Drug:
Reaction: DRUG DOSE OMISSION BY DEVICE
20260101 - 20261231
No. 701 - 800
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 701 | 26432463 |
US |
||
Drug dose omission by device, Device malfunction, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 702 | 26433134 |
CO |
2 | |
Device defective, Needle issue, Drug dose omission by device, Psoriasis, Rash, Skin burning sensation, Pruritus, Stress, Malaise, Nervousness, Psoriasis, Pruritus, Anxiety, Device issue, Device physical property issue, Drug ineffective, Product availability issue, Product prescribing error, Psoriasis, Cerumen impaction, Hypoacusis, Ear discomfort, Skin burning sensation, |
||||
SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, |
||||
| 703 | 26433512 |
US |
64 | 1 |
Migraine, Drug dose omission by device, |
||||
FREMANEZUMAB-VFRM, |
||||
| 704 | 26433742 |
US |
12 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 705 | 26433824 |
KR |
13 | 1 |
Device use error, Drug dose omission by device, Device material issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 706 | 26434523 |
US |
11 | 2 |
Drug dose omission by device, Device use error, Device breakage, |
||||
SOMATROPIN, VILOXAZINE HYDROCHLORIDE, ARIPIPRAZOLE, |
||||
| 707 | 26435409 |
US |
24 | 2 |
Blood glucose decreased, Illness, Off label use, Device defective, Drug dose omission by device, |
||||
INSULIN GLARGINE, |
||||
| 708 | 26436016 |
US |
74 | 2 |
Drug dose omission by device, Device difficult to use, Cognitive disorder, |
||||
EVOLOCUMAB, DENOSUMAB, |
||||
| 709 | 26426383 |
US |
||
Device adhesion issue, Drug dose omission by device, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 710 | 26426874 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 711 | 26426878 |
US |
||
Lung disorder, Condition aggravated, Drug dose omission by device, Device delivery system issue, Product delivery mechanism issue, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 712 | 26426880 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 713 | 26426881 |
US |
||
Drug dose omission by device, Device delivery system issue, Product knowledge deficit, |
||||
ALBUTEROL SULFATE, ALBUTEROL, LOSARTAN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 714 | 26427345 |
US |
62 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Off label use, |
||||
LEVALBUTEROL TARTRATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 715 | 26428153 |
US |
1 | |
Back pain, Device defective, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 716 | 26428259 |
US |
75 | 2 |
Diabetes mellitus, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 717 | 26428864 |
CO |
2 | |
Drug dose omission by device, Device defective, Device mechanical issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 718 | 26428875 |
GB |
79 | 2 |
Drug dose omission by device, Device defective, Needle issue, |
||||
ETANERCEPT, |
||||
| 719 | 26428884 |
US |
82 | 1 |
Drug dose omission by device, Product communication issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 720 | 26428895 |
US |
15 | 1 |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 721 | 26429012 |
US |
59 | 2 |
Device deployment issue, Drug dose omission by device, |
||||
ABATACEPT, |
||||
| 722 | 26429678 |
US |
5 | 1 |
Drug dose omission by device, Device leakage, Device information output issue, |
||||
SOMATROPIN, |
||||
| 723 | 26429682 |
US |
38 | 2 |
Injury associated with device, Drug dose omission by device, Device use error, Device leakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 724 | 26429685 |
AR |
11 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 725 | 26429688 |
US |
11 | 2 |
Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 726 | 26429690 |
GB |
1 | |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 727 | 26429692 |
US |
11 | 2 |
Drug dose omission by device, Device information output issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 728 | 26429712 |
KR |
14 | 1 |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, |
||||
| 729 | 26430080 |
AR |
||
Pain, Psoriasis, Drug dose omission by device, Device mechanical issue, |
||||
| 730 | 26430486 |
US |
62 | 2 |
Musculoskeletal stiffness, Headache, Device difficult to use, Drug dose omission by device, Product communication issue, Accidental exposure to product, |
||||
EVOLOCUMAB, |
||||
| 731 | 26420870 |
US |
70 | 1 |
Device malfunction, Device leakage, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 732 | 26422008 |
US |
2 | |
Hypersensitivity, Device delivery system issue, Drug dose omission by device, Accidental exposure to product, Device use error, |
||||
SECUKINUMAB, |
||||
| 733 | 26422050 |
US |
67 | 1 |
Accidental exposure to product, Drug dose omission by device, Manufacturing product shipping issue, Device issue, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 734 | 26422283 |
US |
2 | |
Dyspnoea, Drug dose omission by device, Device defective, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 735 | 26422630 |
US |
68 | |
Dyspnoea, Productive cough, Drug dose omission by device, Device delivery system issue, Incorrect dose administered by device, Device malfunction, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 736 | 26424399 |
US |
76 | 1 |
Drug dose omission by device, Device defective, Syringe issue, Device mechanical issue, |
||||
ALPROSTADIL, |
||||
| 737 | 26424401 |
EU |
4 | 2 |
Drug dose omission by device, Device mechanical issue, Device leakage, |
||||
| 738 | 26424410 |
CO |
7 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 739 | 26425232 |
GB |
14 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 740 | 26425254 |
CO |
11 | 1 |
Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 741 | 26425255 |
US |
7 | 1 |
Drug dose omission by device, Liquid product physical issue, |
||||
SOMATROPIN, |
||||
| 742 | 26425304 |
US |
2 | |
Device malfunction, Device leakage, Drug dose omission by device, Accidental exposure to product, |
||||
OFATUMUMAB, |
||||
| 743 | 26418965 |
US |
64 | 2 |
Pruritus, Drug dose omission by device, Device malfunction, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 744 | 26417924 |
US |
51 | 2 |
Therapeutic response shortened, Migraine, Drug dose omission by device, Device difficult to use, |
||||
ERENUMAB-AOOE, |
||||
| 745 | 26418863 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 746 | 26413229 |
US |
76 | 2 |
Asthma, Ventricular tachycardia, Blood electrolytes decreased, Atrial fibrillation, Respiratory failure, Pneumonia, Abdominal pain upper, Drug dose omission by device, Device delivery system issue, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 747 | 26413430 |
US |
47 | 2 |
Hypoacusis, Injection site haemorrhage, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 748 | 26413531 |
US |
||
Dyspnoea, Product ineffective, Off label use, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 749 | 26413816 |
US |
34 | 2 |
Injection site haemorrhage, Injection site pain, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 750 | 26414040 |
US |
71 | 2 |
Upper limb fracture, Personality change, Device defective, Drug dose omission by device, |
||||
ABALOPARATIDE, |
||||
| 751 | 26415054 |
US |
||
Cough, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 752 | 26415778 |
EG |
74 | 2 |
Hip fracture, Diabetic retinopathy, Spinal column injury, Hyperglycaemia, Hypoglycaemia, Intentional product misuse, Glycosylated haemoglobin increased, Mental disorder, Off label use, Dizziness, Hypertension, Depressed mood, Device mechanical issue, Hyperglycaemia, Drug dose omission by device, |
||||
INSULIN GLARGINE AND LIXISENATIDE, INSULIN GLARGINE AND LIXISENATIDE, INSULIN GLARGINE AND LIXISENATIDE, INSULIN GLARGINE AND LIXISENATIDE, INSULIN GLARGINE, INSULIN GLARGINE, INSULIN GLARGINE, INSULIN GLULISINE, INSULIN GLULISINE, INSULIN GLULISINE, CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL, |
||||
| 753 | 26416126 |
US |
2 | |
Device delivery system issue, Device leakage, Drug dose omission by device, Injection site mass, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 754 | 26406744 |
US |
47 | 2 |
Nasopharyngitis, Injection site haemorrhage, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, |
||||
| 755 | 26406855 |
US |
48 | 2 |
Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 756 | 26406990 |
US |
47 | 2 |
Device malfunction, Drug dose omission by device, Stress, |
||||
OFATUMUMAB, |
||||
| 757 | 26407771 |
US |
56 | 2 |
Drug dose omission by device, Injection site pain, Injection site bruising, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 758 | 26409194 |
US |
32 | 2 |
Needle issue, Device defective, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 759 | 26409217 |
US |
10 | 1 |
Drug dose omission by device, Device mechanical issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 760 | 26409281 |
US |
||
Drug dose omission by device, Device delivery system issue, Device malfunction, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 761 | 26409284 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 762 | 26409286 |
US |
||
Drug dose omission by device, Device delivery system issue, Off label use, Product storage error, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 763 | 26409291 |
US |
||
Drug dose omission by device, Device delivery system issue, Product packaging quantity issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 764 | 26409330 |
US |
70 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 765 | 26409463 |
US |
34 | 2 |
Accidental exposure to product, Brain injury, Head injury, Drug dose omission by device, Device difficult to use, Hemicrania continua, Migraine, |
||||
ERENUMAB-AOOE, |
||||
| 766 | 26409516 |
US |
35 | 2 |
Drug dose omission by device, Migraine, Device difficult to use, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, TOPIRAMATE, TOPIRAMATE SPINKLE, ONABOTULINUMTOXINA, RIMEGEPANT SULFATE, |
||||
| 767 | 26409618 |
US |
31 | 2 |
Device defective, Needle issue, Incorrect dose administered, Accidental exposure to product, Drug dose omission by device, |
||||
SECUKINUMAB, |
||||
| 768 | 26411558 |
BR |
1 | |
Device malfunction, Device failure, Drug dose omission by device, Blood glucose abnormal, Off label use, |
||||
SEMAGLUTIDE, |
||||
| 769 | 26412491 |
US |
1 | |
Accidental exposure to product, Drug dose omission by device, Device leakage, Device malfunction, |
||||
SECUKINUMAB, |
||||
| 770 | 26412533 |
US |
38 | 2 |
Hyperacusis, Photophobia, Tension headache, Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 771 | 26412627 |
US |
51 | 1 |
Device difficult to use, Drug dose omission by device, Product communication issue, Blood cholesterol increased, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 772 | 26401675 |
US |
70 | |
Wrong technique in product usage process, Drug dose omission by device, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 773 | 26401701 |
US |
78 | 2 |
Drug dose omission by device, Device deployment issue, |
||||
ABATACEPT, |
||||
| 774 | 26401879 |
US |
62 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 775 | 26401918 |
US |
73 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 776 | 26401939 |
US |
42 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, |
||||
| 777 | 26402232 |
US |
1 | |
Accidental exposure to product, Device leakage, Drug dose omission by device, Exposure via skin contact, Device delivery system issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 778 | 26402880 |
US |
||
Dyspnoea, Drug dose omission by device, Device occlusion, Device delivery system issue, Off label use, |
||||
ALBUTEROL SULFATE, |
||||
| 779 | 26402881 |
US |
56 | |
Adverse event, Drug dose omission by device, Wrong technique in product usage process, Wrong technique in device usage process, Device deposit issue, Product label issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 780 | 26403047 |
US |
25 | 1 |
Device difficult to use, Accidental exposure to product, Exposure via skin contact, Device use error, Drug dose omission by device, |
||||
ERENUMAB-AOOE, |
||||
| 781 | 26403224 |
US |
73 | 1 |
Diabetes mellitus, Drug dose omission by device, Device difficult to use, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 782 | 26404024 |
CO |
75 | 2 |
Drug dose omission by device, Device delivery system issue, Needle issue, Device mechanical issue, |
||||
ETANERCEPT, |
||||
| 783 | 26404118 |
CA |
69 | 2 |
Drug dose omission by device, Device mechanical issue, |
||||
ALLOPURINOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CELECOXIB, HYDROCHLOROTHIAZIDE, RABEPRAZOLE, |
||||
| 784 | 26404131 |
US |
24 | 1 |
Drug dose omission by device, Wrong technique in device usage process, Device breakage, Device physical property issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 785 | 26404157 |
AR |
15 | 1 |
Device physical property issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 786 | 26404595 |
EG |
2 | |
Hyperglycaemia, Drug dose omission by device, Device failure, Wrong technique in device usage process, |
||||
| 787 | 26405873 |
GB |
20 | 1 |
Drug dose omission by device, Device defective, |
||||
SOMATROPIN, |
||||
| 788 | 26405907 |
US |
80 | 1 |
Drug dose omission by device, Parkinson^s disease, Device delivery system issue, |
||||
SECUKINUMAB, |
||||
| 789 | 26405909 |
LB |
66 | 1 |
Drug dose omission by device, Drug delivery system issue, |
||||
| 790 | 26406355 |
US |
68 | 1 |
Accidental exposure to product, Exposure via skin contact, Drug dose omission by device, Product communication issue, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 791 | 26406415 |
US |
51 | 2 |
Drug delivery system malfunction, Headache, Drug dose omission by device, |
||||
PEGINTERFERON BETA-1A, FAMOTIDINE, SUMATRIPTAN SUCCINATE, ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, ACETAMINOPHEN, ASPIRIN (NSAID) AND CAFFEINE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, ATENOLOL, |
||||
| 792 | 26406418 |
US |
81 | 1 |
Injection site pain, Injection site haemorrhage, Injection site vesicles, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 793 | 26406435 |
US |
69 | |
Device delivery system issue, Drug dose omission by device, Device malfunction, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 794 | 26406437 |
US |
34 | |
Dyspnoea, Wrong technique in product usage process, Drug dose omission by device, Loss of personal independence in daily activities, |
||||
ALBUTEROL SULFATE, |
||||
| 795 | 26406443 |
US |
15 | |
Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 796 | 26395987 |
US |
1 | |
Drug ineffective, Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 797 | 26396019 |
US |
70 | |
Drug dose omission by device, Device delivery system issue, Device malfunction, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 798 | 26396043 |
US |
||
Dyspnoea, Off label use, Drug dose omission by device, Wrong technique in product usage process, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 799 | 26396165 |
US |
54 | 2 |
Migraine, Drug dose omission by device, Device difficult to use, |
||||
ERENUMAB-AOOE, |
||||
| 800 | 26396200 |
US |
38 | 1 |
Migraine, Accidental exposure to product, Device malfunction, Drug dose omission by device, |
||||
FREMANEZUMAB-VFRM, |
||||
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