Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 25491795 |
US |
1 | |
Drug dose omission by device, Device delivery system issue, Product delivery mechanism issue, |
||||
ALBUTEROL SULFATE, |
||||
| 2 | 25491910 |
CO |
||
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 3 | 25491942 |
US |
59 | 2 |
Device defective, Drug dose omission by device, Renal impairment, Vomiting, Nausea, Diarrhoea, Abdominal pain, Blood glucose increased, Blood glucose decreased, Urine albumin/creatinine ratio increased, |
||||
SEMAGLUTIDE, SEMAGLUTIDE, SEMAGLUTIDE, |
||||
| 4 | 25492081 |
US |
35 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 5 | 25492137 |
US |
2 | |
Drug dose omission by device, Device delivery system issue, Device use error, |
||||
ALBUTEROL SULFATE, |
||||
| 6 | 25492520 |
US |
81 | 2 |
Migraine, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, |
||||
| 7 | 25492529 |
US |
||
Drug dose omission by device, Device deposit issue, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 8 | 25492552 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Incorrect dose administered by device, Device issue, Device deposit issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 9 | 25492721 |
US |
2 | |
Drug dose omission by device, Device mechanical issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 10 | 25493012 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 11 | 25493394 |
US |
71 | 1 |
Road traffic accident, Device difficult to use, Accidental exposure to product, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 12 | 25493506 |
US |
81 | 2 |
Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 13 | 25493833 |
US |
1 | |
Device malfunction, Complication of device insertion, Accidental exposure to product, Device leakage, Drug dose omission by device, |
||||
OFATUMUMAB, LEVOTHYROXINE SODIUM, |
||||
| 14 | 25494105 |
US |
87 | 2 |
Visual impairment, Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 15 | 25494260 |
US |
2 | |
Asthma, Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 16 | 25494747 |
US |
62 | 2 |
Joint stiffness, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 17 | 25495519 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 18 | 25495960 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 19 | 25495964 |
GB |
16 | 1 |
Thyroid disorder, Fear of injection, Insomnia, Sleep terror, Tremor, Anxiety, Somnambulism, Abnormal dreams, Drug dose omission by device, Wrong technique in device usage process, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 20 | 25496125 |
CL |
5 | 1 |
Penis disorder, Product substitution, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 21 | 25496490 |
US |
46 | 2 |
Drug dose omission by device, Product administration error, Device issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, METHOCARBAMOL, METHOCARBAMOL TABLETS, OXYCODONE, |
||||
| 22 | 25490978 |
US |
74 | 2 |
Peripheral swelling, Stress, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 23 | 25491023 |
US |
72 | 2 |
Drug dose omission by device, Seasonal allergy, |
||||
TERIPARATIDE, TERIPARATIDE, TERIPARATIDE, TERIPARATIDE, |
||||
| 24 | 25491267 |
US |
78 | 1 |
Extra dose administered, Feeling abnormal, Drug dose omission by device, |
||||
TERIPARATIDE, TERIPARATIDE, TERIPARATIDE, |
||||
| 25 | 25491613 |
US |
70 | 2 |
Device difficult to use, Drug dose omission by device, Malaise, Joint swelling, Peripheral swelling, Therapy interrupted, |
||||
ETANERCEPT, PREDNISONE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, CARBAMAZEPINE, ROSUVASTATIN CALCIUM, HYDROXYCHLOROQUINE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LORATADINE, LORATADINE ORAL, LEVOTHYROXINE, |
||||
| 26 | 25490093 |
US |
46 | 2 |
Headache, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 27 | 25490153 |
US |
61 | 2 |
Accidental exposure to product, Device difficult to use, Drug dose omission by device, Injection site pain, |
||||
ETANERCEPT, |
||||
| 28 | 25490164 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Wrong technique in device usage process, Circumstance or information capable of leading to device use error, |
||||
ALBUTEROL SULFATE, |
||||
| 29 | 25490170 |
US |
67 | |
Chest discomfort, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 30 | 25490228 |
US |
40 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 31 | 25490229 |
US |
46 | |
Dyspnoea, Wheezing, Cough, Drug dose omission by device, Device delivery system issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 32 | 25490230 |
US |
52 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, |
||||
ALBUTEROL SULFATE, |
||||
| 33 | 25490264 |
US |
88 | 2 |
Hip fracture, Cognitive disorder, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 34 | 25490318 |
US |
||
Chest discomfort, Drug dose omission by device, Device delivery system issue, Product identification number issue, |
||||
ALBUTEROL SULFATE, |
||||
| 35 | 25490356 |
US |
68 | |
Wheezing, Breath sounds abnormal, Drug dose omission by device, Wrong technique in product usage process, Product use in unapproved indication, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, LISINOPRIL, |
||||
| 36 | 25490357 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in device usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 37 | 25490423 |
US |
49 | |
Dyspnoea, Chest discomfort, Abdominal discomfort, Drug dose omission by device, Wrong technique in product usage process, Wrong technique in device usage process, |
||||
ALBUTEROL SULFATE, PREDNISONE, |
||||
| 38 | 25490641 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 39 | 25490642 |
US |
72 | |
Drug dose omission by device, Dyspnoea, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, NIFEDIPINE, HYDRALAZINE HYDROCHLORIDE, CARVEDILOL, FUROSEMIDE, CINACALCET, |
||||
| 40 | 25486479 |
US |
74 | |
Rash, Pruritus, Device difficult to use, Accidental exposure to product, Rubber sensitivity, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 41 | 25486815 |
US |
||
Drug dose omission by device, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 42 | 25487027 |
US |
2 | |
Drug dose omission by device, Wrong technique in device usage process, Drug delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 43 | 25487120 |
US |
60 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 44 | 25487156 |
IT |
13 | 2 |
Device computer issue, Therapy interrupted, Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 45 | 25487159 |
US |
15 | |
Drug dose omission by device, Wrong technique in product usage process, Device difficult to use, Product use issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 46 | 25487219 |
US |
81 | |
Off label use, Drug dose omission by device, Device deposit issue, Device malfunction, Expired product administered, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 47 | 25487229 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 48 | 25487324 |
US |
67 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 49 | 25487350 |
US |
55 | |
Dyspnoea, Malaise, Irritability, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 50 | 25487599 |
US |
||
Drug dose omission by device, Device delivery system issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 51 | 25487633 |
US |
78 | 1 |
Memory impairment, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 52 | 25487653 |
US |
82 | 2 |
Hypoacusis, Confusional state, Device difficult to use, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, |
||||
| 53 | 25487670 |
US |
73 | 1 |
Ill-defined disorder, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 54 | 25487691 |
US |
44 | 2 |
Migraine, Device difficult to use, Wrong technique in device usage process, Drug dose omission by device, Product communication issue, |
||||
ERENUMAB-AOOE, |
||||
| 55 | 25488021 |
US |
63 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, |
||||
| 56 | 25488054 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 57 | 25488348 |
US |
63 | |
Dysphonia, Asthma, Drug dose omission by device, Device deposit issue, Wrong technique in product usage process, Device occlusion, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 58 | 25488562 |
US |
15 | |
Drug dose omission by device, Wrong technique in product usage process, Device use issue, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 59 | 25488920 |
US |
||
Chest discomfort, Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, |
||||
| 60 | 25488947 |
KR |
||
Device power source issue, Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 61 | 25488965 |
US |
13 | 1 |
Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 62 | 25490831 |
US |
59 | |
Dyspnoea, Drug dose omission by device, Wrong technique in device usage process, |
||||
ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 63 | 25481281 |
US |
70 | 1 |
Injection site bruising, Device difficult to use, Drug dose omission by device, Product administration error, Product preparation error, Product packaging confusion, |
||||
EVOLOCUMAB, |
||||
| 64 | 25481403 |
US |
1 | |
Needle issue, Accidental exposure to product, Drug dose omission by device, |
||||
| 65 | 25481420 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, EPINEPHRINE INHALATION, |
||||
| 66 | 25482163 |
US |
70 | |
Malaise, Dyspnoea, Wrong technique in product usage process, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 67 | 25482212 |
US |
85 | 2 |
Device difficult to use, Drug dose omission by device, Hypoacusis, |
||||
EVOLOCUMAB, |
||||
| 68 | 25482245 |
US |
41 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 69 | 25482582 |
US |
||
Asthma, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 70 | 25482642 |
US |
1 | |
Drug dose omission by device, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 71 | 25482805 |
US |
65 | |
Drug dose omission by device, Device delivery system issue, Device deposit issue, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 72 | 25482964 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 73 | 25483434 |
US |
69 | 2 |
Injection site pain, Injection site bruising, Injection site haemorrhage, Device difficult to use, Accidental exposure to product, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 74 | 25483444 |
CL |
22 | 2 |
Device delivery system issue, Device physical property issue, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 75 | 25483471 |
AR |
37 | 2 |
Device malfunction, Drug dose omission by device, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 76 | 25483512 |
TR |
||
Device failure, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 77 | 25484796 |
US |
78 | 2 |
Eye disorder, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 78 | 25484900 |
US |
72 | 2 |
Device difficult to use, Drug dose omission by device, Device use error, Headache, |
||||
ERENUMAB-AOOE, RIZATRIPTAN, ONABOTULINUMTOXINA, |
||||
| 79 | 25484917 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 80 | 25484918 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 81 | 25485290 |
US |
||
Drug dose omission by device, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 82 | 25485293 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 83 | 25485301 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 84 | 25486284 |
US |
77 | 1 |
Wrong technique in product usage process, Device difficult to use, Blood cholesterol increased, Drug dose omission by device, Therapy interrupted, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 85 | 25475908 |
US |
2 | |
Injection site bruising, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 86 | 25475972 |
US |
2 | |
Drug dose omission by device, Device breakage, |
||||
GLATIRAMER ACETATE, |
||||
| 87 | 25476079 |
US |
69 | 1 |
Injection site indentation, Device difficult to use, Drug dose omission by device, Device use error, Therapy interrupted, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 88 | 25476149 |
US |
2 | |
Drug dose omission by device, Device issue, |
||||
ALBUTEROL SULFATE, |
||||
| 89 | 25476168 |
US |
77 | 1 |
Death, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 90 | 25476371 |
AU |
90 | 1 |
Hyperglycaemia, Device failure, Device issue, Device leakage, Product quality issue, Fatigue, Discomfort, Flushing, Head discomfort, Drug dose omission by device, |
||||
| 91 | 25476388 |
BR |
||
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 92 | 25476790 |
IT |
11 | 1 |
Drug dose omission by device, Device mechanical issue, Device malfunction, |
||||
SOMATROPIN, |
||||
| 93 | 25476914 |
US |
64 | 2 |
Neoplasm malignant, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 94 | 25476985 |
US |
58 | 2 |
Drug dose omission by device, Accidental overdose, |
||||
TERIPARATIDE, |
||||
| 95 | 25477011 |
US |
65 | |
Dyspnoea, Drug dose omission by device, Device deposit issue, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 96 | 25477375 |
US |
61 | |
Drug dose omission by device, Device delivery system issue, No adverse event, Product storage error, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 97 | 25477539 |
US |
44 | 2 |
Drug dose omission by device, Injection site pain, Injection site erythema, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 98 | 25477744 |
US |
30 | 1 |
Fatigue, Somnolence, Headache, Drug dose omission by device, Device difficult to use, Injection site haemorrhage, |
||||
ERENUMAB-AOOE, |
||||
| 99 | 25477794 |
US |
84 | 2 |
Alopecia, Blood cholesterol decreased, Product communication issue, Device difficult to use, Drug dose omission by device, Fear of injection, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 100 | 25477820 |
US |
||
Drug dose omission by device, Device delivery system issue, Expired device used, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
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
2025-07-29