Table 1.

Differences in label categories between EMA (or FIDMD/MEB) and FDA for gene–drug interactions that have a label by at least one agency, as well as guidance by the CPIC and/or DPWG

Drug	Gene	Institution	Therapeutic recommendation	ATC code
Abacavir	HLA‐B	EMA	Mandatory	J
		FDA	Recommendation dealing with contraindication
Amitriptyline	CYP2C19	EMA	N.A.	N
		FIDMD	Strong recommendation
		MEB	Strong recommendation
		FDA	No information
	CYP2D6	EMA	N.A.
		FIDMD	Strong recommendation
		MEB	Strong recommendation
		FDA	Pharmacogenomic information
Aripiprazole	CYP2D6	EMA	Pharmacogenomic information	N
		FDA	Strong recommendation
Atomoxetine	CYP2D6	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	Strong recommendation
Atorvastatin	SLCO1B1	EMA	N.A.	C
		FIDMD	Pharmacogenomic information
		MEB	Pharmacogenomic information
		FDA	No information
Carbamazepine	HLA‐B	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	Recommendation dealing with contraindication
Clomipramine	CYP2C19	EMA	N.A.	N
		FIDMD	Pharmacogenomic information
		MEB	Pharmacogenomic information
		FDA	No information
Clopidogrel	CYP2C19	EMA	Pharmacogenomic information	B
		FDA	Recommendation
Codeine	CYP2D6	EMA	N.A.	R
		FIDMD	Pharmacogenomic information
		MEB	Recommendation dealing with contraindication
		FDA	Recommendation dealing with contraindication
Doxepin	CYP2C19	EMA	N.A.	N
		FIDMD	No information
		MEB	No information
		FDA	Pharmacogenomic information
	CYP2D6	EMA	N.A.
		FIDMD	No information
		MEB	No information
		FDA	Pharmacogenomic information
Eliglustat	CYP2D6	EMA	Recommendation dealing with contraindication	A
		FDA	Strong recommendation
Escitalopram	CYP2C19	EMA	N.A.	N
		FIDMD	Strong recommendation
		MEB	Strong recommendation
		FDA	Pharmacogenomic information
Fluvoxamine	CYP2D6	EMA	N.A.	N
		FIDMD	Pharmacogenomic information
		MEB	Pharmacogenomic information
		FDA	Recommendation
Halogenated volatile anesthetics (enflurane, isoflurane) or succinyl choline	RYR1/CACNA1S	EMA	N.A.	N
		FIDMD	Recommendation dealing with contraindication
		MEB	No information
		FDA	Recommendation dealing with contraindication
Haloperidol	CYP2D6	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	No information
Imipramine	CYP2D6	EMA	N.A.	N
		FIDMD	No information
		MEB	No information
		FDA	Pharmacogenomic information
Irinotecan	UGT1A1	EMA	N.A.	L
		FIDMD	Strong recommendation
		MEB	Recommendation
		FDA	Recommendation
Ivacaftor	CFTR	EMA	Indication	R
		FDA	Mandatory
Mercaptopurine	TPMT	EMA	Recommendation	L
		FDA	Strong recommendation
	NIUDT15	EMA	Recommendation
		FDA	Strong recommendation
Metoprolol	CYP2D6	EMA	N.A.	C
		FIDMD	No information
		MEB	No information
		FDA	Pharmacogenomic information
Oxcarbazepine	HLA‐B	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	Recommendation dealing with contraindication
Phenytoin	CYP2C9	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Pharmacogenomic information
		FDA	Pharmacogenomic information
	HLA‐B	EMA	N.A.
		FIDMD	Pharmacogenomic information
		MEB	Recommendation
		FDA	Recommendation
Propafenone	CYP2D6	EMA	N.A.	C
		FIDMD	Pharmacogenomic information
		MEB	Pharmacogenomic information
		FDA	Recommendation
Sertraline	CYP2C19	EMA	N.A.	N
		FIDMD	Recommendation
		MEB	Pharmacogenomic information
		FDA	No information
Simvastatin	SLCO1B1	EMA	Pharmacogenomic information	C
		FDA	No information
Thioguanine	TPMT	EMA	N.A.	L
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	Strong recommendation
	NUDT15	EMA	N.A.
		FIDMD	Recommendation
		MEB	Recommendation
		FDA	Strong recommendation
Tramadol	CYP2D6	EMA	N.A.	N
		FIDMD	Pharmacogenomic information
		MEB	Pharmacogenomic information
		FDA	Recommendation dealing with contraindication
Warfarin	CYP2C9	EMA	N.A.	B
		FIDMD	No information
		MEB	N.A.
		FDA	Strong recommendation
	VKORC1	EMA	N.A.
		FIDMD	No information
		MEB	N.A.
		FDA	Strong recommendation

ATC, Anatomical Therapeutic Chemical; CPIC, Clinical Pharmacogenetics Implementation Consortium; DPWG, Dutch Pharmacogenetics Working Group; EMA, European Medicines Agency; FDA, US Food and Drug Administration; FIDMD, Federal Institute for Drugs and Medical Devices; MEB, Medicines Evaluation Board; N.A., not available.