Product name as reported
Bedaquiline: adverse event reports filed with FDA
2,530 reports list it as a suspect or interacting product, 2014–2026.
- 2,530
- reports as suspect product
- 0% of all reports · about 203 a year
- 343
- reports, 12 months to June 2026
- 223 in the 12 months before
- 98.6%
- marked serious by the reporter
- 57.4% across all reports
- 33.6%
- record death among outcomes, as reported
- 850 reports · not verified by FDA
2,530 adverse event reports received by FDA list the product name "Bedaquiline" as reporters wrote it as a suspect or interacting product, from January 2014 to June 2026. A further 596 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 343 reports listed it, up 54% from 223 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 203 reports a year and 0% of the 20,646,523 reports in the database. How many people take it is not in the data, so a count is not a rate of occurrence.
The reactions recorded most often are electrocardiogram QT prolonged (15.9%), off label use (10.9%) and anaemia (9.9%). A report can list several reactions, so shares add to more than 100%; 517 different terms appear across these reports. Electrocardiogram QT prolonged is recorded in 15.9% of these reports, against 0.2% of all reports in the database.
98.6% of the reports are marked serious by the reporter; 33.6% record death among the outcomes and 32.9% record hospitalisation, as reported. 48.7% of the reports came from physicians, and the largest patient age group is 18 to 44 (43.7%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Bedaquiline reports recording the termall reports in the database
- Electrocardiogram QT prolongeda QT prolongation on the ECG15.9%403
- Off label useused for a purpose or in a way not on the label10.9%275
- Anaemialow red blood cells9.9%251
- Vomitingbeing sick9.4%238
- Deaththe patient died; cause not stated by this term8.7%221
- Neuropathy peripheralnerve damage in hands or feet8.3%210
- Nauseafeeling sick7%177
- Dyspnoeashortness of breath6.4%162
- Tuberculosistuberculosis5.2%131
- Hepatotoxicityliver injury4.1%104
- Intentional product use issuedeliberate use not as intended4%100
- Respiratory failurethe lungs could not supply enough oxygen3.5%88
- Astheniaweakness or lack of energy3.4%87
- Aspartate aminotransferase increasedraised liver enzyme (AST)3.2%82
- Product use in unapproved indicationused for a purpose not on the label3.2%80
- Decreased appetitereduced appetite3.1%79
- Diarrhoealoose or frequent stools3.1%78
- Treatment failurethe treatment did not work3.1%78
- Alanine aminotransferase increasedraised liver enzyme (ALT)3%76
- Drug resistance3%75
- Haemoglobin decreasedlow haemoglobin3%75
- Hypokalaemialow blood potassium2.6%67
- Arthralgiajoint pain2.5%62
- Drug ineffectivethe medicine did not work as expected2.4%61
- Acute kidney injurysudden loss of kidney function2.2%56
- Pyrexiafever2.2%56
- Coughcough2.1%52
- Headachehead pain2%50
Top 30 of 517 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the share of all reports in the database; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 20,646,523 reports. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 8.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Tuberculosis | 1,578 | 62.4% |
| Pulmonary tuberculosis | 437 | 17.3% |
| Mycobacterium avium complex infection | 27 | 1.1% |
| Mycobacterium abscessus infection | 19 | 0.8% |
| Disseminated tuberculosis | 16 | 0.6% |
| Mycobacterial infection | 15 | 0.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 2,530 reports.
Drugs most often listed in the same reports
| Drug (any role in the report) | Reports | Share of Bedaquiline reports |
|---|---|---|
| Linezolid | 2,015 | 79.6% |
| Clofazimine | 1,644 | 65% |
| Moxifloxacin | 758 | 30% |
| Pyrazinamide | 743 | 29.4% |
| Cycloserine | 689 | 27.2% |
| Levofloxacin | 674 | 26.6% |
| Pyridoxine | 453 | 17.9% |
| Imipenem | 295 | 11.7% |
| Ethambutol | 278 | 11% |
| Amikacin | 262 | 10.4% |
Other products listed in reports where Bedaquiline is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.
In context
| Measure | Bedaquiline | All reports |
|---|---|---|
| Reports as suspect product | 2,530 | 20,646,523 |
| Share of that pool | — | 0% |
| Reports, latest 12 months | 343 | 1,332,454 |
| Marked serious | 98.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 336 | 91 |
| Hospitalisation recorded, per 1,000 reports | 329 | 213 |
| Consumer-filed share | 12.7% | 45.8% |
| Top term, share of reports | Electrocardiogram QT prolonged 15.9% | 0.2% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Questions about Bedaquiline reports
How many adverse event reports has FDA received for Bedaquiline?
2,530 reports list Bedaquiline as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 343 of them arrived in the latest 12 months. Another 596 list it only as a concomitant medication.
What reactions are recorded in Bedaquiline reports?
electrocardiogram QT prolonged (15.9%), off label use (10.9%), anaemia (9.9%), vomiting (9.4%) and death (8.7%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Bedaquiline was responsible.
How serious are the reports?
98.6% are marked serious by the reporter. Among the outcomes recorded, 33.6% of reports include death and 32.9% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
physician (48.7%), other health professional (36.8%) and consumer or non-health professional (12.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Bedaquiline rising?
343 reports in the 12 months to June 2026, up 54% from 223 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Bedaquiline was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Bedaquiline?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Bedaquiline as a suspect or interacting product; reports listing it only as a concomitant medication (596) are excluded. 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.