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 | 26555369 |
US |
2 | |
Colitis ulcerative, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 2 | 26555372 |
EU |
63 | 1 |
Fall, Ligament sprain, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, MELATONIN, ROTIGOTINE, ROTIGOTINE, |
||||
| 3 | 26555476 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 4 | 26555520 |
EU |
2 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 5 | 26556059 |
US |
1 | |
Injection site pain, Injection site injury, Device issue, Accidental exposure to product, Device leakage, Incorrect dose administered by device, |
||||
SECUKINUMAB, INSULIN GLARGINE, INSULIN ASPART, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, EMPAGLIFLOZIN, |
||||
| 6 | 26556553 |
EU |
||
Device issue, Product delivery mechanism issue, |
||||
AFLIBERCEPT, |
||||
| 7 | 26556868 |
EU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 8 | 26556886 |
JP |
||
Device issue, |
||||
AFLIBERCEPT, |
||||
| 9 | 26557692 |
US |
73 | 2 |
Incorrect dose administered, Device issue, Asthma, Chronic obstructive pulmonary disease, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 10 | 26557919 |
US |
2 | |
Product dose omission issue, Wrong technique in device usage process, Device issue, Accidental exposure to product, Ill-defined disorder, |
||||
OMALIZUMAB, |
||||
| 11 | 26558428 |
US |
||
Device safety feature issue, Needle issue, Device issue, |
||||
ENOXAPARIN SODIUM, |
||||
| 12 | 26558454 |
CO |
||
Device issue, |
||||
| 13 | 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, |
||||
| 14 | 26558994 |
US |
69 | 2 |
Dyspnoea at rest, Choking, Quality of life decreased, Hepatic enzyme increased, Fatigue, Injection site bruising, Device issue, |
||||
EFGARTIGIMOD ALFA AND HYALURONIDASE (HUMAN RECOMBINANT), PREDNISONE, ALBUTEROL SULFATE, |
||||
| 15 | 26559223 |
GB |
1 | |
Intestinal perforation, Device issue, Injection site mass, Intra-abdominal fluid collection, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 16 | 26559305 |
EU |
83 | |
Vasoplegia syndrome, Vertigo, Tremor, Bradycardia, Bradycardia, Hypotension, Headache, Nausea, Chills, Tremor, Headache, Nausea, Chills, Dizziness, Device issue, |
||||
DEGARELIX, DEGARELIX, DEGARELIX, DEGARELIX, ALLOPURINOL, FUROSEMIDE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, CANDESARTAN, ENZALUTAMIDE, |
||||
| 17 | 26559550 |
US |
17 | 1 |
Device information output issue, Device issue, |
||||
SOMATROPIN, |
||||
| 18 | 26560011 |
|||
Injection site pain, Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 19 | 26560154 |
US |
||
Device issue, |
||||
ALBUTEROL SULFATE AND BUDESONIDE, |
||||
| 20 | 26560569 |
US |
2 | |
Malaise, Device issue, Sinusitis, Immunodeficiency, Sleep deficit, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 21 | 26560892 |
US |
12 | 1 |
Device information output issue, Device issue, |
||||
SOMATROPIN, |
||||
| 22 | 26561491 |
EU |
24 | 2 |
Device issue, Telangiectasia, Product use in unapproved indication, |
||||
EPOPROSTENOL, SOTATERCEPT-CSRK, SOTATERCEPT-CSRK, AMBRISENTAN, TADALAFIL, |
||||
| 23 | 26561585 |
US |
2 | |
Neoplasm malignant, Psoriasis, Respiratory disorder, Skin burning sensation, Burning sensation, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 24 | 26550019 |
EU |
58 | 2 |
Device issue, Device defective, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 25 | 26550326 |
US |
46 | 2 |
Malaise, Procedural pain, Device issue, |
||||
LEVONORGESTREL, MISOPROSTOL, |
||||
| 26 | 26550329 |
US |
1 | |
Device issue, No adverse event, Product dose omission issue, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, |
||||
| 27 | 26550366 |
KR |
||
Device issue, Product label issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 28 | 26550530 |
US |
55 | 2 |
Device issue, Pain, Diabetic foot, Depression, Incorrect dose administered, |
||||
GUSELKUMAB, CARVEDILOL, CLOPIDOGREL, CLOPIDOGREL BISULFATE, DULOXETINE HYDROCHLORIDE, DULOXETINE, EPINEPHRINE, ADRENALINUM, FUROSEMIDE, GABAPENTIN, ISOSORBIDE MONONITRATE, EMPAGLIFLOZIN, INSULIN GLARGINE, MAGNESIUM, MELOXICAM, TIRZEPATIDE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, PANTOPRAZOLE, RANOLAZINE, EVOLOCUMAB, LINAGLIPTIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CYCLOBENZAPRINE, ERGOCALCIFEROL, |
||||
| 29 | 26550753 |
US |
65 | 1 |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, PRIMIDONE, LISINOPRIL, ATENOLOL, |
||||
| 30 | 26551276 |
US |
57 | 2 |
Device operational issue, Product dose omission issue, Device issue, |
||||
ABATACEPT, DIGOXIN, LEFLUNOMIDE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, |
||||
| 31 | 26551401 |
US |
57 | |
Product dose omission issue, Cough, Device issue, |
||||
| 32 | 26551450 |
US |
80 | 1 |
Visual impairment, Product taste abnormal, Incorrect dose administered, Device issue, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 33 | 26551602 |
JP |
||
Device issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 34 | 26551677 |
50 | ||
Psoriasis, Dermatitis contact, Incorrect dose administered, Product leakage, Accidental exposure to product, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 35 | 26551768 |
US |
58 | 2 |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 36 | 26551807 |
EU |
||
Device issue, |
||||
DARUNAVIR, DARUNAVIR, |
||||
| 37 | 26551823 |
JP |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 38 | 26551835 |
US |
95 | 2 |
Cerebrovascular accident, Device issue, Headache, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 39 | 26551994 |
US |
2 | |
Device issue, Incorrect dose administered, Accidental exposure to product, Device leakage, |
||||
SECUKINUMAB, |
||||
| 40 | 26552529 |
2 | ||
Embedded device, Device issue, Uterine leiomyoma, |
||||
LEVONORGESTREL, LEVONORGESTREL, |
||||
| 41 | 26553095 |
EU |
2 | |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 42 | 26554281 |
US |
70 | 2 |
Application site pain, Application site erythema, Device issue, Therapy interrupted, |
||||
EFINACONAZOLE, |
||||
| 43 | 26547092 |
41 | ||
Visual impairment, Device issue, |
||||
ZILUCOPLAN, ECULIZUMAB, PREDNISONE, PYRIDOSTIGMINE BROMIDE, HYDROXYZINE, ERGOCALCIFEROL, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DOXYCYCLINE, DOXYCYCLINE HYCLATE, HYDROCHLOROTHIAZIDE, FERROUS SULFATE, METRONIDAZOLE, METRONIDAZOLE TOPICAL, SUCRALFATE, SUCRALFATE ORAL SUSPENSION, SUCRALFATE ORAL, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, ROSUVASTATIN, SITAGLIPTIN, INSULIN GLARGINE, LOSARTAN, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, AMOXICILLIN AND CLAVULANATE POTASSIUM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, |
||||
| 44 | 26547196 |
29 | ||
Tonsillitis, Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 45 | 26547475 |
US |
||
Intercepted product preparation error, Device occlusion, Device issue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 46 | 26547573 |
CA |
||
Death, Device issue, Device issue, |
||||
| 47 | 26548120 |
US |
2 | |
Oral surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 48 | 26548456 |
|||
Accidental exposure to product, Wrong technique in product usage process, Needle issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 49 | 26541973 |
US |
27 | 2 |
Inappropriate schedule of product administration, Asthma, Device issue, Device malfunction, Product dose omission issue, Wrong technique in device usage process, |
||||
BENRALIZUMAB, BENRALIZUMAB, |
||||
| 50 | 26542040 |
US |
2 | |
Pain, Device issue, Injection site pain, Injection site coldness, Illness, Mucous stools, Vomiting, Abdominal rigidity, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 51 | 26542063 |
US |
74 | 1 |
Colostomy, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 52 | 26543004 |
US |
2 | |
Injection site injury, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 53 | 26543070 |
US |
1 | |
Injection site discomfort, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 54 | 26543326 |
US |
53 | 1 |
Product dose omission issue, Device issue, Needle issue, |
||||
GUSELKUMAB, |
||||
| 55 | 26543949 |
US |
2 | |
Taste disorder, Device issue, |
||||
| 56 | 26544344 |
US |
2 | |
Dyspnoea, Oral candidiasis, Visual impairment, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 57 | 26544533 |
EU |
||
Device deployment issue, Device issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 58 | 26544536 |
AE |
||
Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 59 | 26544744 |
US |
2 | |
Injection site erythema, Injection site urticaria, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 60 | 26545096 |
US |
27 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 61 | 26545151 |
US |
2 | |
Injection site mass, Injection site discharge, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 62 | 26545272 |
US |
5 | 1 |
Device issue, Product dose omission issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 63 | 26545275 |
US |
49 | 2 |
Product dose omission issue, Contusion, Pruritus, Accidental exposure to product, Device issue, |
||||
OMALIZUMAB, DULOXETINE HYDROCHLORIDE, |
||||
| 64 | 26545304 |
US |
71 | |
Device issue, Product dose omission issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 65 | 26545388 |
CO |
2 | |
Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 66 | 26545424 |
AR |
||
Device issue, |
||||
SOMATROPIN, |
||||
| 67 | 26545450 |
CO |
2 | |
Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 68 | 26545563 |
US |
2 | |
Asthma, Product dose omission issue, Device issue, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 69 | 26545565 |
US |
76 | 1 |
Ventricular extrasystoles, Device issue, Heart rate irregular, |
||||
FOSCARBIDOPA/FOSLEVODOPA, ERGOCALCIFEROL, PANTOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, RIVASTIGMINE, FAMOTIDINE, PIMAVANSERIN TARTRATE, FINASTERIDE, ALBUTEROL SULFATE, AZELASTINE, FLUTICASONE PROPIONATE, |
||||
| 70 | 26545573 |
TR |
75 | 2 |
Peripheral embolism, Device issue, Pulmonary embolism, Hypokinesia, |
||||
| 71 | 26545750 |
US |
47 | 2 |
Product dose omission issue, Nausea, Headache, Device issue, |
||||
TOCILIZUMAB, METHOTREXATE, METHOTREXATE SODIUM, GALCANEZUMAB-GNLM, |
||||
| 72 | 26546346 |
92 | 2 | |
Adverse event, Device issue, Wrong technique in product usage process, Incorrect dose administered by device, Poor quality device used, |
||||
MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 73 | 26546685 |
US |
1 | |
Hypoacusis, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 74 | 26535846 |
US |
1 | |
Death, General physical health deterioration, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 75 | 26536210 |
43 | ||
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 76 | 26536334 |
US |
2 | |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 77 | 26536391 |
US |
2 | |
Disability, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 78 | 26536604 |
EU |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 79 | 26536659 |
US |
||
Device issue, Incorrect dose administered, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 80 | 26536718 |
US |
2 | |
Off label use, Device issue, |
||||
CYCLOSPORINE, |
||||
| 81 | 26537149 |
2 | ||
Product dose omission issue, Device mechanical issue, Device issue, |
||||
TERIPARATIDE, |
||||
| 82 | 26537229 |
US |
2 | |
Drug delivery system issue, Oral discomfort, Device issue, |
||||
| 83 | 26537441 |
US |
80 | 2 |
Device issue, Injection site haemorrhage, Pain, Needle issue, Device deployment issue, |
||||
ABATACEPT, |
||||
| 84 | 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, |
||||
| 85 | 26537635 |
2 | ||
Product dose omission issue, Device issue, |
||||
TERIPARATIDE, |
||||
| 86 | 26538048 |
US |
1 | |
Surgery, Device issue, Malaise, |
||||
RISANKIZUMAB-RZAA, |
||||
| 87 | 26538702 |
US |
33 | 2 |
Thyroid cancer, Dyspnoea, Fatigue, Thyroid disorder, Malaise, Swelling, Hypotension, Injection site irritation, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TADALAFIL, POTASSIUM BICARBONATE, FUROSEMIDE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, SILDENAFIL CITRATE, SILDENAFIL, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, IRON, OXYGEN, 0XYGEN, ESCITALOPRAM, ONDANSETRON HYDROCHLORIDE, |
||||
| 88 | 26538928 |
US |
52 | 1 |
Surgery, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 89 | 26539315 |
US |
66 | 2 |
Wrong technique in product usage process, Device issue, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 90 | 26539343 |
62 | ||
Myasthenia gravis, Device issue, Incorrect dose administered, |
||||
ROZANOLIXIZUMAB, |
||||
| 91 | 26539347 |
US |
77 | 2 |
Speech disorder, Wrong technique in device usage process, Incorrect dose administered by device, Device difficult to use, Device issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 92 | 26539439 |
US |
79 | 2 |
Cough, Device issue, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE, |
||||
| 93 | 26539536 |
US |
1 | |
Colectomy, Mobility decreased, Exostosis, Pyoderma gangrenosum, Device issue, Hypoacusis, Colitis ulcerative, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 94 | 26539666 |
US |
2 | |
Device issue, Wrong technique in product usage process, |
||||
EXENATIDE, |
||||
| 95 | 26540210 |
EU |
73 | 2 |
Injection site abscess, Vascular encephalopathy, Essential hypertension, Injection site infection, Dysarthria, Urinary incontinence, General physical health deterioration, Malnutrition, Injection site pain, Hypertonia, Reduced facial expression, Facial asymmetry, Dyscalculia, Speech disorder, Dysphonia, Dysarthria, Disorientation, Aggression, Sensory disturbance, Fall, Anxiety, Memory impairment, Depression, Affective disorder, Confusional state, Drug resistance, Balance disorder, Behaviour disorder, Dehydration, Dysdiadochokinesis, Sarcopenia, Paraesthesia, Delirium, Injection site cellulitis, Device issue, Silent sinus syndrome, Muscular weakness, Fine motor skill dysfunction, Hyperreflexia, Cogwheel rigidity, Bradykinesia, Dyskinesia, Aphasia, Muscle atrophy, Echolalia, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, CLOZAPINE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, RIVASTIGMINE, DALTEPARIN SODIUM, |
||||
| 96 | 26540527 |
US |
2 | |
Wrong technique in product usage process, Injection site bruising, Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 97 | 26541195 |
US |
18 | 1 |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 98 | 26541293 |
US |
1 | |
Injection site papule, Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 99 | 26541302 |
US |
2 | |
Injection site pain, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 100 | 26541675 |
US |
26 | 1 |
Swelling, Injection site pain, Device issue, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
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