Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 25111197 |
US |
52 | 2 |
Visual impairment, Injection site pain, Drug dose omission by device, Device difficult to use, Accidental exposure to product, |
||||
ERENUMAB-AOOE, |
||||
| 202 | 25111504 |
SE |
6 | 2 |
Dyspnoea, Drug dose omission by device, Device malfunction, |
||||
BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE, FORMOTEROL FUMARATE, FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 203 | 25111838 |
US |
78 | 2 |
Accidental exposure to product, Device difficult to use, Drug dose omission by device, Injection site discolouration, |
||||
EVOLOCUMAB, |
||||
| 204 | 25111920 |
US |
60 | 2 |
Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 205 | 25112235 |
US |
14 | 1 |
Drug dose omission by device, Device use error, |
||||
SOMATROPIN, |
||||
| 206 | 25112237 |
US |
3 | 2 |
Wrong technique in device usage process, Device material issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 207 | 25112242 |
US |
16 | 1 |
Drug dose omission by device, Device leakage, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 208 | 25112274 |
US |
14 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 209 | 25112275 |
US |
12 | 2 |
Device leakage, Device material issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 210 | 25112279 |
US |
7 | 2 |
Device issue, Device use error, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 211 | 25112286 |
US |
74 | 2 |
Musculoskeletal discomfort, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 212 | 25112325 |
US |
74 | 2 |
Device use error, Device mechanical issue, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 213 | 25112327 |
US |
12 | 1 |
Drug dose omission by device, Device difficult to use, Device issue, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 214 | 25112329 |
US |
13 | 1 |
Device information output issue, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 215 | 25112374 |
US |
||
Dyspnoea, Illness, Drug dose omission by device, Device delivery system issue, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 216 | 25112860 |
AU |
62 | 2 |
Migraine, Vision blurred, Visual impairment, Drug dose omission by device, Vertigo, |
||||
GALCANEZUMAB-GNLM, |
||||
| 217 | 25113825 |
US |
29 | 2 |
Drug dose omission by device, Device power source issue, Device information output issue, Device use issue, |
||||
SOMATROPIN, |
||||
| 218 | 25114019 |
US |
59 | 2 |
Arthritis, Device difficult to use, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 219 | 25114111 |
CO |
1 | |
Drug dose omission by device, Device information output issue, Device mechanical issue, Expired device used, |
||||
SOMATROPIN, |
||||
| 220 | 25114292 |
US |
1 | |
Pruritus, Skin lesion, Therapeutic response decreased, Drug dose omission by device, Device operational issue, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 221 | 25114364 |
US |
79 | 1 |
Glycosylated haemoglobin increased, Wrong technique in product usage process, Drug dose omission by device, Device difficult to use, Injection site pain, |
||||
EVOLOCUMAB, BUDESONIDE, TIOTROPIUM BROMIDE, INSULIN GLARGINE, EMPAGLIFLOZIN, |
||||
| 222 | 25115047 |
US |
47 | |
Insomnia, Device use issue, Intentional device misuse, Incorrect dose administered by device, Respiratory tract congestion, Chest discomfort, Device delivery system issue, Drug dose omission by device, Wrong technique in device usage process, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 223 | 25115143 |
US |
2 | |
Device defective, Accidental exposure to product, Drug dose omission by device, Inappropriate schedule of product administration, |
||||
SECUKINUMAB, CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, |
||||
| 224 | 25115145 |
US |
2 | |
Device leakage, Accidental exposure to product, Needle issue, Drug dose omission by device, |
||||
SECUKINUMAB, LEVOTHYROXINE, CITALOPRAM, |
||||
| 225 | 25115338 |
IT |
14 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 226 | 25109294 |
US |
25 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL, LEVALBUTEROL HYDROCHLORIDE, MONTELUKAST, |
||||
| 227 | 25109296 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 228 | 25109304 |
US |
79 | |
Dyspnoea, Cough, Product use in unapproved indication, Wrong technique in product usage process, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 229 | 25109319 |
US |
||
Dyspnoea, Cough, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 230 | 25109327 |
US |
63 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, Off label use, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 231 | 25109662 |
US |
73 | 2 |
Injection site bruising, Injection site haemorrhage, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 232 | 25107690 |
US |
77 | 2 |
Dry age-related macular degeneration, Cataract, Visual impairment, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, METOPROLOL SUCCINATE, |
||||
| 233 | 25108264 |
US |
54 | 2 |
Device difficult to use, Drug dose omission by device, Headache, Wrong technique in product usage process, |
||||
ERENUMAB-AOOE, |
||||
| 234 | 25108491 |
US |
60 | 2 |
Device delivery system issue, Drug dose omission by device, |
||||
ABATACEPT, |
||||
| 235 | 25108671 |
US |
63 | |
Device issue, Drug dose omission by device, Wrong technique in product usage process, Off label use, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 236 | 25108679 |
US |
||
Drug dose omission by device, Device use error, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 237 | 25108680 |
US |
62 | |
Dyspnoea, Cough, Wheezing, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 238 | 25108704 |
US |
27 | 2 |
Drug dose omission by device, Accidental exposure to product, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 239 | 25108989 |
US |
70 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 240 | 25109003 |
US |
||
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 241 | 25102556 |
US |
42 | 2 |
Device issue, Accidental exposure to product, Injury associated with device, Drug dose omission by device, |
||||
OFATUMUMAB, |
||||
| 242 | 25102715 |
US |
69 | 2 |
Blood cholesterol increased, Fear of injection, Visual impairment, Wrong technique in product usage process, Device difficult to use, Drug dose omission by device, Injection site bruising, |
||||
EVOLOCUMAB, |
||||
| 243 | 25102782 |
US |
62 | 2 |
Blood cholesterol increased, Accidental exposure to product, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 244 | 25102917 |
US |
19 | |
Wheezing, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 245 | 25102928 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 246 | 25102935 |
US |
72 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 247 | 25102974 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 248 | 25102985 |
US |
||
Asthma, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 249 | 25103116 |
US |
||
Dyspnoea, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 250 | 25103133 |
US |
20 | |
Drug dose omission by device, Wrong technique in product usage process, Prescription drug used without a prescription, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE, ALBUTEROL SULFATE, CETIRIZINE HYDROCHLORIDE, |
||||
| 251 | 25103175 |
US |
6 | |
Wheezing, Cough, Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 252 | 25103206 |
US |
73 | |
Drug dose omission by device, Device delivery system issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 253 | 25103222 |
US |
38 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 254 | 25103242 |
US |
81 | |
Dyspnoea, Wrong technique in product usage process, Drug dose omission by device, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 255 | 25103432 |
US |
0 | |
Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 256 | 25103672 |
US |
||
Malaise, Dyspnoea, Off label use, Drug dose omission by device, Device delivery system issue, Product quality issue, Product container seal issue, Drug ineffective, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 257 | 25103735 |
US |
38 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 258 | 25103777 |
US |
78 | 2 |
Hypoacusis, Nasopharyngitis, Device difficult to use, Drug dose omission by device, Device use error, |
||||
ERENUMAB-AOOE, |
||||
| 259 | 25103832 |
US |
65 | 2 |
Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, Device use error, Irritability, |
||||
ERENUMAB-AOOE, |
||||
| 260 | 25104001 |
US |
||
Drug delivery system issue, Pneumonia, Wrong technique in product usage process, Product availability issue, Device use issue, Drug dose omission by device, Incorrect dose administered, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 261 | 25104255 |
US |
||
Drug dose omission by device, No adverse event, |
||||
GLUCAGON, |
||||
| 262 | 25104306 |
US |
20 | 2 |
Accidental exposure to product, Drug dose omission by device, Depression, Dizziness, Sleep disorder, Stress, Vomiting, Depressed mood, Wrong technique in product usage process, Sleep deficit, |
||||
ERENUMAB-AOOE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE, |
||||
| 263 | 25104623 |
US |
22 | 2 |
Drug dose omission by device, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 264 | 25105145 |
US |
||
Illness, Asthma, Influenza, Dyspnoea, Drug dose omission by device, Device delivery system issue, Product quality issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 265 | 25105192 |
US |
34 | 2 |
Drug dose omission by device, Underdose, |
||||
GALCANEZUMAB-GNLM, |
||||
| 266 | 25105426 |
US |
75 | 1 |
Glaucoma, Blindness unilateral, Retinal artery occlusion, Hypotension, Cardiac failure congestive, Device difficult to use, Drug dose omission by device, Angiopathy, Device use error, |
||||
EVOLOCUMAB, |
||||
| 267 | 25105698 |
US |
||
Device issue, Drug dose omission by device, |
||||
BUPRENORPHINE, |
||||
| 268 | 25105830 |
US |
2 | |
Injection site discharge, Syringe issue, Drug dose omission by device, |
||||
BUPRENORPHINE, |
||||
| 269 | 25106124 |
GR |
4 | 1 |
Drug dose omission by device, Device use error, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 270 | 25106130 |
CO |
1 | |
Device defective, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 271 | 25106144 |
US |
2 | |
Drug dose omission by device, Device power source issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 272 | 25106307 |
US |
12 | 2 |
Device mechanical issue, Device delivery system issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 273 | 25106313 |
IT |
40 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 274 | 25106316 |
US |
44 | 1 |
Device difficult to use, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, Injection site haemorrhage, Incorrect disposal of product, |
||||
ERENUMAB-AOOE, |
||||
| 275 | 25106322 |
US |
13 | 1 |
Drug dose omission by device, Device issue, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 276 | 25106323 |
US |
14 | 1 |
Device use error, Device breakage, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 277 | 25106326 |
US |
14 | 2 |
Drug dose omission by device, Liquid product physical issue, |
||||
SOMATROPIN, |
||||
| 278 | 25106327 |
US |
13 | 1 |
Drug dose omission by device, Device use error, Device mechanical issue, Device information output issue, |
||||
SOMATROPIN, |
||||
| 279 | 25106329 |
US |
13 | 1 |
Device use error, Device material issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 280 | 25106795 |
US |
||
Retching, Drug dose omission by device, Product delivery mechanism issue, Poor quality product administered, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 281 | 25106851 |
US |
2 | |
Drug dose omission by device, Device defective, |
||||
ALBUTEROL SULFATE, |
||||
| 282 | 25107010 |
CO |
2 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 283 | 25107217 |
US |
67 | 2 |
Injection site bruising, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 284 | 25097346 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 285 | 25097350 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 286 | 25097402 |
US |
2 | |
Drug dose omission by device, Needle issue, Device delivery system issue, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 287 | 25097424 |
US |
74 | 2 |
Injury associated with device, Wrong technique in product usage process, Device use error, Accidental exposure to product, Drug dose omission by device, Injection site haemorrhage, |
||||
EVOLOCUMAB, |
||||
| 288 | 25097660 |
US |
||
Drug dose omission by device, Device mechanical issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 289 | 25097692 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 290 | 25097923 |
US |
71 | 2 |
Device difficult to use, Wrong technique in product usage process, Incorrect disposal of product, Rhinorrhoea, Cough, Throat clearing, Drug dose omission by device, Device use error, |
||||
EVOLOCUMAB, |
||||
| 291 | 25097980 |
US |
33 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 292 | 25098034 |
CH |
22 | 2 |
Hyperkalaemia, Diabetic metabolic decompensation, Diabetic ketoacidosis, Drug dose omission by device, Vomiting, Infection, Diarrhoea, COVID-19, |
||||
INSULIN ASPART INJECTION, INSULIN ASPART, |
||||
| 293 | 25098084 |
US |
68 | 2 |
Drug dose omission by device, Therapeutic product effect incomplete, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, ONABOTULINUMTOXINA, |
||||
| 294 | 25098130 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 295 | 25098210 |
US |
79 | 2 |
Hospitalisation, Dyspnoea, Urticaria, Therapy interrupted, Device issue, Drug dose omission by device, Incorrect dose administered, |
||||
AMIKACIN, AMIKACIN, |
||||
| 296 | 25098221 |
US |
38 | 2 |
Injection site pain, Device difficult to use, Wrong technique in product usage process, Accidental exposure to product, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 297 | 25098289 |
US |
2 | |
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 298 | 25098468 |
US |
57 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 299 | 25098479 |
US |
65 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 300 | 25098509 |
US |
||
Drug dose omission by device, Fatigue, Thinking abnormal, Device malfunction, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
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.
terms
license
last_updated
2025-04-28