Drug:
Reaction: ACCIDENTAL EXPOSURE TO PRODUCT
20250101 - 20251231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 25121420 |
US |
79 | 2 |
Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, Nasopharyngitis, |
||||
EVOLOCUMAB, |
||||
| 102 | 25121435 |
US |
36 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 103 | 25121765 |
US |
51 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 104 | 25121992 |
CN |
||
Device deployment issue, Accidental exposure to product, Inappropriate schedule of product administration, |
||||
GUSELKUMAB, |
||||
| 105 | 25122308 |
US |
72 | 1 |
Needle issue, Product dose omission issue, Accidental exposure to product, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 106 | 25123059 |
US |
2 | |
Product quality issue, Accidental exposure to product, No adverse event, |
||||
| 107 | 25123167 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 108 | 25123183 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 109 | 25123206 |
US |
64 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 110 | 25123221 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 111 | 25123331 |
US |
16 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 112 | 25123347 |
US |
11 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 113 | 25123349 |
US |
31 | 2 |
Injection site urticaria, Injection site swelling, Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 114 | 25123688 |
US |
58 | 2 |
Inappropriate schedule of product administration, Accidental exposure to product, Product label issue, Off label use, |
||||
GUSELKUMAB, |
||||
| 115 | 25123729 |
US |
1 | |
Pruritus, Feeling hot, Accidental exposure to product, |
||||
FLUTICASONE PROPIONATE, |
||||
| 116 | 25124047 |
US |
31 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 117 | 25124062 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 118 | 25124070 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 119 | 25124091 |
US |
53 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 120 | 25124112 |
US |
75 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 121 | 25124123 |
US |
2 | |
Accidental exposure to product, Wrong technique in product usage process, Needle issue, |
||||
SECUKINUMAB, |
||||
| 122 | 25124527 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 123 | 25124735 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 124 | 25124748 |
US |
44 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 125 | 25124815 |
US |
46 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 126 | 25124873 |
US |
58 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 127 | 25126223 |
US |
59 | 1 |
Underdose, Accidental exposure to product, |
||||
MOMETASONE FUROATE, MOMETASONE FUROATE, |
||||
| 128 | 25126249 |
US |
||
Accidental exposure to product, Occupational exposure to product, Device physical property issue, |
||||
PEGFILGRASTIM, |
||||
| 129 | 25115749 |
US |
72 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 130 | 25116162 |
US |
7 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 131 | 25116216 |
US |
64 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 132 | 25116324 |
US |
72 | 2 |
Accidental exposure to product, Device defective, Product dose omission issue, Ill-defined disorder, Device issue, Wrong technique in product usage process, Device malfunction, |
||||
TOCILIZUMAB, CETIRIZINE HYDROCHLORIDE, LEVOTHYROXINE, PREDNISONE, EVOLOCUMAB, |
||||
| 133 | 25116660 |
US |
51 | 1 |
Application site hypoaesthesia, Pain, Pain in extremity, Pain in extremity, Pruritus, Paraesthesia oral, Accidental exposure to product, Limb discomfort, |
||||
CAPSAICIN, |
||||
| 134 | 25116811 |
BR |
67 | 2 |
Device deployment issue, Underdose, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 135 | 25116857 |
US |
2 | |
Device defective, Incorrect dose administered, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 136 | 25116867 |
US |
20 | 1 |
Accidental exposure to product, Underdose, Needle issue, Device malfunction, No adverse event, |
||||
OMALIZUMAB, |
||||
| 137 | 25116943 |
US |
||
Accidental exposure to product, Occupational exposure to product, Device leakage, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 138 | 25117016 |
US |
||
Nausea, Accidental exposure to product, Product use in unapproved indication, |
||||
| 139 | 25117235 |
US |
54 | 2 |
Device leakage, Accidental exposure to product, Incorrect dose administered by device, |
||||
OFATUMUMAB, OFATUMUMAB, |
||||
| 140 | 25118149 |
CA |
51 | 2 |
Off label use, Exposure via skin contact, Accidental exposure to product, Device defective, Device leakage, |
||||
PEGVISOMANT, CABERGOLINE, |
||||
| 141 | 25118331 |
US |
13 | 2 |
Injection site discomfort, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, NORETHINDRONE ACETATE/ETHINYL ESTRADIOL, |
||||
| 142 | 25118529 |
US |
16 | 1 |
Device malfunction, Accidental exposure to product, No adverse event, Underdose, |
||||
OMALIZUMAB, |
||||
| 143 | 25118675 |
US |
72 | 2 |
Accidental exposure to product, Product complaint, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, ACYCLOVIR, ACYCLOVIR, ALBUTEROL SULFATE, ALBUTEROL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, CLONAZEPAM, DICLOFENAC, DICLOFENAC SODIUM, DICLOFENAC, DICLOFENAC SODIUM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, GABAPENTIN, LEVOTHYROXINE, LINACLOTIDE, LINACLOTIDE, SERTRALINE, SERTRALINE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, |
||||
| 144 | 25118898 |
US |
1 | 1 |
Rash macular, Dry skin, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 145 | 25118912 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 146 | 25118959 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 147 | 25118983 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 148 | 25118986 |
US |
59 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 149 | 25119055 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 150 | 25119089 |
US |
62 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 151 | 25119112 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 152 | 25119121 |
US |
1 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 153 | 25119179 |
US |
71 | 2 |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 154 | 25119180 |
US |
66 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 155 | 25119186 |
US |
61 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 156 | 25119237 |
US |
61 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 157 | 25119326 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 158 | 25119686 |
US |
62 | 2 |
Exposure via skin contact, Wrong technique in device usage process, Accidental exposure to product, Incorrect dose administered, |
||||
MEPOLIZUMAB, |
||||
| 159 | 25119886 |
US |
2 | |
Needle issue, Accidental exposure to product, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 160 | 25120125 |
US |
2 | |
Drug dose omission by device, Device issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, |
||||
| 161 | 25120812 |
SV |
33 | 2 |
Device deployment issue, Accidental exposure to product, Product dose omission issue, Incorrect route of product administration, |
||||
GOLIMUMAB, |
||||
| 162 | 25109950 |
US |
79 | 1 |
Injection site erythema, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 163 | 25109996 |
US |
64 | 2 |
Accidental exposure to product, Product complaint, No adverse event, |
||||
TOCILIZUMAB, |
||||
| 164 | 25110036 |
US |
27 | 2 |
Accidental exposure to product, Exposure via skin contact, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 165 | 25110079 |
JP |
2 | 1 |
Toxicity to various agents, Cardiac arrest, Accidental exposure to product, |
||||
NIFEDIPINE, |
||||
| 166 | 25110293 |
US |
45 | |
Device difficult to use, Accidental exposure to product, Incorrect dose administered by device, Injection site pain, |
||||
ERENUMAB-AOOE, |
||||
| 167 | 25110294 |
US |
61 | 1 |
COVID-19, Injection site pain, Product communication issue, Accidental exposure to product, Drug dose omission by device, |
||||
EVOLOCUMAB, ADALIMUMAB, |
||||
| 168 | 25110506 |
US |
76 | 2 |
Accidental exposure to product, Off label use, No adverse event, Incorrect dose administered, Device defective, Wrong technique in product usage process, |
||||
TOCILIZUMAB, |
||||
| 169 | 25110657 |
US |
1 | |
Accidental underdose, Product complaint, Accidental exposure to product, Wrong technique in product usage process, No adverse event, |
||||
OMALIZUMAB, |
||||
| 170 | 25110789 |
US |
1 | |
Product use complaint, Device malfunction, Product leakage, Accidental exposure to product, Product dose omission issue, |
||||
SECUKINUMAB, TESTOSTERONE, TESTOSTERONE,, |
||||
| 171 | 25111197 |
US |
52 | 2 |
Visual impairment, Injection site pain, Drug dose omission by device, Device difficult to use, Accidental exposure to product, |
||||
ERENUMAB-AOOE, |
||||
| 172 | 25111838 |
US |
78 | 2 |
Accidental exposure to product, Device difficult to use, Drug dose omission by device, Injection site discolouration, |
||||
EVOLOCUMAB, |
||||
| 173 | 25112301 |
US |
2 | |
Accidental exposure to product, |
||||
BRIVARACETAM, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, MONTELUKAST, |
||||
| 174 | 25112668 |
US |
||
Pharyngeal haemorrhage, Pain, Skin fissures, Wound complication, Renal pain, Dyspnoea, Dry mouth, Plicated tongue, Tongue haemorrhage, Pain in extremity, Back pain, Faeces hard, Headache, Eye pain, Glossodynia, Tongue dry, Dry throat, Accidental exposure to product, Product formulation issue, |
||||
MUPIROCIN, MUPIROCIN CALCIUM, |
||||
| 175 | 25112822 |
US |
48 | 2 |
Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 176 | 25112975 |
US |
2 | |
Product administration error, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 177 | 25113095 |
US |
38 | 2 |
Burning sensation, Injection site urticaria, Malaise, Skin reaction, Hypoaesthesia, Accidental exposure to product, Incorrect dose administered, Wrong technique in product usage process, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 178 | 25113281 |
US |
64 | 1 |
Product dose omission issue, Accidental exposure to product, Device malfunction, Incorrect dose administered, Device use error, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 179 | 25113310 |
US |
2 | |
Product dose omission issue, Device issue, Accidental exposure to product, |
||||
BIMEKIZUMAB, |
||||
| 180 | 25113316 |
US |
52 | 1 |
Arthralgia, Intentional dose omission, Accidental exposure to product, Device malfunction, Incorrect dose administered, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 181 | 25113463 |
US |
20 | |
Wrong technique in product usage process, Device issue, Accidental exposure to product, Product dose omission issue, Off label use, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 182 | 25113669 |
US |
1 | |
Accidental exposure to product, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 183 | 25113918 |
US |
2 | |
Somnolence, Accidental exposure to product, |
||||
| 184 | 25113999 |
US |
||
Device deployment issue, Accidental exposure to product, Product dose omission issue, Syringe issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 185 | 25114174 |
US |
1 | |
Vision blurred, Product packaging quantity issue, Exposure via skin contact, Accidental exposure to product, |
||||
PERFLUOROHEXYLOCTANE, |
||||
| 186 | 25114206 |
US |
72 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 187 | 25114213 |
US |
66 | 1 |
Accidental exposure to product, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 188 | 25114231 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 189 | 25114232 |
US |
67 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 190 | 25114244 |
US |
22 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 191 | 25114286 |
US |
85 | 1 |
Cough, Dyspnoea, Incorrect dose administered, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 192 | 25114323 |
US |
2 | |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 193 | 25114378 |
US |
2 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 194 | 25114379 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 195 | 25114390 |
US |
75 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 196 | 25114400 |
US |
6 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 197 | 25114470 |
US |
3 | 1 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 198 | 25114523 |
US |
||
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 199 | 25114543 |
US |
83 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 200 | 25114552 |
US |
64 | 2 |
Accidental exposure to product, Exposure via skin contact, |
||||
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
2025-04-28