Table 1.
Descriptive characteristics of COVID-19 casesa reported to FAERS from January 1st (Q1), 2020 to March 31st (Q1), 2021
| Characteristic | Lopinavir-ritonavir (n = 845) |
All other drugsb (n = 18,937) |
|---|---|---|
| Age, years (n =) | ||
| Mean ± SD | 63.09 ± 14.79 | 59.23 ± 19.95 |
| > = 65 years, n = | 395 | 7295 |
| < 65 years, n = | 393 | 8,559 |
| Sex, n = | ||
| Female | 233 | 6879 |
| Male | 555 | 10,111 |
| Country, n = | ||
| Within the united states | 19 | 11,496 |
| Outside of the united states | 826 | 7441 |
| Concurrent drugs, n = | ||
| Hydroxychloroquine/chloroquine | 225 | 4017 |
| Remdesivir | 7 | 5142 |
| ADEs of interest, n = | ||
| Drug-induced liver injuryc | 313 | 3112 |
| Severe drug-induced liver injuryd | 90 | 672 |
ADE adverse events, SD standard deviation, FAERS food and drug administration adverse event reporting system
aMedDRA preferred terms related to COVID-19 including "asymptomatic COVID-19", "COVID-19", "COVID-19 pneumonia", "suspected COVID-19", "SARS-COV-2 carrier", "exposure to SARS-COV-2", "occupational exposure to communicable disease", "occupational exposure to SARS-COV-2", "coronavirus test", "coronavirus test negative", "SARS-COV-2 test", "SARS-COV-2 test false negative", "SARS-COV-2 test negative", "SARS-COV-2 test positive", "COVID-19 prophylaxis", "COVID-19 treatment", "COVID-19 immunisation", "patient isolation", "quarantine", "multisystem inflammatory syndrome in children", "SARS-COV-2 sepsis", "SARS-COV-2 viraemia", "SARS-COV-2 test false positive", "SARS-COV-2 antibody test"
bAll other drugs including the all drugs except lopinavir-ritonavir used in the COVID-19 cases
cIdentified by a narrow SMQ of “Drug related hepatic disorders,” which includes narrow scope of cholestasis and jaundice of hepatic origin, liver related investigations, signs and symptoms, liver-related coagulation and bleeding disturbances, noninfectious hepatitis, hepatic failure, fibrosis, cirrhosis, other drug-related liver damage, liver neoplasms (benign, including cysts and polyps), and liver neoplasms (malignant and unspecified)
dIdentified by a narrow SMQ of “Drug related hepatic disorders—severe events only,” which includes narrow scope of noninfectious hepatitis, hepatic failure, fibrosis, cirrhosis, other drug-related liver damage, liver neoplasms (benign, including cysts and polyps), and liver neoplasms (malignant and unspecified)