Amikacin sulfate adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Amikacin sulfate
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Aminoglycoside antibacterial
Also reported as: Amikacin Sulfate Injection Usp

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From February 2004 to June 2026, FDA received 828 adverse event reports that name Amikacin sulfate. In these reports the drug is a suspect or interacting product.

In the same period, 880 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 49 reports in the 12 months to June 2026 and 68 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 49 (under 0.1%) name Amikacin sulfate. Reports from consumers or other non-health professionals were 10.4% of the reports that name Amikacin sulfate and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Amikacin sulfate is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 11 reports that name Amikacin sulfate.
In January to March 2026, FDA received 12.
In April to June 2025, FDA received 12.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 127 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 787 of the 828 reports (95%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 127 terms.

Reaction terms in the reports that name Amikacin sulfate, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 828 reports
Drug ineffectivethe medicine did not work as expected	118	14.3%
Off label useused for a purpose or in a way not on the label	75	9.1%
Pyrexiafever	74	8.9%
Drug resistance	51	6.2%
Acute kidney injurysudden loss of kidney function	43	5.2%
Condition aggravatedthe condition being treated got worse	42	5.1%
Nauseafeeling sick	42	5.1%
Vomitingbeing sick	32	3.9%
Thrombocytopenialow platelets	31	3.7%
Dyspnoeashortness of breath	30	3.6%
Product use in unapproved indicationused for a purpose not on the label	28	3.4%
Ototoxicity	25	3%
Diarrhoealoose or frequent stools	24	2.9%
Drug interactionan interaction between medicines	24	2.9%
Sepsisa severe body-wide response to infection	24	2.9%
Somnolencedrowsiness	24	2.9%
Pathogen resistance	22	2.7%
Cardiovascular disorder	21	2.5%
Deafnesshearing loss	21	2.5%
General physical health deteriorationgeneral decline in health	21	2.5%
Heart rate increaseda fast heart rate reading	21	2.5%
Performance status decreased	21	2.5%
Multiple organ dysfunction syndromeseveral organs failing	20	2.4%
C-reactive protein increased	19	2.3%
Deaththe patient died; cause not stated by this term	19	2.3%
Dizzinesslight-headedness or unsteadiness	19	2.3%
Rashskin rash	19	2.3%
Neutropenialow neutrophils, a type of white blood cell	18	2.2%
Astheniaweakness or lack of energy	17	2.1%
Chest pain	17	2.1%
Eosinophilia	17	2.1%
Hypertransaminasaemia	17	2.1%
Oropharyngeal painsore throat	17	2.1%
Pneumonialung infection	17	2.1%
Hepatotoxicityliver injury	16	1.9%
Coma scale abnormal	15	1.8%
Drug intolerancethe medicine was not tolerated	15	1.8%
Flatulencewind	15	1.8%
Vision blurredblurred vision	15	1.8%
Chest discomfort	14	1.7%
Hyperventilation	14	1.7%
Impaired work abilityreduced ability to work	14	1.7%
Klebsiella infection	14	1.7%
Nephropathy toxic	14	1.7%
Oropharyngeal discomfort	14	1.7%
Renal impairmentreduced kidney function	14	1.7%
Speech disordera speech problem	14	1.7%
Visual impairmentreduced vision	14	1.7%
Weight bearing difficulty	14	1.7%
Blood creatinine increasedraised creatinine, a kidney test	13	1.6%

Download all 127 terms of Amikacin sulfate (CSV)

The counts add to more than 828 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Amikacin with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Amikacin	Generic name	5,380
Amikacin sulfate (this page)	Generic name	828
Arikayce	Brand name	6,471

Sum of the separately reported names: 12,679. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Amikacin sulfate, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	14	13	1	3	7	2	0	2	1
2005	8	7	1	1	4	0	0	2	1
2006	10	10	2	1	6	3	0	2	0
2007	17	17	4	2	7	0	0	9	0
2008	22	22	5	4	9	0	0	13	0
2009	17	17	4	4	12	1	0	4	0
2010	19	19	5	0	12	1	0	4	0
2011	20	20	11	2	13	0	0	4	0
2012	12	12	4	0	3	1	0	7	0
2013	10	9	1	1	7	0	0	4	1
2014	7	7	2	1	4	0	0	1	0
2015	4	4	0	0	2	0	0	3	0
2016	33	31	8	0	18	0	0	18	2
2017	23	23	6	0	10	1	0	10	0
2018	72	68	24	5	32	0	0	41	4
2019	101	94	22	19	42	4	2	71	7
2020	66	62	14	8	28	7	0	44	4
2021	62	60	15	10	38	6	0	41	2
2022	74	72	16	6	33	2	0	54	2
2023	55	46	4	9	19	10	0	37	9
2024	91	77	5	10	28	12	0	53	14
2025	62	57	5	9	20	2	0	50	5
2026	29	27	2	2	11	0	0	21	2

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Amikacin sulfate, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Amikacin sulfate, by the year in which FDA received them
Year	Reports
2004	13
2005	9
2006	10
2007	19
2008	22
2009	19
2010	18
2011	23
2012	15
2013	10
2014	9
2015	8
2016	26
2017	26
2018	81
2019	114
2020	80
2021	55
2022	69
2023	50
2024	80
2025	49
2026	23

Reports that name Amikacin sulfate, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Amikacin sulfate
Age	Reports	Share
Under 2	45	5.4%
2 to 11	51	6.2%
12 to 17	30	3.6%
18 to 44	157	19%
45 to 64	197	23.8%
65 to 74	93	11.2%
75 and over	99	12%
Age not given	156	18.8%

Sex of the patient in the reports that name Amikacin sulfate
Sex	Reports	Share
Female	316	38.2%
Male	420	50.7%
Unknown or not given	92	11.1%

Type of reporter in the reports that name Amikacin sulfate
Reporter	Reports	Share
Physician	296	35.7%
Pharmacist	39	4.7%
Other health professional	387	46.7%
Lawyer	1	0.1%
Consumer or non-health professional	86	10.4%
Not given	19	2.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 19.6% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Amikacin sulfate record
Indication as recorded (MedDRA)	Reports	Share
Mycobacterium abscessus infection	44	5.3%
Tuberculosis	38	4.6%
Mycobacterium avium complex infection	34	4.1%
Infection	31	3.7%
Sepsis	26	3.1%
Pneumonia	17	2.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 828 reports.

Pages near this one

Amikacin same ingredient
Arikayce same ingredient
Bacitracin same class
Bethkis same class
Amikacine next in the A to Z list
Amgevita next in the A to Z list
Amiloride next in the A to Z list
Amg-510 next in the A to Z list
Amino Acids Dextrose Electrolytes Soybean Oil next in the A to Z list
Amg 145 next in the A to Z list
Aminobenzoic Acid next in the A to Z list
Amfetamine next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for Amikacin sulfateThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Amikacin sulfate: adverse event reports that FDA received. https://reportedreactions.com/drug/amikacin-sulfate/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Amikacin sulfate as a suspect or interacting product. The 880 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Amikacin sulfate was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Amikacin sulfate?

No. It is a count of what people reported to FDA: 828 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (46.7%), physician (35.7%) and consumer or non-health professional (10.4%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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