[7] Side effects associated with etifoxine use include slight drowsiness, headache, skin eruptions, and allergic reactions.
[2][8][9] In rare cases, etifoxine has been linked to severe skin and liver toxicity, as well as menstrual bleeding between periods.
[10][3] Etifoxine acts as a GABAA receptor positive allosteric modulator and as a ligand for translocator proteins.
[7][11][12] Throughout the 2010s and early 2020s, the safety profile of etifoxine was scrutinized within France and the European Union, prompted by reports of toxicity.
[13][8][7] Etifoxine has historically been used in the treatment of "psychosomatic manifestations of anxiety", for instance "autonomic dystonia, particularly with cardiovascular expression".
[2][8][1] Etifoxine shows less adverse effects of anterograde amnesia, sedation, impaired psychomotor performance, and withdrawal syndromes than those of benzodiazepines.
This results in stimulation of the biosynthesis of endogenous neurosteroids, for instance allopregnanolone, a highly potent GABAA receptor positive allosteric modulator.
[25] This direct allosteric potentiation can only be observed at relatively high concentrations (starting at >1 mM) and is perhaps not physiologically relevant at normal human doses.
[5] Etifoxine is a nonbenzodiazepine—that is, it is similarly a GABAA receptor positive allosteric modulator but its chemical structure is distinct from that of benzodiazepines.
[31][29][37][19] Following reports of post-marketing toxicity, the safety of etifoxine was reassessed by the French government[13][8] and the European Medicines Agency (EMA).
"[38][39] Etifoxine is the generic name of the drug and its INNTooltip International Nonproprietary Name, BANTooltip British Approved Name, and DCFTooltip Dénomination Commune Française.
[7][11] Some of the countries in which etifoxine has been marketed include Argentina, Bulgaria, Chile, France, Luxembourg, Malta, Romania, Russia, South Africa, Thailand, and Ukraine.
[11][7] However, etifoxine is marketed in five European Union member states (France, Bulgaria, Luxembourg, Malta, Romania).