Reaction

Product Label Issue reporting signals

Last recalculated 2026-09-14T18:28:35.993900+00:00 · 6,617 reports · 92 co-occurring drugs

As of the last recalculation, Product Label Issue appears in 6,617 FAERS reports alongside 92 co-occurring drug terms. The strongest observed disproportionality signal is GUSELKUMAB (PRR 20.0).

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
Guselkumab	220	20.0	20.1
Loperamide Hydrochloride And Dimethicone	169	17.0	17.1
Budesonide, Glycopyrrolate, And Formoterol Fumarate	41	12.4	12.5
Carboxymethylcellulose Sodium	20	6.7	6.7
Naltrexone Hydrochloride And Bupropion Hydrochloride	18	6.7	6.7
Rivaroxaban	409	6.5	6.5
Ketoconazole	33	6.0	6.0
Ustekinumab	184	5.8	5.8
Icosapent Ethyl	15	5.6	5.6
Ibuprofen Tablets, Coated	70	5.2	5.2
Ibuprofen Sodium	70	5.2	5.2
Apalutamide	19	5.1	5.1
Lifitegrast	25	4.8	4.8
Ketoconazole Foam	22	4.7	4.7
Loperamide Hydrochloride	66	4.7	4.7
Ketoconazole Cream, 2%	22	4.7	4.7
Cyclobenzaprine Hydrochloride	11	3.9	3.9
Darunavir	17	3.5	3.5
Mometasone Furoate And Formoterol Fumarate Dihydrate	17	3.4	3.4
Polyethylene Glycol 3350	103	3.4	3.4
Travoprost	9	3.3	3.3
Lisdexamfetamine Dimesylate	34	3.3	3.3
Ibuprofen And Diphenhydramine Citrate	24	3.3	3.3
Cetirizine Hydrochloride	167	3.2	3.2
Linaclotide	27	3.2	3.2
Golimumab	86	3.2	3.2
Loratadine And Pseudoephedrine Sulfate	8	3.2	3.2
Canagliflozin	30	3.2	3.2
Brinzolamide	8	2.9	2.9
Naproxen Sodium Tablet	48	2.9	2.9
Testosterone Cypionate	8	2.8	2.8
Brimonidine Tartrate	15	2.7	2.7
Paliperidone Palmitate	27	2.6	2.6
Raloxifene Hydrochloride	12	2.6	2.6
Estradiol Gel 0.1%	37	2.6	2.6
Estradiol Transdermal	37	2.6	2.6
Nirmatrelvir And Ritonavir	44	2.6	2.6
Bimatoprost	23	2.5	2.5
Emtricitabine And Tenofovir Alafenamide	9	2.5	2.5
Acetaminophen	337	2.4	2.4
Testosterone	18	2.4	2.4
Vibegron	6	2.4	2.4
Timolol	9	2.3	2.3
Fexofenadine Hydrochloride	16	2.3	2.3
Epinephrine	47	2.3	2.3
Biotin	21	2.1	2.1
Minoxidil	30	2.1	2.1
Estradiol	57	2.1	2.1
Thyroid, Porcine	7	2.1	2.1
Vilazodone Hydrochloride	6	2.0	2.0
Metoprolol Tartrate Injection	118	2.0	2.0
Suvorexant	8	1.9	1.9
Fremanezumab-Vfrm	7	1.9	1.9
Sitagliptin And Metformin Hydrochloride	13	1.9	1.9
Sotalol Hydrochloride	10	1.9	1.9
Mirabegron	23	1.9	1.9
Dronedarone	6	1.9	1.9
Oxybutynin	17	1.8	1.8
Loratadine Tablet	29	1.7	1.7
Tiotropium Bromide Inhalation Spray	6	1.7	1.7
Dextroamphetamine Sulfate, Dextroamphetamine Saccharate, Amphetamine Sulfate And Amphetamine Aspartate	22	1.7	1.7
Teduglutide	7	1.6	1.6
Oral Semaglutide	38	1.6	1.6
Oseltamivir	4	1.6	1.6
Latanoprost	25	1.6	1.6
Levodopa	6	1.6	1.6
Brexpiprazole	8	1.5	1.5
Miconazole Nitrate	4	1.4	1.4
Rucaparib	4	1.4	1.4
Benralizumab	9	1.4	1.4
Somatropin	32	1.4	1.4
Regorafenib	5	1.4	1.4
Acetaminophen, Aspirin, And Caffeine	9	1.3	1.3
Desvenlafaxine Succinate	11	1.3	1.3
Bictegravir Sodium, Emtricitabine, And Tenofovir Alafenamide Fumarate	7	1.2	1.2
Dofetilide	4	1.2	1.2
Diclofenac Potassium	4	1.2	1.2
Naltrexone	11	1.1	1.1
Diclofenac Potassium, Film Coated	3	1.1	1.1
Diclofenac Potassium Tablets	3	1.1	1.1
Acetaminophen, Aspirin (Nsaid) And Caffeine	6	1.1	1.1
Lurasidone Hydrochloride	7	1.1	1.1
Onabotulinumtoxina	24	1.0	1.0
Remdesivir	4	0.9	0.9
Pseudoephedrine Hydrochloride	3	0.9	0.9
Abiraterone Acetate	11	0.8	0.8
Erenumab-Aooe	13	0.7	0.7
Pimavanserin Tartrate	10	0.6	0.6
Etonogestrel	8	0.5	0.5
Droxidopa	3	0.4	0.4
Galcanezumab-Gnlm	4	0.4	0.4
Salicylic Acid	3	0.2	0.2

Related reactions

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