Drug:
Reaction: DEVICE ISSUE
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26940208 |
US |
||
Device issue, No adverse event, |
||||
RISPERIDONE, |
||||
| 2 | 26940385 |
US |
2 | |
Irritable bowel syndrome, Asthenia, Nausea, Hypotension, Bone pain, Drug dose omission by device, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 3 | 26940757 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 4 | 26941040 |
US |
75 | 2 |
Oropharyngeal pain, Productive cough, Fall, Tooth fracture, Device defective, Product dose omission issue, Device issue, Injury associated with device, |
||||
ABALOPARATIDE, |
||||
| 5 | 26941175 |
US |
2 | |
Scoliosis, Fall, Dyspnoea, Device issue, Product dose omission issue, |
||||
ABALOPARATIDE, |
||||
| 6 | 26941211 |
EG |
2 | |
Device issue, Diabetic ketoacidosis, |
||||
| 7 | 26941447 |
US |
53 | 2 |
Accidental exposure to product, Device issue, |
||||
BRIMONIDINE TARTRATE, NETARSUDIL AND LATANOPROST OPHTHALMIC SOLUTION, 0.02%/0.005%, BROMFENAC SODIUM, |
||||
| 8 | 26941517 |
US |
2 | |
Brain fog, Eye pain, Breast discomfort, Fatigue, Injection site pain, Drug dose omission by device, Device issue, |
||||
ABALOPARATIDE, |
||||
| 9 | 26941593 |
US |
68 | 2 |
Product dose omission in error, Device issue, Drug dose omission by device, Product use issue, |
||||
ABALOPARATIDE, |
||||
| 10 | 26941861 |
US |
||
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 11 | 26941912 |
US |
1 | |
Heart rate increased, Device mechanical issue, Accidental exposure to product, Device issue, |
||||
ABALOPARATIDE, |
||||
| 12 | 26942109 |
US |
57 | |
Blood glucose increased, Device issue, Incorrect dose administered, |
||||
INSULIN GLARGINE, |
||||
| 13 | 26942323 |
US |
50 | 1 |
Injection site urticaria, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 14 | 26942398 |
US |
67 | 1 |
Injection site rash, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 15 | 26942872 |
US |
1 | |
Injury associated with device, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 16 | 26943936 |
US |
30 | 1 |
Device issue, Device leakage, |
||||
SOMATROPIN, |
||||
| 17 | 26944122 |
US |
2 | |
Deafness, COVID-19, Hypoacusis, Device issue, Product dose omission issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, TIOTROPIUM BROMIDE, |
||||
| 18 | 26944350 |
US |
15 | 1 |
Device issue, Product dose omission issue, |
||||
LONAPEGSOMATROPIN-TCGD, LONAPEGSOMATROPIN-TCGD, |
||||
| 19 | 26944513 |
EU |
||
Device issue, |
||||
GUSELKUMAB, |
||||
| 20 | 26944851 |
EU |
1 | |
Malaise, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 21 | 26944866 |
US |
2 | |
Weight decreased, Blood calcium increased, Device issue, |
||||
ABALOPARATIDE, |
||||
| 22 | 26944985 |
US |
2 | |
Injury associated with device, Device issue, Off label use, |
||||
INSULIN GLARGINE, |
||||
| 23 | 26945019 |
US |
64 | 2 |
Headache, Bone pain, Arthralgia, Abdominal pain upper, Product dose omission issue, Device leakage, Device issue, Device defective, Device mechanical issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, NEMOLIZUMAB-ILTO, |
||||
| 24 | 26945021 |
US |
2 | |
Chest discomfort, Blood pressure fluctuation, General physical health deterioration, Sinusitis bacterial, Chronic sinusitis, Feeling abnormal, Blood pressure increased, Heart rate increased, Headache, Palpitations, Nausea, Product use complaint, Device issue, |
||||
ABALOPARATIDE, |
||||
| 25 | 26945109 |
US |
83 | 2 |
Product container seal issue, Incorrect dose administered by device, Product use issue, Wrong technique in product usage process, Product communication issue, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 26 | 26945219 |
US |
2 | |
Alopecia, Device issue, Drug dose omission by device, |
||||
ABALOPARATIDE, ABALOPARATIDE, AMLODIPINE, LOSARTAN, |
||||
| 27 | 26945407 |
US |
1 | |
Product dose omission in error, Device issue, |
||||
ABALOPARATIDE, |
||||
| 28 | 26945622 |
US |
80 | 2 |
Drug dose omission by device, Drug delivery system issue, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 29 | 26945774 |
US |
88 | 2 |
Feeling abnormal, Device issue, |
||||
ABALOPARATIDE, |
||||
| 30 | 26946457 |
US |
2 | |
Fear of injection, Poor quality sleep, Abdominal discomfort, Nausea, Fatigue, Muscle spasms, Abdominal pain upper, Headache, Malaise, Device use error, Liquid product physical issue, Device issue, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, CYANOCOBALAMIN, ERGOCALCIFEROL, PROGESTERONE, |
||||
| 31 | 26946544 |
US |
66 | 2 |
Device defective, Incorrect dose administered, Product dose omission issue, Product dose omission issue, Device issue, Device use issue, |
||||
ABALOPARATIDE, |
||||
| 32 | 26946590 |
US |
2 | |
Spinal operation, Intervertebral disc protrusion, Pain, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 33 | 26946748 |
US |
68 | 1 |
Injection site bruising, Injection site reaction, Injection site pain, Device issue, Injection site rash, |
||||
ADALIMUMAB, |
||||
| 34 | 26946764 |
US |
44 | 1 |
Product dose omission issue, Device issue, Device malfunction, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 35 | 26946792 |
US |
73 | 1 |
Device mechanical issue, Wrong technique in device usage process, Device use issue, Needle issue, Device issue, Product preparation error, |
||||
ABALOPARATIDE, |
||||
| 36 | 26946804 |
US |
53 | 2 |
Device delivery system issue, Drug dose omission by device, Device issue, |
||||
ABALOPARATIDE, |
||||
| 37 | 26946996 |
US |
82 | 2 |
Sciatica, Vertigo, Nausea, Wrong technique in device usage process, Product dose omission issue, Circumstance or information capable of leading to medication error, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 38 | 26947040 |
US |
84 | 2 |
Illness, Product dose omission issue, Needle issue, Device issue, Device dispensing error, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 39 | 26947105 |
US |
1 | |
Blood glucose increased, Device issue, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 40 | 26947184 |
US |
87 | 2 |
Hypoacusis, Product dose omission issue, Device issue, |
||||
ABALOPARATIDE, |
||||
| 41 | 26947215 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 42 | 26947288 |
EU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 43 | 26947311 |
US |
66 | 2 |
Product dose omission in error, Device malfunction, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 44 | 26947320 |
AU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 45 | 26947382 |
US |
62 | 2 |
Flushing, Night sweats, Dizziness, Heart rate increased, Injection site haemorrhage, Product dose omission in error, Drug dose omission by device, Device issue, |
||||
ABALOPARATIDE, |
||||
| 46 | 26947494 |
US |
59 | 2 |
Injection site bruising, Drug delivery system issue, Device use issue, Device issue, Wrong technique in product usage process, Drug dose omission by device, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 47 | 26947543 |
US |
74 | 2 |
Chest discomfort, Flushing, Chest pain, Headache, Palpitations, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ERGOCALCIFEROL, CALCIUM, |
||||
| 48 | 26947829 |
US |
78 | 1 |
Aphonia, Vocal cord disorder, Scoliosis, Abdominal distension, Wrong technique in device usage process, Device issue, |
||||
ABALOPARATIDE, DICLOFENAC, DICLOFENAC SODIUM, LEVOCARNITINE, LEVOCARNITINE ORAL, PREGABALIN, METHADONE, OXYCODONE, |
||||
| 49 | 26947898 |
US |
||
Asthma, Product dose omission issue, Device issue, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 50 | 26947988 |
US |
71 | 2 |
Influenza, Malaise, Device mechanical issue, Device issue, Drug dose omission by device, |
||||
ABALOPARATIDE, |
||||
| 51 | 26948133 |
US |
61 | 2 |
Septic shock, Loss of consciousness, Hyperhidrosis, Cardiac disorder, Vagus nerve disorder, Device issue, Blood pressure abnormal, Clostridium difficile infection, Illness, |
||||
RISANKIZUMAB-RZAA, |
||||
| 52 | 26948203 |
US |
82 | 2 |
Dizziness, Arthralgia, Injection site pain, Anxiety, Depression, Device issue, Needle issue, |
||||
ABALOPARATIDE, |
||||
| 53 | 26948262 |
US |
75 | 1 |
Inappropriate schedule of product administration, Wrong technique in device usage process, Drug dose omission by device, Product dose omission in error, Device use issue, Device issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 54 | 26952124 |
74 | 2 | |
Atrial fibrillation, Injection site pain, Device issue, |
||||
ETANERCEPT, |
||||
| 55 | 26934275 |
CA |
1 | |
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 56 | 26934279 |
US |
||
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 57 | 26934316 |
JP |
||
Device issue, Device defective, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 58 | 26934687 |
US |
51 | 2 |
Injection site urticaria, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 59 | 26934763 |
US |
2 | |
Pregnancy, Device issue, No adverse event, |
||||
| 60 | 26934829 |
US |
27 | 2 |
Injection site haemorrhage, Device issue, Injection site bruising, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 61 | 26934944 |
US |
1 | |
Product preparation error, Device issue, Device leakage, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 62 | 26934985 |
KR |
||
Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 63 | 26935113 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 64 | 26935471 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 65 | 26935616 |
US |
61 | 2 |
Illness, Device issue, Glycosylated haemoglobin increased, Overdose, |
||||
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE, |
||||
| 66 | 26935720 |
2 | ||
Product dose omission issue, Device issue, No adverse event, |
||||
AZELASTINE, |
||||
| 67 | 26935731 |
US |
2 | |
Injection site injury, Device issue, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 68 | 26935825 |
US |
59 | 2 |
Device issue, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 69 | 26936087 |
US |
73 | 1 |
Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, |
||||
| 70 | 26936191 |
US |
57 | 1 |
Injection site haemorrhage, Device issue, Injection site pain, |
||||
RISANKIZUMAB-RZAA, |
||||
| 71 | 26936512 |
CA |
2 | |
Device issue, Device issue, |
||||
CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, |
||||
| 72 | 26936804 |
US |
10 | 2 |
Device issue, Wrong technique in device usage process, |
||||
SOMATROPIN, |
||||
| 73 | 26936947 |
TR |
||
Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 74 | 26936963 |
US |
69 | 1 |
Injection site reaction, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 75 | 26937029 |
US |
24 | 2 |
Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 76 | 26937436 |
US |
1 | |
Administration site pain, Emotional distress, Infusion site extravasation, Device issue, Incorrect dose administered, |
||||
ETEPLIRSEN, |
||||
| 77 | 26937440 |
US |
14 | 1 |
Device issue, Product dose omission issue, |
||||
ETEPLIRSEN, |
||||
| 78 | 26937443 |
US |
11 | 1 |
Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, ETEPLIRSEN, LISINOPRIL, DEFLAZACORT, VAMOROLONE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 79 | 26937458 |
US |
20 | 1 |
Device issue, |
||||
ETEPLIRSEN, ETEPLIRSEN, |
||||
| 80 | 26937459 |
US |
17 | 1 |
Poor venous access, Weight increased, Device issue, |
||||
ETEPLIRSEN, |
||||
| 81 | 26937505 |
US |
16 | 1 |
Device issue, |
||||
ETEPLIRSEN, LISINOPRIL, DEFLAZACORT, DEFLAZACORT, CALCIUM, ERGOCALCIFEROL, |
||||
| 82 | 26937539 |
US |
2 | |
Injection site injury, Device issue, |
||||
INSULIN GLARGINE, |
||||
| 83 | 26937547 |
US |
19 | 1 |
Device issue, |
||||
ETEPLIRSEN, |
||||
| 84 | 26937556 |
US |
22 | 1 |
Device issue, |
||||
ETEPLIRSEN, |
||||
| 85 | 26937561 |
US |
24 | 1 |
Device issue, Product dose omission issue, |
||||
ETEPLIRSEN, |
||||
| 86 | 26937575 |
US |
14 | 1 |
Product dose omission issue, Device issue, |
||||
ETEPLIRSEN, |
||||
| 87 | 26937577 |
US |
18 | 1 |
Poor venous access, Product dose omission issue, Device issue, No adverse event, |
||||
ETEPLIRSEN, ETEPLIRSEN, ENALAPRIL MALEATE, ENALAPRIL, PREDNISOLONE SODIUM PHOSPHATE, |
||||
| 88 | 26937582 |
US |
20 | 1 |
Device issue, Product dose omission issue, |
||||
ETEPLIRSEN, ETEPLIRSEN, |
||||
| 89 | 26937583 |
US |
13 | 1 |
Extravasation, Injection site erythema, Injection site swelling, Device issue, Product dispensing issue, Device occlusion, |
||||
ETEPLIRSEN, ETEPLIRSEN, |
||||
| 90 | 26937596 |
US |
25 | 1 |
Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, ETEPLIRSEN, PREDNISONE, LISINOPRIL, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, |
||||
| 91 | 26937599 |
US |
1 | |
Device issue, No adverse event, |
||||
ETEPLIRSEN, |
||||
| 92 | 26937606 |
US |
9 | 1 |
Procedural pain, Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, ETEPLIRSEN, ETEPLIRSEN, |
||||
| 93 | 26937612 |
US |
10 | 1 |
Patient uncooperative, Device issue, |
||||
ETEPLIRSEN, |
||||
| 94 | 26937613 |
US |
17 | 1 |
Device issue, Product dose omission issue, |
||||
ETEPLIRSEN, |
||||
| 95 | 26937619 |
US |
9 | 1 |
Stress, Poor venous access, Device issue, Intentional dose omission, Product dose omission issue, |
||||
ETEPLIRSEN, ETEPLIRSEN, DEFLAZACORT, DEFLAZACORT, DEFLAZACORT, LISINOPRIL, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, LORATADINE, LORATADINE ORAL, DEFLAZACORT, HYDROCORTISONE SODIUM SUCCINATE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, |
||||
| 96 | 26937621 |
US |
9 | 1 |
Sensitive skin, Malaise, Device issue, Product dose omission issue, |
||||
ETEPLIRSEN, ETEPLIRSEN, ETEPLIRSEN, ETEPLIRSEN, DEFLAZACORT, ERGOCALCIFEROL, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, |
||||
| 97 | 26937657 |
US |
20 | 1 |
Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, |
||||
| 98 | 26937666 |
US |
17 | 1 |
Infusion related reaction, Device issue, |
||||
ETEPLIRSEN, ETEPLIRSEN, PREDNISONE, MELATONIN, PREDNISOLONE SODIUM PHOSPHATE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, |
||||
| 99 | 26937671 |
US |
21 | 1 |
Device issue, Product dose omission issue, No adverse event, Increased dose administered, |
||||
ETEPLIRSEN, ETEPLIRSEN, ETEPLIRSEN, ALBUTEROL SULFATE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, CARVEDILOL, FAMOTIDINE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, |
||||
| 100 | 26937712 |
US |
14 | 1 |
Device issue, Product dose omission issue, No adverse event, |
||||
ETEPLIRSEN, ETEPLIRSEN, |
||||
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
2026-07-30