Drug:
Reaction: DEVICE ISSUE
20250101 - 20251231
No. 801 - 900
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 801 | 24980756 |
US |
||
Drug dose omission by device, Device occlusion, Device delivery system issue, Device issue, No adverse event, |
||||
ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, ALPRAZOLAM, |
||||
| 802 | 24981036 |
US |
2 | |
Therapeutic product effect delayed, Product use issue, Drooling, Condition aggravated, Wrong technique in device usage process, Incorrect dose administered by device, Device issue, Parkinson^s disease, Inappropriate schedule of product administration, Product dose omission issue, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LINACLOTIDE, PANTOPRAZOLE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE, |
||||
| 803 | 24981041 |
US |
70 | 2 |
Tremor, Incorrect dose administered by device, Wrong technique in device usage process, Device difficult to use, Device issue, Cough, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, AMANTADINE, RASAGILINE, RASAGILINE MESYLATE, |
||||
| 804 | 24981046 |
US |
72 | 2 |
Therapeutic product effect incomplete, Product communication issue, Device difficult to use, Wrong technique in device usage process, Incorrect dose administered by device, Product residue present, Device issue, Cough, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 805 | 24981049 |
US |
45 | 2 |
Loss of control of legs, Parkinson^s disease, Overdose, Treatment noncompliance, Device issue, Drug dose omission by device, Device malfunction, Device use issue, Drug ineffective, Dyskinesia, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, AMANTADINE, AMANTADINE, AMANTADINE, PROGESTERONE, ERGOCALCIFEROL, CYANOCOBALAMIN, MAGNESIUM GLYCINATE, ENTACAPONE, AMANTADINE, ROTIGOTINE, SELEGILINE, |
||||
| 806 | 24981050 |
US |
80 | 1 |
Glaucoma, Rash pruritic, Unevaluable event, Dysarthria, Condition aggravated, Condition aggravated, Coordination abnormal, Condition aggravated, Incorrect route of product administration, Incorrect dose administered by device, Therapy interrupted, Device issue, Wrong technique in product usage process, Hyperhidrosis, Gait disturbance, Asthenia, Drug ineffective, Cough, Confusional state, Headache, Dyskinesia, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, TELMISARTAN, FAMOTIDINE, |
||||
| 807 | 24981063 |
US |
1 | |
Dry mouth, Muscular weakness, Intentional underdose, Device issue, Incorrect dose administered by device, Product residue present, Device difficult to use, Wrong technique in device usage process, Wrong schedule, Therapy interrupted, Device delivery system issue, Productive cough, |
||||
LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, RASAGILINE, RASAGILINE MESYLATE, |
||||
| 808 | 24981064 |
US |
78 | 2 |
Throat irritation, Device issue, Expulsion of medication, Intentional underdose, Product residue present, Cough, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, AMANTADINE, PRAMIPEXOLE, PRAMIPEXOLE, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 809 | 24981069 |
US |
1 | |
Device occlusion, Device difficult to use, Peripheral swelling, Dysstasia, Balance disorder, Device defective, Device issue, Incorrect dose administered by device, Wrong technique in product usage process, Hypoacusis, |
||||
LEVODOPA, LEVODOPA, FINASTERIDE, TORSEMIDE, AMLODIPINE, ERGOCALCIFEROL, |
||||
| 810 | 24981077 |
US |
86 | 1 |
Limb discomfort, Feeling abnormal, Wrong technique in device usage process, Product communication issue, Limb discomfort, Device issue, Device difficult to use, Product cleaning inadequate, Device defective, Product dose omission issue, Device use issue, Therapy interrupted, Cough, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, ROTIGOTINE, |
||||
| 811 | 24981084 |
US |
72 | 2 |
Device issue, Drug effect less than expected, Device occlusion, Product storage error, Device use issue, Cough, |
||||
LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 812 | 24981095 |
US |
56 | 1 |
Speech disorder, Wrong technique in product usage process, Device issue, Device deposit issue, Product storage error, Therapeutic product effect variable, Device delivery system issue, Product packaging issue, Drug ineffective, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, |
||||
| 813 | 24981096 |
US |
67 | 2 |
Therapeutic product effect variable, Wrong technique in device usage process, Device colour issue, Product cleaning inadequate, Device occlusion, Device issue, Somnolence, Cough, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, |
||||
| 814 | 24981099 |
US |
2 | |
Panic attack, Unevaluable event, Abdominal pain, Incorrect dose administered by device, Wrong schedule, Device difficult to use, Device defective, Device issue, Wrong technique in device usage process, Device difficult to use, Drug ineffective, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DONEPEZIL HYDROCHLORIDE, ENTACAPONE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, POLYETHYLENE GLYCOL 3350, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, PRUCALOPRIDE, QUETIAPINE, CARBIDOPA, CARBIDOPA TABLETS, |
||||
| 815 | 24981100 |
US |
2 | |
Freezing phenomenon, Wrist fracture, Device issue, Wrong technique in device usage process, Wrong schedule, Feeling abnormal, Balance disorder, Incorrect dose administered by device, Restless legs syndrome, Limb discomfort, Insomnia, Sputum discoloured, Fall, Headache, |
||||
LEVODOPA, LEVODOPA, AMANTADINE, OMEPRAZOLE MAGNESIUM, CARBIDOPA AND LEVODOPA, GABAPENTIN, MIRTAZAPINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 816 | 24981110 |
US |
78 | 1 |
Malaise, Expulsion of medication, Product communication issue, Device issue, Device difficult to use, Wrong technique in device usage process, Product residue present, Drug dose omission by device, Device occlusion, Product colour issue, Product packaging difficult to open, Device use issue, Cough, Nasal discomfort, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, CLONAZEPAM, CARBIDOPA AND LEVODOPA, ROPINIROLE, FINASTERIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 817 | 24981164 |
US |
72 | 1 |
Device use issue, Wrong technique in device usage process, Incorrect route of product administration, Incorrect dose administered by device, Device issue, Drug ineffective, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, |
||||
| 818 | 24981167 |
US |
1 | |
Device malfunction, Device issue, Inappropriate schedule of product administration, Drug ineffective, |
||||
LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, MIRABEGRON, FOLIC ACID, CYANOCOBALAMIN, ROTIGOTINE, MIRTAZAPINE, |
||||
| 819 | 24981168 |
US |
77 | 2 |
Parkinson^s disease, Device difficult to use, Patient dissatisfaction with device, Product packaging difficult to open, Incorrect dose administered by device, Wrong technique in device usage process, Device issue, Device malfunction, Product physical issue, Device occlusion, Intentional underdose, Product dose omission issue, Cough, Arthritis, |
||||
LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, LEVODOPA, ENTACAPONE, FUROSEMIDE, LEFLUNOMIDE, ESCITALOPRAM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, PRAMIPEXOLE, RALOXIFENE, CARBIDOPA AND LEVODOPA, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 820 | 24981169 |
US |
68 | 2 |
Memory impairment, Product communication issue, Device use issue, Device issue, Drug effect less than expected, Wrong technique in device usage process, Device use error, Device issue, Cough, Cough, |
||||
LEVODOPA, LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
| 821 | 24981203 |
CA |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 822 | 24981260 |
US |
56 | 2 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 823 | 24981347 |
TR |
||
Device issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 824 | 24981663 |
US |
2 | |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 825 | 24981719 |
US |
||
Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 826 | 24982676 |
US |
60 | 1 |
Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, |
||||
| 827 | 24982770 |
US |
2 | |
Accidental exposure to product, Drug dose omission by device, Device issue, |
||||
SECUKINUMAB, |
||||
| 828 | 24982982 |
CA |
50 | 2 |
Product dose omission issue, Agitation, Device issue, |
||||
GOLIMUMAB, |
||||
| 829 | 24982991 |
US |
39 | 1 |
Injection site papule, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 830 | 24983061 |
US |
78 | 2 |
Device issue, Device operational issue, Product dose omission issue, |
||||
ABATACEPT, ABATACEPT, ANASTROZOLE, ANASTROZOLE TABLETS, FENOFIBRATE, LOSARTAN, AMLODIPINE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, |
||||
| 831 | 24983084 |
FR |
21 | 1 |
Device issue, Product dose omission issue, Syringe issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 832 | 24983120 |
US |
18 | 1 |
Disability, Device issue, Aphasia, |
||||
ADALIMUMAB, |
||||
| 833 | 24983158 |
US |
56 | 1 |
Drug ineffective, Device difficult to use, Device issue, |
||||
GLATIRAMER ACETATE, |
||||
| 834 | 24974235 |
US |
69 | |
Injection site scar, Device issue, Incorrect dose administered by device, Product dose omission issue, |
||||
EXENATIDE, |
||||
| 835 | 24975131 |
US |
||
Syringe issue, Needle issue, Accidental exposure to product, Device issue, |
||||
DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT), |
||||
| 836 | 24975818 |
US |
2 | |
Reproductive complication associated with device, Caesarean section, Device breakage, Foreign body in reproductive tract, Complication of device removal, Device issue, Depression, Device expulsion, Abnormal uterine bleeding, |
||||
COPPER, |
||||
| 837 | 24976032 |
US |
22 | 2 |
Reproductive complication associated with device, High risk pregnancy, Abortion spontaneous, Device breakage, Foreign body in reproductive tract, Complication of device removal, Embedded device, Device issue, Device mechanical issue, Complication of pregnancy, Cervicitis, Emotional disorder, Abnormal uterine bleeding, Menstruation irregular, Dysmenorrhoea, Muscle spasms, Pelvic pain, Pain, Device expulsion, |
||||
COPPER, ALBUTEROL SULFATE, |
||||
| 838 | 24976171 |
CA |
36 | 2 |
Device issue, Product dose omission issue, Off label use, |
||||
GOLIMUMAB, |
||||
| 839 | 24976292 |
US |
28 | 1 |
Drug ineffective, Device issue, |
||||
ADALIMUMAB-ADAZ, |
||||
| 840 | 24976304 |
US |
2 | |
Death, Oxygen therapy, Neoplasm malignant, Mechanical ventilation, Nasopharyngitis, Influenza, Laziness, Dysgeusia, Cough, Diarrhoea, Malaise, Intentional dose omission, Product dose omission issue, Therapy interrupted, Product distribution issue, Device issue, |
||||
AMIKACIN, |
||||
| 841 | 24976385 |
US |
40 | 2 |
Wrong technique in product usage process, Pain, Device issue, Product quality issue, Liquid product physical issue, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 842 | 24976448 |
US |
1 | |
Hospitalisation, Illness, Living in residential institution, Asthenia, Aphonia, Product dose omission issue, Accidental underdose, Therapy interrupted, Device issue, Drug dose omission by device, |
||||
AMIKACIN, AMIKACIN, |
||||
| 843 | 24976596 |
US |
57 | 2 |
Device issue, Injection site haemorrhage, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 844 | 24976992 |
US |
2 | |
Device leakage, Drug dose omission by device, Device malfunction, Needle issue, Device issue, Pruritus, Psoriasis, |
||||
SECUKINUMAB, SECUKINUMAB, |
||||
| 845 | 24977052 |
AR |
9 | 1 |
Off label use, Device use issue, Device issue, Drug dose omission by device, |
||||
SOMATROPIN, |
||||
| 846 | 24977243 |
US |
2 | |
Pregnancy with implant contraceptive, Unintended pregnancy, Complication associated with device, Device issue, Complication of device removal, Product use issue, Incorrect product administration duration, |
||||
ETONOGESTREL, |
||||
| 847 | 24977284 |
US |
2 | |
Device issue, Abdominal pain lower, |
||||
LEVONORGESTREL, CELECOXIB, CLONAZEPAM, DULOXETINE HYDROCHLORIDE, DULOXETINE, GABAPENTIN, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MELOXICAM, SOLIFENACIN SUCCIATE, SOLIFENACIN SUCCINATE, TIZANIDINE HYDROCHLORIDE, CARIPRAZINE, |
||||
| 848 | 24977323 |
US |
55 | 2 |
Off label use, Device issue, |
||||
FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 849 | 24977336 |
FR |
41 | 2 |
Device issue, Angioedema, Incorrect dose administered by device, Haematoma, Face oedema, Drug interaction, Urticaria, |
||||
OMALIZUMAB, |
||||
| 850 | 24977530 |
US |
1 | |
Injection site pain, Device difficult to use, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 851 | 24977641 |
US |
1 | |
Accidental exposure to product, Device issue, Device delivery system issue, Device leakage, Exposure via skin contact, |
||||
SECUKINUMAB, |
||||
| 852 | 24977841 |
IT |
12 | 1 |
Drug dose omission by device, Device mechanical issue, Device issue, |
||||
SOMATROPIN, |
||||
| 853 | 24977872 |
US |
||
Product dose omission issue, Liquid product physical issue, Device issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 854 | 24978226 |
US |
47 | 2 |
Drug dose omission by device, Device issue, Device breakage, |
||||
SOMATROPIN, |
||||
| 855 | 24978250 |
US |
1 | |
Product use complaint, Injection site pain, Device leakage, Device issue, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 856 | 24978319 |
US |
2 | |
Device issue, Accidental exposure to product, Incorrect dose administered by device, |
||||
SECUKINUMAB, |
||||
| 857 | 24978390 |
NL |
66 | 1 |
Loss of consciousness, Orthostatic hypotension, Muscle rigidity, Hypertonic bladder, Device issue, |
||||
CLOZAPINE, |
||||
| 858 | 24978404 |
US |
77 | 2 |
Infusion site pain, Product leakage, Sleep deficit, Headache, Device issue, Device occlusion, Device adhesion issue, Infusion site scar, Crying, Fatigue, Weight increased, Depressed mood, Device issue, Device use error, |
||||
TREPROSTINIL, TREPROSTINIL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, MAGNESIUM, ERGOCALCIFEROL, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, IRON, OXYGEN, 0XYGEN, BUMETANIDE, SPIRONOLACTONE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, |
||||
| 859 | 24978441 |
US |
||
White blood cell count abnormal, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, FILGRASTIM, FILGRASTIM-SNDZ, TBO-FILGRASTIM, |
||||
| 860 | 24973207 |
US |
51 | |
Liquid product physical issue, Underdose, Device issue, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 861 | 24973222 |
US |
53 | 2 |
Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 862 | 24973232 |
US |
49 | 2 |
Accidental exposure to product, Device issue, |
||||
PEGFILGRASTIM, PEGFILGRASTIM, |
||||
| 863 | 24973301 |
EG |
1 | |
Drug dose omission by device, Device issue, |
||||
SOMATROPIN, |
||||
| 864 | 24973386 |
IL |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 865 | 24973504 |
US |
||
Injection site pain, Puncture site pain, Injection site haemorrhage, Incorrect dose administered, Device issue, Product dispensing issue, Wrong technique in product usage process, |
||||
EXENATIDE, |
||||
| 866 | 24972660 |
US |
44 | 2 |
Nausea, Flushing, Device use error, Device issue, Infusion site erythema, Infusion site pain, Infusion site swelling, |
||||
TREPROSTINIL, TREPROSTINIL, FUROSEMIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, KETAMINE HYDROCHLORIDE, GABAPENTIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CLONIDINE, KETOPROFEN, IRON, OXYGEN, 0XYGEN, SPIRONOLACTONE, LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, TIRZEPATIDE, AMITRIPTYLINE HYDROCHLORIDE, SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, |
||||
| 867 | 24972784 |
US |
62 | 2 |
Injection site mass, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 868 | 24972813 |
US |
63 | 2 |
Product dose omission issue, Device issue, Needle issue, Accidental exposure to product, |
||||
GUSELKUMAB, |
||||
| 869 | 24972932 |
US |
19 | 1 |
Injection site papule, Injection site swelling, Device issue, Injection site swelling, Injection site papule, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 870 | 24972933 |
US |
61 | 2 |
Injection site haemorrhage, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 871 | 24973004 |
IT |
1 | |
Drug dose omission by device, Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 872 | 24967367 |
US |
70 | 2 |
Injection site discharge, Injection site haemorrhage, Device issue, |
||||
ADALIMUMAB, LEFLUNOMIDE, TIZANIDINE HYDROCHLORIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, POTASSIUM CHLORIDE, RAMIPRIL, FOLIC ACID, |
||||
| 873 | 24967500 |
FR |
2 | |
Device issue, Product dose omission issue, Product leakage, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 874 | 24967544 |
MA |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 875 | 24968475 |
US |
||
Device issue, |
||||
PEGFILGRASTIM, |
||||
| 876 | 24968921 |
US |
2 | |
Pyrexia, Cough, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 877 | 24969264 |
CA |
62 | 2 |
Device issue, Hypersomnia, Infusion site swelling, Neutropenia, Product quality issue, Tooth disorder, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, METHOTREXATE, METHOTREXATE SODIUM, NALTREXONE HYDROCHLORIDE, |
||||
| 878 | 24969346 |
US |
21 | 1 |
Large intestine operation, Intestinal resection, Device issue, Drug ineffective, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 879 | 24969353 |
CA |
15 | 1 |
Bedridden, Blood pressure increased, Deep brain stimulation, Device issue, Injection site erythema, Injection site swelling, Muscle spasms, Spinal compression fracture, Wheelchair user, Off label use, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, PREDNISONE, |
||||
| 880 | 24969431 |
TR |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 881 | 24969631 |
CA |
50 | 1 |
Respiratory tract infection viral, Incorrect dose administered, Chills, Wrong technique in product usage process, Arthralgia, Bone pain, Device issue, Fatigue, Pruritus, Pyrexia, Nasal mucosal disorder, Rhinorrhoea, Nasal mucosal discolouration, Inflammation, Upper-airway cough syndrome, |
||||
FREMANEZUMAB-VFRM, |
||||
| 882 | 24969647 |
US |
||
Device issue, |
||||
GOLIMUMAB, |
||||
| 883 | 24969891 |
US |
65 | 2 |
Dyspnoea, Device issue, |
||||
TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 884 | 24969896 |
US |
36 | 2 |
Product dose omission issue, Device issue, |
||||
GUSELKUMAB, |
||||
| 885 | 24970495 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 886 | 24970883 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 887 | 24970884 |
US |
||
Device issue, |
||||
NITRIC OXIDE, |
||||
| 888 | 24971443 |
US |
1 | |
Syringe issue, Product dose omission issue, Device issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 889 | 24971513 |
US |
11 | 1 |
Device issue, Device mechanical issue, |
||||
SOMATROPIN, |
||||
| 890 | 24971858 |
FR |
||
Device issue, |
||||
GUSELKUMAB, |
||||
| 891 | 24962758 |
US |
2 | |
Maternal exposure during pregnancy, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 892 | 24963045 |
US |
2 | |
Syringe issue, Device issue, Off label use, |
||||
USTEKINUMAB, USTEKINUMAB, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, GABAPENTIN, TIZANIDINE HYDROCHLORIDE, SEMAGLUTIDE, DICYCLOMINE HYDROCHLORIDE, DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, |
||||
| 893 | 24963097 |
US |
2 | |
Pyrexia, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 894 | 24963178 |
DE |
80 | 1 |
Sleep disorder, Device issue, Hallucination, Cognitive disorder, Poor quality sleep, Rapid eye movement sleep behaviour disorder, On and off phenomenon, Pneumonia aspiration, Urosepsis, Hiatus hernia, Gastrooesophageal reflux disease, Vitamin B6 deficiency, Folate deficiency, Axonal and demyelinating polyneuropathy, Normochromic normocytic anaemia, Nausea, Vomiting, Weight decreased, Device dislocation, Osteochondrosis, Atrioventricular block, Hypertension, Lumbar vertebral fracture, Fall, Feeding disorder, Hypoaesthesia, General physical health deterioration, Disorientation, Aggression, Nocturia, Constipation, Depressed mood, Psychomotor skills impaired, Asthenia, Diastolic dysfunction, Gait disturbance, Mobility decreased, Thrombocytopenia, Abdominal pain, Cough, Dysphagia, Intentional medical device removal by patient, Intentional device misuse, Device related thrombosis, Haematuria, Polyneuropathy, Cardiomegaly, Psychotic symptom, Bradykinesia, Decreased appetite, Hallucination, visual, Hallucination, auditory, Paranoia, Malaise, |
||||
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, POLYETHYLENE GLYCOL 3350, SODIUM SULFATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE, ASCORBIC ACID, SODIUM ASCORBATE, OXYCODONE HYDROCHLORIDE, OXYCODONE, NALOXONE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PREGABALIN, RISPERIDONE, THIAMINE HYDROCHLORIDE, FOLIC ACID, POLYETHYLENE GLYCOL (3350), POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 400, OXYCODONE, PANTOPRAZOLE, PYRIDOXINE HYDROCHLORIDE, |
||||
| 895 | 24963444 |
US |
56 | 2 |
Device related sepsis, Renal disorder, Injection site infection, Complication associated with device, Device issue, Device dislocation, Arthritis, Seasonal allergy, Therapy non-responder, |
||||
TREPROSTINIL, TREPROSTINIL, BENRALIZUMAB, CETIRIZINE HYDROCHLORIDE, BISMUTH SUBSALICYLATE, LEVOTHYROXINE SODIUM, FOLIC ACID, ACETAMINOPHEN, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, BUMETANIDE, IRON DEXTRAN, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, BUDESONIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, MACITENTAN, OXYGEN, 0XYGEN, PAROXETINE HYDROCHLORIDE, NADOLOL, ZOLPIDEM TARTRATE, GUAIFENESIN, BENZONATATE, ALPRAZOLAM, SILDENAFIL CITRATE, SILDENAFIL, |
||||
| 896 | 24963739 |
US |
||
Adverse drug reaction, Chills, Body temperature decreased, Wrong technique in device usage process, Device issue, Device ineffective, Incorrect dose administered, Device use issue, Device malfunction, |
||||
EXENATIDE, |
||||
| 897 | 24963839 |
US |
11 | 2 |
Circumstance or information capable of leading to medication error, Device difficult to use, Device malfunction, Device issue, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 898 | 24964147 |
US |
1 | |
Neoplasm malignant, Impaired quality of life, Therapy interrupted, Product distribution issue, Device issue, Drug dose omission by device, |
||||
AMIKACIN, AMIKACIN, |
||||
| 899 | 24964372 |
US |
53 | 2 |
Product dose omission issue, Device issue, Accidental exposure to product, Pain, |
||||
GUSELKUMAB, |
||||
| 900 | 24964662 |
US |
||
Device issue, |
||||
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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