ² 278 / p 1e-62 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.0 | no trial data cached |
| Brain oedema | 13 | 12.6 7.3–21.7ROR 12.7 · χ² 128 / p 7e-30 | 11.2 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Rash maculo-papular | 21 | 11.6 7.6–17.8ROR 11.7 · χ² 193 / p 3e-44 | 10.8 EB05 7.0 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.8 · ♀ 20% (drug 43%) · 95% clinician | no trial data cached |
| Febrile neutropenia | 61 | 11.3 8.8–14.4ROR 11.7 · χ² 563 / p 8e-125 | 11.0 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 97% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 20 | 11.1 7.2–17.1ROR 11.2 · χ² 173 / p 8e-40 | 10.1 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.9 · ♀ 90% (drug 43%) · 95% clinician | no trial data cached |
| Bone marrow failure | 18 | 10.8 6.8–17.1ROR 10.9 · χ² 150 / p 8e-35 | 9.7 EB05 6.1 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Cardiovascular disorder | 22 | 10.5 7.0–16.0ROR 10.7 · χ² 181 / p 2e-41 | 9.6 EB05 6.4 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.9 · ♀ 0% (drug 43%) | no trial data cached |
| Acute respiratory distress syndrome | 15 | 10.4 6.3–17.2ROR 10.5 · χ² 118 / p 8e-28 | 9.0 EB05 5.4 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Hypokalaemia (low potassium) | 37 | 9.9 7.2–13.6ROR 10.1 · χ² 287 / p 1e-64 | 9.3 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 6.1 · 92% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 13 | 9.7 5.7–16.7ROR 9.8 · χ² 93 / p 2e-22 | 8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
| Neutrophil count decreased | 32 | 9.7 6.9–13.6ROR 9.8 · χ² 241 / p 1e-54 | 9.0 EB05 6.5 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.9 · 94% clinician | no trial data cached |
| Lymphopenia | 11 | 9.6 5.3–17.3ROR 9.6 · χ² 76 / p 1e-18 | 7.7 EB05 4.3 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 | no trial data cached |
| Drug-induced liver injury | 24 | 9.5 6.4–14.2ROR 9.7 · χ² 175 / p 3e-40 | 8.7 EB05 5.9 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 · 92% clinician | no trial data cached |
| Leukocytosis | 14 | 9.5 5.6–16.0ROR 9.6 · χ² 98 / p 2e-23 | 8.0 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Acute myeloid leukaemia | 12 | 9.4 5.4–16.6ROR 9.5 · χ² 82 / p 6e-20 | 7.7 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Oral candidiasis (oral thrush) | 10 | 9.4 5.1–17.5ROR 9.5 · χ² 67 / p 1e-16 | 7.4 EB05 4.0 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Impaired work ability | 16 | 9.1 5.6–14.9ROR 9.2 · χ² 108 / p 1e-25 | 7.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Sepsis (blood infection) | 83 | 9.1 7.4–11.2ROR 9.5 · χ² 594 / p 1e-131 | 8.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 95% clinician | no trial data cached |
| Multi-organ failure | 13 | 9.1 5.3–15.6ROR 9.1 · χ² 86 / p 1e-20 | 7.5 EB05 4.4 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Pancreatitis acute | 16 | 8.8 5.4–14.3ROR 8.9 · χ² 103 / p 2e-24 | 7.5 EB05 4.7 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Alanine aminotransferase increased | 44 | 8.8 6.6–11.8ROR 9.0 · χ² 296 / p 1e-66 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · 90% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
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 |
|---|---|---|---|---|---|---|
| Sepsis (blood infection) | 83 | 9.1 7.4–11.2ROR 9.5 · χ² 594 / p 1e-131 | 8.9 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · 95% clinician | no trial data cached |
| Thrombocytopenia (low platelets) | 62 | 6.8 5.3–8.7ROR 7.0 · χ² 303 / p 3e-68 | 6.5 EB05 5.3 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 · 95% clinician | no trial data cached |
| Drug resistance | 62 | 29.6 23.2–37.8ROR 30.7 · χ² 1,685 / p <1e-300 | 29.3 EB05 23.7 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 18.6 · 97% clinician | no trial data cached |
| Febrile neutropenia | 61 | 11.3 8.8–14.4ROR 11.7 · χ² 563 / p 8e-125 | 11.0 EB05 8.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 97% clinician | no trial data cached |
| Platelet count decreased | 60 | 6.9 5.4–8.9ROR 7.1 · χ² 298 / p 4e-67 | 6.6 EB05 5.3 · IC025 +2.3 3/3 methods agree | Lab value / disease marker | serious PRR 5.2 · 95% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 52 | 4.7 3.6–6.1ROR 4.8 · χ² 149 / p 2e-34 | 4.5 EB05 3.6 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 3.0 · 92% clinician | no trial data cached |
| Septic shock | 52 | 14.8 11.3–19.3ROR 15.2 · χ² 654 / p 2e-144 | 14.6 EB05 11.5 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.0 · 90% clinician | no trial data cached |
| Alanine aminotransferase increased | 44 | 8.8 6.6–11.8ROR 9.0 · χ² 296 / p 1e-66 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · 90% clinician | no trial data cached |
| Electrocardiogram qt prolonged | 44 | 15.0 11.2–20.1ROR 15.4 · χ² 561 / p 3e-124 | 14.8 EB05 11.4 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 | no trial data cached |
| Blood alkaline phosphatase increased | 43 | 21.2 15.8–28.5ROR 21.7 · χ² 807 / p 7e-178 | 21.0 EB05 16.2 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious PRR 14.5 | no trial data cached |
| White blood cell count decreased | 42 | 4.7 3.5–6.4ROR 4.8 · χ² 121 / p 2e-28 | 4.5 EB05 3.5 · IC025 +1.7 3/3 methods agree | Lab value / disease marker | serious PRR 4.1 · 90% clinician | no trial data cached |
| Hepatic function abnormal | 41 | 13.6 10.0–18.4ROR 13.9 · χ² 465 / p 2e-103 | 13.3 EB05 10.1 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| C-reactive protein increased | 40 | 13.5 9.9–18.3ROR 13.8 · χ² 450 / p 3e-100 | 13.2 EB05 9.9 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.5 · ♀ 21% (drug 43%) | no trial data cached |
| Aspartate aminotransferase increased | 38 | 8.8 6.4–12.0ROR 8.9 · χ² 254 / p 1e-57 | 8.2 EB05 6.1 · IC025 +2.5 3/3 methods agree | Lab value / disease marker | serious PRR 6.1 · 92% clinician | no trial data cached |
| Blood creatinine increased | 37 | 6.9 5.0–9.5ROR 7.1 · χ² 182 / p 7e-42 | 6.4 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.7 · ♀ 22% (drug 43%) | 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.
- Disseminated intravascular coagulation — n=33, PRR 28.7
- Nephropathy toxic — n=21, PRR 23.1
- Eosinophilia — n=28, PRR 19.7
- Candida infection — n=22, PRR 16.2
- Drug reaction with eosinophilia and systemic symptoms — n=32, PRR 15.4
- Electrocardiogram qt prolonged — n=44, PRR 15.0
- Septic shock — n=52, PRR 14.8
- Hepatic function abnormal — n=41, PRR 13.6
- Febrile neutropenia — n=61, PRR 11.3
- Hepatotoxicity — n=20, PRR 11.1
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 Amikacin?
In FDA FAERS, the most frequently co-reported reaction terms for Amikacin are sepsis, thrombocytopenia, febrile neutropenia, platelet count decreased, neutropenia, septic shock. 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 Amikacin have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: RISK OF INCREASED RESPIRATORY ADVERSE REACTIONS ARIKAYCE has been associated with an increased risk of respiratory adverse reactions including, hypersensitivity pneumonitis, hemoptysis, bronchospasm, exacerbation of underlying pulmonary disease that have led to hospitalizations in some cases [see Warnings and Precautions (5.1 , 5.2 , 5.3 , 5.4) ] .
Do FAERS signals prove that Amikacin 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 499ab990-2b21-474f-aaba-d86388965f40, effective 20260804; matched on
openfda.generic_name.exact:"AMIKACIN") - 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, 108 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.