Amikacin side effects: what 16,955 FDA adverse event reports show
Drug class
Brand names
Arikayce
Who reports
16,955 reports · 82% serious · 3,387 with death outcome · 54% 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.
- 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. 1,054 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 |
|---|---|---|---|---|---|---|
| Vascular pseudoaneurysm thrombosis | 11 | 838.2 389.0–1,805.8ROR 838.7 · χ² 4,965 / p <1e-300 | 266.9 EB05 159.0 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Neonatal candida infection | 11 | 419.1 211.3–831.3ROR 419.4 · χ² 3,110 / p <1e-300 | 202.8 EB05 120.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Mycobacterium abscessus infection | 166 | 381.9 321.0–454.3ROR 385.6 · χ² 47,728 / p <1e-300 | 281.6 EB05 247.4 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=165 | not reported in cached trials |
| Sputum decreased | 10 | 338.7 168.1–682.3ROR 338.9 · χ² 2,377 / p <1e-300 | 176.5 EB05 102.5 · IC025 +3.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=9 | NCT01799993: 1/359 (0.3%) control (serious AE) |
| Mycobacterial peritonitis | 17 | 265.7 157.3–448.9ROR 266.0 · χ² 3,467 / p <1e-300 | 175.6 EB05 116.1 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=17 | not reported in cached trials |
| Mycobacterium fortuitum infection | 30 | 239.1 161.7–353.5ROR 239.5 · χ² 5,748 / p <1e-300 | 177.6 EB05 130.4 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=30 · ♀ 0% (drug 54%) | not reported in cached trials |
| Geotrichum infection | 31 | 211.1 144.2–309.1ROR 211.5 · χ² 5,349 / p <1e-300 | 162.3 EB05 119.8 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · ♀ 81% (drug 54%) · 100% clinician | not reported in cached trials |
| Mycobacterium avium complex infection | 383 | 208.1 186.9–231.7ROR 212.9 · χ² 67,256 / p <1e-300 | 176.3 EB05 162.0 · IC025 +7.0 3/3 methods agree | Labeled (related wording) related wording | serious n=378 · ♀ 75% (drug 54%) | not reported in cached trials |
| Atypical mycobacterium test positive | 13 | 191.0 106.4–342.6ROR 191.1 · χ² 1,963 / p <1e-300 | 133.4 EB05 82.9 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | – | not reported in cached trials |
| Disseminated mycobacterium avium complex infection | 27 | 179.9 120.1–269.4ROR 180.2 · χ² 4,031 / p <1e-300 | 141.4 EB05 102.0 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=27 · ♀ 85% (drug 54%) · 100% clinician | not reported in cached trials |
| Post-tussive vomiting | 18 | 161.4 98.7–263.8ROR 161.5 · χ² 2,394 / p <1e-300 | 124.1 EB05 83.1 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=18 | not reported in cached trials |
| Sputum increased | 219 | 142.9 124.3–164.2ROR 144.7 · χ² 27,489 / p <1e-300 | 126.6 EB05 113.1 · IC025 +6.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=188 · 73% consumer | NCT01799993: 1/359 (0.3%) control (serious AE) |
| Bronchoscopy | 24 | 139.3 91.4–212.5ROR 139.5 · χ² 2,835 / p <1e-300 | 114.0 EB05 80.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=22 · 100% consumer | not reported in cached trials |
| Ototoxicity | 183 | 135.5 116.4–157.7ROR 136.9 · χ² 21,863 / p <1e-300 | 120.5 EB05 106.6 · IC025 +6.3 3/3 methods agree | Labeled — boxed warning exact term | serious n=178 · 93% clinician | not reported in cached trials |
| Overgrowth fungal | 10 | 132.5 69.0–254.5ROR 132.6 · χ² 1,062 / p 4e-233 | 97.9 EB05 56.8 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Hepatosplenic candidiasis | 14 | 129.3 74.5–224.3ROR 129.4 · χ² 1,497 / p <1e-300 | 101.2 EB05 64.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Pulmonary resection | 21 | 116.9 74.7–182.9ROR 117.0 · χ² 2,097 / p <1e-300 | 97.5 EB05 67.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Infective exacerbation of bronchiectasis | 24 | 110.0 72.5–167.0ROR 110.2 · χ² 2,279 / p <1e-300 | 93.7 EB05 66.2 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious n=24 | not reported in cached trials |
| Increased viscosity of bronchial secretion | 50 | 106.2 79.6–141.7ROR 106.5 · χ² 4,697 / p <1e-300 | 94.3 EB05 74.4 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=46 · 84% consumer | not reported in cached trials |
| Dependence on oxygen therapy | 36 | 100.2 71.4–140.7ROR 100.4 · χ² 3,176 / p <1e-300 | 88.4 EB05 66.8 · IC025 +4.8 3/3 methods agree | Reporting / coding artifact | serious n=36 · 78% consumer | not reported in cached trials |
| Sputum retention | 71 | 96.8 76.1–123.2ROR 97.2 · χ² 6,150 / p <1e-300 | 87.7 EB05 71.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=65 · 76% consumer | NCT01799993: 1/359 (0.3%) control (serious AE) |
| Device maintenance issue | 31 | 71.9 50.0–103.2ROR 72.0 · χ² 1,979 / p <1e-300 | 65.3 EB05 48.2 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious n=31 · ♀ 77% (drug 54%) · 100% consumer | not reported in cached trials |
| Mycobacterium chelonae infection | 37 | 65.4 47.0–91.0ROR 65.5 · χ² 2,165 / p <1e-300 | 60.3 EB05 45.7 · IC025 +4.5 3/3 methods agree | Labeled (related wording) related wording | serious n=37 | not reported in cached trials |
| Pulmonary cavitation | 38 | 56.8 41.1–78.7ROR 57.0 · χ² 1,939 / p <1e-300 | 53.0 EB05 40.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=38 | not reported in cached trials |
| Candida pneumonia | 14 | 55.8 32.7–95.3ROR 55.8 · χ² 669 / p 9e-148 | 50.0 EB05 31.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Trichosporon infection | 16 | 52.0 31.5–85.8ROR 52.1 · χ² 720 / p 8e-159 | 47.3 EB05 30.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Mycobacterial infection | 67 | 50.0 39.2–63.8ROR 50.2 · χ² 3,045 / p <1e-300 | 47.5 EB05 38.7 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=66 | not reported in cached trials |
| Herpes zoster meningoencephalitis | 14 | 49.9 29.3–85.1ROR 49.9 · χ² 598 / p 2e-132 | 45.2 EB05 28.6 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=14 | not reported in cached trials |
| Necrotising enterocolitis neonatal | 15 | 47.9 28.6–80.2ROR 47.9 · χ² 618 / p 1e-136 | 43.7 EB05 28.1 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Hypersensitivity pneumonitis | 42 | 47.6 35.0–64.8ROR 47.7 · χ² 1,801 / p <1e-300 | 45.0 EB05 34.7 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious n=42 · ♀ 78% (drug 54%) | not reported in cached trials |
| Aphonia | 507 | 46.6 42.7–50.9ROR 48.0 · χ² 21,771 / p <1e-300 | 44.9 EB05 41.7 · IC025 +5.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 35.4 · ♀ 87% (drug 54%) · 82% consumer | not reported in cached trials |
| Moraxella infection | 10 | 46.5 24.7–87.5ROR 46.6 · χ² 386 / p 3e-86 | 41.6 EB05 24.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Rhinocerebral mucormycosis | 12 | 44.9 25.2–79.8ROR 44.9 · χ² 455 / p 3e-101 | 40.7 EB05 24.8 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=12 | not reported in cached trials |
| Respiratory tract infection fungal | 18 | 43.4 27.1–69.4ROR 43.4 · χ² 679 / p 5e-150 | 40.3 EB05 26.9 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | not reported in cached trials |
| Sputum abnormal | 22 | 43.1 28.1–65.8ROR 43.1 · χ² 833 / p 2e-183 | 40.3 EB05 28.0 · IC025 +3.7 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=20 · ♀ 76% (drug 54%) | NCT01799993: 1/359 (0.3%) control (serious AE) |
| Acinetobacter infection | 35 | 41.3 29.5–57.8ROR 41.4 · χ² 1,292 / p 4e-283 | 39.2 EB05 29.4 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=35 · 100% clinician | not reported in cached trials |
| Atypical mycobacterial infection | 45 | 41.2 30.7–55.5ROR 41.4 · χ² 1,671 / p <1e-300 | 39.3 EB05 30.6 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=45 · 91% clinician | not reported in cached trials |
| Scedosporium infection | 21 | 38.6 25.0–59.6ROR 38.7 · χ² 710 / p 1e-156 | 36.3 EB05 25.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=21 · 100% clinician | not reported in cached trials |
| Respiratory tract irritation | 31 | 37.9 26.5–54.2ROR 38.0 · χ² 1,045 / p 2e-229 | 36.1 EB05 26.6 · IC025 +4.0 3/3 methods agree | Labeled (related wording) related wording | serious n=18 · 77% consumer | not reported in cached trials |
| Respiratory gas exchange disorder | 11 | 37.8 20.7–68.8ROR 37.8 · χ² 347 / p 9e-78 | 34.7 EB05 20.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Amikacin as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (4 of 40 signal terms matched).
- NCT01799993 — Inhaled Amikacin Solution BAY41-6551 as Adjunctive Therapy in the Treatment of Gram-Negative Pneumonia (N=725, PHASE3; 138 AE terms posted; arms: Amikacin Inhale 400mg q12h; Placebo)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
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 |
|---|---|---|---|---|---|---|
| Off label use (used outside approved label) | 2,009 | 2.9 2.8–3.0ROR 3.1 · χ² 2,540 / p <1e-300 | 2.9 EB05 2.8 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious PRR 3.0 | not reported in cached trials |
| Drug ineffective (drug did not work) | 1,774 | 1.7 1.6–1.7ROR 1.7 · χ² 504 / p 8e-112 | 1.7 EB05 1.6 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.0 | not reported in cached trials |
| Cough | 1,706 | 7.6 7.2–7.9ROR 8.3 · χ² 9,808 / p <1e-300 | 7.5 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.0 | not reported in cached trials |
| Dyspnoea (shortness of breath) | 1,626 | 3.6 3.4–3.7ROR 3.8 · χ² 3,068 / p <1e-300 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.9 | NCT01799993: 7/353 (2.0%) on Amikacin; 9/359 (2.5%) control |
| Therapy interrupted | 1,405 | 25.7 24.4–27.0ROR 27.9 · χ² 32,734 / p <1e-300 | 25.2 EB05 24.1 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious PRR 37.2 · 83% consumer | not reported in cached trials |
| Hospitalisation | 1,396 | 11.4 10.9–12.0ROR 12.4 · χ² 13,242 / p <1e-300 | 11.3 EB05 10.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 8.1 · 80% consumer | not reported in cached trials |
| Death | 1,138 | 1.6 1.5–1.7ROR 1.7 · χ² 291 / p 1e-65 | 1.6 EB05 1.6 · IC025 +0.6 | Outcome field, not a reaction | serious PRR 1.1 | not reported in cached trials |
| Dysphonia | 1,030 | 22.2 20.9–23.5ROR 23.5 · χ² 20,494 / p <1e-300 | 21.8 EB05 20.7 · IC025 +4.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.1 · ♀ 82% (drug 54%) · 76% consumer | not reported in cached trials |
| Nausea | 779 | 1.2 1.1–1.3ROR 1.2 · χ² 32 / p 7e-9 | 1.2 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | not reported in cached trials |
| Product dose omission issue | 770 | 3.4 3.1–3.6ROR 3.5 · χ² 1,281 / p 7e-281 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 7.8 · 85% consumer | not reported in cached trials |
| Fatigue (tiredness) | 752 | 1.2 1.1–1.3ROR 1.2 · χ² 25 / p 3e-7 | 1.2 EB05 1.1 · IC025 +0.1 | Labeled — boxed warning synonym match | serious PRR 1.2 · 70% consumer | not reported in cached trials |
| Pneumonia (lung infection) | 681 | 2.6 2.4–2.8ROR 2.7 · χ² 683 / p 8e-151 | 2.6 EB05 2.4 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01799993: 5/353 (1.4%) on Amikacin; 5/359 (1.4%) control (serious AE) |
| Diarrhoea (diarrhea) | 669 | 1.3 1.2–1.4ROR 1.3 · χ² 44 / p 2e-11 | 1.3 EB05 1.2 · IC025 +0.2 | Labeled adverse reaction exact term | serious PRR 1.3 | NCT01799993: 27/353 (7.6%) on Amikacin; 33/359 (9.2%) control |
| Pyrexia (fever) | 648 | 2.3 2.1–2.5ROR 2.4 · χ² 491 / p 5e-109 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 1.9 | NCT01799993: 1/353 (0.3%) on Amikacin (serious AE) |
| Condition aggravated | 631 | 2.6 2.4–2.8ROR 2.6 · χ² 620 / p 3e-137 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
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.
- Geotrichum infection — n=31, PRR 211.1
- Bronchoscopy — n=24, PRR 139.3
- Pulmonary resection — n=21, PRR 116.9
- Sputum retention — n=71, PRR 96.8 (also seen in trial arm)
- Pulmonary cavitation — n=38, PRR 56.8
- Acinetobacter infection — n=35, PRR 41.3
- Scedosporium infection — n=21, PRR 38.6
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 cough, dyspnoea, dysphonia, nausea, fatigue, pneumonia. 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, 1,094 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 - ClinicalTrials.gov API v2 (query
AMIKACIN, results-bearing studies sorted by enrollment)
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.