Pharmacologic class (EPC) · 17 drug pages

Cephalosporin antibacterial: adverse event reports filed with FDA

57,006 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.

57,006
reports across the class: 0.3% of all reports; 4,246
reports, 12 months to June 2026: 5,107 in the 12 months before; 89.1%
marked serious by the reporter: 57.4% across all reports; 17
drugs with a page: brand and generic names counted separately

Cephalosporin antibacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 17 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 57,006 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

4,246 reports arrived in the 12 months to June 2026, down 17% from 5,107 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 89.1% of the class's reports are marked serious, 13.3% record death among the outcomes and 45.4% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug ineffective (9.9%), off label use (7.4%) and rash (5.3%). 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
Ceftriaxone	generic	17,155	1,294	93.7%	Off label use
Cephalexin	generic	5,647	472	70.6%	Rash
Cefepime	generic	5,419	505	95%	Drug ineffective
Cefuroxime	generic	5,078	293	93.9%	Dyspnoea
Cefazolin	generic	4,193	293	92%	Anaphylactic reaction
Ceftriaxone sodium	generic	3,779	311	93.3%	Dyspnoea
Ceftazidime	generic	3,316	241	96.7%	Drug ineffective
Cefotaxime	generic	2,210	104	98.1%	Drug ineffective
Cefuroxime axetil	generic	2,100	172	75.7%	Diarrhoea
Cefdinir	generic	1,614	83	50.3%	Diarrhoea
Cefazolin sodium	generic	1,331	191	95.5%	Anaphylactic shock
Cefepime hydrochloride	generic	1,021	51	86.6%	Acute kidney injury
Cefixime	generic	933	86	89.8%	Drug ineffective
ZerbaxaCeftolozane and tazobactam	brand	891	18	66.1%	Off label use
Cefuroxime sodium	generic	865	51	97.3%	Dyspnoea
Cefaclor	generic	729	38	78.9%	Drug hypersensitivity
Cefoxitin	generic	725	43	88.7%	Drug reaction with eosinophilia and systemic symptoms

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

Drug ineffectivethe medicine did not work as expected9.9%5,660
Off label useused for a purpose or in a way not on the label7.4%4,234
Rashskin rash5.3%3,024
Drug hypersensitivityan allergic-type reaction to a medicine4.9%2,765
Dyspnoeashortness of breath4.8%2,732
Condition aggravatedthe condition being treated got worse4.7%2,676
Pyrexiafever4.2%2,393
Diarrhoealoose or frequent stools4%2,277
Acute kidney injurysudden loss of kidney function3.7%2,128
Vomitingbeing sick3.5%1,971
Nauseafeeling sick3.4%1,945
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement3.3%1,894
Urticariahives3.2%1,808
Pruritusitching3.1%1,793
Anaphylactic reactiona severe, sudden allergic reaction3%1,702
Hypotensionlow blood pressure2.7%1,556
Abdominal painstomach or belly pain2.5%1,425
Product use in unapproved indicationused for a purpose not on the label2.3%1,317
Pneumonialung infection2.1%1,207
Hypersensitivityan allergic-type reaction2%1,144
Anaphylactic shocka severe allergic reaction with collapse2%1,124
Drug interactionan interaction between medicines1.9%1,097
Multiple organ dysfunction syndromeseveral organs failing1.9%1,081
Asthmaasthma1.9%1,073
Wheezingwheezing1.9%1,072

Solid bar: share of all class reports. Hollow bar: the median share across the 17 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death13.3%7,605

Life-threatening13.9%7,917

Hospitalisation (initial or prolonged)45.4%25,884

Disability2.7%1,525

Congenital anomaly0.8%444

Other serious57.9%32,994

Not serious10.9%6,225

Patient age

Under 22.1%1,175

2 to 114.9%2,775

12 to 172.5%1,428

18 to 4416.8%9,580

45 to 6423.4%13,335

65 to 7414.9%8,512

75 and over16.1%9,174

Age not given19.3%11,027

Who reported

Physician29.5%16,801

Pharmacist12%6,833

Other health professional42.9%24,464

Lawyer0.1%73

Consumer or non-health professional11.7%6,690

Not given3.8%2,145

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 Cephalosporin antibacterial reports

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

Ceftriaxone, Cephalexin, Cefepime, Cefuroxime, Cefazolin and Ceftriaxone sodium and 11 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

57,006 reports through June 2026, 4,246 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?

drug ineffective (9.9%), off label use (7.4%), rash (5.3%), drug hypersensitivity (4.9%) and dyspnoea (4.8%).

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.