PRODUCT USE IN UNAPPROVED INDICATION

Adverse reaction reported in 253,477 FDA reports across 155 drugs.

253,477
Total Reports
155
Drugs Involved
Dupilumab
Most Reported Drug

Drugs Associated with PRODUCT USE IN UNAPPROVED INDICATION

Drugs where "PRODUCT USE IN UNAPPROVED INDICATION" was reported as an adverse event.

# Drug Reports % of Total
1 Dupilumab 38,078
15.0%
2 Gabapentin 7,585
3.0%
3 Mycophenolate 7,193
2.8%
4 Cyclophosphamide 6,446
2.5%
5 Cyclophosphamide For 6,446
2.5%
6 Tacrolimus 6,247
2.5%
7 Risperidone 5,974
2.4%
8 Tacrolimus Extended- 5,942
2.3%
9 Methylprednisolone 5,591
2.2%
10 Aripiprazole 5,297
2.1%
11 Prednisolone 4,960
2.0%
12 Cyclosporine 4,265
1.7%
13 Adapalene 3,971
1.6%
14 Acetaminophen, Aspirin, / Caffeine 3,839
1.5%
15 Polyethylene Glycol 3350 3,657
1.4%
16 Pembrolizumab 3,468
1.4%
17 Topiramate 3,130
1.2%
18 Semaglutide 3,023
1.2%
19 Doxorubicin 2,960
1.2%
20 Etoposide 2,939
1.2%
21 Propranolol 2,918
1.2%
22 Azathioprine 2,652
1.0%
23 Carboplatin 2,622
1.0%
24 Hydrocortisone 1% 2,518
1.0%
25 Anti Itch 2,518
1.0%
26 Anti-Itch 2,518
1.0%
27 Anti-Pruritic 2,518
1.0%
28 Antipruritic (Anti-Itch) 2,518
1.0%
29 Cool Relief With Aloe 2,518
1.0%
30 Drs Hydrocortisone 2,518
1.0%
31 Hydrocortisone Continuous Spray 2,518
1.0%
32 Hydrocortisone Spray 2,518
1.0%
33 Topiramate Spinkle 2,434
1.0%
34 Fluticasone 2,245
0.9%
35 Fludarabine 2,239
0.9%
36 Aripiprazole Orally Disintegrating 2,209
0.9%
37 Sarilumab 2,162
0.9%
38 Montelukast 2,106
0.8%
39 Acetaminophen, Aspirin (Nsaid) / Caffeine 2,042
0.8%
40 Sacubitril / Valsartan 1,988
0.8%
41 Busulfan 1,827
0.7%
42 Cannabidiol 1,797
0.7%
43 Cytarabine 1,755
0.7%
44 Budesonide 1,700
0.7%
45 Triamcinolone Acetonide 1,634
0.6%
46 Triamcinolone Acetonide Ointment Usp, 0.05% 1,572
0.6%
47 Cisplatin 1,527
0.6%
48 Bortezomib 1,432
0.6%
49 Temozolomide 1,426
0.6%
50 Nivolumab 1,347
0.5%
51 Brexpiprazole 1,315
0.5%
52 Azithromycin 1,246
0.5%
53 Botulinum Toxin Type A 1,237
0.5%
54 Fluticasone Furoate, Umeclidinium Bromide / Vilanterol Trifenatate 1,234
0.5%
55 Minoxidil 1,173
0.5%
56 Everolimus 1,161
0.5%
57 Hydroxyzine 1,091
0.4%
58 Trametinib 1,083
0.4%
59 Adrenalinum 1,077
0.4%
60 Fluticasone Furoate / Vilanterol Trifenatate 1,022
0.4%
61 Posaconazole 977
0.4%
62 Mycophenolic Acid 942
0.4%
63 Ifosfamide 939
0.4%
64 Melphalan 908
0.4%
65 Salicylic Acid 874
0.3%
66 Gemcitabine 874
0.3%
67 Valproic Acid 839
0.3%
68 Mupirocin 832
0.3%
69 Ceftriaxone 805
0.3%
70 Meropenem 787
0.3%
71 Sirolimus 774
0.3%
72 Pazopanib 762
0.3%
73 Mycophenilic Acid 744
0.3%
74 Eltrombopag Olamine 740
0.3%
75 Guaifenesin 732
0.3%
76 Voriconazole 731
0.3%
77 Fluticasone Furoate 707
0.3%
78 Clobazam 701
0.3%
79 Linezolid 692
0.3%
80 Vincristine 692
0.3%
81 Amiodarone 672
0.3%
82 Paliperidone Palmitate 644
0.3%
83 Paliperidone 622
0.2%
84 Piperacillin Sodium,Tazobactam Sodium 601
0.2%
85 Thiotepa 595
0.2%
86 Lithium 589
0.2%
87 Lithium Bromatum 589
0.2%
88 Rifampin 587
0.2%
89 Propofol 585
0.2%
90 Midazolam 583
0.2%
91 Alemtuzumab 577
0.2%
92 Minocycline 570
0.2%
93 Ketoconazole 565
0.2%
94 Clindamycin 564
0.2%
95 Valganciclovir 553
0.2%
96 Ganciclovir 550
0.2%
97 Rizatriptan Benzoate 544
0.2%
98 Moxifloxacin 541
0.2%
99 Amphotericin B 537
0.2%
100 Basiliximab 536
0.2%
101 Posaconazole Delayed- 534
0.2%
102 Dabrafenib 532
0.2%
103 Amikacin 531
0.2%
104 Rifaximin 527
0.2%
105 Encorafenib 520
0.2%
106 Ketoconazole Foam 507
0.2%
107 Tolvaptan 490
0.2%
108 Clobetasol Propionate Ointment Usp, 0.05% 489
0.2%
109 Clobetasol 487
0.2%
110 Naproxen Sodium, Pseudoephedrine Hydrochloride 486
0.2%
111 Naproxen Sodium, Dextromethorphan Hydrobromide, Guaifenesin 484
0.2%
112 Tretinoin 484
0.2%
113 Dextrose 457
0.2%
114 Imatinib 442
0.2%
115 Valproate 439
0.2%
116 Umeclidinium Bromide / Vilanterol Trifenatate 437
0.2%
117 Norepinephrine ( ) 399
0.2%
118 Micafungin 393
0.2%
119 Tobramycin 392
0.2%
120 Phenobarbital 381
0.2%
121 Fexofenadine 372
0.1%
122 Thiamine 369
0.1%
123 Azelastine 359
0.1%
124 Bendamustine 347
0.1%
125 Trazodone 346
0.1%
126 Oseltamivir 342
0.1%
127 Gentamicin 337
0.1%
128 Crisaborole 334
0.1%
129 Canakinumab 330
0.1%
130 Dapsone 330
0.1%
131 Norepinephrine 324
0.1%
132 Daspone 321
0.1%
133 Misoprostol 315
0.1%
134 Mometasone Furoate / Formoterol Fumarate Dihydrate 306
0.1%
135 Cefepime 302
0.1%
136 Zonisamide 298
0.1%
137 Bleomycin 287
0.1%
138 Daptomycin 280
0.1%
139 Ampicillin 276
0.1%
140 Anti-Thymocyte Globulin (Rabbit) 258
0.1%
141 Docosanol 252
0.1%
142 Umeclidinium 244
0.1%
143 Irinotecan 242
0.1%
144 Itraconazole 236
0.1%
145 Sulfur 223
0.1%
146 Terbinafine 222
0.1%
147 Glycerin, Lidocaine 215
0.1%
148 Mesna 213
0.1%
149 Remdesivir 212
0.1%
150 Brentuximab Vedotin 192
0.1%
151 Brivaracetam 178
0.1%
152 Pyrazinamide 172
0.1%
153 Atovaquone 169
0.1%
154 Cariprazine 142
0.1%
155 Loratadine / Pseudoephedrine Sulfate 119
0.0%

Important Disclaimer

FDA adverse event reports are submitted voluntarily and do not prove causation. The presence of a drug in this list does not mean the drug caused product use in unapproved indication. Always consult your healthcare provider.