Pharmacologic class (EPC) · 15 drug pages

Aminoglycoside antibacterial: adverse event reports filed with FDA

37,840 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

37,840
reports across the class: 0.2% of all reports; 2,631
reports, 12 months to June 2026: 3,203 in the 12 months before; 80.3%
marked serious by the reporter: 57.4% across all reports; 15
drugs with a page: brand and generic names counted separately

Aminoglycoside antibacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 15 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 37,840 adverse event reports received by FDA, 0.2% of the database, from January 2004 to June 2026.

2,631 reports arrived in the 12 months to June 2026, down 18% from 3,203 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 80.3% of the class's reports are marked serious, 17.3% record death among the outcomes and 41.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (10.8%), drug ineffective (9.7%) and dyspnoea (8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
ArikayceAmikacin	brand	6,471	714	68.7%	Cough
Gentamicin	generic	5,591	285	94.7%	Drug ineffective
Amikacin	generic	5,380	531	91.9%	Drug ineffective
Tobramycin	generic	4,827	388	83.4%	Drug ineffective
TobiTobramycin	brand	3,702	12	82.7%	Death
TOBI PodhalerTobramycin	brand	2,649	40	72.7%	Cough
BethkisTobramycin	brand	1,931	62	57.5%	Off label use
Gentamicin sulfate	generic	1,638	67	83.5%	Drug ineffective
NeomycinNeomycin ointment	brand	1,110	256	92.7%	Infusion related reaction
TobraDexTobramycin and dexamethasone	brand	961	88	73.9%	Eye pain
Amikacin sulfate	generic	828	49	93.5%	Drug ineffective
Neomycin sulfate	generic	770	57	59.4%	Drug hypersensitivity
Streptomycin	generic	692	8	89.6%	Drug resistance
Kitabis PakTobramycin	brand	657	68	73.2%	Off label use
Bacitracin	generic	633	6	22.6%	Drug hypersensitivity

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Off label useused for a purpose or in a way not on the label10.8%4,082
Drug ineffectivethe medicine did not work as expected9.7%3,682
Dyspnoeashortness of breath8%3,010
Coughcough7.1%2,683
Deaththe patient died; cause not stated by this term6.7%2,554
Condition aggravatedthe condition being treated got worse5.1%1,947
Hospitalisationadmission to hospital5.1%1,945
Pyrexiafever4.5%1,719
Pneumonialung infection4.3%1,638
Acute kidney injurysudden loss of kidney function4%1,524
Fatiguetiredness4%1,516
Malaisegeneral feeling of being unwell4%1,516
Drug hypersensitivityan allergic-type reaction to a medicine3.9%1,470
Therapy interrupted3.8%1,454
Nauseafeeling sick3.8%1,450
Dysphoniaa hoarse voice3.5%1,310
Rashskin rash3.2%1,200
Product use in unapproved indicationused for a purpose not on the label2.9%1,104
Diarrhoealoose or frequent stools2.9%1,094
Vomitingbeing sick2.9%1,082
Ill-defined disordera condition that was not clearly described2.6%987
Headachehead pain2.5%958
Infectionan infection, type not specified2.5%937
Product dose omission issuea dose was missed2.4%921
Weight decreasedweight loss2.4%908

Solid bar: share of all class reports. Hollow bar: the median share across the 15 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.3%6,552

Life-threatening7.5%2,834

Hospitalisation (initial or prolonged)41.5%15,714

Disability4.4%1,675

Congenital anomaly1%374

Other serious45.3%17,133

Not serious19.7%7,453

Patient age

Under 22%757

2 to 113.9%1,489

12 to 173.3%1,252

18 to 4416%6,065

45 to 6414%5,297

65 to 7410.5%3,969

75 and over9%3,417

Age not given41.2%15,594

Who reported

Physician22.5%8,521

Pharmacist7.5%2,846

Other health professional34.3%12,994

Lawyer0.1%26

Consumer or non-health professional31.9%12,069

Not given3.7%1,384

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Aminoglycoside antibacterial reports

Which drugs are in the Aminoglycoside antibacterial class on this site?

Arikayce, Gentamicin, Amikacin, Tobramycin, Tobi and TOBI Podhaler and 9 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

37,840 reports through June 2026, 2,631 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

off label use (10.8%), drug ineffective (9.7%), dyspnoea (8%), cough (7.1%) and death (6.7%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.