PMID- 37144730
OWN - NLM
STAT- MEDLINE
DCOM- 20240111
LR  - 20240111
IS  - 1542-6270 (Electronic)
IS  - 1060-0280 (Print)
IS  - 1060-0280 (Linking)
VI  - 58
IP  - 2
DP  - 2024 Feb
TI  - Adverse Events of SARS-CoV-2 Therapy: A Pharmacovigilance Study of the FAERS 
      Database.
PG  - 105-109
LID - 10.1177/10600280231169256 [doi]
LID - 10600280231169256
AB  - BACKGROUND: Over the past 2 years of the several strategies recommended to help 
      fight COVID-19, nirmatrelvir/ritonavir is a novel drug shown in the EPIC-HR phase 
      2 to 3 clinical trial to lower COVID-19-related death or hospitalization at day 
      28 when compared with placebo. OBJECTIVE: Our study's aim was to explore the 
      reported adverse events (AEs) associated with nirmatrelvir/ritonavir use for 
      COVID-19. METHOD: We conducted a retrospective analysis using the FDA Adverse 
      Event Reporting System (FAERS) database for AEs, listing nirmatrelvir/ritonavir 
      as the primary drug between January and June 2022. The primary outcome was the 
      incidence of reported AEs associated with nirmatrelvir/ritonavir. The OpenFDA 
      database was queried using Python 3.10 to collect the AEs and Stata 17 was used 
      to analyze the database. Adverse events were analyzed by associated medication, 
      with "Covid-19" excluded. RESULTS: A total of 8098 reports were identified 
      between January and June 2022. Most reported complaints in the AE system were 
      COVID-19 and disease recurrence. The most common symptomatic AEs were dysgeusia, 
      diarrhea, cough, fatigue, and headache. Event rates significantly rose between 
      April and May. Disease recurrence and dysgeusia were the most commonly reported 
      complaints for the top 8 concomitant drugs identified. Cardiac arrest, tremor, 
      akathisia, and death were reported in 1, 3, 67, and 5 cases, respectively. 
      CONCLUSIONS AND RELEVANCE: This is the first retrospective study done on reported 
      AEs associated with nirmatrelvir/ritonavir use for COVID-19. COVID-19 and disease 
      recurrence were the most reported AEs. Further monitoring of the FAERS database 
      is warranted to periodically reassess the safety profile of this medication.
FAU - Pannu, Viraaj
AU  - Pannu V
AUID- ORCID: 0000-0001-6315-0186
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Udongwo, Ndausung
AU  - Udongwo N
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Imburgio, Steven
AU  - Imburgio S
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Johal, Anmol
AU  - Johal A
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Mararenko, Anton
AU  - Mararenko A
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Pozdniakova, Helen
AU  - Pozdniakova H
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Amin, Tasnuva
AU  - Amin T
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Patel, Swapnil
AU  - Patel S
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Hossain, Mohammad
AU  - Hossain M
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Mushtaq, Arman
AU  - Mushtaq A
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Liu, Edward
AU  - Liu E
AD  - Department of Infectious Disease, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Fune, Jose M
AU  - Fune JM
AD  - Department of Infectious Disease, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
FAU - Heaton, Joseph
AU  - Heaton J
AD  - Department of Internal Medicine, Jersey Shore University Medical Center, Neptune 
      City, NJ, USA.
LA  - eng
PT  - Journal Article
DEP - 20230505
PL  - United States
TA  - Ann Pharmacother
JT  - The Annals of pharmacotherapy
JID - 9203131
RN  - 7R9A5P7H32 (nirmatrelvir)
RN  - O3J8G9O825 (Ritonavir)
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Humans
MH  - *SARS-CoV-2
MH  - *COVID-19
MH  - Retrospective Studies
MH  - Ritonavir/adverse effects
MH  - Dysgeusia
MH  - Pharmacovigilance
MH  - Antiviral Agents/adverse effects
PMC - PMC10164089
OTO - NOTNLM
OT  - COVID-19
OT  - FAERS
OT  - adverse events
OT  - antivirals
OT  - nirmatrelvir/ritonavir
COIS- Declaration of Conflicting InterestsThe authors declared no potential conflicts 
      of interest with respect to the research, authorship, and/or publication of this 
      article.
EDAT- 2023/05/05 12:42
MHDA- 2024/01/11 07:43
PMCR- 2023/05/05
CRDT- 2023/05/05 07:33
PHST- 2024/01/11 07:43 [medline]
PHST- 2023/05/05 12:42 [pubmed]
PHST- 2023/05/05 07:33 [entrez]
PHST- 2023/05/05 00:00 [pmc-release]
AID - 10.1177_10600280231169256 [pii]
AID - 10.1177/10600280231169256 [doi]
PST - ppublish
SO  - Ann Pharmacother. 2024 Feb;58(2):105-109. doi: 10.1177/10600280231169256. Epub 
      2023 May 5.