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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

DELAMANID: 1,646 Adverse Event Reports & Safety Profile

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1,646
Total FAERS Reports
496 (30.1%)
Deaths Reported
695
Hospitalizations
1,646
As Primary/Secondary Suspect
127
Life-Threatening
71
Disabilities

First Report: 20010206 · Latest Report: 20250814

What Are the Most Common DELAMANID Side Effects?

#1 Most Reported
Electrocardiogram qt prolonged
263 reports (16.0%)
#2 Most Reported
Vomiting
237 reports (14.4%)
#3 Most Reported
Anaemia
209 reports (12.7%)

All DELAMANID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Electrocardiogram qt prolonged 263 16.0% 58 99
Vomiting 237 14.4% 83 126
Anaemia 209 12.7% 42 100
Off label use 207 12.6% 65 82
Dyspnoea 160 9.7% 90 99
Neuropathy peripheral 135 8.2% 21 45
Nausea 126 7.7% 27 56
Haemoglobin decreased 104 6.3% 38 54
Tuberculosis 94 5.7% 59 26
Intentional product use issue 89 5.4% 43 47
Asthenia 81 4.9% 35 46
Incorrect product administration duration 80 4.9% 27 33
Hypokalaemia 77 4.7% 29 47
Death 76 4.6% 76 37
Aspartate aminotransferase increased 75 4.6% 34 43
Respiratory failure 75 4.6% 63 32
Product use in unapproved indication 70 4.3% 16 23
Diarrhoea 66 4.0% 36 37
Alanine aminotransferase increased 63 3.8% 25 35
Decreased appetite 61 3.7% 16 35

Who Reports DELAMANID Side Effects? Age & Gender Data

Gender: 43.4% female, 56.6% male. Average age: 38.4 years. Most reports from: ZA. View detailed demographics →

Is DELAMANID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2001 1 0 0
2013 2 0 2
2014 3 0 2
2015 14 2 4
2016 58 12 28
2017 196 67 96
2018 569 204 234
2019 275 81 147
2020 102 31 54
2021 40 11 15
2022 39 7 19
2023 55 2 37
2024 40 2 14
2025 18 0 5

View full timeline →

What Is DELAMANID Used For?

IndicationReports
Tuberculosis 1,101
Pulmonary tuberculosis 408
Product used for unknown indication 57
Disseminated tuberculosis 10
Extrapulmonary tuberculosis 10

DELAMANID vs Alternatives: Which Is Safer?

DELAMANID vs DELANDISTROGENE MOXEPARVOVEC-ROKL DELAMANID vs DELAVIRDINE DELAMANID vs DELORAZEPAM DELAMANID vs DELTA.8-TETRAHYDROCANNABINOL\HERBALS DELAMANID vs DEMCIZUMAB DELAMANID vs DEMEROL DELAMANID vs DENOSUMAB DELAMANID vs DEOXYCHOLIC ACID DELAMANID vs DEPAKINE CHRONO DELAMANID vs DEPAKOTE

Official FDA Label for DELAMANID

Official prescribing information from the FDA-approved drug label.