Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20260101 - 20261231
No. 801 - 900
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 801 | 26396253 |
US |
2 | |
Device delivery system issue, Device leakage, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, LISINOPRIL, BUSPIRONE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, |
||||
| 802 | 26396491 |
US |
68 | 1 |
Device difficult to use, Injury associated with device, Injection site pain, Wrong technique in product usage process, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
ETANERCEPT, |
||||
| 803 | 26398110 |
US |
8 | 1 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 804 | 26398330 |
CO |
||
Device delivery system issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 805 | 26398387 |
US |
49 | 2 |
Device defective, Injection site mass, Drug dose omission by device, Device breakage, Diabetes mellitus, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 806 | 26398788 |
US |
40 | 2 |
Accidental exposure to product, Pulmonary embolism, Mental disorder, Condition aggravated, Pneumonia, Drug dose omission by device, COVID-19, Pain, |
||||
SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, |
||||
| 807 | 26399255 |
US |
75 | 2 |
Chronic kidney disease, Drug dose omission by device, Device difficult to use, Blood cholesterol increased, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 808 | 26399365 |
EU |
1 | |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 809 | 26399674 |
US |
51 | 2 |
Needle issue, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 810 | 26399776 |
US |
44 | 2 |
Device malfunction, Accidental exposure to product, Device operational issue, Injection site vesicles, Injection site pain, Device leakage, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 811 | 26399909 |
CO |
2 | |
Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 812 | 26400873 |
US |
||
Wrong technique in product usage process, Drug dose omission by device, |
||||
USTEKINUMAB-STBA, |
||||
| 813 | 26401003 |
US |
||
Ear infection, Illness, Influenza, Bronchitis, Drug dose omission by device, Device delivery system issue, Device mechanical issue, Incorrect dose administered by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 814 | 26391960 |
US |
70 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
TESTOSTERONE GEL, 1%, |
||||
| 815 | 26391971 |
US |
50 | |
Drug dose omission by device, Device delivery system issue, Wrong technique in device usage process, No adverse event, |
||||
TESTOSTERONE GEL, 1%, |
||||
| 816 | 26391998 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 817 | 26392616 |
US |
||
Drug dose omission by device, Device delivery system issue, Device mechanical issue, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 818 | 26392727 |
US |
76 | 2 |
Accidental exposure to product, Drug dose omission by device, Injection site pain, Injection site erythema, Injection site haemorrhage, |
||||
EVOLOCUMAB, |
||||
| 819 | 26393019 |
US |
74 | |
Dyspnoea, Transient ischaemic attack, Drug dose omission by device, Off label use, Device delivery system issue, Product storage error, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 820 | 26393137 |
IL |
2 | |
Product packaging quantity issue, Drug dose omission by device, |
||||
| 821 | 26393339 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
PREDNISOLONE ACETATE, |
||||
| 822 | 26393464 |
US |
67 | 2 |
Migraine, Device difficult to use, Drug dose omission by device, Accidental exposure to product, |
||||
ERENUMAB-AOOE, |
||||
| 823 | 26393813 |
US |
76 | |
Cough, Drug dose omission by device, Wrong technique in product usage process, Incorrect dose administered by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 824 | 26394061 |
US |
86 | 2 |
Neurodermatitis, Drug dose omission by device, Device defective, |
||||
DUPILUMAB, |
||||
| 825 | 26394360 |
US |
||
Drug dose omission by device, Device delivery system issue, Product quality issue, Insomnia, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 826 | 26394372 |
US |
37 | 2 |
Migraine, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 827 | 26394797 |
AR |
13 | 1 |
Device physical property issue, Wrong technique in device usage process, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 828 | 26394801 |
CO |
2 | |
Device information output issue, Device mechanical issue, Device use issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 829 | 26394829 |
EU |
56 | 1 |
Drug dose omission by device, Device deployment issue, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 830 | 26395159 |
US |
68 | 2 |
Injection site indentation, Accidental exposure to product, Exposure via skin contact, Device difficult to use, Drug dose omission by device, Arthritis, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 831 | 26395577 |
US |
3 | |
Off label use, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 832 | 26395601 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 833 | 26390688 |
US |
77 | |
Drug dose omission by device, Product packaging quantity issue, Wrong technique in product usage process, Off label use, |
||||
TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, |
||||
| 834 | 26390704 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 835 | 26389630 |
US |
59 | 2 |
Migraine, Nausea, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 836 | 26389801 |
US |
81 | 1 |
Device use error, Exposure via skin contact, Accidental exposure to product, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 837 | 26389878 |
US |
76 | 2 |
Blood glucose increased, Drug dose omission by device, Device delivery system issue, |
||||
INSULIN GLARGINE, INSULIN GLARGINE, |
||||
| 838 | 26384518 |
US |
61 | 2 |
Accidental exposure to product, Injection site pain, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 839 | 26384759 |
US |
2 | |
Headache, Drug dose omission by device, Device difficult to use, |
||||
ERENUMAB-AOOE, |
||||
| 840 | 26384886 |
US |
||
Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 841 | 26385780 |
US |
||
Adverse event, Device delivery system issue, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 842 | 26385981 |
US |
79 | 2 |
Hyperglycaemia, Drug dose omission by device, Device difficult to use, Peripheral swelling, Device dispensing error, Osteoarthritis, Musculoskeletal stiffness, Synovitis, Bone hypertrophy, Arthralgia, Haemoglobin decreased, Haematocrit decreased, Mean cell volume decreased, Mean cell haemoglobin decreased, Blood creatinine abnormal, Glomerular filtration rate decreased, |
||||
ETANERCEPT, ETANERCEPT, PREDNISONE, VITAMIN C, CARVEDILOL, CELECOXIB, GABAPENTIN, INSULIN ASPART, LEVOTHYROXINE SODIUM, METFORMIN HYDROCHLORIDE, OLMESARTAN MEDOXOMIL, CLOPIDOGREL, FERROUS SULFATE, INSULIN GLARGINE, |
||||
| 843 | 26386193 |
US |
||
Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, Wrong technique in device usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 844 | 26386373 |
US |
66 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, TIOTROPIUM BROMIDE AND OLODATEROL, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, |
||||
| 845 | 26387214 |
US |
75 | 2 |
Knee arthroplasty, Fall, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, SEMAGLUTIDE, ORAL SEMAGLUTIDE, INSULIN GLARGINE, |
||||
| 846 | 26387340 |
US |
2 | 1 |
Drug dose omission by device, Device material issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 847 | 26387352 |
BR |
79 | 2 |
Neoplasm malignant, Drug dose omission by device, Wrong technique in product usage process, |
||||
DENOSUMAB, CALCIUM, ERGOCALCIFEROL, |
||||
| 848 | 26387356 |
US |
16 | 1 |
Drug dose omission by device, Device defective, |
||||
SOMATROPIN, |
||||
| 849 | 26387362 |
US |
21 | 1 |
Device leakage, Product reconstitution quality issue, Drug dose omission by device, Product administration error, Wrong technique in device usage process, |
||||
SOMATROPIN, |
||||
| 850 | 26387363 |
US |
16 | 1 |
Drug dose omission by device, Device defective, |
||||
SOMATROPIN, |
||||
| 851 | 26387364 |
US |
61 | 2 |
Drug dose omission by device, Device leakage, |
||||
PEGVISOMANT, |
||||
| 852 | 26387365 |
US |
6 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 853 | 26387366 |
US |
33 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 854 | 26388331 |
EU |
2 | |
Drug dose omission by device, Device defective, |
||||
ETANERCEPT, |
||||
| 855 | 26380477 |
US |
||
Drug dose omission by device, Device malfunction, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 856 | 26380735 |
US |
92 | |
Drug dose omission by device, Device mechanical issue, No adverse event, |
||||
TIOTROPIUM BROMIDE, |
||||
| 857 | 26381336 |
US |
60 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Off label use, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 858 | 26381339 |
US |
24 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 859 | 26381344 |
US |
75 | |
Asthma, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, PROPRANOLOL HYDROCHLORIDE, LISINOPRIL, LORATADINE, LORATADINE TABLET, |
||||
| 860 | 26381676 |
US |
||
Device malfunction, Product leakage, Drug dose omission by device, Intentional product use issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 861 | 26381718 |
US |
||
Device issue, Device breakage, Drug dose omission by device, |
||||
USTEKINUMAB, |
||||
| 862 | 26381749 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 863 | 26381755 |
US |
||
Illness, Drug dose omission by device, Device difficult to use, Device delivery system issue, Device malfunction, Device mechanical issue, Product quality issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 864 | 26381815 |
US |
18 | 2 |
Device difficult to use, Drug dose omission by device, Headache, |
||||
ERENUMAB-AOOE, |
||||
| 865 | 26381837 |
US |
||
Drug dose omission by device, Device malfunction, Product administration error, Accidental exposure to product, Exposure via skin contact, Intentional product use issue, |
||||
USTEKINUMAB-STBA, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, |
||||
| 866 | 26381844 |
US |
67 | |
Cough, Chest discomfort, Drug dose omission by device, Off label use, Device delivery system issue, Device issue, |
||||
ALBUTEROL SULFATE, FENOFIBRATE, CARVEDILOL, LOSARTAN, PANTOPRAZOLE, |
||||
| 867 | 26381860 |
US |
||
Device malfunction, Drug dose omission by device, Exposure via skin contact, Accidental exposure to product, Intentional product use issue, |
||||
USTEKINUMAB, |
||||
| 868 | 26381888 |
US |
||
Needle issue, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, |
||||
USTEKINUMAB-STBA, |
||||
| 869 | 26382171 |
US |
||
Device leakage, Drug dose omission by device, |
||||
USTEKINUMAB, |
||||
| 870 | 26382213 |
US |
||
Drug dose omission by device, Intentional product use issue, Device malfunction, |
||||
USTEKINUMAB-STBA, USTEKINUMAB-STBA, AZATHIOPRINE, EMPAGLIFLOZIN, INSULIN DEGLUDEC, CITALOPRAM, CITALOPRAM HYDROBROMIDE, ROSUVASTATIN, |
||||
| 871 | 26382536 |
US |
82 | 1 |
Drug dose omission by device, Device information output issue, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 872 | 26382552 |
CA |
14 | 2 |
Drug dose omission by device, Device malfunction, |
||||
| 873 | 26382559 |
US |
2 | 1 |
Drug dose omission by device, Device use error, Device information output issue, |
||||
SOMATROPIN, |
||||
| 874 | 26382562 |
US |
16 | 1 |
Drug dose omission by device, Ill-defined disorder, Device defective, Device delivery system issue, |
||||
SOMATROPIN, |
||||
| 875 | 26383810 |
EU |
56 | 1 |
Drug dose omission by device, Device failure, Off label use, |
||||
ETANERCEPT, |
||||
| 876 | 26384081 |
US |
1 | |
Drug dose omission by device, Product delivery mechanism issue, Device defective, |
||||
ALBUTEROL SULFATE, |
||||
| 877 | 26386488 |
64 | 1 | |
Device delivery system issue, Device delivery system issue, Drug dose omission by device, Incorrect dose administered by device, Device deployment issue, |
||||
OFATUMUMAB, |
||||
| 878 | 26374174 |
US |
2 | |
Viral infection, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 879 | 26374184 |
US |
1 | |
Drug dose omission by device, Needle issue, Device deployment issue, Device delivery system issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 880 | 26374266 |
US |
1 | |
Device dispensing error, Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 881 | 26374302 |
US |
1 | |
Drug dose omission by device, Device use error, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 882 | 26374324 |
US |
67 | 2 |
Injection site haemorrhage, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 883 | 26374585 |
US |
22 | 2 |
Injection site pain, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 884 | 26375018 |
US |
||
Illness, Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, Wrong technique in product usage process, Product lot number issue, Product expiration date issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 885 | 26375090 |
US |
80 | |
Drug dose omission by device, Device delivery system issue, Device malfunction, No adverse event, |
||||
TIOTROPIUM BROMIDE, |
||||
| 886 | 26375113 |
US |
60 | |
Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 887 | 26375643 |
US |
1 | |
Illness, Drug dose omission by device, Device malfunction, |
||||
FILGRASTIM-SNDZ, |
||||
| 888 | 26375646 |
US |
||
Dyspnoea, Drug dose omission by device, Device mechanical issue, |
||||
TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, |
||||
| 889 | 26375909 |
US |
||
Device malfunction, Drug dose omission by device, |
||||
USTEKINUMAB-STBA, |
||||
| 890 | 26375998 |
US |
||
Device malfunction, Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, Intentional product use issue, |
||||
USTEKINUMAB-STBA, ZOLPIDEM TARTRATE, |
||||
| 891 | 26376317 |
US |
||
Device loosening, Device leakage, Drug dose omission by device, Intentional product use issue, |
||||
USTEKINUMAB-STBA, |
||||
| 892 | 26376787 |
US |
9 | 1 |
Incorrect dose administered by device, Drug dose omission by device, Device leakage, |
||||
SOMATROPIN, |
||||
| 893 | 26377726 |
US |
16 | 1 |
Drug dose omission by device, Device information output issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 894 | 26377752 |
US |
48 | 2 |
Drug dose omission by device, Device use error, Device material issue, Device defective, |
||||
SOMATROPIN, |
||||
| 895 | 26378517 |
US |
||
Pain, Sleep disorder, Device defective, Drug dose omission by device, |
||||
FREMANEZUMAB-VFRM, |
||||
| 896 | 26378666 |
US |
64 | |
Drug dose omission by device, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 897 | 26378842 |
US |
||
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, |
||||
TIOTROPIUM BROMIDE, |
||||
| 898 | 26379250 |
US |
2 | |
Drug dose omission by device, Device malfunction, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 899 | 26379831 |
US |
61 | 1 |
Injury associated with device, Device use error, Accidental exposure to product, Injection site haemorrhage, Injection site pain, Drug dose omission by device, Device difficult to use, Product dose omission issue, Injection site haemorrhage, Accidental exposure to product, Drug dose omission by device, Wrong technique in product usage process, Pain in extremity, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 900 | 26379843 |
US |
||
Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, Headache, |
||||
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.
terms
license
last_updated
2026-04-28