Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26555307 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 2 | 26558552 |
US |
||
Drug dose omission by device, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 3 | 26558585 |
EG |
156 | 1 |
Acidosis, Blood gases abnormal, Hyperglycaemia, Device issue, Device failure, Drug dose omission by device, Device mechanical issue, Device issue, Product storage error, Wrong technique in product usage process, Product knowledge deficit, |
||||
INSULIN DEGLUDEC, |
||||
| 4 | 26559303 |
GB |
2 | |
Drug dose omission by device, Device leakage, |
||||
SOMATROPIN, |
||||
| 5 | 26560760 |
US |
56 | 2 |
Accidental exposure to product, Drug dose omission by device, Exposure via skin contact, |
||||
ERENUMAB-AOOE, |
||||
| 6 | 26550238 |
US |
72 | 2 |
Blood glucose increased, Drug dose omission by device, Device mechanical issue, |
||||
INSULIN GLARGINE, |
||||
| 7 | 26552751 |
US |
81 | 2 |
Device difficult to use, Drug dose omission by device, Pain in extremity, Back pain, Dysstasia, Blood cholesterol increased, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 8 | 26549802 |
US |
46 | 2 |
Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, Product communication issue, Device difficult to use, |
||||
ERENUMAB-AOOE, |
||||
| 9 | 26548223 |
US |
49 | 2 |
Gait disturbance, Psoriasis, Drug dose omission by device, |
||||
IXEKIZUMAB, |
||||
| 10 | 26542167 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 11 | 26542169 |
US |
74 | |
Drug dose omission by device, Device deposit issue, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, LOSARTAN, |
||||
| 12 | 26544677 |
US |
75 | 1 |
Dementia, Device difficult to use, Drug dose omission by device, Product communication issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 13 | 26544899 |
US |
72 | 1 |
Drug dose omission by device, Device mechanical issue, Device defective, Device malfunction, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 14 | 26545389 |
CO |
1 | |
Product prescribing error, Product dispensing error, Incorrect dose administered, Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 15 | 26545398 |
US |
15 | 1 |
Device delivery system issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 16 | 26545426 |
GB |
11 | 1 |
Patient-device interaction issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 17 | 26545444 |
US |
56 | 2 |
Drug dose omission by device, Device breakage, Device material issue, |
||||
SOMATROPIN, |
||||
| 18 | 26545452 |
CA |
43 | 1 |
Drug dose omission by device, Device defective, Device mechanical issue, |
||||
CELECOXIB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 19 | 26545455 |
US |
14 | 1 |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 20 | 26545461 |
US |
66 | 2 |
Device use error, Drug dose omission by device, Product prescribing error, |
||||
SOMATROPIN, |
||||
| 21 | 26545465 |
US |
12 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 22 | 26545483 |
US |
14 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 23 | 26545501 |
US |
14 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 24 | 26535999 |
US |
2 | |
Heart disease congenital, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 25 | 26536179 |
US |
55 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 26 | 26536206 |
US |
62 | |
Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 27 | 26536264 |
US |
78 | 2 |
Device breakage, Drug dose omission by device, |
||||
INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, INTERFERON BETA-1A, |
||||
| 28 | 26536310 |
US |
1 | |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 29 | 26536333 |
US |
6 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 30 | 26536356 |
US |
2 | |
Drug dose omission by device, Device malfunction, Device delivery system issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 31 | 26537498 |
US |
42 | |
Device issue, Drug dose omission by device, Wrong technique in product usage process, Device deposit issue, Product delivery mechanism issue, Circumstance or information capable of leading to device use error, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 32 | 26537694 |
US |
65 | |
Drug dose omission by device, Product packaging quantity issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 33 | 26537999 |
US |
83 | 2 |
Device delivery system issue, Drug dose omission by device, Off label use, |
||||
ABATACEPT, ADALIMUMAB, ADALIMUMAB-ADAZ, |
||||
| 34 | 26538177 |
US |
83 | 2 |
Hip arthroplasty, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 35 | 26538808 |
CA |
77 | 2 |
Neoplasm malignant, Drug dose omission by device, Weight decreased, Muscle atrophy, Asthenia, Muscular weakness, |
||||
EVOLOCUMAB, |
||||
| 36 | 26538879 |
AR |
2 | |
Device failure, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 37 | 26539531 |
US |
79 | 2 |
Migraine, Device difficult to use, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 38 | 26539812 |
US |
76 | 2 |
Drug ineffective, Drug dose omission by device, Device delivery system issue, |
||||
ACOLTREMON, FEXOFENADINE HYDROCHLORIDE, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE HYDROCHLORIDE, FEXOFENADINE HCL, CHLORPHENIRAMINE MALEATE, CETIRIZINE HCL, LORATADINE, FLUTICASONE PROPIONATE, CETIRIZINE HYDROCHLORIDE, DIPHENHYDRAMINE HCL 25 MG, ALLERGY RELIEF, TRIAMCINOLONE ACETONIDE, CETIRIZINE HCL 10 MG, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL, MOMETASONE FUROATE, LEVOCETIRIZINE DIHYDROCHLORIDE, ONION, APIS MELLIFERA, DROSERA ROTUNDIFOLIA, EUPHRASIA STRICTA, URTICA URENS, LORATADINE 10MG, DIPHENHYDRAMINE HYDROCHLORIDE 25MG, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL, DIPHENHYDRAMINE HCI, FEXOFENADINE HYDROCHLORIDE 60 MG, ALLIUM CEPA, APIS MELLIFICA, ARALIA RACEMOSA, BLATTA ORIENTALIS, BOVISTA, CARDUUS MARIANUS, CHELIDONIUM MAJUS, EUPHRASIA OFFICINALAS, GALPHIMIA GLAUCA, HEDERA HELIX, HYDRASTIS CANADENSIS, LUFFA OPERCULATA, NASTURTIUM AQUATICUM, OKOUBAKA, SABADILLA, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE., ESOMEPRAZOLE MAGNESIUM, |
||||
| 39 | 26539912 |
US |
81 | 2 |
Blood glucose increased, Drug dose omission by device, Device mechanical issue, |
||||
INSULIN GLARGINE, |
||||
| 40 | 26540381 |
CA |
35 | 2 |
Device failure, Drug dose omission by device, |
||||
EPINEPHRINE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ALBUTEROL SULFATE, ALBUTEROL, TIOTROPIUM BROMIDE, PREDNISONE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, |
||||
| 41 | 26540616 |
US |
||
Device breakage, Injury associated with device, Drug dose omission by device, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 42 | 26541028 |
US |
30 | 2 |
Device leakage, Device material issue, Drug dose omission by device, Accidental exposure to product, Exposure via skin contact, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 43 | 26541032 |
US |
14 | 2 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 44 | 26541161 |
CO |
2 | |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 45 | 26541195 |
US |
18 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 46 | 26531278 |
US |
46 | 2 |
Device malfunction, Drug dose omission by device, |
||||
SECUKINUMAB, WARFARIN, SPIRONOLACTONE, LISINOPRIL, DAPAGLIFLOZIN, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, |
||||
| 47 | 26531373 |
US |
59 | |
Drug dose omission by device, Dyspnoea, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE, |
||||
| 48 | 26532018 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 49 | 26532019 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 50 | 26532027 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 51 | 26532173 |
US |
||
Drug dose omission by device, Device issue, Wrong technique in device usage process, No adverse event, |
||||
RISPERIDONE, |
||||
| 52 | 26532831 |
US |
40 | 2 |
Illness, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, |
||||
| 53 | 26533506 |
US |
||
Drug dose omission by device, Device delivery system issue, Product container seal issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 54 | 26533750 |
US |
49 | 1 |
Device defective, Device leakage, Device malfunction, Device issue, Accidental exposure to product, Drug delivery system issue, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 55 | 26533914 |
US |
2 | |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 56 | 26533972 |
CO |
1 | |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 57 | 26533991 |
US |
10 | 1 |
Drug dose omission by device, Device breakage, Device delivery system issue, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 58 | 26533995 |
CO |
2 | |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 59 | 26534020 |
US |
1 | |
Needle issue, Device leakage, Drug dose omission by device, Accidental exposure to product, Incorrect dose administered, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 60 | 26534263 |
US |
71 | 2 |
Accidental exposure to product, Device leakage, Drug dose omission by device, Psoriasis, |
||||
SECUKINUMAB, DESVENLAFAXINE SUCCINATE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), |
||||
| 61 | 26535709 |
US |
44 | 2 |
Injection site pain, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, SUMATRIPTAN, |
||||
| 62 | 26526928 |
US |
39 | |
Drug dose omission by device, Device delivery system issue, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 63 | 26526972 |
US |
52 | |
Drug dose omission by device, Incorrect dose administered by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 64 | 26527378 |
US |
46 | 2 |
Device malfunction, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 65 | 26527686 |
US |
66 | |
Drug dose omission by device, Device defective, Device delivery system issue, No adverse event, |
||||
LIRAGLUTIDE, LIRAGLUTIDE, |
||||
| 66 | 26528051 |
US |
53 | 2 |
Rheumatoid arthritis, Suicidal ideation, Drug dose omission by device, |
||||
ETANERCEPT, ETANERCEPT, ERGOCALCIFEROL, ERGOCALCIFEROL, ERGOCALCIFEROL, FOLIC ACID, FOLIC ACID, FOLIC ACID, |
||||
| 67 | 26528413 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 68 | 26528415 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 69 | 26528926 |
US |
||
Chest discomfort, Drug dose omission by device, Device breakage, Device delivery system issue, Product container seal issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 70 | 26529737 |
MX |
2 | |
Device deployment issue, Drug dose omission by device, |
||||
GOLIMUMAB, |
||||
| 71 | 26529810 |
US |
||
Needle issue, Drug dose omission by device, |
||||
GUSELKUMAB, |
||||
| 72 | 26529877 |
US |
2 | |
Accidental exposure to product, Drug dose omission by device, Product dispensing issue, |
||||
SECUKINUMAB, |
||||
| 73 | 26529925 |
US |
2 | |
Needle issue, Drug dose omission by device, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 74 | 26530470 |
US |
12 | 2 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 75 | 26530479 |
CO |
2 | |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 76 | 26530498 |
CO |
2 | |
Device breakage, Device leakage, Device deployment issue, Wrong technique in device usage process, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 77 | 26530601 |
TR |
||
Device mechanical issue, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 78 | 26522662 |
US |
83 | 2 |
Drug dose omission by device, Needle issue, |
||||
ABATACEPT, EMPAGLIFLOZIN, |
||||
| 79 | 26523174 |
US |
47 | 2 |
Injection site pain, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 80 | 26523201 |
US |
2 | |
Device deployment issue, Drug dose omission by device, |
||||
GOLIMUMAB, |
||||
| 81 | 26523349 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 82 | 26524439 |
US |
62 | |
Drug dose omission by device, Wrong technique in device usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 83 | 26524582 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 84 | 26525385 |
KR |
10 | 1 |
Drug dose omission by device, Device power source issue, |
||||
SOMATROPIN, |
||||
| 85 | 26525393 |
US |
14 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 86 | 26525401 |
US |
78 | 1 |
Device power source issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 87 | 26525600 |
US |
45 | 1 |
Needle issue, Device issue, Drug dose omission by device, Device operational issue, Device leakage, Accidental exposure to product, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 88 | 26526073 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 89 | 26526110 |
US |
||
Drug dose omission by device, Device leakage, |
||||
LEUPROLIDE ACETATE, |
||||
| 90 | 26526393 |
US |
52 | 1 |
Accidental exposure to product, Drug dose omission by device, Device leakage, |
||||
SECUKINUMAB, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, DIVALPROEX SODIUM, DICLOFENAC, DICLOFENAC SODIUM, DULOXETINE HYDROCHLORIDE, DULOXETINE, LISINOPRIL, SIMVASTATIN, MIDAZOLAM, |
||||
| 91 | 26522314 |
US |
21 | 2 |
Device leakage, Accidental exposure to product, Inappropriate schedule of product administration, Drug dose omission by device, |
||||
SECUKINUMAB, SERTRALINE, SPIRONOLACTONE, |
||||
| 92 | 26521872 |
US |
72 | |
Drug dose omission by device, Wrong technique in product usage process, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 93 | 26516894 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 94 | 26516898 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, |
||||
| 95 | 26517313 |
US |
74 | |
Respiration abnormal, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 96 | 26517478 |
55 | ||
General physical health deterioration, Drug dose omission by device, Device mechanical issue, |
||||
ADALIMUMAB-FKJP, ADALIMUMAB-FKJP, |
||||
| 97 | 26517663 |
|||
Blood glucose increased, Drug dose omission by device, Device mechanical issue, |
||||
| 98 | 26517717 |
US |
53 | 1 |
Device leakage, Product dose omission issue, Needle issue, Drug dose omission by device, Accidental exposure to product, |
||||
SECUKINUMAB, ENALAPRIL, METOPROLOL TARTRATE, METOPROLOL, HYDROCHLOROTHIAZIDE, GABAPENTIN, AMLODIPINE, |
||||
| 99 | 26517793 |
US |
||
Drug dose omission by device, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 100 | 26518065 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
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
2026-04-28