Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 25138982 |
US |
1 | |
Injection site injury, Device issue, Injection site bruising, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 2 | 25138996 |
US |
67 | 2 |
Incorrect dose administered by device, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 3 | 25139141 |
EG |
1 | |
Device use error, Device issue, |
||||
SOMATROPIN, |
||||
| 4 | 25139552 |
US |
52 | 1 |
Injection site pain, Device issue, |
||||
ADALIMUMAB, MESALAMINE, FERROUS SULFATE, |
||||
| 5 | 25139596 |
GB |
||
Device issue, Device defective, Inappropriate schedule of product administration, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 6 | 25139837 |
US |
8 | 2 |
General anaesthesia, Device issue, Complication of device removal, Complication associated with device, Device breakage, Product use issue, Incorrect product administration duration, |
||||
ETONOGESTREL, |
||||
| 7 | 25140157 |
US |
||
Device issue, No adverse event, |
||||
DEXMEDETOMIDINE HYDROCHLORIDE IN SODIUM CHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE IN 0.9% SODIUM CHLORIDE, |
||||
| 8 | 25140427 |
US |
27 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 9 | 25140428 |
US |
53 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 10 | 25140724 |
JP |
47 | 1 |
Stent placement, Low density lipoprotein abnormal, Influenza, Cholangitis acute, Cholangitis acute, Device issue, |
||||
UPADACITINIB, UPADACITINIB, UPADACITINIB, UPADACITINIB, UPADACITINIB, UPADACITINIB, UPADACITINIB, UPADACITINIB, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, EZETIMIBE, ICOSAPENT ETHYL, ICOSAPENT ETHYL CAPSULES, RISEDRONATE SODIUM, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, MESALAMINE, |
||||
| 11 | 25141057 |
IT |
||
Intercepted product preparation error, Device issue, |
||||
LEUPROLIDE ACETATE, |
||||
| 12 | 25141414 |
US |
2 | |
Blood glucose decreased, Discomfort, Device issue, Inappropriate schedule of product administration, |
||||
INSULIN LISPRO, |
||||
| 13 | 25142600 |
US |
3 | 2 |
Device use error, Device mechanical issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 14 | 25142606 |
US |
13 | 2 |
Drug dose omission by device, Device use error, Device issue, Poor quality device used, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 15 | 25142637 |
GR |
10 | 2 |
Device issue, |
||||
SOMATROPIN, |
||||
| 16 | 25142819 |
US |
40 | 2 |
Device issue, Product dose omission issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 17 | 25138327 |
FR |
52 | 2 |
Crohn^s disease, Accidental exposure to product, Device issue, Product dose omission issue, Off label use, Eye inflammation, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 18 | 25137193 |
US |
2 | |
Injection site papule, Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 19 | 25137321 |
US |
74 | 1 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 20 | 25137554 |
US |
44 | 2 |
Crohn^s disease, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 21 | 25137651 |
US |
59 | 1 |
Injection site injury, Device issue, Product dispensing error, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 22 | 25137722 |
US |
||
Tremor, Device issue, |
||||
ADALIMUMAB, |
||||
| 23 | 25137843 |
US |
2 | |
Injection site papule, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, |
||||
| 24 | 25137998 |
US |
75 | |
Product dose omission issue, Product dose omission in error, Device issue, |
||||
TEZEPELUMAB-EKKO, |
||||
| 25 | 25132481 |
US |
72 | 2 |
Nausea, Device issue, |
||||
TREPROSTINIL, TREPROSTINIL, EPOPROSTENOL, WATER, STERILE WATER, STERILE WATER FOR INJECTION, NIFEDIPINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, LOVASTATIN, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, ALBUTEROL SULFATE, SILDENAFIL CITRATE, SILDENAFIL, SILVER SULFADIAZINE, APIXABAN, OXYGEN, 0XYGEN, MAGNESIUM, MONTELUKAST SODIUM, MONTELUKAST, |
||||
| 26 | 25132555 |
US |
86 | 1 |
Device leakage, Device issue, Device dislocation, |
||||
CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 27 | 25132889 |
US |
56 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, SEMAGLUTIDE, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, |
||||
| 28 | 25132940 |
BE |
||
Product dose omission issue, Device issue, |
||||
GOLIMUMAB, |
||||
| 29 | 25133470 |
US |
36 | 2 |
Product dose omission issue, Accidental exposure to product, Device issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 30 | 25133493 |
US |
20 | |
Blood glucose increased, Device issue, |
||||
INSULIN ASPART, |
||||
| 31 | 25134739 |
US |
76 | 1 |
Medical device change, Device issue, |
||||
IBRUTINIB, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, METHOCARBAMOL, METHOCARBAMOL TABLETS, METHYLPREDNISOLONE, GABAPENTIN, DAPAGLIFLOZIN, OXYCODONE AND ACETAMINOPHEN, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, OXYCODONE AND ACETAMINOPHEN TABLETS, |
||||
| 32 | 25134859 |
US |
78 | 2 |
Injection site haemorrhage, Fall, Off label use, Accidental exposure to product, Vitamin D decreased, Product dose omission issue, Device issue, |
||||
OMALIZUMAB, ROSUVASTATIN, LEVOTHYROXINE, LOSARTAN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, HYDROXYZINE, AMLODIPINE BESYLATE, AMLODIPINE BESYLATE, AMLODIPINE BESYLATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, CLONAZEPAM, |
||||
| 33 | 25134924 |
JP |
41 | 2 |
Vaginal perforation, Device expulsion, Procedural pain, Ovarian cyst, Device issue, |
||||
LEVONORGESTREL, |
||||
| 34 | 25135040 |
CA |
71 | 2 |
Inappropriate schedule of product administration, Device issue, |
||||
ADALIMUMAB-AFZB, ADALIMUMAB-AFZB, FOLIC ACID, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 35 | 25135557 |
US |
31 | 2 |
Malaise, Illness, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 36 | 25135591 |
US |
83 | |
Eye disorder, Muscular weakness, Wrong technique in product usage process, Incorrect dose administered, Product dose omission issue, Device issue, Device use issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 37 | 25136048 |
US |
78 | 1 |
Knee arthroplasty, Colitis ulcerative, Device issue, Paraesthesia, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 38 | 25136092 |
US |
||
Drug dose omission by device, Device issue, Device delivery system issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, |
||||
| 39 | 25136157 |
US |
16 | 1 |
Device use error, Device issue, |
||||
SOMATROPIN, |
||||
| 40 | 25136167 |
US |
17 | 1 |
Device issue, |
||||
SOMATROPIN, |
||||
| 41 | 25136169 |
CO |
8 | 1 |
Device issue, Wrong technique in product usage process, |
||||
SOMATROPIN, |
||||
| 42 | 25136361 |
US |
2 | |
Device issue, |
||||
LEVONORGESTREL, |
||||
| 43 | 25136514 |
US |
33 | 1 |
Surgery, Wound complication, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 44 | 25136613 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 45 | 25136663 |
CA |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 46 | 25136793 |
US |
1 | |
Accidental exposure to product, Product dose omission issue, Device issue, |
||||
SECUKINUMAB, |
||||
| 47 | 25136809 |
CZ |
31 | 2 |
Uterine perforation, Uterine adhesions, Device dislocation, Device issue, |
||||
LEVONORGESTREL, |
||||
| 48 | 25136868 |
CN |
65 | 2 |
Blood pressure increased, Product physical issue, Device issue, Cardiac discomfort, Blood glucose increased, |
||||
| 49 | 25137075 |
US |
2 | |
Malaise, Abdominal distension, Diarrhoea, Flatulence, Gastrointestinal sounds abnormal, Colitis ulcerative, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 50 | 25137120 |
DE |
75 | 2 |
Deafness, Ear discomfort, Device issue, |
||||
FOSCARBIDOPA/FOSLEVODOPA, |
||||
| 51 | 25126288 |
PT |
91 | |
Product dose omission issue, Drug delivery system issue, Device issue, |
||||
| 52 | 25126438 |
US |
72 | 2 |
Injection site pain, Device issue, Needle issue, Product complaint, |
||||
TOCILIZUMAB, |
||||
| 53 | 25126519 |
US |
25 | 1 |
Device issue, Product dose omission issue, Contusion, |
||||
GUSELKUMAB, |
||||
| 54 | 25126741 |
US |
34 | 2 |
Ovarian cyst, Complication of device removal, Device issue, Device dislocation, |
||||
COPPER, LACTIC ACID, L-, CITRIC ACID MONOHYDRATE, AND POTASSIUM BITARTRATE, |
||||
| 55 | 25126947 |
US |
43 | 2 |
Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, IXEKIZUMAB, |
||||
| 56 | 25127011 |
US |
1 | |
Incorrect dose administered, Accidental exposure to product, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 57 | 25127013 |
US |
35 | 1 |
Injection site pain, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 58 | 25127017 |
US |
1 | |
Psoriasis, Needle issue, Incorrect dose administered, Product availability issue, Device issue, Product distribution issue, |
||||
BIMEKIZUMAB, |
||||
| 59 | 25127106 |
US |
2 | |
Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 60 | 25127171 |
US |
2 | |
Incorrect dose administered, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 61 | 25127199 |
US |
46 | 1 |
Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, SECUKINUMAB, |
||||
| 62 | 25127243 |
US |
2 | |
Product availability issue, Device issue, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
| 63 | 25127296 |
US |
2 | |
Abortion induced, Pregnancy with contraceptive device, Drug ineffective, Complication of device removal, Device issue, |
||||
COPPER, |
||||
| 64 | 25128115 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 65 | 25128304 |
US |
||
Device issue, Product outer packaging issue, Liquid product physical issue, |
||||
MEDROXYPROGESTERONE ACETATE, |
||||
| 66 | 25129221 |
US |
4 | 2 |
Device issue, Device power source issue, |
||||
SOMATROPIN, |
||||
| 67 | 25129419 |
US |
31 | 1 |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, |
||||
| 68 | 25129444 |
US |
43 | 2 |
Product dose omission issue, Device issue, Accidental exposure to product, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, CYCLOSPORINE, CYCLOSPORINE, FAMOTIDINE, CETIRIZINE HYDROCHLORIDE, |
||||
| 69 | 25129716 |
US |
67 | 2 |
Injection site haemorrhage, Injection site pain, Device issue, Blood glucose increased, Product storage error, |
||||
INSULIN GLARGINE AND LIXISENATIDE, |
||||
| 70 | 25129986 |
CA |
2 | |
Pneumonia, Device issue, Rash erythematous, Pruritus, |
||||
RABEPRAZOLE, RIVAROXABAN, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, SULFAMETHOXAZOLE AND TRIMETHOPRIM, |
||||
| 71 | 25130098 |
US |
57 | 2 |
Nasopharyngitis, Device issue, |
||||
RISANKIZUMAB-RZAA, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, ATENOLOL AND CHLORTHALIDONE, ATENOLOL AND CHLORTHALIDONE TABLET, BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE (XL), FLUOXETINE HYDROCHLORIDE, FLUOXETINE, |
||||
| 72 | 25131059 |
US |
2 | |
Pain, Contusion, Device issue, Device issue, |
||||
TOCILIZUMAB, TOCILIZUMAB, |
||||
| 73 | 25131158 |
IN |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 74 | 25131281 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 75 | 25131467 |
US |
24 | 2 |
Injection site papule, Injection site papule, Device issue, Injection site haemorrhage, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, IRON, CETIRIZINE HYDROCHLORIDE, NORETHINDRONE, RISANKIZUMAB-RZAA, |
||||
| 76 | 25131867 |
DE |
||
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 77 | 25131904 |
US |
17 | 2 |
Mental disorder, Weight increased, Complication of device removal, Device issue, Incorrect product administration duration, |
||||
ETONOGESTREL, |
||||
| 78 | 25120987 |
CA |
1 | |
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 79 | 25121489 |
US |
||
Dyspnoea, Fatigue, Decreased activity, Device issue, Product dose omission issue, Incorrect dose administered by device, Device delivery system issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 80 | 25121525 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 81 | 25122031 |
US |
77 | 2 |
Vulvovaginal discomfort, Device issue, |
||||
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 82 | 25122959 |
US |
69 | 2 |
Cataract, Device issue, Needle issue, Product leakage, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 83 | 25123079 |
US |
65 | |
Wrong technique in product usage process, Device deposit issue, No adverse event, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL SULFATE, |
||||
| 84 | 25123103 |
US |
31 | 1 |
Device issue, Injection site urticaria, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 85 | 25124700 |
US |
2 | |
Application site rash, Application site pruritus, Product storage error, Product residue present, Product administration error, Product adhesion issue, Device issue, |
||||
| 86 | 25125254 |
TW |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 87 | 25125269 |
US |
7 | 1 |
Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 88 | 25125515 |
US |
13 | 1 |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 89 | 25125810 |
CO |
2 | |
Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 90 | 25115594 |
US |
60 | 1 |
Large intestinal haemorrhage, Crohn^s disease, Haematochezia, Gastrointestinal sounds abnormal, Dyspnoea, Musculoskeletal disorder, Haemoglobin decreased, Device issue, |
||||
RISANKIZUMAB-RZAA, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ROSUVASTATIN, AMLODIPINE, GLIMEPIRIDE, EMPAGLIFLOZIN, LISINOPRIL, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, RISANKIZUMAB-RZAA, |
||||
| 91 | 25115632 |
CA |
1 | |
Pneumonia, Asthenia, Device issue, Malaise, Back pain, Dizziness, Fibromyalgia, Nasopharyngitis, Incorrect dose administered, Mobility decreased, Neck pain, Headache, Wrong technique in product usage process, Pain, Swelling, Fall, Arthralgia, |
||||
DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, CELECOXIB, METHOTREXATE, METHOTREXATE SODIUM, PREGABALIN, RANITIDINE, NAPROXEN, NAPROXEN SODIUM, ETANERCEPT, ADALIMUMAB, SECUKINUMAB, SECUKINUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 92 | 25115771 |
US |
||
Device loosening, Device leakage, Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 93 | 25115815 |
US |
59 | 2 |
Wrong technique in product usage process, Underdose, Contusion, Device issue, Needle issue, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 94 | 25115962 |
US |
1 | |
Drug dose omission by device, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 95 | 25116091 |
US |
68 | 2 |
Diarrhoea, Drug dose omission by device, Tachycardia, Device malfunction, Device issue, Device leakage, |
||||
TERIPARATIDE, |
||||
| 96 | 25116324 |
US |
72 | 2 |
Accidental exposure to product, Device defective, Product dose omission issue, Ill-defined disorder, Device issue, Wrong technique in product usage process, Device malfunction, |
||||
TOCILIZUMAB, CETIRIZINE HYDROCHLORIDE, LEVOTHYROXINE, PREDNISONE, EVOLOCUMAB, |
||||
| 97 | 25116340 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 98 | 25116673 |
US |
2 | |
Enterocolitis haemorrhagic, Colitis ulcerative, Enterocolitis haemorrhagic, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 99 | 25116735 |
US |
51 | 1 |
Pancreatic stent removal, Device issue, Product administration error, Hospitalisation, Pancreatic disorder, Pain, Diarrhoea, Weight decreased, Vomiting, Electrolyte imbalance, Dehydration, |
||||
PANCRELIPASE, PANCRELIPASE, |
||||
| 100 | 25116820 |
US |
||
Product with quality issue administered, Product delivery mechanism issue, Device malfunction, Device issue, |
||||
ALBUTEROL SULFATE, ALBUTEROL, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, |
||||
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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