Evidence map›Paper›PMID 33078372›Full record

ArticleDrug safety2020

Psychiatric Disorders and Hydroxychloroquine for Coronavirus Disease 2019 (COVID-19): A VigiBase Study.

Philippe Garcia, Alexis Revet, Antoine Yrondi, Vanessa Rousseau, Yannick Degboe, François Montastruc

Open access · bronzeAbstract read
In one paragraph

Article in Drug safety, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.

0numbers the graph read from it
0cells of the map it votes in
24citing papers in PubMed
0.9field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

24 citing papers in PubMed, 40 citations in OpenAlex.

  1. Review
  2. Safety of Hydroxychloroquine: What a Dermatologist Should Know.American journal of clinical dermatology · 2025
    Review
  3. Article
  4. COVID-19 and New-Onset Psychosis: A Comprehensive Review.Journal of personalized medicine · 2023
    Review
  5. Hydroxychloroquine, Interleukin-6 Receptor Antagonists and Corticoid Treatments of Acute COVID-19 Infection: Psychiatric Symptoms and Mental Disorders 4 Months Later.Clinical psychopharmacology and neuroscience : the official scientific journal of the Korean College of Neuropsychopharmacology · 2022
    Article
  6. Article
  7. Review
  8. Article
  9. Article
  10. Article
  11. Review
  12. Article
  13. Article
  14. Article
  15. Review
  16. Neuropsychiatric Manifestations of COVID-19: A Review.Advances in psychiatry and behavioral health · 2021
    Review
  17. Review
  18. Review
  19. Article
  20. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 1 country.

Philippe GarciaDepartment of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, 31000, Toulouse, France.
Alexis RevetDepartment of Child and Adolescent Psychiatry, Faculty of Medicine, Toulouse University Hospital (CHU), Toulouse, France.
Antoine YrondiDepartment of Medical Psychiatry, Toulouse University Hospital (CHU), Faculty of Medicine, Treatment Resistant Depression Expert Center, FondaMental, ToNIC Toulouse NeuroImaging Center, University Paul Sabatier Toulouse, INSERM, Toulouse, France.
Vanessa RousseauDepartment of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, 31000, Toulouse, France.
Yannick DegboeDepartment of Rheumatology, Faculty of Medicine, Toulouse University Hospital (CHU), Toulouse, France.
François MontastrucDepartment of Medical and Clinical Pharmacology, Centre of PharmacoVigilance and Pharmacoepidemiology, Faculty of Medicine, Toulouse University Hospital (CHU), 37 Allées Jules Guesde, 31000, Toulouse, France. francois.montastruc@univ-tlse3.fr.ORCID http://orcid.org/0000-0001-7056-8126
Université Toulouse III - Paul Sabatier · FRPharmacochimie et Pharmacologie pour le Développement · FRUniversité Fédérale de Toulouse Midi-Pyrénées · FR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionIn the stressful context of the coronavirus disease 2019 (COVID-19) pandemic, some reports have raised concerns regarding psychiatric disorders with the use of hydroxychloroquine. In this study, we reviewed all psychiatric adverse effects with hydroxychloroquine in COVID-19 patients, as well as in other indications, reported in VigiBase, the World Health Organization's (WHO) global database of individual case safety reports.

methodsFirst, we analyzed all psychiatric adverse effects, including suicide, of hydroxychloroquine in COVID-19 patients reported to 16 June 2020. We also performed disproportionality analysis to investigate the risk of reporting psychiatric disorders with hydroxychloroquine compared with remdesivir, tocilizumab, or lopinavir/ritonavir prescribed in COVID-19 patients. We used reporting odds ratios (RORs) and their 95% confidence intervals (CIs) to calculate disproportionality. Second, we sought to examine the psychiatric safety profile of hydroxychloroquine in other indications (before 2020).

resultsAmong the 1754 reports with hydroxychloroquine in COVID-19 patients, we found 56 psychiatric adverse effects. Half of these adverse effects were serious, including four completed suicides, three cases of intentional self-injury, and 12 cases of psychotic disorders with hallucinations. Compared with remdesivir, tocilizumab, or lopinavir/ritonavir, the use of hydroxychloroquine was associated with an increased risk of reporting psychiatric disorders (ROR 6.27, 95% CI 2.74-14.35). Before 2020, suicide was the main cause of death among all adverse drug reactions reported with hydroxychloroquine, followed by cardiac adverse effects (cardiomyopathy) and respiratory failure.

conclusionsThis pharmacovigilance analysis suggests that COVID-19 patients exposed to hydroxychloroquine experienced serious psychiatric disorders, and, among these patients, some committed suicide. Further real-world studies are needed to quantify the psychiatric risk associated with hydroxychloroquine during the COVID-19 pandemic.

Indexed as

COVID-19 Drug TreatmentAdenosine MonophosphateAdultAgedAged, 80 and overAlanineAntibodies, Monoclonal, HumanizedAntiviral AgentsDatabases, PharmaceuticalDrug CombinationsFemaleHallucinationsHumansHydroxychloroquineLopinavirMaleAdenosine MonophosphateAlanineAntibodies, Monoclonal, HumanizedAntiviral AgentsDrug CombinationsHydroxychloroquineLopinavirlopinavir-ritonavir drug combinationremdesivirRitonavirtocilizumab

Identifiers

PMID33078372
PMCPMC7571787
OpenAlexW3093133859

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.