Reaction

Suspected Off Label Use reporting signals

Last recalculated 2026-09-14T18:28:35.993900+00:00 · 1,713 reports · 65 co-occurring drugs

As of the last recalculation, Suspected Off Label Use appears in 1,713 FAERS reports alongside 65 co-occurring drug terms. The strongest observed disproportionality signal is INFLIXIMAB-DYYB (PRR 62.8).

Important: FAERS is a spontaneous, voluntary, unverified reporting system. PRR and ROR identify reporting patterns for investigation; they are not incidence rates and do not establish causation.

Drug	Co-reports	PRR	ROR
Infliximab-Dyyb	139	62.8	63.1
Diclofenac Potassium, Film Coated	20	29.2	29.3
Diclofenac Potassium Tablets	20	29.2	29.3
Methylprednisolone Acetate	18	27.6	27.7
Dimenhydrinate	22	25.4	25.4
Diclofenac Potassium	21	23.9	23.9
Methylprednisolone Sodium Succinate	81	22.2	22.2
Adalimumab-Aaty	80	21.5	21.5
Rituximab	306	21.2	21.2
Diphenhydramine	99	20.1	20.2
Hydrocortisone Sodium Succinate	15	19.6	19.6
Methylprednisolone	196	19.3	19.4
Encorafenib	15	18.6	18.6
Diphenhydramine Hydrochloride Capsule, Liquid Filled	32	18.5	18.6
Tofacitinib Citrate	19	17.8	17.8
Chlorhexidine Gluconate	13	17.4	17.4
Naproxen Sodium Tablet, Coated	19	17.2	17.3
Naproxen Sodium, Coated Tablets	19	17.2	17.3
Naproxen Sodium 220Mg	19	17.2	17.2
Desoximetasone	25	16.2	16.2
Cortisone Acetate	16	15.9	15.9
Adalimumab-Adaz	65	15.5	15.5
Linezolid	35	14.6	14.6
Adalimumab-Fkjp	50	13.5	13.5
Human Immunoglobulin G	22	13.1	13.1
Pseudoephedrine Hydrochloride	10	11.9	11.9
Sirolimus	13	11.8	11.8
Diphenhydramine Hydrochloride	146	11.6	11.6
Misoprostol	9	11.3	11.3
Pseudoephedrine Hcl	10	11.1	11.1
Diclofenac Sodium 1%	30	10.4	10.4
Diclofenac Sodium Topical	30	10.4	10.4
Diclofenac Sodium Topical Gel, 1%	30	10.3	10.4
Atezolizumab	32	10.2	10.2
Irinotecan Hydrochloride	10	9.5	9.5
Bendamustine Hcl	12	9.5	9.5
Ustekinumab	74	9.1	9.1
Cetirizine Hydrochloride Allergy	22	8.9	8.9
Cetirizine Hydrochloride Tablets	22	8.9	8.9
Instalax Polyethylene Glycol 3350	9	8.9	8.9
Polyethylene Glycol 400	9	8.7	8.7
Piperacillin And Tazobactam	9	8.6	8.6
Regorafenib	8	8.4	8.4
Dexamethasone Sodium Phosphate	7	8.4	8.4
Somatropin	46	7.8	7.8
Dutasteride	5	7.5	7.5
Triamcinolone Acetonide Ointment Usp, 0.05%	14	7.3	7.3
Voriconazole	18	7.3	7.3
Acetaminophen And Codeine	7	7.0	7.0
Meropenem	18	6.9	6.9
Botulinum Toxin Type A	7	6.9	6.9
Doxorubicin Hydrochloride	18	6.8	6.8
Bevacizumab	65	6.6	6.6
Nirmatrelvir And Ritonavir	28	6.4	6.4
Bendamustine Hydrochloride	6	6.1	6.1
Rimegepant Sulfate	6	5.8	5.8
Ifosfamide	10	5.7	5.7
Remdesivir	6	5.5	5.5
Brentuximab Vedotin	4	4.8	4.8
Obinutuzumab	6	4.4	4.4
Fam-Trastuzumab Deruxtecan-Nxki	3	3.6	3.6
Erenumab-Aooe	16	3.6	3.6
Palbociclib	25	3.2	3.2
Apremilast	19	1.6	1.6
Salicylic Acid	4	0.9	0.9

Related reactions

Data source: openFDA FAERS. See the OpenPV methodology and limitations.