Table 9.

Drugs with Black Box warnings for hepatotoxicity.³⁵⁾ A “Black Box” warning is the strongest type of warning that the U. S. Food and Drug Administration can require for a drug and is generally reserved for warning prescribers about adverse drug reactions that can cause serious injury or death. At issue here is the benefit/risk ratio.

Drug	Dose (mg/day)	Reactive products	Reference
Acitretin	25–50	No
Bosentan	125–250	No
Dacarbazine	140–315	Yes	47)
Dantrolene	300–400	Yes	48)
Felbamate	1200	Yes	49)
Flutamide	750	Yes	50)
Gemtuzumab	(9 mg m−3)	Yes (?)	51)
Isoniazid	300	Yes	52)
Ketoconazole	200	Yes	53)
Naltrexone	50	No
Nevirapine	200	Yes
Tolcapone	300	Yes	54)
Trovafloxacin	100–500	No
Valporic acid	1000–2400	Yes	55)
		10/14 = 71%