Drug:
Reaction: PRODUCT USE IN UNAPPROVED INDICATION
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26551239 |
US |
72 | 1 |
Circulatory collapse, Pyrexia, Haematochezia, Cystitis, Product use in unapproved indication, |
||||
CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, |
||||
| 102 | 26551309 |
US |
60 | 2 |
Hypertension, Fluid retention, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 103 | 26551321 |
US |
64 | 2 |
Infective exacerbation of asthma, Pulmonary eosinophilia, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 104 | 26551394 |
US |
31 | 1 |
Blood glucose increased, Product use in unapproved indication, |
||||
BELUMOSUDIL, ACYCLOVIR, FAMOTIDINE, HYDROXYZINE, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, PREDNISONE, LETERMOVIR, ELTROMBOPAG OLAMINE, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, URSODIOL, URSOSIOL, |
||||
| 105 | 26551443 |
RU |
33 | 2 |
Suicide attempt, Product use in unapproved indication, |
||||
INSULIN GLULISINE, |
||||
| 106 | 26551494 |
EU |
72 | 1 |
Acute myocardial infarction, Multiple use of single-use product, Product use in unapproved indication, |
||||
ORITAVANCIN, |
||||
| 107 | 26551496 |
US |
87 | 1 |
Dizziness, Vertigo, Hypotension, Eczema, Intentional dose omission, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 108 | 26551519 |
US |
1 | |
Transient ischaemic attack, Insomnia, Confusional state, Agitation, Product use in unapproved indication, |
||||
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, FINASTERIDE, QUETIAPINE, |
||||
| 109 | 26551522 |
5 | 1 | |
Vomiting, Product prescribing issue, Product use in unapproved indication, Product contamination physical, |
||||
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, |
||||
| 110 | 26551662 |
US |
||
Product use in unapproved indication, |
||||
ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 111 | 26551680 |
US |
2 | |
Product use in unapproved indication, |
||||
ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, TREPROSTINIL, TREPROSTINIL, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, AMBRISENTAN, |
||||
| 112 | 26551695 |
US |
55 | 2 |
Fatigue, Drug ineffective, Product use in unapproved indication, |
||||
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, |
||||
| 113 | 26551875 |
64 | 2 | |
Eructation, Product use in unapproved indication, Incorrect product administration duration, |
||||
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM, |
||||
| 114 | 26551972 |
US |
1 | |
Drug ineffective, Blood pressure decreased, Product use in unapproved indication, |
||||
NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE BITARTRATE, DEXMEDETOMIDINE HYDROCHLORIDE, FENTANYL, PROPOFOL, |
||||
| 115 | 26552157 |
US |
2 | |
Vision blurred, Product use in unapproved indication, |
||||
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE, |
||||
| 116 | 26552236 |
EU |
39 | 2 |
Blister, Malaise, Diarrhoea, Pyrexia, Lymphadenopathy, Product use in unapproved indication, |
||||
ETANERCEPT, |
||||
| 117 | 26552290 |
EU |
16 | 2 |
Confusional state, Product use in unapproved indication, |
||||
DABRAFENIB, TRAMETINIB, LIRAGLUTIDE, LIRAGLUTIDE, 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, ENALAPRIL, SOMATROPIN, |
||||
| 118 | 26552406 |
EU |
29 | |
Hydronephrosis, Urosepsis, Acute kidney injury, Product use in unapproved indication, |
||||
BOTULINUM TOXIN TYPE A, BOTULINUM TOXIN TYPE A, |
||||
| 119 | 26552407 |
KR |
1 | |
Suicidal ideation, Product use in unapproved indication, |
||||
ALPRAZOLAM, CIPROFLOXACIN HYDROCHLORIDE, MIRABEGRON, TAMSULOSIN HYDROCHLORIDE, |
||||
| 120 | 26552423 |
US |
82 | 2 |
Limb discomfort, Tinnitus, Oropharyngeal pain, Dysstasia, Somnolence, Asthenia, Fatigue, Headache, Product use in unapproved indication, |
||||
QUETIAPINE FUMARATE, QUETIAPINE, |
||||
| 121 | 26552471 |
EU |
37 | 2 |
Diarrhoea, Product use in unapproved indication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, |
||||
| 122 | 26552478 |
EU |
30 | 1 |
Hiccups, Product use in unapproved indication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, RISPERIDONE, |
||||
| 123 | 26552481 |
EU |
54 | 2 |
Headache, Product use in unapproved indication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, HYDROCHLOROTHIAZIDE, TELMISARTAN, |
||||
| 124 | 26552517 |
JP |
52 | 1 |
Pleuroparenchymal fibroelastosis, Alveolar proteinosis, COVID-19, Respiratory failure, Interstitial lung disease, Product use in unapproved indication, |
||||
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, |
||||
| 125 | 26552541 |
US |
||
Spinal fracture, Product use in unapproved indication, |
||||
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, TAZEMETOSTAT, |
||||
| 126 | 26552558 |
US |
70 | 2 |
Dysbiosis, Drug ineffective, Product use in unapproved indication, |
||||
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, DULOXETINE HYDROCHLORIDE, DULOXETINE, FUROSEMIDE, INSULIN GLARGINE-YFGN, INSULIN GLARGINE, |
||||
| 127 | 26552757 |
US |
69 | 1 |
Barrett^s oesophagus, Pruritus, Appetite disorder, Abdominal distension, Feeling abnormal, Gastrooesophageal reflux disease, Dry skin, Night sweats, Blood pressure increased, Headache, Hot flush, Constipation, Nocturia, Tooth infection, Pain, Middle insomnia, Weight increased, Arthralgia, Asthenia, Myalgia, Product use in unapproved indication, |
||||
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, ENZALUTAMIDE, ENZALUTAMIDE, ENZALUTAMIDE, ENZALUTAMIDE, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM, |
||||
| 128 | 26552899 |
EU |
39 | 2 |
Vasculitis, Pruritus, Product use in unapproved indication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, |
||||
| 129 | 26553019 |
US |
||
Hypotension, Hypertension, Feeling abnormal, Drug interaction, Product use in unapproved indication, Wrong technique in product usage process, |
||||
DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, |
||||
| 130 | 26553072 |
US |
||
Product use complaint, Product use in unapproved indication, Incorrect product administration duration, |
||||
DEXTROMETHORPHAN HYDROBROMIDE,GUAIFENESIN, LEVOCETIRIZINE DIHYDROCHLORIDE, |
||||
| 131 | 26553238 |
EU |
7 | 2 |
Metabolic acidosis, Hypokalaemia, Acute kidney injury, Sprue-like enteropathy, Product use in unapproved indication, |
||||
OLMESARTAN MEDOXOMIL, AMLODIPINE, |
||||
| 132 | 26553283 |
EU |
||
Haemolytic anaemia, Product use in unapproved indication, |
||||
ROFLUMILAST, CYCLOSPORINE, CYCLOSPORINE, CYCLOSPORINE, |
||||
| 133 | 26553365 |
MA |
46 | 1 |
Drug reaction with eosinophilia and systemic symptoms, Product use in unapproved indication, |
||||
GEMCITABINE HYDROCHLORIDE, GEMCITABINE, CISPLATIN, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, |
||||
| 134 | 26553452 |
86 | ||
Rash, Taste disorder, Product use in unapproved indication, |
||||
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, |
||||
| 135 | 26553457 |
|||
Piloerection, Skin irritation, Thirst, Abdominal pain upper, Feeling jittery, Feeling of body temperature change, Irritability, Restlessness, Pruritus, Pruritus, Anxiety, Product quality issue, Product use in unapproved indication, |
||||
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, RIVAROXABAN, |
||||
| 136 | 26553463 |
CH |
47 | |
Hypokalaemia, Hypomagnesaemia, Hypophosphataemia, Product use in unapproved indication, |
||||
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, IFOSFAMIDE, |
||||
| 137 | 26553477 |
EU |
57 | 2 |
Cardiac arrest, Acute myocardial infarction, Syncope, Fall, Head injury, Product use in unapproved indication, |
||||
ALPRAZOLAM, ALPRAZOLAM, ALPRAZOLAM, ALPRAZOLAM, AMLODIPINE, AMLODIPINE, AMLODIPINE, AMLODIPINE, |
||||
| 138 | 26553489 |
US |
37 | 1 |
Hospitalisation, Product use in unapproved indication, |
||||
SPARSENTAN, |
||||
| 139 | 26553553 |
EU |
20 | 2 |
Neutropenia, Product use in unapproved indication, Product use issue, Off label use, |
||||
CLOZAPINE, CLOZAPINE, CLOZAPINE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, OXAZEPAM, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400, INSTALAX POLYETHYLENE GLYCOL 3350, ARIPIPRAZOLE, TOPIRAMATE, TOPIRAMATE SPINKLE, MELATONIN, SCOPOLAMINE, |
||||
| 140 | 26553559 |
US |
2 | |
Gastric ulcer, Dyspnoea, Anaemia, Product use in unapproved indication, |
||||
CEDAZURIDINE AND DECITABINE, |
||||
| 141 | 26553964 |
|||
Dementia Alzheimer^s type, Pneumonia, Partial seizures, Cough, Product use issue, Product use in unapproved indication, |
||||
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, BRIVARACETAM, BRIVARACETAM, LACOSAMIDE, LACOSAMIDE, |
||||
| 142 | 26554216 |
US |
41 | 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, |
||||
| 143 | 26554333 |
CO |
33 | 2 |
Nephrolithiasis, Product use in unapproved indication, |
||||
SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 144 | 26554435 |
US |
2 | |
Cataract, Product use in unapproved indication, |
||||
SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 145 | 26554437 |
CN |
23 | 2 |
Dry mouth, Urine output decreased, Vomiting, Nausea, Abdominal distension, Asthenia, Dizziness, Decreased appetite, Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 146 | 26554563 |
US |
1 | |
Radiation injury, Flatulence, Product dose omission issue, Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
DUVELISIB, |
||||
| 147 | 26554639 |
US |
1 | |
Spinal operation, Arthralgia, Myalgia, Product residue present, Wrong technique in product usage process, Product use in unapproved indication, Dysphonia, |
||||
UPADACITINIB, UPADACITINIB, UPADACITINIB, |
||||
| 148 | 26554841 |
US |
2 | |
Product use in unapproved indication, |
||||
SPARSENTAN, SPARSENTAN, |
||||
| 149 | 26555051 |
US |
81 | 1 |
Product use in unapproved indication, |
||||
ERTAPENEM, ERTAPENEM SODIUM, |
||||
| 150 | 26566479 |
|||
Product use in unapproved indication, Blindness, Product label issue, Incorrect route of product administration, Product origin unknown, |
||||
ONABOTULINUMTOXINA, |
||||
| 151 | 26548900 |
US |
60 | 1 |
Pneumocystis jirovecii pneumonia, Immunodeficiency, Product use in unapproved indication, |
||||
TEMOZOLOMIDE, APIXABAN, DULOXETINE HYDROCHLORIDE, DULOXETINE, PROPRANOLOL HYDROCHLORIDE, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, PANTOPRAZOLE, SUCRALFATE, SUCRALFATE ORAL SUSPENSION, SUCRALFATE ORAL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 152 | 26549028 |
US |
82 | 2 |
Constipation, Product prescribing issue, Diarrhoea, Product use in unapproved indication, |
||||
CLONAZEPAM, CLONAZEPAM, |
||||
| 153 | 26549121 |
US |
42 | 1 |
Product use in unapproved indication, |
||||
TEMOZOLOMIDE, |
||||
| 154 | 26549137 |
US |
60 | 2 |
Oropharyngeal pain, Cough, Headache, Fatigue, Malaise, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 155 | 26549140 |
US |
14 | 1 |
Product use in unapproved indication, |
||||
TEMOZOLOMIDE, |
||||
| 156 | 26549142 |
US |
25 | 1 |
Vision blurred, Dry eye, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 157 | 26549145 |
US |
38 | 2 |
Condition aggravated, Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 158 | 26549174 |
US |
17 | 2 |
Dermatitis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 159 | 26549206 |
US |
21 | 2 |
Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 160 | 26549224 |
US |
62 | 1 |
Rash erythematous, Skin burning sensation, Pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 161 | 26549237 |
US |
39 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Dermatitis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 162 | 26549250 |
US |
39 | 2 |
Pruritus, Product use in unapproved indication, |
||||
BELUMOSUDIL, BACLOFEN, SULFAMETHOXAZOLE AND TRIMETHOPRIM, NEBIVOLOL HYDROCHLORIDE, CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPICAL, ISAVUCONAZONIUM SULFATE, FAMOTIDINE, 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, MAGNESIUM OXIDE, TIRZEPATIDE, NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE, NORETHINDRONE, ROSUVASTATIN, SERTRALINE, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, ERGOCALCIFEROL, |
||||
| 163 | 26549252 |
US |
61 | 1 |
Sinus headache, Secretion discharge, Cough, Asthma, Chronic sinusitis, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 164 | 26549254 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 165 | 26549259 |
US |
20 | 2 |
Influenza, Pyrexia, Respiratory tract congestion, Cough, Product use in unapproved indication, Incorrect dose administered, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 166 | 26549263 |
US |
54 | 2 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 167 | 26549268 |
US |
48 | 2 |
Thyroidectomy, Pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 168 | 26549269 |
US |
45 | 1 |
Psoriasis, Dermatitis atopic, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 169 | 26549278 |
US |
17 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 170 | 26549290 |
US |
29 | 1 |
Psoriasis, Product dose omission issue, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 171 | 26549294 |
US |
71 | 1 |
Pruritus, Product dose omission issue, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 172 | 26549296 |
US |
37 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Condition aggravated, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 173 | 26549337 |
US |
62 | 2 |
Herpes virus infection, Product use in unapproved indication, |
||||
DUPILUMAB, MEPOLIZUMAB, |
||||
| 174 | 26549338 |
US |
18 | 1 |
Dermatitis atopic, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 175 | 26549342 |
US |
2 | |
Hypersensitivity, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 176 | 26549345 |
US |
43 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 177 | 26549351 |
US |
74 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 178 | 26549362 |
US |
84 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 179 | 26549377 |
US |
45 | 2 |
Eczema, Rash erythematous, Rash, Product dose omission in error, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 180 | 26549384 |
US |
36 | 2 |
Dermatitis, Product use in unapproved indication, Eczema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 181 | 26549393 |
US |
2 | |
Product use in unapproved indication, |
||||
DUPILUMAB, ADALIMUMAB, |
||||
| 182 | 26549409 |
US |
67 | 1 |
Rash, Pruritus, Tinea pedis, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 183 | 26549439 |
US |
37 | 2 |
Urticaria, Pruritus, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 184 | 26549446 |
US |
70 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Eczema, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 185 | 26549452 |
US |
21 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 186 | 26549453 |
US |
30 | 2 |
Rash, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 187 | 26549463 |
US |
73 | 2 |
Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 188 | 26549468 |
US |
51 | 2 |
Fatigue, Rash, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 189 | 26549480 |
US |
34 | 1 |
Urticaria, Rash erythematous, Product use in unapproved indication, |
||||
DUPILUMAB, OMALIZUMAB, |
||||
| 190 | 26549485 |
US |
61 | 1 |
Neurodermatitis, Product dose omission issue, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, LENALIDOMIDE, |
||||
| 191 | 26549509 |
US |
71 | 1 |
Dermatitis atopic, Pruritus, Therapeutic response shortened, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 192 | 26549551 |
US |
54 | 1 |
Condition aggravated, Rash erythematous, Pruritus, Skin burning sensation, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 193 | 26549580 |
US |
45 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 194 | 26549589 |
US |
27 | 2 |
Urticaria, Rash, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 195 | 26549591 |
US |
77 | 2 |
Gait disturbance, Inappropriate schedule of product administration, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 196 | 26549611 |
US |
35 | 2 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 197 | 26549626 |
US |
46 | 1 |
Urticaria, Therapeutic product effect incomplete, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DENOSUMAB, |
||||
| 198 | 26549630 |
US |
18 | 2 |
Asthma, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 199 | 26549637 |
US |
36 | 2 |
Photosensitivity reaction, Urticaria, Dyspepsia, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, ESKETAMINE HYDROCHLORIDE, |
||||
| 200 | 26549640 |
US |
6 | 1 |
Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
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