Pharmacologic class (EPC) · 3 drug pages

Tetracycline-class antibacterial: adverse event reports filed with FDA

5,699 reports list a drug in this class as a suspect or interacting product, 2005–2026.

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.

5,699
reports across the class: 0% of all reports; 568
reports, 12 months to June 2026: 650 in the 12 months before; 85.3%
marked serious by the reporter: 57.4% across all reports; 3
drugs with a page: brand and generic names counted separately

Tetracycline-class antibacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 3 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 5,699 adverse event reports received by FDA, 0% of the database, from January 2005 to June 2026.

568 reports arrived in the 12 months to June 2026, down 13% from 650 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 85.3% of the class's reports are marked serious, 22.7% record death among the outcomes and 35.5% record hospitalisation, as reported.

Across the class the reactions recorded most often are off label use (15.1%), drug ineffective (11.6%) and nausea (10.1%). 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
Tigecycline	generic	2,949	264	94.5%	Drug ineffective
TygacilTigecycline	brand	1,663	66	90.6%	Off label use
NuzyraOmadacycline	brand	1,087	238	52.3%	Off label use

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 label15.1%860
Drug ineffectivethe medicine did not work as expected11.6%661
Nauseafeeling sick10.1%577
Vomitingbeing sick6.4%363
Deaththe patient died; cause not stated by this term4.4%249
Diarrhoealoose or frequent stools4.2%239
Condition aggravatedthe condition being treated got worse3.4%195
Coagulopathy3.4%191
Thrombocytopenialow platelets3.3%188
Septic shockshock arising from infection2.8%160
Drug resistance2.8%159
Pathogen resistance2.8%159
Sepsisa severe body-wide response to infection2.8%157
Pancreatitis acute2.3%131
Platelet count decreasedlow platelet count2.3%131
Pancreatitisinflammation of the pancreas2.2%125
Treatment failurethe treatment did not work2.1%119
Rashskin rash2.1%118
Blood bilirubin increased1.9%110
Pyrexiafever1.9%106
Hepatic function abnormal1.6%94
Acute kidney injurysudden loss of kidney function1.6%91
Product use in unapproved indicationused for a purpose not on the label1.6%91
Fatiguetiredness1.6%90
Drug ineffective for unapproved indication1.6%89

Solid bar: share of all class reports. Hollow bar: the median share across the 3 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death22.7%1,293

Life-threatening8%454

Hospitalisation (initial or prolonged)35.5%2,021

Disability1.6%92

Congenital anomaly0%0

Other serious53.4%3,044

Not serious14.7%837

Patient age

Under 20.8%46

2 to 111.5%88

12 to 171.7%97

18 to 4414.2%807

45 to 6422.5%1,281

65 to 7415.8%903

75 and over16.4%935

Age not given27.1%1,542

Who reported

Physician30.8%1,755

Pharmacist8.5%485

Other health professional44.1%2,511

Lawyer0%1

Consumer or non-health professional14.6%833

Not given2%114

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 Tetracycline-class antibacterial reports

Which drugs are in the Tetracycline-class antibacterial class on this site?

Tigecycline, Tygacil and Nuzyra. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

5,699 reports through June 2026, 568 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 (15.1%), drug ineffective (11.6%), nausea (10.1%), vomiting (6.4%) and death (4.4%).

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.