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 | 25138804 |
US |
30 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 2 | 25138822 |
PT |
48 | |
Off label use, Drug dose omission by device, Oxygen saturation decreased, Illness, Device delivery system issue, |
||||
| 3 | 25138916 |
US |
60 | 2 |
Drug dose omission by device, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 4 | 25138958 |
US |
78 | 2 |
Injection site pain, Injection site nodule, Device difficult to use, Drug dose omission by device, Incorrect disposal of product, Accidental exposure to product, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 5 | 25139268 |
US |
78 | 2 |
Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, Injection site indentation, Accidental exposure to product, Discomfort, |
||||
EVOLOCUMAB, |
||||
| 6 | 25139349 |
US |
77 | 2 |
Drug dose omission by device, Headache, Injection site haemorrhage, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 7 | 25139471 |
US |
74 | 2 |
Device difficult to use, Drug dose omission by device, Back pain, Musculoskeletal stiffness, Wrong technique in product usage process, |
||||
EVOLOCUMAB, EVOLOCUMAB, ICOSAPENT ETHYL, ALPRAZOLAM, BISOPROLOL FUMARATE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, |
||||
| 8 | 25139644 |
US |
73 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 9 | 25139673 |
US |
63 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 10 | 25139764 |
US |
||
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, |
||||
| 11 | 25140017 |
US |
||
Drug dose omission by device, Product use in unapproved indication, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 12 | 25140201 |
US |
12 | 2 |
Drug dose omission by device, Device delivery system issue, Wrong technique in device usage process, |
||||
SOMATROPIN, |
||||
| 13 | 25140623 |
US |
53 | 2 |
Device difficult to use, Drug dose omission by device, Wrong technique in product usage process, Injection site pain, Migraine, |
||||
ERENUMAB-AOOE, UBROGEPANT, |
||||
| 14 | 25140802 |
US |
16 | 1 |
Wrong technique in device usage process, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 15 | 25140804 |
CO |
11 | 1 |
Poor quality device used, Drug dose omission by device, Device information output issue, Device delivery system issue, Device mechanical issue, Device defective, |
||||
SOMATROPIN, |
||||
| 16 | 25140878 |
US |
46 | 2 |
Drug dose omission by device, Device difficult to use, Therapy interrupted, Injection site injury, Psoriasis, |
||||
ETANERCEPT, LOSARTAN, VITAMIN E, CREAM, OIL, BIOTIN, HAIR, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 17 | 25140953 |
US |
82 | 2 |
Cerebrovascular accident, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 18 | 25141070 |
US |
70 | 2 |
Arthritis, Accidental exposure to product, Wrong technique in product usage process, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 19 | 25142041 |
US |
88 | |
Dyspnoea, Drug dose omission by device, Product use in unapproved indication, Wrong technique in product usage process, Device malfunction, |
||||
ALBUTEROL SULFATE, |
||||
| 20 | 25142275 |
US |
74 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ROSUVASTATIN, CLOPIDOGREL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, IBANDRONATE SODIUM, PANTOPRAZOLE, |
||||
| 21 | 25142596 |
US |
16 | 1 |
Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 22 | 25142597 |
US |
13 | 1 |
Device breakage, Poor quality device used, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 23 | 25142599 |
US |
13 | 1 |
Device information output issue, Device breakage, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, LEVETIRACETAM, CETIRIZINE HYDROCHLORIDE, CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPICAL, |
||||
| 24 | 25142600 |
US |
3 | 2 |
Device use error, Device mechanical issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 25 | 25142605 |
GR |
10 | 2 |
Device use error, Device breakage, Drug dose omission by device, |
||||
SOMATROPIN, LEVOTHYROXINE, |
||||
| 26 | 25142606 |
US |
13 | 2 |
Drug dose omission by device, Device use error, Device issue, Poor quality device used, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 27 | 25142610 |
US |
8 | 1 |
Drug dose omission by device, Device use error, Device malfunction, Device breakage, Device material issue, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 28 | 25142612 |
US |
16 | 1 |
Drug dose omission by device, Device delivery system issue, Device use issue, |
||||
SOMATROPIN, |
||||
| 29 | 25142626 |
US |
2 | 2 |
Drug dose omission by device, Device breakage, Device mechanical issue, Device difficult to use, Product knowledge deficit, |
||||
SOMATROPIN, |
||||
| 30 | 25138123 |
US |
1 | |
Drug dose omission by device, Product quality issue, Device leakage, Device mechanical issue, |
||||
ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, |
||||
| 31 | 25138159 |
US |
1 | |
Drug dose omission by device, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 32 | 25138245 |
US |
16 | |
Dyspnoea, Wrong technique in product usage process, Drug dose omission by device, |
||||
ALBUTEROL SULFATE, |
||||
| 33 | 25138250 |
US |
65 | |
Wrong technique in product usage process, Drug dose omission by device, Wrong technique in device usage process, Device deposit issue, No adverse event, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 34 | 25138687 |
US |
56 | 2 |
Device difficult to use, Drug dose omission by device, Injection site mass, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 35 | 25138736 |
US |
66 | 2 |
Injection site indentation, Injection site pruritus, Device difficult to use, Wrong technique in product usage process, Drug dose omission by device, Device use error, |
||||
EVOLOCUMAB, |
||||
| 36 | 25137935 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 37 | 25132172 |
US |
68 | 2 |
Therapy non-responder, Device difficult to use, Accidental exposure to product, Drug dose omission by device, |
||||
EVOLOCUMAB, |
||||
| 38 | 25132211 |
US |
60 | 1 |
Rhinorrhoea, Back pain, Pain in extremity, Myalgia, Device difficult to use, Product communication issue, Drug dose omission by device, Accidental exposure to product, |
||||
EVOLOCUMAB, METOPROLOL TARTRATE, METOPROLOL, LOSARTAN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ERGOCALCIFEROL, |
||||
| 39 | 25132319 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 40 | 25132460 |
US |
||
Drug dose omission by device, Device delivery system issue, Device breakage, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 41 | 25132467 |
US |
83 | 1 |
Device difficult to use, Therapy interrupted, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 42 | 25132653 |
US |
72 | |
Device delivery system issue, Drug dose omission by device, No adverse event, |
||||
LEVALBUTEROL TARTRATE, LEVALBUTEROL TARTRATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 43 | 25132764 |
US |
40 | |
Drug dose omission by device, Wrong technique in product usage process, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 44 | 25132773 |
US |
||
Wrong technique in product usage process, Drug dose omission by device, No adverse event, |
||||
ALBUTEROL SULFATE, |
||||
| 45 | 25132786 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 46 | 25132805 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
SUMATRIPTAN, SUMATRIPTAN SUCCINATE, |
||||
| 47 | 25132806 |
US |
||
Drug dose omission by device, Device delivery system issue, Wrong technique in device usage process, Device mechanical issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 48 | 25132811 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 49 | 25132821 |
US |
64 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 50 | 25133725 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, SERTRALINE HYDROCHLORIDE, |
||||
| 51 | 25133728 |
US |
||
Drug dose omission by device, Device delivery system issue, Device occlusion, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 52 | 25133733 |
US |
2 | |
Device leakage, Needle issue, Drug dose omission by device, Accidental exposure to product, |
||||
SECUKINUMAB, |
||||
| 53 | 25133908 |
US |
94 | 2 |
Blood glucose increased, Drug dose omission by device, Device mechanical issue, Wrong technique in device usage process, |
||||
INSULIN GLARGINE, |
||||
| 54 | 25133973 |
BR |
||
Device malfunction, Drug dose omission by device, |
||||
PEGFILGRASTIM, |
||||
| 55 | 25134584 |
US |
81 | 1 |
Hip arthroplasty, Device difficult to use, Drug dose omission by device, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 56 | 25135773 |
US |
75 | 1 |
Device difficult to use, Injection site pain, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 57 | 25135894 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 58 | 25136092 |
US |
||
Drug dose omission by device, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 59 | 25136172 |
US |
11 | 1 |
Device use error, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 60 | 25136173 |
AR |
12 | 2 |
Product dispensing error, Drug dose omission by device, Off label use, Device information output issue, |
||||
SOMATROPIN, |
||||
| 61 | 25136249 |
US |
16 | 1 |
Drug dose omission by device, Device leakage, |
||||
SOMATROPIN, |
||||
| 62 | 25136250 |
US |
13 | 2 |
Drug dose omission by device, Product storage error, Device physical property issue, |
||||
SOMATROPIN, |
||||
| 63 | 25136252 |
US |
14 | 1 |
Drug dose omission by device, Device material issue, Device use error, |
||||
SOMATROPIN, |
||||
| 64 | 25136253 |
US |
15 | 2 |
Drug dose omission by device, Device mechanical issue, Device difficult to use, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 65 | 25136254 |
US |
11 | 2 |
Incorrect dose administered, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE, |
||||
| 66 | 25136255 |
US |
17 | 1 |
Device use issue, Drug dose omission by device, Device information output issue, |
||||
SOMATROPIN, |
||||
| 67 | 25136264 |
US |
12 | 1 |
Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 68 | 25136267 |
US |
9 | 1 |
Device information output issue, Expired device used, Poor quality device used, Drug dose omission by device, Product administered at inappropriate site, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SERTRALINE, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE DIMESYLATE, MIRTAZAPINE, CLONIDINE, CLONIDINE, |
||||
| 69 | 25136794 |
US |
62 | 1 |
Drug dose omission by device, Accidental exposure to product, Needle issue, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 70 | 25137086 |
US |
||
Drug dose omission by device, No adverse event, Device breakage, |
||||
GLUCAGON, |
||||
| 71 | 25126491 |
US |
43 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 72 | 25126906 |
US |
48 | |
Dyspnoea, Drug dose omission by device, Wrong technique in product usage process, Product lot number issue, |
||||
ALBUTEROL SULFATE, |
||||
| 73 | 25127302 |
US |
||
Drug dose omission by device, Wrong technique in device usage process, Device difficult to use, Wrong technique in product usage process, Device mechanical issue, No adverse event, |
||||
TIOTROPIUM BROMIDE, TIOTROPIUM BROMIDE, |
||||
| 74 | 25127343 |
US |
12 | |
Dyspnoea, Discomfort, Drug dose omission by device, Wrong technique in product usage process, Device information output issue, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 75 | 25127347 |
US |
||
Dementia, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, |
||||
| 76 | 25127578 |
US |
||
Drug dose omission by device, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 77 | 25127759 |
US |
73 | 1 |
Drug dose omission by device, Device malfunction, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 78 | 25127803 |
US |
66 | 1 |
Accidental exposure to product, Drug dose omission by device, Visual impairment, Off label use, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 79 | 25127903 |
US |
73 | |
Device difficult to use, Drug dose omission by device, Fatigue, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 80 | 25128180 |
US |
67 | |
Dyspnoea, Wheezing, Drug dose omission by device, Device deposit issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, |
||||
| 81 | 25128483 |
US |
68 | |
Drug dose omission by device, Wrong technique in product usage process, Dyspnoea, Device deposit issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 82 | 25128548 |
CL |
13 | 1 |
Device mechanical issue, Device delivery system issue, Device use issue, Incorrect dose administered by device, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 83 | 25128984 |
US |
68 | |
Drug dose omission by device, Device delivery system issue, No adverse event, |
||||
ALBUTEROL SULFATE, GABAPENTIN, FOLIC ACID, CELECOXIB, |
||||
| 84 | 25129021 |
US |
55 | |
Dyspnoea, Drug dose omission by device, Device delivery system issue, Panic reaction, Off label use, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 85 | 25129147 |
US |
||
Drug dose omission by device, Device delivery system issue, Device leakage, Device mechanical issue, Product substitution issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 86 | 25129220 |
GB |
48 | 2 |
Drug dose omission by device, Device leakage, Device defective, Feeling abnormal, |
||||
SOMATROPIN, |
||||
| 87 | 25129234 |
CO |
15 | 1 |
Device information output issue, Device mechanical issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 88 | 25129235 |
US |
14 | 2 |
Device power source issue, Device information output issue, Drug dose omission by device, Expired device used, |
||||
SOMATROPIN, |
||||
| 89 | 25129237 |
GB |
12 | 2 |
Drug dose omission by device, Device use error, |
||||
SOMATROPIN, |
||||
| 90 | 25129238 |
US |
14 | 1 |
Drug dose omission by device, Device use issue, Device information output issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 91 | 25129240 |
US |
11 | 1 |
Device breakage, Device leakage, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 92 | 25129242 |
US |
11 | 1 |
Drug dose omission by device, Device use error, Device information output issue, |
||||
SOMATROPIN, |
||||
| 93 | 25129243 |
CO |
1 | |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 94 | 25129260 |
US |
13 | 1 |
Injection site bruising, Drug dose omission by device, Wrong technique in device usage process, Device mechanical issue, Device breakage, Device physical property issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 95 | 25129263 |
CO |
13 | 1 |
Device information output issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 96 | 25129264 |
US |
13 | 1 |
Blood glucose abnormal, Migraine, Wrong technique in device usage process, Drug dose omission by device, Device physical property issue, Device leakage, Device breakage, |
||||
SOMATROPIN, |
||||
| 97 | 25129274 |
US |
13 | 1 |
Device use issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 98 | 25129375 |
AR |
45 | 2 |
Device malfunction, Drug dose omission by device, Injection site erythema, |
||||
ETANERCEPT, |
||||
| 99 | 25129700 |
US |
51 | 2 |
Drug dose omission by device, Device information output issue, Device power source issue, Device use issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 100 | 25130767 |
US |
||
Device leakage, Drug dose omission by device, |
||||
GUSELKUMAB, |
||||
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
2025-04-28