Table 2.

Differences in label categories for additional gene–drug interactions without CPIC and/or DPWG guidelines that have a label by at least one agency, comparing the EMA (or FIDMD/MEB) and the FDA

Drug	Gene	Institution	Therapeutic recommendation	ATC code
Acetylsalicylic acid/clopidogrel	G6PD	EMA	Mandatory	B
		FDA	No information
Amifampridine	NAT2	EMA	Pharmacogenomic information	N
		FDA	Strong recommendation
Binimetinib	BRAF V600	EMA	Mandatory	L
		FDA	Indication
Brivaracetam	CYP2C19	EMA	Pharmacogenomic information	N
		FDA	Recommendation
Caplacizumab	Hemophilia, coagulation factor deficiencies	EMA	Recommendation	B
		FDA	Pharmacogenomic information
Carvedilol	CYP2D6	EMA	N.A.	C
		FIDMD	Recommendation
		MEB	No information
		FDA	Pharmacogenomic information
Ceftriaxone	G6PD, nonspecific (congenital methemoglobinemia)	EMA	N.A.	J
		FIDMD	No information
		MEB	No information
		FDA	Recommendation
Chloroquine	G6PD	EMA	N.A.	P
		FIDMD	Recommendation dealing with contraindication
		MEB	N.A.
		FDA	Recommendation
Clozapine	CYP2D6	EMA	N.A.	N
		FIDMD	No information
		MEB	No information
		FDA	Recommendation
Cobimetinib hemifumarate	BRAF V600	EMA	Mandatory	L
		FDA	Indication
Dabrafenib	BRAF V600	EMA	Mandatory	L
		FDA	Indication
	G6PD	EMA	No information
		FDA	Recommendation
	RAS	EMA	Recommendation
		FDA	Strong recommendation
Dapsone	G6PD	EMA	N.A.	D
		FIDMD	Recommendation
		MEB	N.A.
		FDA	Pharmacogenomic information
	Nonspecific (congenital methemoglobinemia)	EMA	N.A.
		FIDMD	No information
		MEB	N.A.
		FDA	Recommendation
Durvalumab	CD274 (PD‐L1)	EMA	Indication	L
		FDA	Pharmacogenomic information
Eluxadoline	SLCO1B1	EMA	Recommendation	A
		FDA	No information
Elvitegravir/Cobicistat/Emtricitabine/Tenofovir alafenamide fumarate	HIV mutations	EMA	Indication	J
		FDA	Pharmacogenomic information
Encorafenib	BRAF V600	EMA	Mandatory	L
		FDA	Indication
Evolocumab	PCSK9	EMA	Indication	C
		FDA	No information
Flurbiprofen	CYP2C9	EMA	N.A.	M
		FIDMD	N.A.
		MEB	No information
		FDA	Recommendation
Gemtuzumab ozogamicin	CD33	EMA	Indication	L
		FDA	No information
Glibenclamide	β‐cell ATP‐sensitive potassium channel and chromosome 6q24‐related transient neonatal diabetes mellitus	EMA	Indication	A
		FDA	No information
Goserelin	ESR, PGR	EMA	N.A.	L
		FIDMD	No information
		MEB	Indication
		FDA	Pharmacogenomic information
Hydroxychloroquine	G6PD	EMA	N.A.	J
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation
		FDA	Recommendation
Ibrutinib	Chromosome 17p	EMA	Pharmacogenomic information	L
		FDA	Indication
Ipilimumab	Microsatellite Instability, Mismatch Repair	EMA	No information	L
		FDA	Indication
Isoniazid, Pyrazinamide, and Rifampin	nonspecific (NAT)	EMA	N.A.	J
		FIDMD	Recommendation
		MEB	Strong recommendation
		FDA	Pharmacogenomic information
Lenalidomide	Chromosome 5q	EMA	No information	L
		FDA	Indication
Mepivacaine	Nonspecific (Congenital Methemoglobinemia) /G6PD	EMA	N.A.	N
		FIDMD	No information
		MEB	No information
		FDA	Recommendation
Metoclopramide	CYB5R	EMA	N.A.	A
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation dealing with contraindication
		FDA	Pharmacogenomic information
	G6PD	EMA	N.A.
		FIDMD	No information
		MEB	No information
		FDA	Recommendation
Midostaurin	FLT3 mutation	EMA	Mandatory	L
		FDA	Indication
Necitumumab	EGFR	EMA	Indication	L
		FDA	No information
Neratinib	ERBB2 (HER2)	EMA	Mandatory	L
		FDA	Indication
Nitrofurantoin	G6PD	EMA	N.A.	J
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation dealing with contraindication
		FDA	Pharmacogenomic information
Nivolumab	BRAF	EMA	Pharmacogenomic information	L
		FDA	Indication
	Microsatellite Instability, Mismatch Repair	EMA	No information
		FDA	Indication
Olaparib	BRCA/ERBB2 (HER2)/ESR, PGR	EMA	Mandatory	L
		FDA	Indication
Pantoprazole	CYP2C19	EMA	No information	A
		FDA	Recommendation
Pembrolizumab	Microsatellite Instability, Mismatch Repair	EMA	No information	L
		FDA	Indication
Peramivir	Influenza virus genotype	EMA	Recommendation	J
		FDA	Pharmacogenomic information
Pertuzumab	ERBB2 (HER2)	EMA	Mandatory	L
		FDA	Indication
Piroxicam	CYP2C9	EMA	N.A.	M
		FIDMD	N.A.
		MEB	No information
		FDA	Recommendation
Ranolazine	CYP2D6	EMA	Recommendation	C
		FDA	No information
Rucaparib	UGT1A1	EMA	Recommendation	L
		FDA	No information
	BRCA	EMA	Mandatory
		FDA	Indication
Sevoflurane	Nonspecific (Genetic Susceptibility to Malignant Hyperthermia)	EMA	N.A.	N
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation dealing with contraindication
		FDA	Pharmacogenomic information
Succinylcholine	BCHE	EMA	N.A.	V
		FIDMD	N.A.
		MEB	Recommendation
		FDA	Strong recommendation
Sulfadiazine	G6PD	EMA	N.A.	J
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation
		FDA	Pharmacogenomic information
Sulfamethoxazole and Trimethoprim	G6PD	EMA	N.A.	J
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation
		FDA	Pharmacogenomic information
Sulfasalazine	G6PD	EMA	N.A.	A
		FIDMD	Recommendation dealing with contraindication
		MEB	Recommendation dealing with contraindication
		FDA	Recommendation
Trametinib	BRAF V600	EMA	Mandatory	L
		FDA	Indication
Trastuzumab	ERBB2 (HER2)	EMA	Mandatory	L
		FDA	Indication
	ESR, PGR	EMA	Indication
		FDA	Pharmacogenomic information
Tretinoin	PML‐RARA	EMA	N.A.	D
		FIDMD	N.A.
		MEB	No information
		FDA	Recommendation
Vandetanib	RET	EMA	Recommendation	L
		FDA	No information
Vemurafenib	RAS	EMA	Recommendation	L
		FDA	Pharmacogenomic information
	BRAF V600	EMA	Mandatory
		FDA	Indication
Vincristine	BCR‐ABL1 (Ph+)	EMA	N.A.	L
		FIDMD	No information
		MEB	No information
		FDA	Indication
Vortioxetine	CYP2D6	EMA	Recommendation	N

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.