Drug:
Reaction: PRODUCT DOSE OMISSION ISSUE
20250101 - 20251231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 25126122 |
JP |
57 | 1 |
Death, Cancer pain, Protein urine present, Decreased appetite, Product dose omission issue, |
||||
FRUQUINTINIB, FRUQUINTINIB, |
||||
| 502 | 25126164 |
CA |
||
Death, Product dose omission issue, |
||||
USTEKINUMAB-STBA, |
||||
| 503 | 25126200 |
US |
8 | 2 |
Erythema, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 504 | 25126251 |
US |
2 | |
Arthropod bite, Rash, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 505 | 25115592 |
CA |
42 | 2 |
Diarrhoea haemorrhagic, Osteoarthritis, Illness, Product dose omission issue, |
||||
INFLIXIMAB-AXXQ, INFLIXIMAB-AXXQ, INFLIXIMAB-AXXQ, INFLIXIMAB-AXXQ, INFLIXIMAB-AXXQ, PREDNISONE, |
||||
| 506 | 25115605 |
US |
2 | |
Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 507 | 25115626 |
US |
22 | 1 |
Adverse drug reaction, Product dose omission issue, |
||||
OZANIMOD HYDROCHLORIDE, |
||||
| 508 | 25115637 |
US |
||
Thinking abnormal, Product dose omission issue, |
||||
TEZEPELUMAB-EKKO, |
||||
| 509 | 25115670 |
US |
9 | 1 |
Product dose omission issue, Product prescribing issue, |
||||
FLUTICASONE PROPIONATE, |
||||
| 510 | 25115675 |
US |
||
Chronic obstructive pulmonary disease, Hypoaesthesia, Dyspnoea, Product dose omission issue, Incorrect dose administered, Device malfunction, Incorrect dose administered by device, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 511 | 25115719 |
US |
60 | 1 |
Peripheral vascular haematoma, Product dose omission issue, Pain, |
||||
ADALIMUMAB, |
||||
| 512 | 25115736 |
US |
44 | 2 |
Product dose omission issue, |
||||
CABOTEGRAVIR, |
||||
| 513 | 25115771 |
US |
||
Device loosening, Device leakage, Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 514 | 25115789 |
US |
2 | |
Syringe issue, Product quality issue, Product dose omission issue, No adverse event, Device defective, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 515 | 25115791 |
US |
40 | 1 |
Product dose omission issue, |
||||
CABOTEGRAVIR, |
||||
| 516 | 25115807 |
US |
14 | 2 |
Product dose omission issue, Drug delivery system malfunction, Device malfunction, Needle issue, No adverse event, |
||||
OMALIZUMAB, |
||||
| 517 | 25115809 |
US |
24 | 2 |
Migraine, Product dose omission issue, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 518 | 25115851 |
GB |
1 | |
Surgery, Psoriatic arthropathy, Inappropriate schedule of product administration, Product dose omission issue, |
||||
| 519 | 25115870 |
US |
72 | 2 |
Secretion discharge, Product dose omission issue, Product use in unapproved indication, |
||||
MEPOLIZUMAB, |
||||
| 520 | 25115882 |
US |
2 | |
Gastrointestinal infection, Decreased appetite, Product use complaint, Product dose omission issue, Prescribed underdose, |
||||
TROFINETIDE, |
||||
| 521 | 25115944 |
US |
||
Ocular toxicity, Rash, Product dose omission issue, |
||||
AMIVANTAMAB, LAZERTINIB, |
||||
| 522 | 25116038 |
US |
78 | 2 |
Product dose omission issue, |
||||
| 523 | 25116052 |
US |
2 | |
Cough, General physical health deterioration, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 524 | 25116068 |
US |
57 | 2 |
Asthma, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 525 | 25116134 |
US |
||
Product dose omission issue, Off label use, Product packaging issue, |
||||
LANREOTIDE ACETATE, ERENUMAB-AOOE, IRON, CLONAZEPAM, DULOXETINE HYDROCHLORIDE, DULOXETINE, |
||||
| 526 | 25116175 |
US |
60 | 2 |
Pain in extremity, Product dose omission issue, Off label use, |
||||
LENALIDOMIDE, |
||||
| 527 | 25116176 |
US |
2 | |
Product dose omission issue, Product delivery mechanism issue, |
||||
FLUTICASONE PROPIONATE, |
||||
| 528 | 25116182 |
US |
1 | |
Hospitalisation, Surgery, Cough, Malaise, Fatigue, Headache, Dyspnoea, Intentional dose omission, Product dose omission issue, Treatment noncompliance, Therapy interrupted, |
||||
AMIKACIN, |
||||
| 529 | 25116201 |
US |
1 | |
Product dose omission issue, Product delivery mechanism issue, |
||||
FLUTICASONE PROPIONATE, |
||||
| 530 | 25116222 |
AR |
55 | 2 |
Pneumonia, Pain, Product dose omission issue, |
||||
GOLIMUMAB, GOLIMUMAB, |
||||
| 531 | 25116257 |
US |
71 | 2 |
Accidental underdose, Product dose omission issue, Off label use, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 532 | 25116289 |
US |
2 | |
Device malfunction, Product complaint, Underdose, Product dose omission issue, Injection site haemorrhage, |
||||
OMALIZUMAB, EPINEPHRINE, |
||||
| 533 | 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, |
||||
| 534 | 25116337 |
US |
81 | 2 |
Product dose omission issue, |
||||
IPRATROPIUM BROMIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LEVOTHYROXINE, |
||||
| 535 | 25116366 |
CO |
91 | |
Asthenia, Pain, Blood cholesterol abnormal, Blood triglycerides abnormal, Blood creatinine abnormal, Blood potassium abnormal, Product dose omission issue, |
||||
SODIUM ZIRCONIUM CYCLOSILICATE, |
||||
| 536 | 25116387 |
US |
1 | |
Product dose omission issue, Product packaging quantity issue, |
||||
| 537 | 25116402 |
US |
||
Device delivery system issue, Wrong technique in product usage process, Drug hypersensitivity, Aphonia, Product dose omission issue, Malaise, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 538 | 25116447 |
US |
||
Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 539 | 25116493 |
US |
2 | |
Drug ineffective, Product dose omission issue, Product storage error, |
||||
ADALIMUMAB-ADAZ, |
||||
| 540 | 25116558 |
US |
||
Fatigue, Hot flush, Product dose omission issue, Product distribution issue, |
||||
RELUGOLIX, RELUGOLIX, ENZALUTAMIDE, NAPROXEN SODIUM, NAPROXEN SODIUM TABLET, |
||||
| 541 | 25116606 |
US |
2 | |
Product dose omission issue, Product availability issue, Therapy interrupted, |
||||
BIMEKIZUMAB, |
||||
| 542 | 25116607 |
US |
1 | |
Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 543 | 25116788 |
US |
61 | 2 |
Product dose omission issue, Blood glucose increased, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 544 | 25116835 |
US |
2 | |
Crohn^s disease, Product dose omission issue, Product distribution issue, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 545 | 25116854 |
US |
||
Off label use, Speech disorder, Product dose omission issue, |
||||
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, |
||||
| 546 | 25116899 |
US |
51 | 2 |
Product dose omission issue, |
||||
MAVACAMTEN, |
||||
| 547 | 25116945 |
US |
76 | 1 |
Device leakage, Product dose omission issue, Injection site pain, |
||||
GUSELKUMAB, |
||||
| 548 | 25117011 |
US |
||
Product dose omission issue, |
||||
BOSENTAN, |
||||
| 549 | 25117058 |
US |
49 | 2 |
Product dose omission issue, Injection site coldness, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 550 | 25117195 |
IN |
||
Device issue, Product dose omission issue, |
||||
GOLIMUMAB, |
||||
| 551 | 25117429 |
80 | 2 | |
Drug ineffective, Product dose omission issue, Abscess limb, Feeling hot, Localised infection, Malaise, Fine motor skill dysfunction, Musculoskeletal stiffness, Nodule, Peripheral swelling, Limb injury, Inappropriate schedule of product administration, |
||||
METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 552 | 25117463 |
US |
43 | |
Product dose omission issue, Seasonal allergy, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 553 | 25117675 |
US |
1 | |
Product adhesion issue, Product dose omission issue, |
||||
ROTIGOTINE, |
||||
| 554 | 25117697 |
US |
2 | |
Seizure, Vomiting, Product dose omission issue, Prescribed underdose, |
||||
TROFINETIDE, |
||||
| 555 | 25117823 |
US |
65 | 2 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
| 556 | 25117841 |
US |
1 | |
Visual impairment, Product dose omission issue, |
||||
INSULIN HUMAN, INSULIN HUMAN, INSULIN HUMAN, INSULIN HUMAN, |
||||
| 557 | 25117864 |
US |
2 | |
Product dose omission issue, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 558 | 25117923 |
US |
||
Surgery, Product dose omission issue, |
||||
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, |
||||
| 559 | 25117934 |
GB |
49 | 2 |
Hospitalisation, Product dose omission issue, Chest discomfort, Product dose omission issue, |
||||
ILOPROST, |
||||
| 560 | 25117945 |
US |
2 | |
Illness, Asthma, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 561 | 25118044 |
US |
||
Renal impairment, Urine odour abnormal, Arthritis, Product dose omission issue, |
||||
DAPAGLIFLOZIN, SEMAGLUTIDE, |
||||
| 562 | 25118081 |
US |
45 | 2 |
Product dose omission issue, |
||||
BELIMUMAB, |
||||
| 563 | 25118125 |
US |
1 | |
Thermal burn, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 564 | 25118352 |
US |
43 | 2 |
Product dose omission issue, Gastrointestinal disorder, Frequent bowel movements, |
||||
ABEMACICLIB, |
||||
| 565 | 25118388 |
CO |
71 | 2 |
Urinary tract infection, Product availability issue, Blood glucose increased, Product dose omission issue, Restlessness, |
||||
SITAGLIPTIN AND METFORMIN HYDROCHLORIDE, SITAGLIPTIN AND METFORMIN HYDROCHLORIDE, AZACITIDINE, AZACITIDINE FOR, METHOTREXATE, METHOTREXATE SODIUM, RITUXIMAB, |
||||
| 566 | 25118420 |
US |
2 | |
Product dispensing issue, Product dose omission issue, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 567 | 25118485 |
US |
2 | |
Menstruation delayed, Product dose omission issue, |
||||
RIMEGEPANT SULFATE, RIMEGEPANT SULFATE, |
||||
| 568 | 25118517 |
US |
23 | 1 |
Device issue, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 569 | 25118557 |
US |
||
Nasopharyngitis, Product dose omission issue, |
||||
BETAINE, LORATADINE, LORATADINE TABLET, ALBUTEROL SULFATE, ALBUTEROL, ATORVASTATIN CALCIUM, FOLIC ACID, LINACLOTIDE, OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE OPHTHALMIC, CYCLOSPORINE, MONTELUKAST SODIUM, TIOTROPIUM BROMIDE AND OLODATEROL, VITAMIN C, CLOPIDOGREL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 570 | 25118729 |
US |
1 | |
Product dose omission issue, |
||||
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, |
||||
| 571 | 25118735 |
US |
||
Pneumonia, Bronchitis, Illness, Immunodeficiency, Dyspnoea, Respiratory muscle weakness, Device malfunction, Product dose omission issue, |
||||
BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, |
||||
| 572 | 25118762 |
US |
32 | 2 |
Nasopharyngitis, Ear infection, Seasonal allergy, Brain fog, Bronchitis, Inappropriate schedule of product administration, Product dose omission issue, Multiple allergies, Intervertebral disc protrusion, Illness, Pain, Influenza, Urinary tract infection, Oropharyngeal pain, Migraine, Infusion site pruritus, Fatigue, |
||||
SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, SEMAGLUTIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, ERGOCALCIFEROL, EMPAGLIFLOZIN, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, MONTELUKAST SODIUM, MELATONIN, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, FLUTICASONE PROPIONATE, IRON, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL, MECLIZINE, BUPROPION HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, NASAL, SALINE, (SALINE), EPINEPHRINE, ADRENALINUM, |
||||
| 573 | 25118765 |
US |
86 | 2 |
Nasopharyngitis, Diarrhoea, Nausea, Cough, Sneezing, Asthenia, Insomnia, Product dose omission issue, |
||||
TAZEMETOSTAT, CARVEDILOL PHOSPHATE, APIXABAN, FAMOTIDINE, LOSARTAN, PANTOPRAZOLE, MONTELUKAST SODIUM, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, ZINC SULFATE, ZINC SULFATE INJECTION,, ZINC SULFATE INJECTION, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 574 | 25118772 |
US |
14 | 1 |
Product dose omission issue, |
||||
AMINOCAPROIC ACID, |
||||
| 575 | 25118778 |
US |
1 | |
Headache, Product dose omission issue, Malaise, |
||||
LANREOTIDE ACETATE, LANREOTIDE ACETATE, LANREOTIDE ACETATE, |
||||
| 576 | 25118803 |
US |
64 | 2 |
Product dose omission issue, |
||||
LENALIDOMIDE, |
||||
| 577 | 25118820 |
US |
20 | 1 |
Device defective, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 578 | 25118844 |
US |
38 | 2 |
Device issue, Product dose omission issue, |
||||
USTEKINUMAB, USTEKINUMAB, TIZANIDINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, ESCITALOPRAM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 579 | 25118877 |
US |
66 | 1 |
Rheumatoid arthritis, Cast application, Product dose omission issue, |
||||
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, |
||||
| 580 | 25119036 |
US |
2 | |
Weight increased, Dermatitis atopic, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 581 | 25119039 |
US |
2 | |
Product dose omission issue, Injection site pain, |
||||
LANADELUMAB-FLYO, LANADELUMAB-FLYO, LANADELUMAB-FLYO, |
||||
| 582 | 25119054 |
US |
57 | 2 |
Dyspnoea, Wheezing, Product dose omission issue, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 583 | 25119188 |
US |
21 | 1 |
Eczema, Pruritus, Rash, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 584 | 25119196 |
US |
29 | 2 |
Dermatitis atopic, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 585 | 25119262 |
US |
2 | |
No adverse event, Product use issue, Product dose omission issue, |
||||
DEXLANSOPRAZOLE, |
||||
| 586 | 25119436 |
US |
20 | 1 |
Product dose omission issue, |
||||
CLOBAZAM, |
||||
| 587 | 25119665 |
US |
1 | |
Hernia repair, Product dose omission issue, |
||||
TOLVAPTAN, |
||||
| 588 | 25119784 |
US |
71 | 2 |
Blood glucose decreased, Alopecia, Psoriasis, Product dose omission issue, |
||||
IXEKIZUMAB, INSULIN LISPRO, INSULIN DEGLUDEC, |
||||
| 589 | 25119818 |
GB |
||
Chest discomfort, Wheezing, Condition aggravated, Product dose omission issue, |
||||
BENRALIZUMAB, |
||||
| 590 | 25119850 |
US |
2 | |
Product dose omission issue, Product use in unapproved indication, |
||||
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 591 | 25119912 |
US |
28 | 2 |
Product dose omission issue, Needle issue, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, |
||||
| 592 | 25119924 |
US |
58 | |
Product dose omission issue, Off label use, |
||||
RUXOLITINIB, |
||||
| 593 | 25120046 |
US |
60 | 1 |
Product dose omission issue, |
||||
DOLUTEGRAVIR SODIUM AND LAMIVUDINE, |
||||
| 594 | 25120066 |
US |
38 | |
Product dose omission issue, Device defective, Liquid product physical issue, |
||||
USTEKINUMAB, USTEKINUMAB, |
||||
| 595 | 25120156 |
US |
64 | 1 |
Prostate cancer, Bradyphrenia, Hot flush, Back pain, Laziness, Influenza like illness, Blood testosterone decreased, Blood cholesterol increased, Fatigue, Product dose omission issue, |
||||
TOFACITINIB, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, RELUGOLIX, DAROLUTAMIDE, |
||||
| 596 | 25120166 |
US |
13 | 1 |
Dermatitis atopic, Erythema, Rash macular, Product dose omission issue, |
||||
DUPILUMAB, SOMATROPIN, |
||||
| 597 | 25120205 |
US |
54 | 1 |
Product dose omission issue, Disease recurrence, |
||||
SECUKINUMAB, |
||||
| 598 | 25120225 |
US |
||
Product dose omission issue, |
||||
RUXOLITINIB, |
||||
| 599 | 25120237 |
US |
||
Asthma, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 600 | 25120253 |
US |
86 | 1 |
Product dose omission issue, Product use in unapproved indication, |
||||
LENALIDOMIDE, |
||||
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