What the label lists and what reports show
Amikacin side effects
Amikacin's FDA label lists its adverse reactions in its own words. FAERS holds 18,617 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is cough (1,727 reports).
- Generic listed
- Boxed warning
Check it at the source: the amikacin FDA label on DailyMed (effective December 10, 2025, Qilu Pharmaceutical Co., Ltd.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of ARIKAYCE?ARIKAYCE may cause serious side effects, including: See " What is the most important information I should know about ARIKAYCE? " hearing loss or ringing in the ears (ototoxicity). Ototoxicity is a serious and common side effect of ARIKAYCE. Tell your healthcare provider right away if you have hearing loss or you hear noises in your ears such as ringing or hissing. Tell your healthcare provider if you start having problems with balance or dizziness (vertigo). worsening kidney problems (nephrotoxicity). ARIKAYCE is in a class of medicines which may cause worsening kidney problems. Your healthcare provider may do a blood test to check how well your kidneys are working during your treatment with ARIKAYCE. worsening muscle weakness (neuromuscular blockade). […]
Source: FDA drug label (ARIKAYCE), Insmed Incorporated, effective August 4, 2026 (SPL set 499ab990-2b21-474f-aaba-d86388965f40), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsAll aminoglycosides have the potential to induce auditory, vestibular, and renal toxicity and neuromuscular blockade (see WARNINGS box). They occur more frequently in patients with present or past history of renal impairment, of treatment with other ototoxic or nephrotoxic drugs, and in patients treated for longer periods and/or with higher doses than recommended. Neurotoxicity-Ototoxicity Toxic effects on the eighth cranial nerve can result in hearing loss, loss of balance, or both. Amikacin primarily affects auditory function. Cochlear damage includes high frequency deafness and usually occurs before clinical hearing loss can be detected. Neurotoxicity-Neuromuscular Blockade Acute muscular paralysis and apnea can occur following treatment with aminoglycoside drugs. …
Table 1: Adverse Reactions in ≥ 5% of ARIKAYCE-treated MAC Patients and More Frequent than Background Regimen Alone in Trial 1
This table is printed in the ARIKAYCE label published by Insmed Incorporated of August 4, 2026; the label quoted above does not print one.
| Adverse Reaction | ARIKAYCE plus Background Regimen (N=223) n (%) | Background Regimen Alone (N=112) n (%) |
|---|---|---|
| Dysphonia Includes aphonia and dysphonia | 106 (48) | 2 (2) |
| Cough Includes cough, productive cough, and upper airway cough syndrome | 88 (40) | 19 (17) |
| Bronchospasm Includes asthma, bronchial hyperreactivity, bronchospasm, dyspnea, dyspnea… | 64 (29) | 12 (11) |
| Hemoptysis | 41 (18) | 15 (13) |
| Musculoskeletal pain Includes back pain, arthralgia, myalgia, pain/body aches, muscle… | 40 (18) | 10 (9) |
| Upper airway irritation Includes oropharyngeal pain, oropharyngeal discomfort, throat… | 39 (18) | 2 (2) |
| Ototoxicity Includes deafness, deafness neurosensory, deafness unilateral, dizziness,… | 38 (17) | 11 (10) |
| Fatigue and asthenia | 36 (16) | 11 (10) |
| Exacerbation of underlying pulmonary disease Includes COPD, infective exacerbation of… | 34 (15) | 11 (10) |
| Diarrhea | 28 (13) | 5 (5) |
| Nausea | 26 (12) | 4 (4) |
| Headache | 22 (10) | 5 (5) |
| Pneumonia Includes atypical pneumonia, empyema, infection pleural effusion, lower… | 20 (9) | 10 (9) |
| Pyrexia | 17 (8) | 5 (5) |
| Weight decreased | 16 (7) | 1 (1) |
| Vomiting Includes vomiting and post-tussive vomiting | 15 (7) | 4 (4) |
| Rash Includes rash, rash maculo-papular, drug eruption, and urticaria | 14 (6) | 1 (1) |
| Change in sputum Includes increased sputum, sputum purulent, and sputum discolored | 13 (6) | 1 (1) |
| Chest discomfort | 12 (5) | 3 (3) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
Source: FDA drug label, Qilu Pharmaceutical Co., Ltd., effective December 10, 2025 (SPL set 20fa61ef-11e2-4d01-82ea-b5412cefaead), via openFDA; the full label on DailyMed
What do FAERS reports show?
18,617 reports list amikacin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,805 are coded as a death and 7,908 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 17 reactions below, 13 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Amikacin: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions