Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

Honma, Takeshi; Onda, Kenji; Masuyama, Koichi

doi:10.1186/s40360-024-00738-6

Table 2 Potential drug-drug interaction analysis based on adverse event reports of hepatotoxicity

From: Drug-drug interaction assessment based on a large-scale spontaneous reporting system for hepato- and renal-toxicity, and thrombocytopenia with concomitant low-dose methotrexate and analgesics use

MTX + Drug	n₁₁₁	n₁₁₊	E₁₁₁	Ω shrinkage model		Additive model		Multiplicative model		CRR model
Acetaminophen	896	15,488	1235.42	-0.46 (-0.56– -0.37)	N	-0.02	N	0.43	N	0.67	N
Celecoxib	524	8,481	616.25	-0.23 (-0.36– -0.11)	N	-0.01	N	0.57	N	0.71	N
Acetylsalicylic Acid	517	9,119	695.74	-0.43 (-0.55– -0.3)	N	-0.02	N	0.47	N	0.65	N
Diclofenac	475	6,579	640.65	-0.43 (-0.56– -0.3)	N	-0.03	N	0.38	N	0.83	N
Ibuprofen	274	4,255	294.89	-0.11 (-0.28–0.06)	N	-0.01	N	0.66	N	0.74	N
Naproxen	273	5,598	387.43	-0.5 (-0.68– -0.33)	N	-0.02	N	0.51	N	0.56	N
Meloxicam	207	4,569	320.6	-0.63 (-0.83– -0.43)	N	-0.03	N	0.46	N	0.52	N
Loxoprofen	172	1,280	182.54	-0.09 (-0.3–0.13)	N	-0.01	N	0.4	N	1.06	N
Rofecoxib	74	1,265	96.27	-0.38 (-0.71– -0.05)	N	-0.02	N	0.49	N	0.66	N
Ketoprofen	68	829	121.49	-0.83 (-1.18– -0.49)	N	-0.07	N	0.24	N	0.84	N
Indometacin	66	869	96.07	-0.54 (-0.89– -0.19)	N	-0.04	N	0.33	N	0.86	N
Etodolac	61	906	92.8	-0.6 (-0.96– -0.24)	N	-0.04	N	0.33	N	0.77	N
Sulindac	36	439	61.75	-0.77 (-1.24– -0.3)	N	-0.07	N	0.25	N	0.87	N
Piroxicam	24	431	39.31	-0.7 (-1.28– -0.12)	N	-0.04	N	0.33	N	0.63	N
Oxaprozin	16	159	12.1	0.39 (-0.32–1.1)	N	0.02	P	0.85	N	1.14	N
Flurbiprofen	14	181	15.22	-0.12 (-0.87–0.64)	N	-0.01	N	0.54	N	0.88	N
Mefenamic Acid	14	129	10.09	0.45 (-0.3–1.21)	N	0.03	P	0.86	N	1.23	N
Ketorolac	10	219	14.88	-0.55 (-1.45–0.34)	N	-0.02	N	0.49	N	0.52	N
Aceclofenac	10	134	17.69	-0.79 (-1.69–0.1)	N	-0.06	N	0.25	N	0.85	N
Lornoxicam	10	93	9.55	0.06 (-0.83–0.96)	N	0	N	0.53	N	1.19	N
Tiaprofenic Acid	9	26	1.98	1.94 (0.99–2.88)	P	0.27	P	2.9	P	1.77	N
Zaltoprofen	7	55	10.68	-0.58 (-1.64–0.49)	N	-0.08	N	0.26	N	0.89	N
Acemetacin	2	46	5.09	-1.16 (-3.16–0.84)	N	-0.07	N	0.19	N	0.49	N
Dexketoprofen	2	9	0.51	1.3 (-0.7–3.3)	N	0.18	P	–	N	2.52	N
Tenoxicam	1	40	5.19	-1.92 (-4.75–0.9)	N	-0.11	N	0.09	N	0.28	N
Tolmetin	1	18	1.46	-0.39 (-3.22–2.44)	N	-0.03	N	0.41	N	0.63	N
Bromfenac	1	12	0.68	0.34 (-2.49–3.17)	N	0.05	P	–	N	0.95	N

Methotrexate (MTX) was concomitantly used with acetaminophen (APAP) or non-steroidal anti-inflammatory drugs (NSAIDs) in rheumatoid arthritis (RA) patients. n₁₁₁, the number of adverse event cases where MTX and the analgesic were used concomitantly; n₁₁₊, the number of cases where MTX and the analgesic were used concomitantly; E₁₁₁, the expected value in the Ω shrinkage measure model; CRR, combination risk ratio; P, positive signal; N, non-positive signal

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