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Drug:

Reaction: PRODUCT DOSE OMISSION ISSUE

20250101 - 20251231

No. 1 - 100

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No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
1
25138769
US
Blindness, Product dose omission issue,
MEPOLIZUMAB, MEPOLIZUMAB,
2
25138818
US
 2
Dermatitis atopic, Product dose omission issue,
DUPILUMAB,
3
25138861
US
Product dose omission issue, Pain,
GOLIMUMAB,
4
25138923
US
 48 2
Rebound atopic dermatitis, Product dose omission issue,
DUPILUMAB,
5
25138926
US
 2
Rebound atopic dermatitis, Product dose omission issue,
DUPILUMAB, FLUOCINOLONE ACETONIDE OIL, FLUOCINOLONE ACETONIDE,
6
25138981
CA
 68 2
Illness, Intra-abdominal fluid collection, Blood pressure increased, Decreased appetite, Nasopharyngitis, Aspartate aminotransferase abnormal, Blood alkaline phosphatase abnormal, Abdominal discomfort, Pruritus, Product dose omission issue, Product use issue,
OBETICHOLIC ACID, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, VITAMIN C, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE,
7
25138998
US
Pneumonia bacterial, Illness, Product dose omission issue,
8
25139113
US
 26 2
Dermatitis atopic, Product dose omission issue, Cholecystectomy,
DUPILUMAB,
9
25139186
US
 41 2
Incorrect dose administered, Product dose omission issue,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
10
25139209
CO
Device deployment issue, Product dose omission issue,
GUSELKUMAB,
11
25139231
US
 71
Device delivery system issue, Insurance issue, Product dose omission issue, Incorrect dose administered, Overdose,
ALBUTEROL SULFATE AND BUDESONIDE,
12
25139258
US
 82 2
Product dose omission issue, Platelet count decreased,
PACRITINIB,
13
25139296
US
Hypothyroidism, Headache, Taste disorder, Parosmia, Nausea, Swelling face, Balance disorder, Product dose omission issue,
OLAPARIB,
14
25139409
US
Localised infection, Product dose omission issue, Dyspnoea,
DAPAGLIFLOZIN,
15
25139410
US
Illness, Product dose omission issue, Musculoskeletal disorder, Device leakage, Muscular weakness,
BENRALIZUMAB,
16
25139475
US
 63 2
Incorrect dose administered, Product dose omission issue,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
17
25139487
US
 1
Product dose omission issue,
BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE,
18
25139505
US
 62 1
Product dose omission issue,
DOLUTEGRAVIR SODIUM AND LAMIVUDINE,
19
25139507
US
 33 1
Product dose omission issue,
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE,
20
25139581
US
Insomnia, Poor quality sleep, Product dose omission issue,
ISTRADEFYLLINE, AMANTADINE, ROPINIROLE, CARBIDOPA AND LEVODOPA,
21
25139620
US
 58 1
Product dose omission issue, Product complaint,
MEPOLIZUMAB,
22
25139718
US
 2
Product dose omission issue,
BELIMUMAB,
23
25139769
US
Product dose omission issue, Coronavirus test, Respiratory syncytial virus test, Insurance issue, Inability to afford medication,
ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG,
24
25139831
US
 54 2
Cholelithiasis, Hepatic cirrhosis, Full blood count abnormal, Product dose omission issue,
PACRITINIB, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, SUCRALFATE, INSULIN GLARGINE, LINACLOTIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, SEMAGLUTIDE, FLUOXETINE HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, RIFAXIMIN,
25
25139878
US
 66 1
Product dose omission issue,
LENALIDOMIDE, LENALIDOMIDE,
26
25139888
US
 1
Insomnia, Product dose omission issue,
PIMAVANSERIN TARTRATE, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, INSULIN GLARGINE, CARBIDOPA LEVODOPA, DEXAMETHASONE SODIUM PHOSPHATE, DAPAGLIFLOZIN, INSULIN GLARGINE, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE, LISINOPRIL, LOSARTAN POTASSIUM, LOSARTAN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, HUMAN INSULIN, SEMAGLUTIDE, RIVASTIGMINE, RIVAROXABAN,
27
25139903
US
 2
Product dose omission issue,
BELIMUMAB,
28
25139958
US
 65 1
Product dose omission issue, Treatment delayed,
LENALIDOMIDE,
29
25139995
US
 2
Gastroenteritis, Product dose omission issue,
TROFINETIDE,
30
25140004
US
 2
Nasopharyngitis, Product dose omission issue,
TROFINETIDE,
31
25140012
US
 2
Illness, Product dose omission issue,
BELIMUMAB,
32
25140047
US
 2
Product dose omission issue, Product use complaint, Product substitution issue, Product size issue,
LENALIDOMIDE,
33
25140049
US
 55 2
Injury associated with device, Product dose omission issue, Needle issue,
GLATIRAMER ACETATE, GLATIRAMER, MODAFINIL,
34
25140050
US
 53 2
Product dose omission issue,
BELIMUMAB,
35
25140073
US
 2
Abortion spontaneous, Maternal exposure before pregnancy, Maternal exposure during pregnancy, Product dose omission issue,
CERTOLIZUMAB PEGOL,
36
25140075
US
 67 1
Thinking abnormal, General physical health deterioration, Product dose omission issue,
PIMAVANSERIN TARTRATE, QUETIAPINE,
37
25140084
US
 33 2
Product dose omission issue,
BELIMUMAB,
38
25140085
US
 2
Asthenia, Product dose omission issue,
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
39
25140127
US
 64 1
Product dose omission issue,
APIXABAN,
40
25140203
US
 57 2
Product dose omission issue,
MEPOLIZUMAB,
41
25140558
US
 78 1
Product dose omission issue, Off label use,
LENALIDOMIDE,
42
25140571
70
Product dose omission issue,
RUXOLITINIB,
43
25140656
US
 68 2
Upper respiratory tract infection, Product dose omission issue,
MEPOLIZUMAB, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, ALBUTEROL SULFATE,
44
25140748
CA
 32 2
COVID-19, Drug ineffective, Influenza like illness, Small intestine ulcer, Therapy interrupted, Intentional dose omission, Incorrect dose administered, Product dose omission issue, Wrong technique in product usage process,
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITALOPRAM, LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, ESZOPICLONE, LEVOTHYROXINE SODIUM,
45
25140841
US
 60 2
Product dose omission issue,
MEPOLIZUMAB,
46
25140893
US
 2
No adverse event, Product dose omission issue,
LANADELUMAB-FLYO, LANADELUMAB-FLYO, LANADELUMAB-FLYO, EPINEPHRINE,
47
25141302
US
 43 1
Crohn^s disease, Inappropriate schedule of product administration, Influenza like illness, Nasopharyngitis, Product dose omission issue,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB,
48
25141308
US
Respiration abnormal, Spinal fracture, Nephrolithiasis, Multiple allergies, Musculoskeletal stiffness, Dyspnoea, Chest discomfort, Product use in unapproved indication, Product dose omission issue,
MEPOLIZUMAB,
49
25141341
US
 71 2
Hospitalisation, Product dose omission issue, Off label use,
FOSTAMATINIB,
50
25141342
US
 84 2
Blood glucose decreased, Decreased appetite, Periorbital swelling, Ocular hyperaemia, Eye swelling, Product dose omission issue,
FOSTAMATINIB, PRIMIDONE, INSULIN HUMAN,
51
25141597
CA
Injection site pruritus, Fatigue, Abdominal pain upper, Feeling abnormal, Tremor, Insomnia, Generalised oedema, Pain, Dysstasia, Heart rate increased, Product dose omission issue, Movement disorder, Abdominal pain, Product deposit, Product colour issue, Haemoglobin abnormal, Blood lactate dehydrogenase abnormal, Alcohol withdrawal syndrome,
PEGCETACOPLAN, PEGCETACOPLAN, PEGCETACOPLAN, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, SILDENAFIL CITRATE, SERTRALINE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, FOLIC ACID,
52
25141658
US
 2
Headache, Product dose omission issue,
DUPILUMAB, DUPILUMAB,
53
25141713
US
 62 2
Rectal haemorrhage, Post procedural infection, Gastrointestinal pain, Gastrointestinal disorder, Abdominal pain upper, Contusion, Stress, Nausea, Arthralgia, Product dose omission issue,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB,
54
25141723
KW
Haemoglobinuria, Product dose omission issue, Product availability issue, Full blood count decreased,
PEGCETACOPLAN, PEGCETACOPLAN,
55
25141726
US
 2
Illness, Product dose omission issue, Product storage error,
BELIMUMAB,
56
25141728
US
 17
Product dose omission issue,
ISOTRETINOIN,
57
25142138
US
 1
Product dose omission issue, Inappropriate schedule of product administration,
MEPOLIZUMAB,
58
25142139
US
Hospitalisation, General physical health deterioration, Product dose omission issue,
MEPOLIZUMAB,
59
25142173
US
 73 1
Death, Illness, Product dose omission issue,
VELAGLUCERASE ALFA, VELAGLUCERASE ALFA,
60
25142177
US
 2
Colitis ulcerative, Impaired quality of life, Diarrhoea, Infection, Skin irritation, Drug ineffective, Alopecia, Product dose omission issue, Trichorrhexis, Memory impairment, Abdominal pain, Injection site erythema, Respiratory tract infection, Rash, Headache, Fatigue, Influenza,
VEDOLIZUMAB, VEDOLIZUMAB, NORELGESTROMIN AND ETHINYL ESTRADIOL, BUDESONIDE, METHYLPHENIDATE HYDROCHLORIDE, LISDEXAMFETAMINE DIMESYLATE, SERDEXMETHYLPHENIDATE AND DEXMETHYLPHENIDATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE,
61
25142265
US
 54 2
Infusion site pruritus, Infusion site mass, Product dose omission issue, Infusion site mass,
62
25142286
US
 60 2
Product dose omission issue, Blood glucose increased, Dizziness,
INSULIN GLARGINE,
63
25142513
US
Staphylococcal infection, Product dose omission issue, Therapeutic product effect incomplete,
RUXOLITINIB,
64
25142516
KW
Abdominal pain, Vomiting, Off label use, Fatigue, Product dose omission issue, Product availability issue,
PEGCETACOPLAN,
65
25142532
US
Wrong technique in product usage process, Product packaging quantity issue, Product dose omission issue,
RUXOLITINIB,
66
25142627
US
 2
Product dose omission issue,
GUSELKUMAB,
67
25142660
US
 59 2
Product dose omission issue, Product adhesion issue,
ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,,
68
25142682
US
 1
Rebound atopic dermatitis, Product dose omission issue,
DUPILUMAB,
69
25142751
US
 72 1
Product dose omission issue, Body height decreased, Mental disorder,
DOLUTEGRAVIR SODIUM AND LAMIVUDINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, HYDROXYZINE, DIPHENHYDRAMINE HYDROCHLORIDE,
70
25142819
US
 40 2
Device issue, Product dose omission issue,
ESKETAMINE HYDROCHLORIDE,
71
25142824
US
Product storage error, Product dose omission issue,
GOLIMUMAB,
72
25142841
US
 47 1
Device leakage, Product dose omission issue,
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE,
73
25138121
US
Dyspnoea, Device use issue, Off label use, Product dose omission issue,
74
25138124
US
Product dose omission issue,
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB,
75
25138155
US
 42 2
Product dose omission issue, Off label use, Injection site pain,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
76
25138173
US
Product after taste, Device delivery system issue, Product dose omission issue, Patient dissatisfaction with treatment, Device mechanical issue,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE,
77
25138174
US
 23 2
Angioedema, Spinal cord injury, Fall, Tonsillectomy, Urticaria chronic, Disturbance in attention, Oral allergy syndrome, Product dose omission issue,
CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, ERGOCALCIFEROL, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, VITAMIN E, CREAM, IRON,
78
25138207
US
 53 1
Dermatitis atopic, Product dose omission issue,
DUPILUMAB,
79
25138246
US
 76
Product dose omission issue, Device delivery system issue, Product packaging quantity issue, No adverse event,
ALBUTEROL SULFATE, ALBUTEROL SULFATE, ALBUTEROL SULFATE, PREDNISONE,
80
25138296
US
Chronic obstructive pulmonary disease, Aneurysm, Wrong technique in device usage process, Product dose omission issue, Device use issue, Device defective, Dialysis,
BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, SODIUM ZIRCONIUM CYCLOSILICATE,
81
25138300
US
 60 2
Product dose omission issue, Injection site bruising, Device deployment issue,
GUSELKUMAB,
82
25138321
US
Hypoglycaemia, Product dose omission issue,
DAPAGLIFLOZIN,
83
25138327
FR
 52 2
Crohn^s disease, Accidental exposure to product, Device issue, Product dose omission issue, Off label use, Eye inflammation,
GUSELKUMAB, GUSELKUMAB,
84
25138351
US
Needle issue, Accidental exposure to product, Product dose omission issue,
GUSELKUMAB,
85
25138386
CN
 1
Product dose omission issue, Device deployment issue,
GUSELKUMAB,
86
25138392
CA
 72 2
Pruritus, Product dose omission issue, Device occlusion, Urticaria, Therapeutic response decreased,
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, SEMAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG,
87
25138434
US
 1
Eczema, Product dose omission issue,
DUPILUMAB,
88
25138442
US
 2
Back injury, Product dose omission issue,
GUSELKUMAB, GUSELKUMAB, GUSELKUMAB, GUSELKUMAB,
89
25138463
GB
 51 2
Device deployment issue, Product dose omission issue,
GUSELKUMAB,
90
25138466
US
 2
Product dose omission issue,
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
91
25138504
US
 69 1
Dyspnoea, Product dose omission issue,
MEPOLIZUMAB,
92
25138511
US
 58 2
Product dose omission issue,
BELIMUMAB,
93
25138604
US
 55 2
Pruritus, Product dose omission issue,
DUPILUMAB,
94
25138669
CA
 1
Colitis ulcerative, Defaecation urgency, Nausea, Product dose omission issue, Therapeutic reaction time decreased,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, FOLIC ACID,
95
25137291
US
 62 2
Product dose omission issue,
96
25137328
US
 60 2
Rheumatoid arthritis, Product dose omission issue,
ABATACEPT,
97
25137334
US
 54 2
Nasal polyps, Rebound effect, Product dose omission issue,
DUPILUMAB,
98
25137359
US
 53 1
Product dose omission issue,
LENALIDOMIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, OLANZAPINE,
99
25137424
US
 75 1
Wrong technique in device usage process, Product dose omission issue, Inappropriate schedule of product administration, Intentional dose omission,
FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
100
25137493
US
 2
Product dose omission issue,
MEPOLIZUMAB,

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last_updated

2025-04-28

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