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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: PRODUCT DOSE OMISSION ISSUE

20250101 - 20251231

No. 1 - 100

Next page: 2 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
1
25491676
US
17 1
Needle issue, Product dose omission issue,
USTEKINUMAB, USTEKINUMAB,
2
25491775
US
2
Product dose omission issue, Adverse event, Condition aggravated,
MACITENTAN,
3
25491838
US
67
Product dose omission issue, Injection site pain,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
4
25491871
US
85 2
Wrong technique in device usage process, Product dose omission issue, Accidental exposure to product,
BELIMUMAB,
5
25491873
JP
2
Pyrexia, Malaise, Product dose omission issue,
MEPOLIZUMAB,
6
25491906
US
49 2
Rebound atopic dermatitis, Rash, Product dose omission issue,
DUPILUMAB,
7
25491917
US
1
Dyspnoea, Product dose omission issue, Lacrimation increased,
DUPILUMAB, FLUTICASONE PROPIONATE AND SALMETEROL, ALBUTEROL SULFATE, MONTELUKAST SODIUM,
8
25491945
US
2
Product dose omission issue,
GUSELKUMAB, GUSELKUMAB,
9
25491995
TR
Device issue, Product dose omission issue, Product administered at inappropriate site,
GOLIMUMAB,
10
25492078
US
15 1
Troponin I increased, Product dose omission issue,
VAMOROLONE, SACUBITRIL AND VALSARTAN, ETEPLIRSEN, LEVOCARNITINE, LEVOCARNITINE ORAL, PREDNISONE, ERGOCALCIFEROL,
11
25492091
49 2
Product dose omission issue, Fear of injection,
ADALIMUMAB-RYVK,
12
25492121
US
70 2
Gastrointestinal disorder, Heart rate decreased, Product dose omission issue,
LENALIDOMIDE,
13
25492186
MX
45 2
Needle issue, Product dose omission issue,
GOLIMUMAB,
14
25492295
US
71 1
Product dose omission issue, Incorrect dose administered,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
15
25492300
US
1
Product dose omission issue, Intercepted product preparation error, Device malfunction,
LEUPROLIDE ACETATE, MIRABEGRON, ALLOPURINOL, CARVEDILOL,
16
25492322
US
Diarrhoea, Product dose omission issue,
GOLIMUMAB,
17
25492324
US
2
Product dose omission issue, Product leakage, Device malfunction,
AZELASTINE HYDROCHLORIDE, AZELASTINE,
18
25492357
US
59 2
Product dose omission issue, Pain, Rheumatoid arthritis, Product complaint,
TOCILIZUMAB,
19
25492414
CA
80 1
Appendicitis, Aortic stenosis, Ascites, Aspiration, Bronchiectasis, Bronchopulmonary aspergillosis allergic, Cardiogenic shock, Congenital hiatus hernia, Diabetes mellitus, End stage renal disease, Hypoxia, Lower respiratory tract infection, Malignant melanoma stage 0, Multiple organ dysfunction syndrome, Myasthenia gravis, Pulmonary embolism, Pulmonary fibrosis, Sepsis, Thrombosis, Ventricular fibrillation, Off label use, Incorrect route of product administration, Intentional product misuse, Product dose omission issue, Product use in unapproved indication,
INSULIN ASPART, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, ALLOPURINOL, AMIODARONE HYDROCHLORIDE, CEFTRIAXONE, CEFTRIAXONE SODIUM, HYDROCORTISONE ACETATE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE, RAMIPRIL, RAMIPRIL, WARFARIN SODIUM, WARFARIN, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, SODIUM FERRIC GLUCONATE COMPLEX,
20
25492471
US
76 1
Product dose omission issue,
LENALIDOMIDE,
21
25492484
US
45 2
Psoriatic arthropathy, Drug ineffective, Product dose omission issue, Device malfunction,
GUSELKUMAB,
22
25492488
GB
Haematemesis, Product use issue, Product dose omission issue,
ADALIMUMAB-AATY,
23
25492682
US
70 1
Therapy interrupted, Product dose omission issue,
LENALIDOMIDE,
24
25492697
US
52 1
Product dose omission issue, Product dispensing issue,
LENALIDOMIDE,
25
25492727
US
93 2
Product dose omission issue,
LENALIDOMIDE,
26
25492735
US
33 1
Product dose omission issue, Abdominal discomfort,
GIVINOSTAT, CARVEDILOL, ERGOCALCIFEROL, NAPROXEN, NAPROXEN SODIUM, LISINOPRIL, EZETIMIBE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM,
27
25492746
US
79 1
Wrong technique in device usage process, Incorrect disposal of product, Product dose omission issue,
MEPOLIZUMAB,
28
25492766
US
Product use issue, Product availability issue, Product dose omission issue, No adverse event,
SUVOREXANT,
29
25492786
US
1
Hallucinations, mixed, Condition aggravated, Product dose omission issue,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE,
30
25492811
US
74
Product dose omission issue,
LENALIDOMIDE,
31
25492822
US
42 1
Incorrect dose administered, Product dose omission issue, Increased appetite,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
32
25492824
US
65 2
Product dose omission issue, Incorrect dose administered,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
33
25492912
US
2
Product dose omission issue, Product storage error,
GUSELKUMAB, GUSELKUMAB,
34
25492999
US
2
Device defective, Product dose omission issue, Product leakage,
GUSELKUMAB,
35
25493106
US
No adverse event, Product dose omission issue,
IDURSULFASE,
36
25493120
DE
Device issue, Product dose omission issue, Device defective,
GUSELKUMAB,
37
25493200
US
Hot flush, Product dose omission issue, Product use issue,
RELUGOLIX, RELUGOLIX, ROSUVASTATIN CALCIUM, CLOPIDOGREL, CLOPIDOGREL BISULFATE, FAMOTIDINE, HYDROCHLOROTHIAZIDE, LISINOPRIL, LISINOPRIL, PANTOPRAZOLE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, EZETIMIBE, BUPROPION, FLUTICASONE PROPIONATE AND SALMETEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, ERGOCALCIFEROL, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, KETOPROFEN, AMITRIPTYLINE HYDROCHLORIDE, BISMUTH SUBSALICYLATE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, CARVEDILOL, AMLODIPINE BESYLATE,
38
25493333
US
88 2
Accident, Product dose omission issue,
DULAGLUTIDE, DULAGLUTIDE,
39
25493338
US
2
Product dose omission issue, Product storage error,
USTEKINUMAB, USTEKINUMAB,
40
25493372
US
Product dose omission issue, Product commingling,
OLANZAPINE, FLUOXETINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE,
41
25493491
US
Sunburn, Fatigue, Hot flush, Product dose omission issue,
RELUGOLIX, RELUGOLIX, DOXYCYCLINE, DOXYCYCLINE HYCLATE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, PREDNISONE, SILDENAFIL CITRATE, SILDENAFIL,
42
25493518
US
2
Oxygen saturation abnormal, Asthma, Respiratory tract infection, Product dose omission issue, Device issue,
FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL, FLUTICASONE PROPIONATE AND SALMETEROL,
43
25493627
AT
66 1
Product dose omission issue, Product storage error,
EDOXABAN TOSYLATE,
44
25493793
US
36 1
Skin lesion, Rash, Product dose omission issue,
45
25493846
US
60 2
Product dose omission issue, Headache, Decreased appetite, Diarrhoea, Fatigue,
ABEMACICLIB,
46
25493877
US
Product dose omission issue,
INCOBOTULINUMTOXINA,
47
25493930
US
2
Product dose omission issue,
PIMAVANSERIN TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, CALCIUM, DIVALPROEX SODIUM, CLONAZEPAM, AMLODIPINE BESYLATE, PREDNISONE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, CARBIDOPA AND LEVODOPA, ERGOCALCIFEROL, SERTRALINE HYDROCHLORIDE,
48
25493975
US
67 1
Memory impairment, Product dose omission issue,
PIMAVANSERIN TARTRATE, ALBUTEROL SULFATE, ALBUTEROL, BUPROPION, CHLORTHALIDONE, DONEPEZIL HYDROCHLORIDE, FENOFIBRATE, TAMSULOSIN HYDROCHLORIDE, FLUTICASONE PROPIONATE, TRIPROLIDINE HCL, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, EMPAGLIFLOZIN, LAMOTRIGINE, LISINOPRIL, LORATADINE, LORATADINE ORAL, MELATONIN, MEMANTINE, MEMANTINE HYDROCHLORIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, MONTELUKAST, ROTIGOTINE, SEMAGLUTIDE, ROFLUMILAST, SERTRALINE, ICOSAPENT ETHYL,
49
25493985
US
2
Seizure, Product dose omission issue,
TROFINETIDE, TROFINETIDE,
50
25494043
CH
Device deployment issue, Product dose omission issue,
GUSELKUMAB,
51
25494107
62
Product dose omission issue, Respiratory tract congestion, Depressed mood, Total lung capacity abnormal, Arthralgia, Joint swelling, Off label use,
RUXOLITINIB, BELUMOSUDIL,
52
25494165
US
2
Product communication issue, Product dose omission issue,
PIMAVANSERIN TARTRATE, LINACLOTIDE, LEVOTHYROXINE, EZETIMIBE, DAPAGLIFLOZIN, FUROSEMIDE, POTASSIUM CHLORIDE, PRAMIPEXOLE, PREDNISONE, LINAGLIPTIN,
53
25494179
US
53 2
Condition aggravated, Product dose omission issue,
TOFACITINIB, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, MELOXICAM,
54
25494376
US
70 2
Blood glucose increased, Product dose omission issue,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, INSULIN ASPART,
55
25494426
US
1
Product dose omission issue, Wrong technique in product usage process, No adverse event,
OMALIZUMAB, OMALIZUMAB,
56
25494464
US
54 1
Product dose omission issue, Gastrointestinal disorder, Nausea,
TIRZEPATIDE,
57
25494484
US
55 2
Product dose omission issue,
INTERFERON BETA-1B,
58
25494612
US
2
Dementia, Inappropriate schedule of product administration, Product dose omission issue,
VEDOLIZUMAB,
59
25494671
CA
34 2
Ludwig angina, Product dose omission issue, Product quality issue,
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, TOPIRAMATE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, INDOMETHACIN, MINOCYCLINE,
60
25494709
US
1
Influenza, Malaise, Product dose omission issue,
MITAPIVAT,
61
25494791
US
60 2
Accidental exposure to product, Product dose omission issue, Device issue,
GUSELKUMAB,
62
25494891
US
14 2
Sleep disorder, Drug ineffective, Product dose omission issue,
ABROCITINIB,
63
25494933
US
66 1
Tinnitus, Product dose omission issue, Blood magnesium decreased,
BUDESONIDE, ALLOPURINOL, ALPRAZOLAM, FENOFIBRATE, LEVOTHYROXINE, LISINOPRIL, MAGNESIUM OXIDE, SERTRALINE, ERGOCALCIFEROL,
64
25495024
FR
64 1
Device leakage, Product dose omission issue,
GUSELKUMAB,
65
25495075
US
73 2
Needle issue, Product dose omission issue, Device issue,
USTEKINUMAB, USTEKINUMAB,
66
25495082
US
Device leakage, Drug delivery system malfunction, Needle issue, Product dose omission issue,
GUSELKUMAB,
67
25495158
US
39 1
Product dose omission issue,
ESKETAMINE HYDROCHLORIDE,
68
25495234
US
49 1
Device deployment issue, Product dose omission issue, Injection site pain,
USTEKINUMAB, USTEKINUMAB,
69
25495324
US
58 2
Product dose omission issue, Glycosylated haemoglobin increased, Incorrect dose administered,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
70
25495333
US
78
Off label use, Product storage error, Product dose omission issue, Injection site haemorrhage,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG,
71
25495339
US
64 2
Product dose omission issue, Extra dose administered, Injection site injury,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
72
25495364
US
1
Product dose omission issue, Eating disorder, Glycosylated haemoglobin increased,
METHYLPHENIDATE HYDROCHLORIDE,
73
25495679
US
23 2
Dermatitis atopic, Product dose omission issue, Maternal exposure during pregnancy,
DUPILUMAB, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), CYCLOSPORINE,
74
25495778
US
34 2
Sleep disorder due to a general medical condition, Rebound atopic dermatitis, Rash, Discomfort, Product dose omission issue,
DUPILUMAB,
75
25495879
US
23 2
Rebound eczema, Asthma, Product dose omission issue, Product use in unapproved indication,
DUPILUMAB,
76
25495898
US
32 1
Pruritus, Product dose omission issue,
DUPILUMAB,
77
25495936
US
85 2
Dementia, Product dose omission issue,
DULAGLUTIDE,
78
25496051
US
48 1
Back pain, Sleep disorder, Product dose omission issue,
BUDESONIDE, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ERGOCALCIFEROL, MONTELUKAST SODIUM, PANTOPRAZOLE SODIUM, TELMISARTAN, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, LOSARTAN, ERGOCALCIFEROL,
79
25496082
GB
1
Brain neoplasm, Product dose omission issue, Product prescribing issue,
SOMATROPIN,
80
25496095
US
25 2
Acne, Product dose omission issue,
DEUCRAVACITINIB,
81
25496191
US
53 1
Condition aggravated, Product dose omission issue,
TOFACITINIB,
82
25496229
US
2
Device use issue, Product dose omission issue, Device failure,
ALBUTEROL SULFATE,
83
25496296
US
1
Product dose omission issue,
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
84
25496308
US
1
Product dose omission issue,
BELIMUMAB,
85
25496359
US
2
White blood cell count decreased, Haemoglobin decreased, Platelet count decreased, Product dose omission issue,
QUIZARTINIB,
86
25496380
US
9 1
Rebound atopic dermatitis, Erythema, Product dose omission issue,
DUPILUMAB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, ALBUTEROL SULFATE,
87
25496479
US
55 2
Device malfunction, Drug delivery system malfunction, Product dose omission issue,
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB,
88
25496500
US
81 1
Product dose omission issue,
POMALIDOMIDE,
89
25496502
US
89 1
Device malfunction, Product delivery mechanism issue, Product dose omission issue,
ALBUTEROL SULFATE,
90
25496532
US
2
Inappropriate schedule of product administration, Product distribution issue, Product use issue, Insurance issue, Product dose omission issue,
LANADELUMAB-FLYO, LANADELUMAB-FLYO, LANADELUMAB-FLYO,
91
25496545
US
1
Haemoglobin decreased, Pallor, Underweight, Product dose omission issue,
GUSELKUMAB,
92
25496633
FR
66 1
Device occlusion, Product dose omission issue,
GOLIMUMAB,
93
25496664
US
55 2
Product dose omission issue, Injection site injury,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
94
25490956
US
54 1
Product dose omission issue, Malaise,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
95
25490961
US
12 1
Rebound atopic dermatitis, Product dose omission issue, Joint swelling, Condition aggravated, Arthralgia,
DUPILUMAB,
96
25491033
US
80 2
Pruritus, Product dose omission issue,
DUPILUMAB,
97
25491042
US
2
Illness, Product dose omission issue,
DUPILUMAB, THIAMINE HYDROCHLORIDE, ERGOCALCIFEROL, CARIPRAZINE,
98
25491181
US
28 2
Illness, Product dose omission issue,
DUPILUMAB,
99
25491214
US
2
Seizure, Product dose omission issue,
VIGABATRIN,
100
25491237
US
1
Crohn^s disease, Surgery, Product dose omission issue, Needle issue,
USTEKINUMAB, USTEKINUMAB,

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

2025-07-29

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