Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 25098779 |
US |
67 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 302 | 25098851 |
US |
66 | 2 |
Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 303 | 25098854 |
US |
75 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 304 | 25098875 |
US |
70 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 305 | 25099111 |
US |
40 | 2 |
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 306 | 25099562 |
US |
42 | 2 |
Dry skin, Pruritus, Drug dose omission by device, Device operational issue, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 307 | 25099663 |
US |
71 | |
Cough, Drug dose omission by device, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 308 | 25099747 |
IT |
12 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 309 | 25099871 |
IT |
14 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 310 | 25099968 |
US |
85 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 311 | 25100250 |
US |
44 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, MONTELUKAST, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, IPRATROPIUM BROMIDE, |
||||
| 312 | 25100585 |
US |
74 | |
Drug dose omission by device, Wrong technique in product usage process, Product use in unapproved indication, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 313 | 25100651 |
IT |
11 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 314 | 25100784 |
US |
2 | 1 |
Drug dose omission by device, Wrong technique in device usage process, Device leakage, |
||||
SOMATROPIN, |
||||
| 315 | 25100805 |
CN |
||
Disease progression, Device delivery system issue, Drug dose omission by device, |
||||
| 316 | 25100808 |
US |
20 | 2 |
Product administration error, Drug dose omission by device, Device issue, |
||||
MEDROXYPROGESTERONE ACETATE, TESTOSTERONE, TESTOSTERONE,, |
||||
| 317 | 25100985 |
US |
14 | 1 |
Drug dose omission by device, Device use issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 318 | 25101470 |
ES |
||
Device delivery system issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 319 | 25101472 |
US |
7 | 1 |
Drug dose omission by device, Device malfunction, |
||||
SOMATROPIN, |
||||
| 320 | 25101488 |
US |
13 | 1 |
Drug dose omission by device, Device use issue, Device information output issue, |
||||
SOMATROPIN, LEVOTHYROXINE, |
||||
| 321 | 25101505 |
US |
14 | 2 |
Drug dose omission by device, Wrong technique in device usage process, Device leakage, |
||||
SOMATROPIN, |
||||
| 322 | 25101507 |
US |
56 | 2 |
Product design issue, Device use issue, Device leakage, Device failure, Device breakage, Liquid product physical issue, Device difficult to use, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 323 | 25101508 |
US |
13 | 1 |
Drug dose omission by device, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 324 | 25101510 |
US |
16 | 1 |
Device power source issue, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 325 | 25101538 |
US |
7 | 1 |
Drug dose omission by device, Device material issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 326 | 25101540 |
KR |
||
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 327 | 25101580 |
US |
2 | |
Drug dose omission by device, Accidental exposure to product, Device leakage, |
||||
SECUKINUMAB, |
||||
| 328 | 25101637 |
US |
15 | 1 |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 329 | 25101849 |
US |
||
Hospitalisation, Drug dose omission by device, Inappropriate schedule of product administration, |
||||
| 330 | 25102365 |
US |
62 | 1 |
Device difficult to use, Drug dose omission by device, Injection site haemorrhage, |
||||
EVOLOCUMAB, SEMAGLUTIDE, SEMAGLUTIDE, |
||||
| 331 | 25092104 |
US |
68 | 1 |
Device difficult to use, Drug dose omission by device, Accidental exposure to product, Nasopharyngitis, Illness, |
||||
EVOLOCUMAB, |
||||
| 332 | 25092396 |
US |
||
Drug dose omission by device, Device delivery system issue, Oral candidiasis, Product use issue, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 333 | 25092574 |
AR |
60 | 1 |
Eye operation, Device malfunction, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 334 | 25092720 |
US |
61 | 1 |
Pain, Drug dose omission by device, Expired device used, |
||||
ETANERCEPT, |
||||
| 335 | 25092721 |
US |
61 | 2 |
Device difficult to use, Drug dose omission by device, Migraine, |
||||
ERENUMAB-AOOE, |
||||
| 336 | 25092877 |
US |
52 | 2 |
Injection site pain, Device difficult to use, Drug dose omission by device, Product communication issue, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 337 | 25092936 |
US |
||
Drug dose omission by device, Incorrect dose administered by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 338 | 25093113 |
US |
||
Product prescribing issue, Wrong technique in product usage process, Drug dose omission by device, Bronchitis, Dysphonia, Asthma, Incorrect dose administered by device, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 339 | 25093216 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
PEGFILGRASTIM, |
||||
| 340 | 25093536 |
US |
70 | |
Dyspnoea, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, CHLORTHALIDONE, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, METHADONE, |
||||
| 341 | 25093583 |
US |
||
Dyspnoea, Device delivery system issue, Drug dose omission by device, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 342 | 25093620 |
US |
11 | |
Asthma, Wrong technique in product usage process, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 343 | 25093680 |
US |
55 | 2 |
Meningitis, Amnesia, Abnormal dreams, Unresponsive to stimuli, Thrombosis, Subclavian artery aneurysm, Gait disturbance, Migraine, Headache, Herpes zoster, Hypopnoea, Ill-defined disorder, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, Product dose omission issue, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 344 | 25093732 |
US |
75 | 2 |
Accidental exposure to product, Device difficult to use, Injection site haemorrhage, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 345 | 25093815 |
US |
57 | 2 |
Injection site pain, Device defective, Drug dose omission by device, |
||||
INSULIN GLARGINE, SEMAGLUTIDE, |
||||
| 346 | 25093818 |
US |
23 | |
Feeling abnormal, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 347 | 25093840 |
US |
88 | 2 |
Injection site indentation, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 348 | 25093841 |
US |
68 | 1 |
Malaise, Accidental exposure to product, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 349 | 25093920 |
US |
57 | |
Cough, Drug dose omission by device, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, LISINOPRIL, |
||||
| 350 | 25093934 |
US |
78 | 2 |
Device difficult to use, Drug dose omission by device, Pain, Drug ineffective, |
||||
ROMOSOZUMAB-AQQG, |
||||
| 351 | 25094069 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 352 | 25094113 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 353 | 25094115 |
JP |
32 | 1 |
Illness, Device breakage, Drug dose omission by device, |
||||
AMIKACIN, |
||||
| 354 | 25094539 |
US |
||
Drug dose omission by device, Device delivery system issue, Product quality issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 355 | 25094683 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 356 | 25094790 |
US |
78 | 1 |
Cerebrovascular accident, Parkinson^s disease, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 357 | 25094796 |
US |
||
Drug dose omission by device, Device delivery system issue, Expired product administered, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 358 | 25094880 |
US |
39 | |
Asthma, Dyspnoea, Drug dose omission by device, Device deposit issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 359 | 25094970 |
US |
35 | 2 |
Injection site reaction, Injection site pain, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 360 | 25095090 |
US |
13 | 1 |
Device information output issue, Drug dose omission by device, Expired device used, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 361 | 25095095 |
US |
10 | 2 |
Device information output issue, Product storage error, Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 362 | 25095101 |
US |
10 | 2 |
Drug dose omission by device, Device failure, |
||||
SOMATROPIN, |
||||
| 363 | 25095145 |
US |
16 | 1 |
Device defective, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 364 | 25095147 |
US |
15 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 365 | 25095150 |
US |
13 | 1 |
Drug dose omission by device, Wrong technique in device usage process, Device leakage, |
||||
SOMATROPIN, |
||||
| 366 | 25095286 |
US |
12 | 1 |
Drug dose omission by device, Device use error, Product communication issue, |
||||
SOMATROPIN, |
||||
| 367 | 25095354 |
US |
||
Dyspnoea, Wrong technique in product usage process, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 368 | 25095386 |
US |
54 | 2 |
Drug dose omission by device, Accidental exposure to product, Device leakage, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 369 | 25095411 |
US |
13 | 2 |
Device mechanical issue, Device breakage, Device difficult to use, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 370 | 25095420 |
US |
32 | 1 |
Drug dose omission by device, Device difficult to use, Device breakage, Device mechanical issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 371 | 25095423 |
US |
12 | 2 |
Device use error, Device issue, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 372 | 25096041 |
US |
90 | 1 |
Accidental exposure to product, Headache, Injection site haemorrhage, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 373 | 25096461 |
US |
2 | |
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 374 | 25096464 |
CO |
12 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 375 | 25096653 |
IT |
10 | 2 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 376 | 25096696 |
EG |
8 | 1 |
Drug administered in wrong device, Drug dose omission by device, Device defective, |
||||
SOMATROPIN, |
||||
| 377 | 25097043 |
US |
53 | 1 |
Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, ATORVASTATIN CALCIUM, |
||||
| 378 | 25097065 |
US |
57 | 2 |
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 379 | 25086730 |
US |
77 | 2 |
Accidental exposure to product, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 380 | 25086796 |
US |
||
Device physical property issue, Drug dose omission by device, |
||||
AFLIBERCEPT-AYYH, |
||||
| 381 | 25086975 |
US |
55 | 2 |
Device difficult to use, Drug dose omission by device, Product preparation error, Fibromyalgia, |
||||
ERENUMAB-AOOE, |
||||
| 382 | 25087016 |
US |
2 | |
Injection site discolouration, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 383 | 25087150 |
US |
85 | 2 |
Device difficult to use, Drug dose omission by device, Product communication issue, Injection site pain, Product dispensing issue, Fear, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 384 | 25087212 |
US |
2 | |
Drug dose omission by device, Injection site pain, |
||||
TERIPARATIDE, TERIPARATIDE, |
||||
| 385 | 25087389 |
US |
60 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 386 | 25087410 |
US |
64 | 2 |
Injection site erythema, Injection site swelling, Injection site pruritus, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 387 | 25087495 |
US |
25 | |
Drug dose omission by device, Device delivery system issue, Off label use, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 388 | 25087708 |
US |
90 | 1 |
Dementia, Wrong technique in product usage process, Device difficult to use, Drug dose omission by device, Multiple use of single-use product, |
||||
EVOLOCUMAB, |
||||
| 389 | 25087765 |
US |
83 | 2 |
Aortic aneurysm rupture, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 390 | 25087772 |
US |
70 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ALPRAZOLAM, |
||||
| 391 | 25087935 |
US |
14 | |
Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, |
||||
| 392 | 25087971 |
US |
60 | |
Device deposit issue, Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, LISINOPRIL, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, GLIMEPIRIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, LOSARTAN, |
||||
| 393 | 25088027 |
US |
69 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 394 | 25088153 |
US |
65 | 2 |
Injection site pain, Device difficult to use, Incorrect disposal of product, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 395 | 25088183 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 396 | 25088398 |
US |
79 | 1 |
Device difficult to use, Drug dose omission by device, Therapy interrupted, Wrong technique in product usage process, |
||||
ETANERCEPT, |
||||
| 397 | 25088481 |
US |
1 | |
Injection site pain, Drug dose omission by device, Device use issue, Device defective, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 398 | 25088486 |
US |
11 | 1 |
Device physical property issue, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 399 | 25088603 |
US |
55 | 2 |
Migraine, Injection site reaction, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 400 | 25089010 |
US |
7 | 2 |
Drug dose omission by device, Device leakage, Wrong technique in device usage process, Device use error, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
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