Table 4.

Reported levels of nitrosamines in certain drug products (US FDA ¹).

Drug Class and Major Indication	Active Pharmaceutical Ingredient (Dose per tablet)	NDMA (μg/tablet)	NDEA (μg/tablet)
Angiotensin II receptor blockers (ARBs): hypertension and related heart conditions	Valsartan (160 mg) *	0.45	1.31
	Valsartan (320 mg) *	<LOD–20.19	<LOD–1.22
Histamine-2 blockers: heartburn and gastroesophageal reflux disease (GERD)	Ranitidine (75 mg) **	0.01–0.04	NR
	Ranitidine (150 mg) **	0.01–0.33	NR
	Ranitidine (300 mg) **	0.01–0.86	NR
	Nizatidine (150 mg)	0.01–0.02	NR
	Nizatidine (300 mg)	0.01–0.03	NR
Antihyperglycemic: type 2 diabetes	Metformin, extended release (500 mg) *	<LOD–0.19	NR
	Metformin, extended release (750 mg) *	0.01–0.08	NR
	Metformin, extended release (1000 mg) *	<LOD–0.01	NR
	Metformin, immediate release (500 mg)	<LOD	NR
	Metformin, immediate release (850 mg)	<LOD–0.01	NR
	Metformin, immediate release (1000 mg)	<LOD	NR

LOD: limit of detection; NR: not reported; * recalled; ** withdrawn from the market. ¹ Information presented in the table is from US FDA as of July 2021 (See References [58,59,60]).