Drug:
Reaction: PRODUCT USE IN UNAPPROVED INDICATION
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26549641 |
US |
5 | 1 |
Skin fissures, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 202 | 26549655 |
US |
33 | 2 |
Rash macular, Rash, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 203 | 26549663 |
US |
35 | 1 |
Arthralgia, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 204 | 26549666 |
US |
36 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 205 | 26549669 |
US |
34 | 2 |
Adverse drug reaction, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 206 | 26549676 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 207 | 26549682 |
US |
23 | 2 |
Dermatitis atopic, Pruritus, Product dose omission issue, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 208 | 26549696 |
US |
47 | 1 |
Myalgia, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 209 | 26549698 |
US |
1 | |
Peripheral swelling, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 210 | 26549699 |
US |
1 | |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 211 | 26549701 |
US |
36 | 1 |
Sleep disorder, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 212 | 26549712 |
US |
17 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 213 | 26549878 |
US |
59 | 1 |
Product use in unapproved indication, |
||||
TEMOZOLOMIDE, |
||||
| 214 | 26549895 |
CA |
||
Nephrolithiasis, Hyperhidrosis, Drug ineffective, Off label use, Sedation, Nightmare, Product use in unapproved indication, Nausea, |
||||
DICLOFENAC SODIUM, GABAPENTIN, KETAMINE HYDROCHLORIDE, ESOMEPRAZOLE MAGNESIUM, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, ALMOTRIPTAN, ALMOTRIPTAN MALATE, ONABOTULINUMTOXINA, BOTULINUM TOXIN TYPE A, CELECOXIB, MEPERIDINE HYDROCHLORIDE, OXYCODONE AND ACETAMINOPHEN, RIZATRIPTAN BENZOATE, MORPHINE SULFATE, NORTRIPTYLINE HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, PROPRANOLOL HYDROCHLORIDE, ATENOLOL AND CHLORTHALIDONE, DULOXETINE HYDROCHLORIDE, DULOXETINE, TOPIRAMATE, TRAMADOL HYDROCHLORIDE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, |
||||
| 215 | 26546796 |
US |
37 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 216 | 26546892 |
US |
68 | 1 |
Myalgia, Diarrhoea, Product use in unapproved indication, |
||||
DUPILUMAB, CABOZANTINIB, ALLOPURINOL, LISINOPRIL, ERGOCALCIFEROL, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, VITAMIN C, INDOMETHACIN, SELPERCATINIB, |
||||
| 217 | 26546896 |
US |
51 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 218 | 26546974 |
US |
48 | 2 |
Eczema, Pruritus, Skin swelling, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 219 | 26547007 |
US |
52 | 2 |
Rash, Pain, Sleep disorder, Product use in unapproved indication, |
||||
DUPILUMAB, EPINEPHRINE, ADRENALINUM, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 220 | 26547037 |
US |
78 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 221 | 26547095 |
US |
66 | 1 |
Dry eye, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 222 | 26547167 |
US |
1 | |
Dermatitis atopic, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 223 | 26547191 |
US |
61 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 224 | 26547200 |
US |
2 | |
Swelling face, Lip swelling, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 225 | 26547278 |
US |
22 | 1 |
Erythema, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 226 | 26547282 |
US |
56 | 2 |
Condition aggravated, Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, ROSUVASTATIN, |
||||
| 227 | 26547330 |
US |
55 | 2 |
Product use in unapproved indication, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 228 | 26547333 |
US |
57 | 2 |
Blood cholesterol increased, Blood triglycerides increased, Product use in unapproved indication, |
||||
BELUMOSUDIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, LIOTHYRONINE SODIUM, DESONIDE, FENOFIBRATE, RUXOLITINIB, BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE, FLUCONAZOLE, FLUOCINONIDE, FLUOCINONIDE TOPICAL SOLUTION USP, 0.05%, FOLIC ACID, SUMATRIPTAN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, CARBOXYMETHYLCELLULOSE SODIUM, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, URSODIOL, URSOSIOL, VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR, ERGOCALCIFEROL, |
||||
| 229 | 26547374 |
US |
1 | |
Product use in unapproved indication, |
||||
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE, |
||||
| 230 | 26547498 |
US |
12 | 2 |
Pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, SECUKINUMAB, GUSELKUMAB, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 231 | 26547523 |
US |
58 | 2 |
Sinusitis, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 232 | 26547615 |
US |
15 | 1 |
Oropharyngeal pain, Product use in unapproved indication, |
||||
DUPILUMAB, SOMATROPIN, |
||||
| 233 | 26547717 |
US |
52 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 234 | 26547729 |
US |
63 | 2 |
Anosmia, Ageusia, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 235 | 26547820 |
US |
2 | |
Cough, Increased upper airway secretion, Product use in unapproved indication, |
||||
DUPILUMAB, BISOPROLOL FUMARATE, MONTELUKAST, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ROSUVASTATIN, |
||||
| 236 | 26547909 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, ROSUVASTATIN, |
||||
| 237 | 26548008 |
US |
7 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 238 | 26548122 |
US |
1 | |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, AMOXICILLIN AND CLAVULANATE POTASSIUM, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, ASCORBIC ACID, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 239 | 26548125 |
US |
1 | |
Product use in unapproved indication, |
||||
DUPILUMAB, DULOXETINE HYDROCHLORIDE, DULOXETINE, AMLODIPINE BESYLATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROCHLOROTHIAZIDE, LORATADINE, LORATADINE ORAL, LOSARTAN POTASSIUM, LOSARTAN, MELOXICAM, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, |
||||
| 240 | 26548149 |
US |
48 | 2 |
Pain in extremity, Inappropriate schedule of product administration, Lack of injection site rotation, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 241 | 26548201 |
US |
55 | 2 |
Nasal congestion, Nasal obstruction, Condition aggravated, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 242 | 26548286 |
US |
9 | 2 |
Weight increased, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 243 | 26548372 |
EU |
39 | 2 |
Vasculitis, Pruritus, Product use in unapproved indication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE, |
||||
| 244 | 26548382 |
US |
62 | 2 |
Rash, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 245 | 26548412 |
US |
80 | 1 |
Abdominal distension, Flatulence, Abdominal discomfort, Arthralgia, Muscular weakness, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 246 | 26548451 |
US |
55 | 1 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 247 | 26548466 |
US |
19 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 248 | 26548544 |
US |
1 | |
Dry eye, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 249 | 26548566 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, ROSUVASTATIN CALCIUM, |
||||
| 250 | 26548598 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, CALCIUM, LOSARTAN, ESOMEPRAZOLE MAGNESIUM, |
||||
| 251 | 26548612 |
US |
2 | |
Dyspnoea, Urticaria, Product use in unapproved indication, |
||||
DUPILUMAB, SULFAMETHOXAZOLE AND TRIMETHOPRIM, CITALOPRAM, CITALOPRAM HYDROBROMIDE, HYDROXYZINE, ALBUTEROL SULFATE, ALBUTEROL, ALPRAZOLAM, ZOLPIDEM TARTRATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, CELECOXIB, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FOLIC ACID, METHYLPREDNISOLONE, MONTELUKAST, NICOTINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, PREDNISONE, PREGABALIN, |
||||
| 252 | 26548625 |
US |
2 | |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, ALBUTEROL SULFATE, CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE OINTMENT USP, 0.05%, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LEVOTHYROXINE SODIUM, VILAZODONE HYDROCHLORIDE, |
||||
| 253 | 26548648 |
US |
69 | 2 |
Headache, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 254 | 26548679 |
US |
82 | 2 |
Rash, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 255 | 26548710 |
US |
54 | 2 |
Nasopharyngitis, Condition aggravated, Rhinorrhoea, Respiratory tract congestion, Injection site urticaria, Injection site erythema, Injection site swelling, Injection site warmth, Product use in unapproved indication, |
||||
DUPILUMAB, CALCIUM, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, RALOXIFENE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, HYDROXYZINE HYDROCHLORIDE ORAL, LINACLOTIDE, MAGNESIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, FAMOTIDINE, METOCLOPRAMIDE HYDROCHLORIDE, SPIRONOLACTONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, ERGOCALCIFEROL, BUPROPION HYDROCHLORIDE, ALPRAZOLAM, |
||||
| 256 | 26548719 |
US |
1 | |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 257 | 26548723 |
US |
57 | 1 |
Gout, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 258 | 26548725 |
US |
15 | 1 |
Hypomania, Product use in unapproved indication, |
||||
CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, |
||||
| 259 | 26548760 |
US |
23 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 260 | 26548765 |
US |
74 | 1 |
Pain, Cardiac pacemaker insertion, Product use in unapproved indication, |
||||
DUPILUMAB, ETANERCEPT, PREDNISONE, |
||||
| 261 | 26542017 |
US |
27 | 2 |
Product use in unapproved indication, |
||||
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 262 | 26542126 |
US |
2 | |
Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, OMALIZUMAB, ALBUTEROL SULFATE, ERGOCALCIFEROL, |
||||
| 263 | 26542144 |
US |
70 | 2 |
Liver function test abnormal, Product use in unapproved indication, |
||||
DOSTARLIMAB, DOSTARLIMAB, CARBOPLATIN, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), |
||||
| 264 | 26542293 |
US |
2 | |
Product use in unapproved indication, |
||||
COLCHICINE, |
||||
| 265 | 26542410 |
US |
2 | |
Exposure during pregnancy, Product use in unapproved indication, |
||||
SIROLIMUS, SIROLIMUS, |
||||
| 266 | 26542726 |
US |
2 | |
Product use in unapproved indication, |
||||
ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, |
||||
| 267 | 26542818 |
US |
67 | 1 |
Product use in unapproved indication, |
||||
PIMAVANSERIN TARTRATE, SERTRALINE, CARBIDOPA AND LEVODOPA, EVOLOCUMAB, AMLODIPINE BESYLATE, LISINOPRIL, DONEPEZIL HYDROCHLORIDE, PANTOPRAZOLE, |
||||
| 268 | 26543067 |
US |
||
Drug ineffective, Product use in unapproved indication, |
||||
MINOXIDIL, MINOXIDIL FOAM 5% (WOMENS), HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, BIMATOPROST, |
||||
| 269 | 26543382 |
US |
60 | 2 |
Loss of consciousness, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 270 | 26543390 |
US |
57 | 1 |
Death, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 271 | 26543493 |
US |
2 | |
Somnolence, Overdose, Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, MONTELUKAST SODIUM, MONTELUKAST, OMALIZUMAB, OMALIZUMAB, PREDNISONE, PREDNISONE, HYDROXYZINE, LEVOCETIRIZINE DIHYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, EPINEPHRINE, ADRENALINUM, LORATADINE, LORATADINE TABLET, FAMOTIDINE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, METHYLPREDNISOLONE SODIUM SUCCINATE, EPINEPHRINE, |
||||
| 272 | 26543609 |
CA |
33 | 2 |
Arthralgia, Blood pressure diastolic increased, Blood pressure increased, Blood pressure systolic increased, Drug ineffective, Gastroenteritis, Gingival erythema, Gingival pain, Gingival swelling, Headache, Influenza virus test positive, Limb injury, Oral candidiasis, Pain in extremity, Product use in unapproved indication, Skin infection, Tooth infection, Toothache, Weight decreased, Weight increased, |
||||
TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, AMLODIPINE, CEFADROXIL, DESVENLAFAXINE SUCCINATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, OSELTAMIVIR PHOSPHATE, OSELTAMIVIR ACID, OSELTAMIVIR, PREDNISONE, OSELTAMIVIR PHOSPHATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 273 | 26543718 |
US |
72 | 2 |
Product use in unapproved indication, Product adhesion issue, |
||||
ESTRADIOL, |
||||
| 274 | 26543815 |
US |
81 | 2 |
Product use in unapproved indication, Wrong technique in device usage process, Device delivery system issue, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 275 | 26543869 |
50 | 2 | |
Therapy change, Diarrhoea, Nausea, Food poisoning, Abdominal distension, Eructation, Drug ineffective, Gastric dilatation, Decreased appetite, Presyncope, Product use in unapproved indication, |
||||
SEMAGLUTIDE, MINOXIDIL, MINOXIDIL FOAM 5% (WOMENS), IRON, CALCIUM, VITAMIN C, BIOTIN, JOINT HEALTH CAPSULES, |
||||
| 276 | 26543876 |
US |
1 | |
Drug ineffective, Product use in unapproved indication, |
||||
PEMBROLIZUMAB, TEMOZOLOMIDE, |
||||
| 277 | 26543975 |
42 | ||
Rash erythematous, Pruritus, Burning sensation, Product use in unapproved indication, |
||||
BIMEKIZUMAB, |
||||
| 278 | 26543982 |
US |
31 | 2 |
Drug hypersensitivity, Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 279 | 26544013 |
US |
2 | |
Therapeutic response unexpected, Product use in unapproved indication, |
||||
| 280 | 26544311 |
US |
1 | |
Liver disorder, Fatigue, Product use in unapproved indication, |
||||
DAROLUTAMIDE, |
||||
| 281 | 26544342 |
KR |
2 | |
Delirium, Product use in unapproved indication, |
||||
PREGABALIN, |
||||
| 282 | 26544343 |
KR |
2 | |
Depressed level of consciousness, Oxygen saturation decreased, Product use in unapproved indication, |
||||
ALPRAZOLAM, |
||||
| 283 | 26544407 |
|||
Product prescribing issue, Product use in unapproved indication, |
||||
POLYETHYLENE GLYCOL 3350, |
||||
| 284 | 26544426 |
US |
70 | 1 |
Product use in unapproved indication, No adverse event, |
||||
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE, |
||||
| 285 | 26544455 |
US |
2 | |
COVID-19, Product use in unapproved indication, |
||||
BELIMUMAB, |
||||
| 286 | 26544460 |
US |
65 | 1 |
Arthralgia, Myalgia, Product use in unapproved indication, |
||||
UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 287 | 26544557 |
JP |
62 | 2 |
Product use in unapproved indication, |
||||
MOLNUPIRAVIR, |
||||
| 288 | 26544609 |
AU |
32 | 2 |
Exposure during pregnancy, Herpes zoster, Condition aggravated, Inflammatory marker increased, Premature delivery, Herpes zoster, Product use in unapproved indication, |
||||
PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, AZATHIOPRINE, |
||||
| 289 | 26544830 |
US |
||
Bedridden, Depression, Weight increased, Product use in unapproved indication, |
||||
SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 290 | 26544837 |
US |
2 | |
Death, Product use in unapproved indication, |
||||
BREXPIPRAZOLE, BREXPIPRAZOLE, |
||||
| 291 | 26544879 |
66 | ||
Aspartate aminotransferase increased, Alanine aminotransferase increased, Blood bilirubin increased, Blood glucose increased, Product use in unapproved indication, |
||||
RESMETIROM, SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 292 | 26544910 |
US |
78 | 2 |
Product use in unapproved indication, |
||||
FAMOTIDINE, |
||||
| 293 | 26545022 |
JP |
74 | 2 |
Spinal subdural haematoma, Paraplegia, Urinary retention, Arterial rupture, Anal sphincter atony, Prothrombin time prolonged, International normalised ratio increased, Product use in unapproved indication, |
||||
WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, |
||||
| 294 | 26545108 |
US |
2 | |
Respiratory syncytial virus infection, Diarrhoea haemorrhagic, Lower gastrointestinal haemorrhage, Abdominal pain lower, Asthma, Product use in unapproved indication, |
||||
DUPILUMAB, ALBUTEROL SULFATE AND BUDESONIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, AZELASTINE, CELECOXIB, DICYCLOMINE HYDROCHLORIDE, FENOFIBRATE, GABAPENTIN, GLIMEPIRIDE, LEVOCETIRIZINE DIHYDROCHLORIDE, MAGNESIUM, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, METHOCARBAMOL, METHOCARBAMOL TABLETS, METOPROLOL TARTRATE, METOPROLOL, MONTELUKAST, RABEPRAZOLE, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, INSULIN GLARGINE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ERGOCALCIFEROL, |
||||
| 295 | 26545730 |
US |
74 | 1 |
Rectal haemorrhage, Arthralgia, Bone pain, Product use in unapproved indication, |
||||
DOSTARLIMAB, |
||||
| 296 | 26545763 |
KR |
2 | |
Delirium, Product use in unapproved indication, |
||||
ALPRAZOLAM, ALPRAZOLAM, ALPRAZOLAM, ALPRAZOLAM, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, |
||||
| 297 | 26545768 |
CA |
45 | 2 |
Generalised tonic-clonic seizure, Product use in unapproved indication, |
||||
CLOZAPINE, AMISULPRIDE, VALPROIC ACID, |
||||
| 298 | 26545777 |
PH |
||
Cardiac arrest, Product prescribing issue, Product use in unapproved indication, |
||||
TOLVAPTAN, TOLVAPTAN, |
||||
| 299 | 26545878 |
EU |
65 | 2 |
Optic ischaemic neuropathy, Product use in unapproved indication, |
||||
SEMAGLUTIDE, SEMAGLUTIDE, ORAL SEMAGLUTIDE, SEMAGLUTIDE, ORAL SEMAGLUTIDE, SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 300 | 26545897 |
US |
2 | |
Blood glucose fluctuation, Increased appetite, Product dose omission issue, Product use in unapproved indication, |
||||
SEMAGLUTIDE, |
||||
disclaimer
Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2026-04-28