Drug:
Reaction: INJECTION SITE ERYTHEMA
20250101 - 20251231
No. 1 - 100
No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
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1 | 25491827 |
US |
60 | 2 |
Limb injury, Accidental exposure to product, Device difficult to use, Injection site erythema, Injection site haemorrhage, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
2 | 25492008 |
US |
52 | |
Extra dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
3 | 25492020 |
US |
69 | 2 |
Extra dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
4 | 25492358 |
US |
62 | 2 |
Injection site erythema, |
||||
DULAGLUTIDE, |
||||
5 | 25493286 |
US |
63 | 1 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
6 | 25493969 |
US |
61 | 1 |
Off label use, Injection site induration, Injection site pruritus, Injection site erythema, Injection site swelling, |
||||
DULAGLUTIDE, SITAGLIPTIN, |
||||
7 | 25494011 |
US |
||
Injection site induration, Injection site swelling, Injection site erythema, Injection site pruritus, Product use in unapproved indication, Product preparation issue, |
||||
INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, INCOBOTULINUMTOXINA, |
||||
8 | 25494676 |
CA |
||
Dysgeusia, Chills, Diarrhoea, Hypoglycaemia, Fatigue, Influenza, Diverticulitis, Nausea, Vomiting, Headache, Injection site rash, Injection site pruritus, Injection site erythema, Weight decreased, Intentional dose omission, Inappropriate schedule of product administration, Therapy partial responder, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, HYDROXYCHLOROQUINE SULFATE, CLONAZEPAM, METHOTREXATE, METHOTREXATE SODIUM, FOLIC ACID, DICLOFENAC, DICLOFENAC SODIUM, SEMAGLUTIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, SEMAGLUTIDE, |
||||
9 | 25494951 |
US |
80 | 1 |
Injection site erythema, Drug ineffective, Blood glucose increased, Glycosylated haemoglobin increased, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
10 | 25495583 |
US |
14 | 2 |
Injection site pain, Injection site erythema, Injection site swelling, Product use in unapproved indication, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
11 | 25495684 |
US |
65 | 1 |
Injection site erythema, Condition aggravated, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
12 | 25495901 |
US |
63 | 1 |
Injection site warmth, Injection site swelling, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
13 | 25495914 |
US |
42 | 2 |
Periorbital swelling, Skin haemorrhage, Skin weeping, Skin fissures, Dry skin, Skin exfoliation, Ocular hyperaemia, Pruritus, Injection site erythema, |
||||
DUPILUMAB, |
||||
14 | 25495941 |
US |
40 | 1 |
Injection site pain, Injection site erythema, Injection site swelling, Injection site urticaria, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
15 | 25496075 |
US |
22 | 2 |
Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, |
||||
16 | 25496482 |
US |
2 | |
Injection site reaction, Device issue, Injection site erythema, |
||||
ADALIMUMAB, |
||||
17 | 25504568 |
44 | 2 | |
Injection related reaction, Cellulitis, Injection site erythema, Injection site swelling, Injection site irritation, Injection site pruritus, Injection site infection, Suspected product contamination, Product impurity, |
||||
TIRZEPATIDE, |
||||
18 | 25490939 |
US |
43 | 2 |
Incorrect dose administered, Injection site swelling, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
19 | 25490984 |
US |
2 | |
Injection site erythema, Injection site pain, |
||||
DUPILUMAB, VALBENAZINE, FISH OIL, NIACIN, ERGOCALCIFEROL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, TIRZEPATIDE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, THYROID, IODIUM,BADIAGA,FUCUS VESICULOSUS,CALCAREAARSENICUM IODATUM, THYROIDINUM,CARBONICA,PULSATILLA,BARYTA CARBONICA,, THYROID, UNSPECIFIED, DAPAGLIFLOZIN, PROGESTERONE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, TIZANIDINE HYDROCHLORIDE, ROSUVASTATIN CALCIUM, CLONAZEPAM, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, FLUOXETINE HYDROCHLORIDE, |
||||
20 | 25491049 |
US |
50 | 2 |
Injection site mass, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
21 | 25491086 |
US |
25 | |
Injection site erythema, Injection site pain, Injection site bruising, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
22 | 25491258 |
US |
2 | |
Injection site erythema, Injection site pain, |
||||
DUPILUMAB, |
||||
23 | 25491367 |
US |
2 | |
Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, MELOXICAM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, LORATADINE, LORATADINE ORAL, ERGOCALCIFEROL, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, PIMECROLIMUS, HYDROCORTISONE, BIOTIN, |
||||
24 | 25491506 |
GB |
2 | |
Lower respiratory tract infection, Injection site erythema, Injection site swelling, |
||||
25 | 25491576 |
US |
4 | 2 |
Injection site erythema, Injection site pain, Eye irritation, |
||||
DUPILUMAB, |
||||
26 | 25490263 |
US |
2 | |
Anxiety, Injection site erythema, |
||||
DUPILUMAB, |
||||
27 | 25490656 |
US |
66 | 1 |
Injection site mass, Injection site erythema, Device use error, |
||||
DUPILUMAB, |
||||
28 | 25490753 |
US |
64 | 2 |
Injection site warmth, Myalgia, Injection site pain, Injection site erythema, |
||||
DUPILUMAB, |
||||
29 | 25490881 |
US |
12 | 1 |
Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
30 | 25486705 |
US |
70 | 2 |
Injection site pain, Injection site erythema, Injection site pruritus, Injection site swelling, Diarrhoea, Dizziness, Alopecia, Weight increased, |
||||
EVOLOCUMAB, ATENOLOL, BIOTIN, ADRENALINUM, ARGENTUM NITRICUM, BOS TAURUS PITUITARUM POSTERIUM, GLYCERINUM, GLYCYRRHIZA GLABRA, KALI CARBONICUM, LACTICUM ACIDUM, MAGNESIA SULPHURICA, NICCOLUM METALLICUM, PANCREATINUM, PHOSPHORICUM ACIDUM, SACCHARINUM, SACCHARUM LACTIS, SACCHARUM OFFICINALE, SARCOLACTICUM ACIDUM, SELENIUM METALLICUM, SYZYGIUM JAMBOLANUM, THYROIDINUM, ZINCUM METALLICUM, ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA ALBA, CALENDULA OFFICINALIS, CHAMOMILLA, CHERRY PLUM, CLEMATIS, COLOCYNTHIS, DULCAMARA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPATORIUM PERFOLIATUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS, MILLEFOLIUM, RHUS TOXICODENDRON, ROCK ROSE, STAR OF BETHLEHEM, SULPHUR, SYMPHYTUM OFFICINALE, VERATRUM ALBUM, ACONITUM NAPELLUS,APIS MELLIFICA,ARNICA MONTANA,ARSENICUM ALBUM,BELLADONNA,BELLIS PERENNIS,BRYONIA,CALENDULA OFFICINALIS,CHAMOMILLA,CHERRY PLUM,CLEMATIS VITALBA,COLOCYNTHIS,COMFREY,DULCAMARA LIGNOSA,ECHINACEA ANGUSTIFOLIA,ECHINACEA PURPUREA,EUPATORIUM PERFOLIATUM,FERRUM PHOSPHORICUM,HAMAMELIS VIRGINIANA,HISTAMINUM,HYPERICUM PERFORATUM,IMPATIENS GLANDULIFERA,LEDUM PALUSTRE,MENTHA PIPERITA,MILLEFOLIUM,ORNITHOGALUM UMBELLATUM,PLANTAGO MAJOR,RHUS TOXICODENDRON,ROCKROSE,SULPHUR,VERATRUM ALBUM,VERBASCUM THAPSUS, ALFALFA, ANTIMONIUM CRUDUM, AVENA SATIVA, BERBERIS VULGARIS, CAJUPUTUM, CARBO ANIMALIS, CARBO VEGETABILIS, CHELIDONIUM MAJUS, FEL TAURI, GENTIANA LUTEA, GLYCYRRHIZA GLABRA, ILLICIUM ANISATUM, INDOLUM, KALI CARBONICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PANCREATINUM, PEPSINUM, RAPHANUS SATIVUS, RHAMNUS PURSHIANA, SKATOLUM, ALLIUM SATIVUM, AVENA SATIVA, CALCAREA CARBONICA, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CALCAREA SULPHURICA, CARBO VEGETABILIS, FERRUM IODATUM, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LACTICUM ACIDUM, MAGNESIA PHOSPHORICA, NATRUM MURIATICUM, NATRUM PHOSPHORICUM, PHOSPHORICUM ACIDUM, URTICA URENS, AVENA SATIVA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COFFEA CRUDA, ENGLISH OAK, ESCHSCHOLTZIA CALIFORNICA, EUROPEAN HORNBEAM, FICUS CARICA, HUMULUS LUPULUS, IGNATIA AMARA, IMPATIENS GLANDULIFERA, KALI PHOSPHORICUM, KALI SILICATUM, MELISSA OFFICINALIS, PASSIFLORA INCARNATA, PHOSPHORICUM ACIDUM, PYRENEES STAR OF BETHLEHEM, ROCKROSE, SUS SCROFA PARASYMPATHETIC NERVE, PINEAL GLAND, SYMPATHETIC NERVE, VALERIANA OFFICINALIS, VERBENA OFFICINALIS, ZINCUM VALERIANICUM, ADRENALINUM, AETHUSA CYNAPIUM, AGNUS CASTUS, ALFALFA, ARGENTUM NITRICUM, AURUM METALLICUM, AVENA SATIVA, CERATOSTIGMA WILLMOTTIANUM FLOWER, CHERRY PLUM FLOWER, DAMIANA, EUROPEAN ASPEN FLOWER, EUROPEAN HORNBEAM FLOWER, GORSE FLOWER, HYPERICUM PERFORATUM, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MANDRAGORA OFFICINARUM, NATRUM MURIATICUM, PASSIFLORA INCARNATA, ROSA CANINA FLOWER, SEPIA, SWEET CHESTNUT FLOWER, THYROIDINUM, WILD MUSTARD FLOWER, BELLADONNA, BLATTA ORIENTALIS, COCCUS CACTI, CORALLIUM RUBRUM, CUPRUM METALLICUM, DROSERA ROTUNDIFOLIA, ECHINACEA ANGUSTIFOLIA, HEDERA HELIX, HYDRASTIS CANADENSIS, IPECACUANHA, KALI NITRICUM, LAC VACCINUM, LOBELIA INFLATA, PASSIFLORA INCARNATA, PERTUSSINUM, SAMBUCUS NIGRA, THYMUS SERPYLLUM, VALERIANA OFFICINALIS, BALSAMUM PERUVIANUM, BORAX, BRYONIA, CALCAREA ACETICA, COCCUS CACTI, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPHORBIUM OFFICINARUM, EUPHRASIA OFFICINALIS, HISTAMINUM HYDROCHLORICUM, IPECACUANHA, KALI BICHROMICUM, LUFFA OPERCULATA, MERCURIUS CYANATUS, MERCURIUS DULCIS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, PANCREATINUM, SAMBUCUS NIGRA, SANGUINARINUM NITRICUM, SAPONARIA OFFICINALIS, ALLIUM CEPA, CALCAREA IODATA, CALCAREA SULPHURICA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUPHORBIUM OFFICINARUM, HEPAR SULPHURIS CALCAREUM, HISTAMINUM HYDROCHLORICUM, HYDRASTIS CANADENSIS, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC DEFLORATUM, LUFFA OPERCULATA, MERCURIUS SULPHURATUS RUBER, PHOSPHORUS, PULSATILLA VULGARIS, SACCHARUM LACTIS, THUJA OCCIDENTALIS, ACONITUM NAPELLUS, ARSENICUM ALBUM, BAPTISIA TINCTORIA, BELLADONNA, BRYONIA, CHERRY PLUM, CLEMATIS VITALBA, ECHINACEA ANGUSTIFOLIA, ECHINACEA PURPUREA, EUCALYPTUS GLOBULUS, EUPATORIUM PERFOLIATUM, EUROPEAN OLIVE, FERRUM PHOSPHORICUM, GENTIANA LUTEA, IMPATIENS GLANDULIFERA, INFLUENZA A VIRUS, LACHESIS MUTUS, LUFFA OPERCULATA, ORNITHOGALUM UMBELLATUM, PHOSPHORUS, ROCKROSE, SARCOLACTICUM ACIDUM, VERATRUM ALBUM, YELLOW JASMINE, ARISTOLOCHIA MILHOMENS, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA OFFICINALIS, CARBO VEGETABILIS, CHAMOMILLA, CHERRY PLUM FLOWER, CLEMATIS VITALBA FLOWER, ECHINACEA ANGUSTIFOLIA, HAMAMELIS VIRGINIANA, HEPAR SULPHURIS CALCAREUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA FLOWER, LACHESIS MUTUS, MILLEFOLIUM, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE FLOWER, RUTA GRAVEOLENS, SARCOLACTICUM ACIDUM, SULPHUR IODATUM, SYMPHYTUM OFFICINALE, VERATRUM ALBUM, ACONITUM NAPELLUS, APIS MELLIFICA, ARNICA MONTANA, ARSENICUM ALBUM, BELLADONNA, BELLIS PERENNIS, BRYONIA, CALENDULA, CHAMOMILLA, CHERRY PLUM, CLEMATIS VITALBA, COLOCYNTHIS, DULCAMARA LIGNOSA, ECHINACEA, EUPATORIUM, FERRUM PHOSPHORICUM, HAMAMELIS VIRGINIANA, HISTAMINUM, HYPERICUM PERFORATUM, IMPATIENS GLANDULIFERA, LEDUM PALUSTRE, MENTHA PIPERITA, MILLEFOLIUM, PLANTAGO MAJOR, PYRENEES STAR OF BETHLEHEM, RHUS TOXICODENDRON, ROCKROSE, SULFUR, COMFREY, VERATRUM ALBUM, VERBASCUM THAPSUS, ACETICUM ACIDUM, ADRENALINUM, AMERICAN GINSENG, ARNICA MONTANA, BALSAMUM PERUVIANUM, BOS TAURUS PITUITARUM POSTERIUM, CHERRY PLUM FLOWER, CHININUM ARSENICOSUM, CINCHONA OFFICINALIS, CLEMATIS VITALBA FLOWER, DAMIANA, EUROPEAN HORNBEAM FLOWER, EUROPEAN OLIVE FLOWER, GLYCYRRHIZA GLABRA, IMPATIENS GLANDULIFERA FLOWER, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, PHOSPHORICUM ACIDUM, PHOSPHORUS, PYRENEES STAR OF BETHLEHEM, ROCKROSE FLOWER, SELENIUM METALLICUM, THYROIDINUM, SACUBITRIL AND VALSARTAN, FAMOTIDINE, FUROSEMIDE, MAGNESIUM, PANTOPRAZOLE, CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, ERGOCALCIFEROL, RIVAROXABAN, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, |
||||
31 | 25486914 |
US |
||
Injection site urticaria, Injection site erythema, Injection site swelling, |
||||
DERMATOPHAGOIDES PTERONYSSINUS, DERMATOPHAGOIDES FARINAE, NIFEDIPINE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, DIPHENHYDRAMINE HYDROCHLORIDE, MONTELUKAST SODIUM, CETIRIZINE HYDROCHLORIDE, |
||||
32 | 25487444 |
US |
2 | |
Squamous cell carcinoma of skin, Injection site erythema, Injection site swelling, Injection site pain, |
||||
OCRELIZUMAB AND HYALURONIDASE, |
||||
33 | 25487525 |
US |
1 | |
Injection site pruritus, Injection site swelling, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
34 | 25488724 |
US |
||
Memory impairment, Injection site erythema, |
||||
TESAMORELIN, BICTEGRAVIR SODIUM, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE FUMARATE, |
||||
35 | 25488793 |
US |
28 | 2 |
Arthralgia, Injection site bruising, Injection site discolouration, Injection site swelling, Injection site pruritus, Injection site erythema, |
||||
ADALIMUMAB, |
||||
36 | 25489107 |
US |
22 | 2 |
Injection site pain, Injection site rash, Injection site erythema, Injection site pruritus, Product use in unapproved indication, |
||||
CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, |
||||
37 | 25489239 |
US |
81 | 2 |
Abnormal weight gain, Eye pain, Condition aggravated, Dry eye, Injection site erythema, Injection site pruritus, Injection site swelling, Device malfunction, |
||||
DUPILUMAB, AMMONIUM LACTATE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
38 | 25489247 |
US |
28 | 2 |
Dry eye, Injection site erythema, Injection site pain, |
||||
DUPILUMAB, |
||||
39 | 25489264 |
US |
68 | 1 |
Injection site erythema, Injection site pruritus, |
||||
DUPILUMAB, |
||||
40 | 25489290 |
US |
42 | 2 |
Injection site erythema, |
||||
DUPILUMAB, |
||||
41 | 25489297 |
US |
65 | 2 |
Injection site erythema, |
||||
DUPILUMAB, |
||||
42 | 25489383 |
US |
36 | 2 |
Injection site rash, Injection site erythema, |
||||
DUPILUMAB, |
||||
43 | 25489409 |
US |
20 | 2 |
Sensitive skin, Injection site pruritus, Injection site swelling, Injection site bruising, Injection site erythema, Dry eye, |
||||
DUPILUMAB, |
||||
44 | 25489499 |
US |
46 | 2 |
Injection site swelling, Injection site erythema, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
45 | 25489724 |
US |
68 | 2 |
Injection site bruising, Injection site erythema, |
||||
METHOTREXATE SODIUM, |
||||
46 | 25489798 |
US |
2 | |
Weight increased, Injection site swelling, Injection site erythema, |
||||
DUPILUMAB, FERROUS SULFATE, FEXOFENADINE HYDROCHLORIDE, |
||||
47 | 25489800 |
US |
32 | 2 |
Injection site erythema, |
||||
DUPILUMAB, |
||||
48 | 25481108 |
US |
68 | 2 |
Eye infection, Blood glucose increased, Product dose omission issue, Incorrect dose administered, Injection site erythema, Injection site pain, Injection site pruritus, Injection site discolouration, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
49 | 25481382 |
US |
1 | |
Injection site pain, Injection site erythema, Injection site swelling, |
||||
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, |
||||
50 | 25481592 |
US |
56 | 2 |
Injection site swelling, Injection site erythema, Injection site pruritus, Injection site warmth, |
||||
TRALOKINUMAB-LDRM, PROGESTERONE, ESTRADIOL, |
||||
51 | 25481658 |
US |
70 | 2 |
Haemorrhoidal haemorrhage, Dyspepsia, Constipation, Fatigue, Injection site rash, Injection site pruritus, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
52 | 25481784 |
US |
66 | 2 |
Injection site erythema, Injection site pruritus, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
53 | 25482227 |
US |
65 | 2 |
Injection site bruising, Injection site pustule, Injection site induration, Injection site erythema, |
||||
BELIMUMAB, |
||||
54 | 25482492 |
US |
63 | 2 |
Injection site pain, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
55 | 25482657 |
US |
39 | 2 |
Injection site haemorrhage, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
56 | 25483115 |
US |
2 | |
Injection site swelling, Injection site erythema, Injection site pain, |
||||
EVOLOCUMAB, |
||||
57 | 25483465 |
US |
52 | 2 |
Accidental overdose, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
58 | 25483568 |
US |
54 | 2 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
59 | 25483929 |
DE |
34 | 1 |
Thrombocytopenia, Skin necrosis, Polyglandular autoimmune syndrome type II, Vocal cord paralysis, Adrenal haemorrhage, Injection site erythema, |
||||
DALTEPARIN SODIUM, HEPARIN SODIUM, |
||||
60 | 25483969 |
67 | 2 | |
Chills, Body temperature increased, Injection site swelling, Injection site erythema, Diarrhoea, Vomiting, Diverticulitis, Disease recurrence, Immune system disorder, |
||||
ROMOSOZUMAB-AQQG, |
||||
61 | 25484050 |
US |
37 | 2 |
Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, |
||||
62 | 25484347 |
US |
40 | 2 |
Injection site erythema, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, |
||||
63 | 25484356 |
US |
58 | 1 |
Injection site rash, Injection site erythema, |
||||
DUPILUMAB, |
||||
64 | 25485087 |
US |
63 | 1 |
Extra dose administered, Injection site erythema, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
65 | 25485256 |
US |
64 | 2 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
66 | 25485265 |
US |
68 | 2 |
Hip fracture, Multiple fractures, Injection site rash, Injection site erythema, Off label use, Pain, Nausea, |
||||
TERIPARATIDE, TERIPARATIDE, ERGOCALCIFEROL, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, MAGNESIUM, |
||||
67 | 25485474 |
US |
38 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
68 | 25486129 |
US |
50 | 2 |
Injection site warmth, Injection site swelling, Injection site erythema, |
||||
ADALIMUMAB, |
||||
69 | 25486209 |
US |
23 | 1 |
Psoriasis, Inappropriate schedule of product administration, Injection site erythema, |
||||
IXEKIZUMAB, |
||||
70 | 25486268 |
US |
72 | 2 |
Fall, Hip fracture, Illness, Psoriasis, Injection site erythema, |
||||
IXEKIZUMAB, IXEKIZUMAB, |
||||
71 | 25475990 |
US |
2 | |
Hypertension, Weight increased, Injection site bruising, Injection site erythema, Injection site reaction, Circumstance or information capable of leading to device use error, |
||||
GLATIRAMER ACETATE, |
||||
72 | 25476420 |
US |
67 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
73 | 25476680 |
US |
6 | 1 |
Injection site pain, Injection site erythema, Injection site swelling, |
||||
CABOTEGRAVIR, |
||||
74 | 25476691 |
CA |
47 | 2 |
Diabetes mellitus, Injection site erythema, Injection site pain, Injection site swelling, Wrong technique in product usage process, Off label use, |
||||
INFLIXIMAB, |
||||
75 | 25476995 |
US |
67 | 2 |
Rash macular, Weight increased, Muscular weakness, Injection site erythema, |
||||
TIRZEPATIDE, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, AMOXICILLIN, DOCUSATE SODIUM, SENNOSIDES, DOCUSATE SODIUM AND SENNOSIDES, SENNOSIDES AND DOCUSATE SODIUM, DOCUSATE SODIUM SENNOSIDES, METHENAMINE HIPPURATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, BUMETANIDE, MAGNESIUM OXIDE, MACITENTAN, ENOXAPARIN SODIUM, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL, MECLIZINE, MECLIZINE HYDROCLORIDE, WARFARIN SODIUM, WARFARIN, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, SPIRONOLACTONE, OXYGEN, 0XYGEN, DIGOXIN, OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE OPHTHALMIC, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, |
||||
76 | 25477539 |
US |
44 | 2 |
Drug dose omission by device, Injection site pain, Injection site erythema, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
77 | 25477546 |
US |
||
Injection site erythema, |
||||
LEBRIKIZUMAB-LBKZ, |
||||
78 | 25478170 |
US |
67 | 2 |
Diarrhoea, Injection site erythema, Injection site urticaria, |
||||
TIRZEPATIDE, |
||||
79 | 25478524 |
US |
77 | 2 |
Polymyalgia rheumatica, Headache, Fatigue, Viral infection, Injection site erythema, Arthralgia, Pain in extremity, Aphonia, |
||||
ADALIMUMAB, SARILUMAB, SARILUMAB, ROSUVASTATIN CALCIUM, LOSARTAN POTASSIUM, LOSARTAN, GOLIMUMAB, ESCITALOPRAM OXALATE, ESCITALOPRAM, PREDNISONE, CALCIUM CARBONATE, ANTACID, DENOSUMAB, |
||||
80 | 25478676 |
CN |
90 | 1 |
Erysipelas, Erythema, Skin swelling, Pain in extremity, Injection site erythema, Injection site pain, Blister, Skin weeping, |
||||
CEFTRIAXONE SODIUM, |
||||
81 | 25478790 |
US |
2 | |
Nausea, Vomiting, Injection site erythema, |
||||
MEPOLIZUMAB, |
||||
82 | 25479349 |
US |
72 | 2 |
Extra dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
83 | 25479542 |
US |
2 | |
Injection site erythema, |
||||
DUPILUMAB, FISH OIL, ERGOCALCIFEROL, MAGNESIUM, FLUTICASONE PROPIONATE, ACYCLOVIR, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, ALBUTEROL SULFATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, LISINOPRIL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, LEVOTHYROXINE SODIUM, |
||||
84 | 25479563 |
US |
2 | |
Eye disorder, Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, |
||||
85 | 25479706 |
US |
41 | 2 |
Cough, Injection site erythema, Injection site pruritus, Maternal exposure during pregnancy, |
||||
DUPILUMAB, DUPILUMAB, |
||||
86 | 25479732 |
US |
11 | 1 |
Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
87 | 25479828 |
US |
47 | 2 |
Cerebrovascular accident, Injection site discomfort, Skin discolouration, Injection site reaction, Injection site erythema, Rash pruritic, Injection site warmth, Injection site pain, Condition aggravated, |
||||
DUPILUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, MELOXICAM, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, ALBUTEROL SULFATE AND BUDESONIDE, |
||||
88 | 25480184 |
CA |
68 | 1 |
Fine motor skill dysfunction, Musculoskeletal stiffness, Lethargy, Pain, Pyrexia, Vomiting, Product use complaint, Injection site swelling, Injection site erythema, |
||||
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, BISOPROLOL FUMARATE, |
||||
89 | 25480780 |
US |
||
Injection site erythema, Needle track marks, Injection site haemorrhage, Inappropriate schedule of product administration, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, ROSUVASTATIN, LEVOTHYROXINE, |
||||
90 | 25470653 |
US |
66 | 2 |
Nausea, Constipation, Diarrhoea, Injection site pain, Injection site erythema, Injection site discolouration, Injection site swelling, |
||||
TIRZEPATIDE, DUPILUMAB, DUPILUMAB, |
||||
91 | 25470807 |
US |
67 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
92 | 25471104 |
CA |
||
Lupus-like syndrome, Drug ineffective, Nausea, Nasopharyngitis, Oropharyngeal pain, Pruritus, Urticaria, Injection site erythema, Off label use, Off label use, Inappropriate schedule of product administration, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, PREDNISONE, PREDNISONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, |
||||
93 | 25471172 |
US |
51 | 2 |
Drug dose omission by device, Injection site erythema, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
94 | 25471612 |
US |
69 | 2 |
Injection site pain, Injection site paraesthesia, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
95 | 25471689 |
US |
2 | |
Blood glucose increased, Incorrect dose administered, Injection site erythema, |
||||
DULAGLUTIDE, DULAGLUTIDE, |
||||
96 | 25472155 |
US |
63 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, INSULIN ASPART, INSULIN DEGLUDEC, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, LEVOTHYROXINE, |
||||
97 | 25472226 |
US |
50 | 2 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
98 | 25472510 |
US |
29 | 1 |
Injection site pain, Injection site erythema, |
||||
IXEKIZUMAB, |
||||
99 | 25473616 |
FR |
78 | 2 |
Living in residential institution, Hallucination, Injection site erythema, Injection site pain, Hallucination, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, CARBIDOPA AND LEVODOPA, |
||||
100 | 25474596 |
US |
44 | 2 |
Injection site erythema, Injection site pruritus, Injection site rash, |
||||
DUPILUMAB, DUPILUMAB, |
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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
2025-07-29