Drug:
Reaction: DEVICE ISSUE
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26911563 |
US |
85 | 1 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, Device issue, |
||||
DUPILUMAB, |
||||
| 202 | 26912420 |
US |
69 | 2 |
Subdural haematoma, Fall, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 203 | 26912503 |
US |
55 | 2 |
Psoriasis, Injection site pain, Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, DIPHENHYDRAMINE HYDROCHLORIDE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, HYDROCORTISONE CREAM 1/2%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, LOSARTAN POTASSIUM, LOSARTAN, ROSUVASTATIN CALCIUM, |
||||
| 204 | 26912579 |
AR |
11 | 2 |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 205 | 26912604 |
US |
14 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 206 | 26912941 |
US |
15 | 1 |
Device occlusion, Device issue, Product dose omission issue, |
||||
SOMATROPIN, |
||||
| 207 | 26913070 |
US |
14 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 208 | 26913099 |
CA |
29 | 2 |
Device issue, Device deployment issue, Complication of device removal, Incorrect product administration duration, |
||||
ETONOGESTREL, |
||||
| 209 | 26913427 |
US |
74 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 210 | 26913571 |
US |
52 | 2 |
Intestinal obstruction, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 211 | 26913772 |
US |
83 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 212 | 26914045 |
US |
51 | 1 |
Device issue, Incorrect dose administered by device, Wrong technique in product usage process, Product dose omission issue, Injury associated with device, |
||||
SIBEPRENLIMAB, |
||||
| 213 | 26914071 |
US |
50 | 2 |
Injection site rash, Injection site pruritus, Injection site erythema, Seasonal allergy, Device leakage, Device issue, |
||||
SIBEPRENLIMAB, |
||||
| 214 | 26914119 |
US |
55 | 1 |
Injection site induration, Underdose, Exposure via skin contact, Wrong technique in product usage process, Device issue, |
||||
SIBEPRENLIMAB, SIBEPRENLIMAB, |
||||
| 215 | 26914182 |
EU |
||
Device issue, |
||||
SOMATROPIN, |
||||
| 216 | 26914438 |
EU |
77 | 1 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 217 | 26914510 |
EU |
81 | 2 |
Aortic valve stenosis, Faeces hard, Device issue, Device issue, |
||||
CLONAZEPAM, CARBIDOPA AND LEVODOPA, |
||||
| 218 | 26904610 |
CL |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 219 | 26905902 |
US |
66 | 2 |
Dementia, Injection site injury, Device issue, |
||||
ADALIMUMAB, |
||||
| 220 | 26906212 |
US |
1 | |
Injection site haemorrhage, Device issue, Injection site papule, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 221 | 26906694 |
US |
68 | 1 |
Injection site swelling, Device issue, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 222 | 26906772 |
US |
2 | |
Dyspnoea, Device issue, Device delivery system issue, Device malfunction, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 223 | 26907687 |
US |
2 | |
Device issue, Device dispensing issue, |
||||
SECUKINUMAB, |
||||
| 224 | 26907869 |
US |
14 | 1 |
Juvenile idiopathic arthritis, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB, HYDROCORTISONE, |
||||
| 225 | 26907939 |
US |
||
Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 226 | 26907983 |
US |
2 | |
Device issue, Product dose omission issue, Incorrect dose administered by device, Taste disorder, Product cleaning inadequate, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 227 | 26908026 |
EU |
11 | 2 |
Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 228 | 26908710 |
US |
2 | |
Cough, Nasal congestion, Dyspnoea, Dysphonia, Device issue, Drug ineffective, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 229 | 26908891 |
US |
37 | 1 |
Visual impairment, Device issue, Device breakage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 230 | 26909218 |
AU |
||
Device issue, Device defective, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 231 | 26909225 |
EU |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 232 | 26909268 |
EU |
||
Device issue, Device defective, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 233 | 26909294 |
CN |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 234 | 26909374 |
GB |
87 | 2 |
Device issue, Product dose omission issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 235 | 26918382 |
2 | ||
Abdominal pain, Device issue, Gallbladder disorder, |
||||
TADALAFIL, SOTATERCEPT-CSRK, TREPROSTINIL, |
||||
| 236 | 26918419 |
2 | ||
Abdominal pain, Device issue, Gallbladder disorder, |
||||
AMBRISENTAN, SOTATERCEPT-CSRK, TREPROSTINIL, |
||||
| 237 | 26904282 |
US |
2 | |
Drug ineffective, Device issue, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 238 | 26904307 |
US |
||
Hospitalisation, Dysphagia, Feeding tube user, Suspected off label use, Device issue, |
||||
PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE, |
||||
| 239 | 26904337 |
AU |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 240 | 26904343 |
US |
51 | |
Product dose omission issue, Device delivery system issue, Device issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 241 | 26904400 |
EU |
80 | 2 |
Joint dislocation, Speech disorder, Musculoskeletal stiffness, Device issue, Device leakage, Gait disturbance, Pain in extremity, Fall, Asthenia, Foot deformity, |
||||
| 242 | 26904463 |
CL |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 243 | 26904486 |
US |
57 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 244 | 26902989 |
US |
39 | 2 |
Hypocalcaemia, Device issue, |
||||
PALOPEGTERIPARATIDE, PALOPEGTERIPARATIDE, LEVOTHYROXINE SODIUM, TIRZEPATIDE, CALCIUM, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG, |
||||
| 245 | 26903098 |
US |
2 | |
Drug ineffective, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 246 | 26903106 |
US |
1 | |
Device issue, Product dose omission issue, Product leakage, |
||||
GUSELKUMAB, |
||||
| 247 | 26903112 |
US |
21 | 2 |
Injection site haemorrhage, Device issue, Injection site pain, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 248 | 26903314 |
US |
||
Device issue, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 249 | 26903315 |
US |
||
Device issue, |
||||
NITRIC OXIDE, NITRIC OXIDE, |
||||
| 250 | 26903339 |
US |
90 | 2 |
Urinary tract infection, Oxygen saturation decreased, Malaise, Device issue, Device power source issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, MELATONIN, ERGOCALCIFEROL, OXYGEN, 0XYGEN, PREDNISONE, FUROSEMIDE, |
||||
| 251 | 26903442 |
US |
69 | 2 |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 252 | 26903593 |
US |
1 | |
Dementia, Hallucination, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 253 | 26897702 |
EU |
78 | 2 |
Blindness, Musculoskeletal stiffness, Glaucoma, Gait disturbance, Anal incontinence, Movement disorder, On and off phenomenon, Loss of personal independence in daily activities, Dyskinesia, Therapeutic product effect incomplete, Emotional disorder, Speech disorder, General physical health deterioration, Hallucination, visual, Stoma site erythema, Device issue, |
||||
| 254 | 26897899 |
US |
28 | |
Device leakage, Injection site pain, Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 255 | 26898002 |
US |
1 | |
Injection site pain, Device issue, Product dose omission issue, |
||||
TEZEPELUMAB-EKKO, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, AZELASTINE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, FUROSEMIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR, ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE, ACETAMINOPHEN, DOXYLAMINE SUCCINATE, MELATONIN, |
||||
| 256 | 26898005 |
US |
30 | 1 |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 257 | 26898061 |
US |
62 | 2 |
Coeliac disease, Device issue, |
||||
TRALOKINUMAB-LDRM, |
||||
| 258 | 26898334 |
TW |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 259 | 26898390 |
US |
38 | 2 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 260 | 26898797 |
US |
2 | |
Colitis ulcerative, Arthralgia, Device issue, |
||||
USTEKINUMAB-TTWE, |
||||
| 261 | 26898984 |
CA |
83 | 1 |
Delirium, On and off phenomenon, Asthenia, Musculoskeletal stiffness, Confusional state, Hallucinations, mixed, Underdose, Speech disorder, Incontinence, Device issue, Freezing phenomenon, Trismus, Psychotic disorder, Urinary tract infection, Pneumonia, Agitation, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, APIXABAN, PANTOPRAZOLE, DUTASTERIDE, AMANTADINE, SENNOSIDES, ERGOCALCIFEROL, MIRTAZAPINE, |
||||
| 262 | 26899267 |
CH |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 263 | 26899381 |
US |
15 | 1 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 264 | 26899382 |
US |
||
Symptom recurrence, Device issue, Device leakage, |
||||
ADALIMUMAB, |
||||
| 265 | 26900181 |
US |
73 | 2 |
Injection site papule, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 266 | 26900239 |
US |
2 | |
Injection site injury, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 267 | 26900272 |
US |
1 | |
Hypoacusis, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 268 | 26900772 |
US |
64 | 2 |
Visual impairment, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 269 | 26901217 |
|||
Hospitalisation, Accidental overdose, Device issue, |
||||
INSULIN GLARGINE-YFGN, INSULIN GLARGINE, INSULIN GLARGINE-YFGN, INSULIN GLARGINE, |
||||
| 270 | 26901666 |
US |
57 | 1 |
Abdominal discomfort, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 271 | 26891904 |
US |
||
Injury associated with device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 272 | 26891921 |
US |
70 | 2 |
Unresponsive to stimuli, Compulsive shopping, Device issue, Wheelchair user, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 273 | 26892048 |
US |
59 | 1 |
Cellulitis, Eczema, Injection site papule, Device issue, Injection site pain, Fatigue, Device physical property issue, Artificial crown procedure, Peripheral swelling, Musculoskeletal disorder, Pyrexia, Hypotension, Staphylococcal infection, Impaired healing, Immune system disorder, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 274 | 26892113 |
US |
2 | |
Device issue, |
||||
ZILUCOPLAN, |
||||
| 275 | 26892218 |
EU |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 276 | 26893396 |
US |
75 | |
Device issue, Product physical issue, Cough, Blood pressure decreased, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, |
||||
| 277 | 26893440 |
US |
46 | 2 |
Cyst, Device issue, Abscess limb, Abscess drainage, Mass excision, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 278 | 26893571 |
US |
62 | 2 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 279 | 26893974 |
US |
58 | 2 |
Appendicectomy, Illness, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB, |
||||
| 280 | 26894081 |
TR |
49 | 1 |
Diabetic ketoacidotic hyperglycaemic coma, Device issue, Wrong technique in product usage process, Product storage issue, |
||||
| 281 | 26894088 |
US |
1 | |
Off label use, Device issue, |
||||
ADALIMUMAB, |
||||
| 282 | 26894854 |
US |
63 | 2 |
Ankylosing spondylitis, Oropharyngeal pain, Pain, Arthropathy, Product physical issue, Nasopharyngitis, Device issue, Product dose omission issue, Drug ineffective, Stress, Viral infection, |
||||
BIMEKIZUMAB, |
||||
| 283 | 26895323 |
US |
9 | 1 |
Drug dose omission by device, Device leakage, Device issue, |
||||
SOMATROPIN, |
||||
| 284 | 26895585 |
US |
||
Inflammation, Fine motor skill dysfunction, Device issue, |
||||
ADALIMUMAB, |
||||
| 285 | 26895707 |
US |
69 | 2 |
Injection site papule, Device issue, Injection site pain, Injection site discomfort, Injection site swelling, Injection site erythema, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 286 | 26895849 |
US |
32 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 287 | 26896254 |
US |
24 | 2 |
Injection site pain, Device issue, Device difficult to use, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 288 | 26896451 |
US |
38 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 289 | 26896766 |
DO |
12 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 290 | 26897173 |
US |
73 | 2 |
Accidental exposure to product, Incorrect dose administered by device, Device issue, Injection site erythema, Device leakage, Injection site discharge, |
||||
| 291 | 26897174 |
US |
40 | 2 |
Device issue, Device leakage, Injection site erythema, |
||||
| 292 | 26897183 |
US |
39 | 1 |
Injection site bruising, Injection site haemorrhage, Device issue, |
||||
| 293 | 26897374 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 294 | 26907002 |
74 | 2 | |
Device issue, |
||||
LENALIDOMIDE, |
||||
| 295 | 26886621 |
US |
2 | |
Injury associated with device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 296 | 26886669 |
CA |
41 | 2 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 297 | 26886773 |
US |
62 | 2 |
Obsessive-compulsive disorder, General symptom, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 298 | 26886976 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 299 | 26887089 |
US |
2 | |
Dizziness, Cough, Arthropathy, Contusion, Hypotension, Seasonal allergy, Device issue, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, NIFEDIPINE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, POLYETHYLENE GLYCOL 3350, PANTOPRAZOLE SODIUM, FLUTICASONE PROPIONATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, MIRTAZAPINE, BUMETANIDE, OXYGEN, 0XYGEN, |
||||
| 300 | 26887219 |
US |
47 | |
Neuropathy peripheral, Abdominal pain upper, Weight fluctuation, Hypoaesthesia, Oedema, Dysgeusia, Fungal infection, Palpitations, Abdominal discomfort, Speech disorder, Gastrointestinal disorder, Injection site pain, Seasonal allergy, Limb discomfort, Peripheral swelling, Carpal tunnel syndrome, Device issue, Nerve injury, Paraesthesia, Headache, Dyspnoea, Cough, Dizziness, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, DOCUSATE SODIUM, CARVEDILOL, FAMOTIDINE, TREPROSTINIL, LORAZEPAM, BUMETANIDE, MACITENTAN, ALBUTEROL SULFATE, ERGOCALCIFEROL, SILDENAFIL CITRATE, SILDENAFIL, OXYGEN, 0XYGEN, CHLORHEXIDINE GLUCONATE, SPIRONOLACTONE, AMLODIPINE BESYLATE, LORATADINE, LORATADINE ORAL, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, DOCUSATE SODIUM, DOCUSATE SODIUM 100MG, METRONIDAZOLE, METRONIDAZOLE TOPICAL, FLUCONAZOLE, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, |
||||
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
2026-07-30