Drug:
Reaction: PRODUCT DOSE OMISSION ISSUE
20250101 - 20251231
No. 601 - 700
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 601 | 25120267 |
US |
2 | |
Candida infection, Wrong technique in device usage process, Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 602 | 25120305 |
GB |
83 | 1 |
Fall, Dementia, Product dose omission issue, |
||||
SOMATROPIN, |
||||
| 603 | 25120410 |
MX |
46 | 2 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 604 | 25120435 |
US |
61 | 2 |
Product dose omission issue, Injection site mass, Injection site pain, |
||||
DULAGLUTIDE, |
||||
| 605 | 25120441 |
US |
69 | 2 |
Product dose omission issue, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 606 | 25120515 |
US |
2 | |
Ammonia increased, Splenic artery embolisation, Depressed mood, Off label use, Product dose omission issue, |
||||
FOSTAMATINIB, LACTULOSE, |
||||
| 607 | 25120542 |
US |
76 | 1 |
Cerebrovascular accident, Oral pain, Feeling of body temperature change, Speech disorder, Product dose omission issue, Mouth swelling, Lip pain, Lip swelling, |
||||
DAROLUTAMIDE, |
||||
| 608 | 25120546 |
US |
||
Product dose omission issue, Hypoacusis, Device delivery system issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 609 | 25120560 |
US |
||
Therapy cessation, Energy increased, Product dose omission issue, Device defective, Feeling abnormal, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 610 | 25120583 |
US |
64 | 1 |
Device leakage, Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 611 | 25120595 |
US |
31 | 2 |
Product dose omission issue, Memory impairment, |
||||
DULAGLUTIDE, |
||||
| 612 | 25120730 |
US |
57 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 613 | 25120778 |
US |
76 | 2 |
Product dose omission issue, No adverse event, |
||||
PEMBROLIZUMAB, |
||||
| 614 | 25120779 |
US |
73 | 1 |
Product dose omission issue, Needle issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 615 | 25120793 |
US |
61 | 1 |
Loss of personal independence in daily activities, Pain, Arthralgia, Product dose omission issue, |
||||
APREMILAST, |
||||
| 616 | 25120796 |
BR |
1 | |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 617 | 25120798 |
US |
1 | |
Product dose omission issue, |
||||
SUVOREXANT, |
||||
| 618 | 25120812 |
SV |
33 | 2 |
Device deployment issue, Accidental exposure to product, Product dose omission issue, Incorrect route of product administration, |
||||
GOLIMUMAB, |
||||
| 619 | 25120880 |
US |
||
Product dose omission issue, General symptom, Productive cough, Fatigue, Decreased appetite, Increased need for sleep, |
||||
AMIVANTAMAB, |
||||
| 620 | 25120892 |
US |
2 | |
Colitis ulcerative, Treatment noncompliance, Drug effect less than expected, Off label use, Product dose omission issue, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 621 | 25120899 |
US |
1 | |
Product dose omission issue, |
||||
APIXABAN, |
||||
| 622 | 25109785 |
US |
51 | 1 |
Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 623 | 25109796 |
US |
||
Myocardial infarction, Spinal fracture, Road traffic accident, Product dose omission issue, Inability to afford medication, |
||||
OXYCODONE, OXYCODONE, |
||||
| 624 | 25109936 |
US |
||
Eye disorder, Drug ineffective, Product packaging quantity issue, Product use issue, Off label use, Product dose omission issue, Wrong technique in device usage process, Dyspnoea, Fatigue, Urinary tract infection, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 625 | 25109940 |
US |
66 | 2 |
Back pain, Lower respiratory tract congestion, Influenza like illness, Bronchitis, Arthralgia, Injection site erythema, Injection site mass, Peripheral swelling, Gastrointestinal disorder, Chest pain, Product dose omission issue, |
||||
EVOLOCUMAB, EVOLOCUMAB, EVOLOCUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, BISOPROLOL FUMARATE, CLOPIDOGREL, CLOPIDOGREL BISULFATE, LOSARTAN, |
||||
| 626 | 25109968 |
US |
24 | 1 |
Urticaria, Erythema, Pruritus, Product dose omission issue, Suspected product contamination, |
||||
FLUOXETINE HYDROCHLORIDE, FLUOXETINE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, |
||||
| 627 | 25109978 |
US |
1 | |
Product dose omission issue, |
||||
DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE, |
||||
| 628 | 25110003 |
US |
65 | 2 |
Product dispensing issue, Pain, Fatigue, Inflammation, Product dose omission issue, Wrong technique in product usage process, Product sterility issue, Drug ineffective, Device malfunction, |
||||
TOCILIZUMAB, TOCILIZUMAB, |
||||
| 629 | 25110010 |
US |
11 | 1 |
Skin exfoliation, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 630 | 25110031 |
US |
46 | 2 |
Product dose omission issue, Dyspepsia, Nausea, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 631 | 25110059 |
US |
43 | 2 |
Hereditary angioedema, Hereditary angioedema, Weight increased, Product dose omission issue, |
||||
| 632 | 25110083 |
US |
61 | 2 |
Product dose omission issue, Sinusitis, Pyrexia, |
||||
GUSELKUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 633 | 25110091 |
US |
||
Product dose omission issue, No adverse event, |
||||
SITAGLIPTIN, |
||||
| 634 | 25110170 |
US |
64 | 2 |
Blood glucose increased, Product dose omission issue, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 635 | 25110199 |
US |
22 | 1 |
Adverse drug reaction, Product dose omission issue, |
||||
DOLUTEGRAVIR SODIUM AND LAMIVUDINE, |
||||
| 636 | 25110244 |
US |
2 | |
Needle issue, Product dose omission issue, No adverse event, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 637 | 25110258 |
US |
2 | |
Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 638 | 25110260 |
US |
2 | |
Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 639 | 25110274 |
US |
2 | |
Gastroenteritis viral, Product dose omission issue, |
||||
EPINEPHRINE, |
||||
| 640 | 25110275 |
US |
12 | 1 |
No adverse event, Product dose omission issue, Needle issue, Device issue, |
||||
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 641 | 25110298 |
US |
2 | |
Product dose omission issue, |
||||
REVUMENIB, |
||||
| 642 | 25110322 |
US |
59 | 1 |
Product dose omission issue, Product leakage, Drug delivery system malfunction, |
||||
GUSELKUMAB, |
||||
| 643 | 25110349 |
US |
1 | |
Product dose omission issue, Inappropriate schedule of product administration, Speech disorder, |
||||
DIROXIMEL FUMARATE, |
||||
| 644 | 25110370 |
US |
||
Product dose omission issue, |
||||
ISOTRETINOIN, |
||||
| 645 | 25110463 |
US |
67 | 2 |
Product dose omission issue, Wrong technique in device usage process, No adverse event, |
||||
| 646 | 25110554 |
US |
1 | |
Oropharyngeal pain, Eating disorder, Product physical issue, Product taste abnormal, Product dose omission issue, |
||||
MEXILETINE HYDROCHLORIDE, |
||||
| 647 | 25110566 |
US |
62 | 2 |
Fatigue, Product dose omission issue, |
||||
BELIMUMAB, |
||||
| 648 | 25110665 |
US |
||
Hot flush, Product dose omission issue, |
||||
RELUGOLIX, RELUGOLIX, DAROLUTAMIDE, |
||||
| 649 | 25110705 |
US |
55 | 2 |
Product dose omission issue, Injection site pruritus, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 650 | 25110789 |
US |
1 | |
Product use complaint, Device malfunction, Product leakage, Accidental exposure to product, Product dose omission issue, |
||||
SECUKINUMAB, TESTOSTERONE, TESTOSTERONE,, |
||||
| 651 | 25110833 |
US |
51 | 1 |
Product dose omission issue, |
||||
DOLUTEGRAVIR SODIUM AND RILPIVIRINE HYDROCHLORIDE, |
||||
| 652 | 25110903 |
US |
2 | |
Cough, Insomnia, Product dose omission issue, Inappropriate schedule of product administration, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 653 | 25110946 |
CA |
71 | 1 |
Fatigue, Feeling cold, Ill-defined disorder, Platelet count decreased, Product dose omission issue, Product use issue, |
||||
ELTROMBOPAG, ELTROMBOPAG, CYCLOSPORINE, CYCLOSPORINE, CYCLOSPORINE, ELTROMBOPAG, IRBESARTAN, MAGNESIUM, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 654 | 25110951 |
US |
72 | 2 |
Blood glucose increased, Product dose omission issue, |
||||
INSULIN LISPRO-AABC, |
||||
| 655 | 25111028 |
US |
||
Transient global amnesia, Macular degeneration, Product dose omission issue, Flatulence, Micturition urgency, Post-traumatic stress disorder, Laboratory test abnormal, |
||||
ACALABRUTINIB, |
||||
| 656 | 25111036 |
US |
69 | 2 |
Product dose omission issue, |
||||
ABATACEPT, |
||||
| 657 | 25111189 |
10 | 2 | |
Diarrhoea infectious, Drug ineffective for unapproved indication, Product use in unapproved indication, Product dose omission issue, Inflammatory marker increased, Lichenoid keratosis, Mouth ulceration, Psoriasis, |
||||
METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, FOLIC ACID, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, |
||||
| 658 | 25111234 |
US |
2 | |
Respiratory tract congestion, Dyspnoea, Cough, Product dose omission issue, |
||||
MEPOLIZUMAB, MEPOLIZUMAB, OXYGEN, 0XYGEN, |
||||
| 659 | 25111242 |
US |
69 | |
Product dose omission issue, Spinal operation, Memory impairment, |
||||
EXENATIDE, |
||||
| 660 | 25111282 |
US |
54 | 1 |
Product dose omission issue, |
||||
DOLUTEGRAVIR SODIUM AND LAMIVUDINE, |
||||
| 661 | 25111345 |
US |
42 | 1 |
Ankylosing spondylitis, Product dose omission issue, |
||||
SECUKINUMAB, |
||||
| 662 | 25111507 |
CA |
55 | 2 |
Acne, Blood pressure systolic increased, Dermal cyst, Erythema, Eye pain, Feeling hot, Haemorrhage urinary tract, Headache, Hypersensitivity, Inappropriate schedule of product administration, Livedo reticularis, Major depression, Mental fatigue, Middle insomnia, Oxygen saturation decreased, Paraesthesia, Product dose omission issue, Pruritus, Rash, Skin burning sensation, Skin irritation, Skin plaque, Skin swelling, Stress, Suicidal ideation, Urinary tract infection, Urticaria, Weight decreased, Drug ineffective, |
||||
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, CICLESONIDE, DIPHENHYDRAMINE HYDROCHLORIDE, CLONIDINE, DEXLANSOPRAZOLE, LORAZEPAM, MONTELUKAST, NABILONE, OXAZEPAM, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, |
||||
| 663 | 25111537 |
US |
58 | 2 |
Product dose omission issue, |
||||
MAVACAMTEN, |
||||
| 664 | 25111551 |
US |
82 | 2 |
Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 665 | 25111557 |
US |
85 | 2 |
Product dose omission issue, |
||||
FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, AFLIBERCEPT, |
||||
| 666 | 25111686 |
US |
2 | |
Rheumatoid arthritis, Product storage error, Product dose omission issue, |
||||
CERTOLIZUMAB PEGOL, |
||||
| 667 | 25111704 |
US |
70 | 2 |
Product dose omission issue, |
||||
OZANIMOD HYDROCHLORIDE, |
||||
| 668 | 25111740 |
US |
69 | |
Product dose omission issue, Increased appetite, Weight increased, Nausea, Drug ineffective, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 669 | 25111785 |
US |
76 | 1 |
Product dose omission issue, |
||||
| 670 | 25111803 |
US |
64 | 2 |
Upper limb fracture, Wrong technique in device usage process, Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 671 | 25111890 |
US |
73 | 2 |
Product dose omission issue, |
||||
TAFAMIDIS, |
||||
| 672 | 25111972 |
US |
2 | |
Migraine, Psoriatic arthropathy, Angioedema, Fibromyalgia, Product dose omission issue, Product use issue, |
||||
ESTRADIOL, ESTRADIOL, |
||||
| 673 | 25112003 |
US |
||
Blood disorder, Product dose omission issue, |
||||
ACALABRUTINIB, |
||||
| 674 | 25112033 |
US |
32 | 2 |
Product dose omission issue, |
||||
BELIMUMAB, |
||||
| 675 | 25112107 |
US |
1 | |
Eye pain, Product dose omission issue, |
||||
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE, |
||||
| 676 | 25112123 |
US |
39 | 2 |
Blood pressure increased, Product dose omission issue, |
||||
BUDESONIDE, LOSARTAN, DAPAGLIFLOZIN, IRON, |
||||
| 677 | 25112194 |
US |
2 | |
Product dose omission issue, |
||||
PIMAVANSERIN TARTRATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CALCIUM, MAGNESIUM, |
||||
| 678 | 25112268 |
US |
2 | |
Poor quality sleep, Dizziness, Tremor, Incorrect dose administered, Product dose omission issue, Product distribution issue, |
||||
BRIVARACETAM, BRIVARACETAM, |
||||
| 679 | 25112277 |
US |
10 | 1 |
Product dose omission issue, |
||||
SOMATROPIN, |
||||
| 680 | 25112354 |
US |
43 | 2 |
Product dose omission issue, |
||||
BRIVARACETAM, |
||||
| 681 | 25112366 |
US |
78 | |
Glaucoma, Fungal infection, Pain, Gait disturbance, Product dose omission issue, Intentional product use issue, |
||||
DAPAGLIFLOZIN, |
||||
| 682 | 25112367 |
US |
58 | 1 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
| 683 | 25112391 |
US |
1 | |
Product packaging quantity issue, Product dose omission issue, Product availability issue, |
||||
BRIVARACETAM, |
||||
| 684 | 25112395 |
US |
||
Product dose omission issue, Product availability issue, |
||||
BRIVARACETAM, |
||||
| 685 | 25112437 |
US |
||
Cataract, Product dose omission issue, |
||||
VORASIDENIB, ALPRAZOLAM, BENZONATATE, CARBIDOPA AND LEVODOPA, TOLTERODINE TARTRATE, ESCITALOPRAM, COLCHICINE, LOSARTAN, ROSUVASTATIN, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 686 | 25112467 |
US |
2 | |
Drug ineffective, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 687 | 25112470 |
US |
2 | |
Drug ineffective, Product dose omission issue, Device malfunction, |
||||
BIMEKIZUMAB, |
||||
| 688 | 25112476 |
BE |
||
Product dose omission issue, Syringe issue, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 689 | 25112486 |
US |
66 | 1 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
| 690 | 25112491 |
US |
71 | 2 |
Product dose omission issue, Off label use, |
||||
LENALIDOMIDE, |
||||
| 691 | 25112495 |
US |
2 | |
Product dose omission issue, Off label use, |
||||
BIMEKIZUMAB, |
||||
| 692 | 25112498 |
US |
1 | |
Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 693 | 25112539 |
US |
2 | |
Psoriasis, Drug ineffective, Product dose omission issue, Insurance issue, Therapy interrupted, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 694 | 25112545 |
US |
2 | |
Pain, Psoriasis, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 695 | 25112550 |
US |
2 | |
Pain, Gait disturbance, Psoriasis, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 696 | 25112572 |
US |
2 | |
Incorrect dose administered, Device issue, Product dose omission issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 697 | 25112573 |
US |
2 | |
Product dose omission issue, Product availability issue, |
||||
BIMEKIZUMAB, |
||||
| 698 | 25112575 |
US |
1 | |
Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 699 | 25112580 |
US |
1 | |
Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 700 | 25112581 |
US |
2 | |
Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
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