Pharmacologic class (EPC) · 6 drug pages

Antimycobacterial: adverse event reports filed with FDA

22,556 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.

22,556
reports across the class: 0.1% of all reports; 1,685
reports, 12 months to June 2026: 1,860 in the 12 months before; 92.6%
marked serious by the reporter: 57.4% across all reports; 6
drugs with a page: brand and generic names counted separately

Antimycobacterial is a pharmacologic class (an FDA Established Pharmacologic Class) with 6 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 22,556 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,685 reports arrived in the 12 months to June 2026, close to the 1,860 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 92.6% of the class's reports are marked serious, 17.9% record death among the outcomes and 39.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are drug-induced liver injury (7%), nausea (6.3%) and pyrexia (5.8%). 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
Isoniazid	generic	9,024	462	93.6%	Drug-induced liver injury
Pyrazinamide	generic	6,334	404	97.7%	Drug-induced liver injury
Clofazimine	generic	4,076	330	90.8%	Electrocardiogram QT prolonged
Ethambutol hydrochloride	generic	1,705	220	75.1%	Product use in unapproved indication
LampreneClofazimine	brand	775	90	84.4%	Dyspnoea
Pretomanid	generic	642	179	98.1%	Death

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-induced liver injury7%1,575
Nauseafeeling sick6.3%1,419
Pyrexiafever5.8%1,315
Drug ineffectivethe medicine did not work as expected5.7%1,276
Off label useused for a purpose or in a way not on the label5.6%1,273
Vomitingbeing sick5.4%1,227
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement5.4%1,223
Paradoxical drug reaction4.6%1,048
Anaemialow red blood cells4.5%1,019
Hepatotoxicityliver injury4.4%999
Electrocardiogram QT prolongeda QT prolongation on the ECG4.3%975
Drug interactionan interaction between medicines4.2%940
Drug resistance4%896
Dyspnoeashortness of breath3.5%793
Tuberculosistuberculosis3.3%744
Neuropathy peripheralnerve damage in hands or feet3.1%692
Diarrhoealoose or frequent stools3%677
Condition aggravatedthe condition being treated got worse3%671
Product use in unapproved indicationused for a purpose not on the label3%668
Rashskin rash2.8%624
Headachehead pain2.7%605
Alanine aminotransferase increasedraised liver enzyme (ALT)2.7%602
Jaundiceyellowing of the skin or eyes2.6%577
Deaththe patient died; cause not stated by this term2.5%561
Aspartate aminotransferase increasedraised liver enzyme (AST)2.4%532

Solid bar: share of all class reports. Hollow bar: the median share across the 6 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death17.9%4,035

Life-threatening6.8%1,544

Hospitalisation (initial or prolonged)39.1%8,815

Disability2%442

Congenital anomaly0.7%162

Other serious65.9%14,865

Not serious7.4%1,659

Patient age

Under 21.4%323

2 to 113.3%735

12 to 173.2%728

18 to 4432.8%7,391

45 to 6421.4%4,835

65 to 749.5%2,153

75 and over6.6%1,496

Age not given21.7%4,895

Who reported

Physician36%8,114

Pharmacist3.1%700

Other health professional50.2%11,326

Lawyer0%2

Consumer or non-health professional7.2%1,620

Not given3.5%794

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 Antimycobacterial reports

Which drugs are in the Antimycobacterial class on this site?

Isoniazid, Pyrazinamide, Clofazimine, Ethambutol hydrochloride, Lamprene and Pretomanid. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

22,556 reports through June 2026, 1,685 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-induced liver injury (7%), nausea (6.3%), pyrexia (5.8%), drug ineffective (5.7%) and off label use (5.6%).

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.