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Gastaldon, Arzenton, Papola, Ostuzzi, Raschi, Moretti, and Barbui have nothing to disclose. Dr. Schoretsanitis has served as a consultant for HLS Therapeutics. Dr. Seifritz has received educational grants, consulting fees and lecture honoraria from Janssen Cilag, Lundbeck, Angelini, Otsuka, Servier, Ricordati, Vifor, Sunovion, Schwabe and Mepha. Dr. Kane has been a consultant and\/or advisor for or has received honoraria from Alkermes, Allergan, LB Pharmaceuticals, H. Lundbeck, Intracellular Therapies, Janssen Pharmaceuticals, Johnson and Johnson, Merck, Minerva, Neurocrine, Newron, Otsuka, Pierre Fabre, Reviva, Roche, Sumitomo Dainippon, Sunovion, Takeda, Teva and UpToDate and is a shareholder in LB Pharmaceuticals and Vanguard Research Group. Dr. Trifir\u00f2 has served in the last three years on advisory boards\/seminars funded by SANOFI, Eli Lilly, AstraZeneca, Abbvie, Servier, Mylan, Gilead, Amgen; he was the scientific director of a Master program on pharmacovigilance, pharmacoepidemiology and real-world evidence which has received non-conditional grant from various pharmaceutical companies; he coordinated a pharmacoepidemiology team at the University of Messina until October 2020, which has received funding for conducting observational studies from various pharmaceutical companies (Boehringer Ingelheim, Daichii Sankyo, PTC Pharmaceuticals). He is also scientific coordinator of the academic spin-off \"INSPIRE srl\" which has received funding for conducting observational studies from contract research organizations (RTI Health Solutions, Pharmo Institute N.V.). All the above-mentioned activities are not related to the topic of the manuscript.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"The study follows the principles of the Helsinki Declaration. VigiBase, the WHO global database of individual case safety reports (ICSRs) is the source of the information; the information comes from a variety of sources, and the probability that the suspected adverse effect is drug-related is not the same in all cases; the information does not represent the opinion of the UMC or the World Health Organization. According to WHO policy and UMC guidelines, reports sent from the WHO PIDM member countries to VigiBase are anonymised. Identifiable data are not published.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval"}},{"value":"Patient consent was waived as VigiBase database\u00a0contains anonymized data that cannot allow patients\u2019 identification.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent to participate"}},{"value":"The authors acknowledge the Uppsala Monitoring Centre (UMC), which provided and gave permission to use the data analysed in the present study.","order":6,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"Vigibase does not allow the distribution of the file, but the electronic supplementary material has all detailed information needed to perform the analyses. Other requests for data can be submitted to the UMC.","order":7,"name":"Ethics","group":{"name":"EthicsHeading","label":"Availability of data and material (data transparency)"}},{"value":"The code will be made available upon reasonable request.","order":8,"name":"Ethics","group":{"name":"EthicsHeading","label":"Code availability"}},{"value":"All authors contributed to the design of the study. The UMS provided the data, based on the search strategy defined by all authors. CG, GS, and EA performed additional search of the data. CG and GS performed the statistical analysis. All authors analysed the data. CG and GS drafted the manuscript, and all other authors revised the manuscript. All authors contributed to and approved the final version of the paper. CG and GS equally contributed to the work.","order":9,"name":"Ethics","group":{"name":"EthicsHeading","label":"Authors' contribution"}}]}}