Prescription medication · Aminoglycoside Antibiotic
amikacin
Also sold as Amikin. Amikacin treats serious infections caused by bacteria.
Data updated 2026-05-15
- 16,238
- FDA reportsModerately reported
- 2
- InteractionsFew interactions
- Rx
- Availability
What the data shows
amikacin (Amikin) is a prescription Aminoglycoside Antibiotic, reported at a middle-of-the-pack volume (16,238 FDA reports), with 2 documented drug interactions.
Reporting volume reflects how widely a drug is used and studied, not how dangerous it is, a FAERS report documents a temporal association, never proof of cause.
amikacin (Amikin) is a prescription Aminoglycoside Antibiotic. Amikacin treats serious infections caused by bacteria.
Amikacin is an antibiotic medicine. It fights serious infections caused by certain types of bacteria.
Verify with FDA → · CMS NADAC pricing →
What it does
Amikacin treats serious infections caused by bacteria.
Common side effects
No common side effects listed.
Key warnings
Amikacin can potentially cause hearing loss and kidney damage.
The sections below are summarized in plain English from amikacin's FDA-approved prescribing information. They describe what the official label says, and are not personal medical advice.
How It Works
Amikacin belongs to a class of drugs called aminoglycosides. It works by stopping the growth of bacteria. This helps your body fight off the infection.
Side Effects (from patient reports)
Based on 16,238 FDA adverse event reports.
Most-reported reactions
Adverse reactions in FAERS for amikacin, by number of reports
- Cough
Cough
1,620 reports
- Dyspnoea
Dyspnoea
1,556 reports
- Hospitalisation
Hospitalisation
1,360 reports
- Therapy Interrupted
Therapy Interrupted
1,348 reports
- Death
Death
1,103 reports
- Dysphonia
Dysphonia
977 reports
- Nausea
Nausea
721 reports
- Fatigue
Fatigue
702 reports
- Pneumonia
Pneumonia
649 reports
- Diarrhoea 634
Diarrhoea
634 reports
What this shows Bars show how often each reaction was reported, not how likely it is to happen, a report records a temporal association, never proof that the drug caused it.
Reports over time
Adverse-event reports filed for amikacin each year to the FDA Adverse Event Reporting System (FAERS).
Year-to-year volume tracks usage, prescribing, and scrutiny, not a change in per-patient risk. Source: FDA FAERS.
Where amikacin sits
amikacin has more FDA adverse-event reports than 50% of the drugs FAERS tracks. A high position reflects how widely a drug is used and watched, not how dangerous it is.
Percentile across all drugs PlainMeds tracks by FAERS report volume. The dot is amikacin; the line is the median (50th percentile).
FDA Adverse Event Report Analysis
Detailed analysis of 16,238 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.
Total Reports
16,238
Reports Mentioning Death
3,283
20.2% of reports — not proof of cause
Hospitalization Reports
6,935
Top Indication
Product Used For Unknown Indication
Gender Distribution
Age Distribution
Most Reported Adverse Reactions (FAERS)
| # | Reaction | Reports |
|---|---|---|
| 3 | COUGH | 1,620 |
| 4 | DYSPNOEA | 1,556 |
| 5 | HOSPITALISATION | 1,360 |
| 6 | THERAPY INTERRUPTED | 1,348 |
| 7 | DEATH | 1,103 |
| 8 | DYSPHONIA | 977 |
| 10 | NAUSEA | 721 |
| 11 | FATIGUE | 702 |
| 12 | PNEUMONIA | 649 |
| 13 | DIARRHOEA | 634 |
| 14 | PYREXIA | 632 |
| 15 | PRODUCTIVE COUGH | 598 |
| 16 | CONDITION AGGRAVATED | 566 |
| 17 | DRUG RESISTANCE | 554 |
| 19 | APHONIA | 491 |
Reactions in Death Reports
Reactions in Hospitalization Reports
Source: FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation
Serious Warnings
Amikacin can potentially cause hearing loss and kidney damage. Tell your doctor if you have kidney problems or are taking other medicines that can affect your hearing or kidneys. Your doctor should closely monitor you for hearing and kidney problems during treatment. This drug can also cause muscle weakness or breathing problems, especially if you are also taking anesthesia or certain muscle relaxants.
Known Drug Interactions
Nephrotoxic agents Concomitant administration of cidofovir injection and agents with nephrotoxic potential [e.g., intravenous aminoglycosides (e.g., tobramycin, gentamicin, and amikacin), amphotericin B, foscarnet, intravenous pentamidine, vancomycin, and nonsteroidal anti-inflammatory agents] is contraindicated.
Mechanism: Both of these drugs can be harmful to the kidneys. Using them together significantly increases the chance of kidney injury.
ZOSYN, which contains EDTA, is compatible with amikacin and gentamicin for simultaneous Y-site infusion in certain diluents and at specific concentrations.
Mechanism: These two drugs can be given through the same IV line at the same time as long as they are mixed in specific liquids and at certain strengths.
This is a plain-language summary of FDA-label interaction records and does not provide individual medication-combination directions.
Common Questions
How long will I need to take amikacin?
What tests will be done while I am taking amikacin?
Can amikacin affect my hearing?
Can amikacin affect my kidneys?
What should I do if I experience dizziness or hearing changes?
Can I take amikacin if I am allergic to other antibiotics?
Will amikacin interact with other medications I am taking?
How will I know if the amikacin is working?
Are there any long-term side effects of amikacin?
When should I call my doctor?
Does amikacin interact with other medications?
What drug class is amikacin?
What pregnancy or breastfeeding source fields are listed for amikacin?
Related Medications in Aminoglycoside Antibiotic
Other drugs grouped near amikacin - same-class peers and common alternatives.
amoxicillin
Amoxil
Amoxicillin and Clavulanate Potassium is a combination medicine used to fight bacterial infections.
Compare with amikacin →
amoxicillin/clavulanate
Augmentin
Augmentin is a combination of two medicines, amoxicillin and clavulanate.
Compare with amikacin →
ampicillin/sulbactam
Unasyn
Unasyn is a combination of two antibiotics that fights bacteria in your body.
Compare with amikacin →
azithromycin
Zithromax, Z-Pack
Azithromycin is an antibiotic that fights bacteria.
Compare with amikacin →
cefazolin
Ancef, Kefzol
Cefazolin is an antibiotic medicine.
Compare with amikacin →
Compare beyond drug class
Nationwide peers by FAERS volume & death-report share
Two PlainMeds-derived comparison paths for amikacin: nearest FDA FAERS report volume and nearest death-report share among drugs with at least 1,000 logged reports, excluding same-class neighbors listed above. Counts reflect reporting volume, not proven individual harm.
Similar FAERS report volume
Nearest drugs by total FAERS reports. This record: 16,238.
Similar death-report share
Nearest drugs by FAERS death-report share. This record: 20.22%.
- atropine Δ 0.01 pts · 7,881 reports · Anticholinergic 20.23%death share
- bupropion Δ 0.14 pts · 41,778 reports · Norepinephrine-Dopamine Reuptake Inhibitor (NDRI) 20.36%death share
- temazepam Δ 0.16 pts · 36,917 reports · Benzodiazepine (Hypnotic) 20.06%death share
- metolazone Δ 0.30 pts · 10,872 reports · Thiazide-Like Diuretic 19.91%death share
Medication Guides
Understanding Drug Interactions
How CYP450 enzymes, inhibitors, and inducers affect your medications
Generic vs Brand Name Drugs
FDA requirements, cost savings, and when the difference matters
Narrow Therapeutic Index Drugs
FDA bioequivalence and label-record context for narrow therapeutic index medicines
Common Drug Interactions
Dangerous medication combinations and how to protect yourself
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What the FDA Data Shows for amikacin
The FDA label for amikacin (sold under brand names such as Amikin) classifies it as a prescription-only medication in the Aminoglycoside Antibiotic class. Amikacin treats serious infections caused by bacteria. Labeling covers dosing, contraindications, and monitoring requirements derived from clinical trials.
Post-market surveillance from the FDA Adverse Event Reporting System (FAERS) captures real-world experience. For this drug, FAERS contains 16,238 voluntary reports. The database also lists 2 documented drug interactions derived from FDA labeling, with the top-flagged interaction rated major severity. Acquisition-cost data is surveyed weekly by CMS and updated as manufacturers report changes.
Report counts do not establish causation, a FAERS entry documents a temporal association, not proof that the drug produced the outcome. Widely prescribed medications naturally accumulate more reports than niche therapies, so raw totals must be interpreted alongside total exposure. Shortage status, recall history, and patent information are separate source-record fields. This page is a public FDA/CMS registry and does not provide medical, treatment, substitution, or medication-change directions.
Data Sources
Drug labeling: FDA Drug Labels (SPL/DailyMed). Adverse events: FDA Adverse Event Reporting System (FAERS).
FAERS reports are voluntary and do not establish causation. Drug interactions are derived from FDA labeling and clinical references. This registry does not provide medication decisions.
Last updated: April 8, 2024
PlainMeds is rendered directly from FDA openFDA/FAERS extracts, DailyMed labels, and CMS drug-pricing files, no number is typed in by an editor. FAERS counts, recalls, shortages, and price figures on this page are queried live from those federal extracts. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of 2026-05-15. Primary sources: openFDA / FAERS, DailyMed and CMS Part B ASP.
Read our methodology - how this data is sourced, computed, and verified.
Data currency: FDA FAERS adverse-event reports through 2025, CMS NADAC acquisition-cost pricing effective December 2024, compiled from the source snapshot dated . See our methodology for per-source dates and refresh cadence. Spot a figure that looks wrong? Report a data issue.
All federal data sources used on this page
- FDA Orange Book - approved drug products with therapeutic equivalence. accessdata.fda.gov/cder/ob
- FDA DailyMed - NIH-hosted drug labeling for FDA-approved meds. dailymed.nlm.nih.gov
- FDA Adverse Event Reporting System (FAERS) - post-marketing safety surveillance. fda.gov/drugs/faers
- NLM RxNorm - standardized clinical drug nomenclature. nlm.nih.gov/research/umls/rxnorm
- CMS Medicare Part B Drug Average Sales Price Files - federal drug pricing data. cms.gov/medicare/part-b-drugs/asp
- FDA Drug Shortages Database - current and resolved drug shortage tracking. accessdata.fda.gov/drugshortages