Drug:
Reaction: INJECTION SITE ERYTHEMA
20260101 - 20261231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 26938156 |
US |
11 | 2 |
Injection site urticaria, Injection site erythema, Injection site pruritus, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 102 | 26938500 |
US |
59 | 2 |
Injection site swelling, Injection site discolouration, Injection site erythema, Injection site bruising, |
||||
TIRZEPATIDE, |
||||
| 103 | 26938723 |
US |
71 | 1 |
Injection site erythema, Injection site swelling, Injection site pain, |
||||
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE ANHYDROUS, BUPIVACAINE HYDROCHLORIDE, |
||||
| 104 | 26938865 |
US |
2 | |
Alopecia, Injection site pain, Pain in extremity, Nausea, Injection site irritation, Injection site erythema, |
||||
ABALOPARATIDE, |
||||
| 105 | 26938917 |
US |
2 | |
Rash erythematous, Rash pruritic, Headache, Injection site pain, Injection site bruising, Injection site pruritus, Injection site erythema, Blood calcium increased, Arthralgia, Dizziness, Nausea, |
||||
ABALOPARATIDE, |
||||
| 106 | 26938980 |
US |
2 | |
Burning sensation, Urethritis, Injection site pruritus, Injection site erythema, Injection site bruising, |
||||
ABALOPARATIDE, |
||||
| 107 | 26938996 |
US |
63 | 2 |
Injection site discolouration, Headache, Dizziness, Fatigue, Nausea, Heart rate increased, Malaise, Injection site erythema, |
||||
ABALOPARATIDE, |
||||
| 108 | 26939060 |
US |
2 | |
Weight increased, Gastrointestinal disorder, Chest discomfort, Throat tightness, Pollakiuria, Injection site erythema, Injection site pain, Nausea, Dizziness, Vertigo, Abdominal distension, Abdominal pain upper, |
||||
ABALOPARATIDE, |
||||
| 109 | 26939064 |
US |
56 | 1 |
Injection site streaking, Injection site reaction, Injection site erythema, Injection site bruising, |
||||
ABALOPARATIDE, |
||||
| 110 | 26939090 |
US |
2 | |
Renal disorder, Headache, Back pain, Injection site erythema, Product dose omission issue, |
||||
ABALOPARATIDE, |
||||
| 111 | 26939132 |
US |
81 | 2 |
Impaired healing, Injection site irritation, Injection site erythema, Injection site haemorrhage, Injection site pruritus, Incorrect route of product administration, Wrong technique in product usage process, |
||||
ABALOPARATIDE, CARVEDILOL, AMLODIPINE, RAMIPRIL, LEVOCETIRIZINE DIHYDROCHLORIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 112 | 26939134 |
US |
1 | |
Hot flush, Dizziness, Headache, Injection site erythema, Injection site reaction, Injection site pain, Nausea, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, CYCLOBENZAPRINE, |
||||
| 113 | 26939201 |
US |
74 | 2 |
Dysgeusia, Heart rate decreased, Feeling abnormal, Injection site erythema, Palpitations, Product dose omission issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, CALCIUM, ERGOCALCIFEROL, FISH OIL, ROSUVASTATIN, SELENIUM, ERGOCALCIFEROL, |
||||
| 114 | 26939211 |
US |
2 | |
Asthma late onset, Injection site mass, Injection site discolouration, Blood calcium increased, Injection site erythema, Off label use, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, LEVOTHYROXINE SODIUM, |
||||
| 115 | 26939222 |
US |
2 | |
Peripheral swelling, Joint swelling, Injection site erythema, Injection site rash, Pain in extremity, Arthralgia, Hypersensitivity, Product use in unapproved indication, |
||||
ABALOPARATIDE, ETANERCEPT, |
||||
| 116 | 26939265 |
US |
2 | |
Dermal cyst, Balance disorder, Musculoskeletal stiffness, Nausea, Injection site erythema, Contusion, Drug dose omission by device, Device malfunction, Needle issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, ERGOCALCIFEROL, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, AMLODIPINE, BIOTIN, BUPROPION HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FOLIC ACID, HYDROXYCHLOROQUINE, METHOTREXATE, METHOTREXATE SODIUM, |
||||
| 117 | 26939403 |
US |
66 | 2 |
Injection site cyst, Injection site pain, Injection site erythema, Injection site pruritus, Injection site rash, Liquid product physical issue, Product dose omission issue, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 118 | 26939420 |
US |
77 | 2 |
Injection site erythema, Device defective, |
||||
ABALOPARATIDE, |
||||
| 119 | 26939442 |
US |
70 | 1 |
Blood pressure decreased, Injection site erythema, Heart rate increased, |
||||
ABALOPARATIDE, |
||||
| 120 | 26939511 |
US |
2 | |
Sensitive skin, Headache, Palpitations, Injection site erythema, Fatigue, Injection site haemorrhage, Injection site bruising, |
||||
ABALOPARATIDE, |
||||
| 121 | 26939512 |
US |
2 | |
Dysgeusia, Muscle spasms, Injection site pain, Injection site erythema, Product dose omission issue, |
||||
ABALOPARATIDE, |
||||
| 122 | 26939540 |
US |
2 | |
Injection site warmth, Injection site pruritus, Injection site erythema, |
||||
ABALOPARATIDE, |
||||
| 123 | 26939571 |
US |
65 | 2 |
Injection site reaction, Injection site erythema, Injection site pruritus, Therapeutic response unexpected, |
||||
ABALOPARATIDE, ABALOPARATIDE, |
||||
| 124 | 26939590 |
US |
2 | |
Condition aggravated, Injection site pruritus, Heart rate increased, Injection site erythema, |
||||
ABALOPARATIDE, |
||||
| 125 | 26939628 |
US |
1 | |
Muscle discomfort, Musculoskeletal discomfort, Dizziness, Injection site erythema, |
||||
ABALOPARATIDE, |
||||
| 126 | 26939752 |
US |
2 | |
Rib fracture, Peripheral swelling, Infection, Bladder disorder, Injection site urticaria, Incision site rash, Rash pruritic, Swelling, Skin burning sensation, Flatulence, Blood iron decreased, Protein total decreased, Weight decreased, Diarrhoea, Injection site reaction, Pruritus, Injection site erythema, Injection site swelling, Insomnia, Product administered at inappropriate site, |
||||
ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, ABALOPARATIDE, |
||||
| 127 | 26939895 |
US |
69 | 2 |
Injection site erythema, Device difficult to use, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 128 | 26944101 |
2 | ||
Breast disorder female, Pharyngeal disorder, Injection site erythema, Injection site swelling, Injection site rash, Urticaria, Alopecia, |
||||
ICATIBANT ACETATE, LANADELUMAB-FLYO, GARADACIMAB, ECALLANTIDE, CILOSTAZOL, PRASUGREL HYDROCHLORIDE, CILOSTAZOL, |
||||
| 129 | 26931652 |
US |
2 | |
Injection site swelling, Injection site erythema, |
||||
SARILUMAB, SPIRONOLACTONE, COLCHICINE, ROSUVASTATIN, SACUBITRIL AND VALSARTAN, EMPAGLIFLOZIN, METOPROLOL TARTRATE, OMEPRAZOLE MAGNESIUM, RANOLAZINE, LEVOTHYROXINE SODIUM, |
||||
| 130 | 26931748 |
US |
11 | 2 |
Injection site reaction, Injection site erythema, Injection site swelling, |
||||
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, |
||||
| 131 | 26931750 |
US |
36 | 2 |
Injection site erythema, Pyrexia, |
||||
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, |
||||
| 132 | 26931933 |
2 | ||
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 133 | 26932151 |
US |
72 | 2 |
Petechiae, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 134 | 26932314 |
US |
53 | 2 |
Injection site vesicles, Injection site erythema, |
||||
DUPILUMAB, ALBUTEROL SULFATE, AMLODIPINE BESYLATE, |
||||
| 135 | 26932466 |
US |
55 | 1 |
Injection site swelling, Injection site erythema, Injection site pain, |
||||
DUPILUMAB, |
||||
| 136 | 26932481 |
US |
76 | 2 |
Dyspnoea, Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 137 | 26932618 |
US |
1 | 1 |
Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 138 | 26932633 |
US |
21 | 2 |
Injection site erythema, Injection site swelling, |
||||
FREMANEZUMAB-VFRM, |
||||
| 139 | 26932666 |
US |
80 | 1 |
Candida infection, Injection site pain, Injection site erythema, Injection site rash, Injection site swelling, Injection site pruritus, Injection site bruising, |
||||
DUPILUMAB, |
||||
| 140 | 26933362 |
US |
36 | 2 |
Injection site warmth, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 141 | 26933402 |
US |
54 | 1 |
Injection site erythema, Injection site discolouration, Rash, |
||||
DUPILUMAB, |
||||
| 142 | 26933407 |
US |
21 | 2 |
Malaise, Injection site swelling, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 143 | 26933443 |
US |
30 | 2 |
Injection site pruritus, Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 144 | 26933598 |
US |
37 | |
Injection site urticaria, Injection site erythema, Dizziness, |
||||
DUPILUMAB, |
||||
| 145 | 26933602 |
US |
49 | 2 |
Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 146 | 26933625 |
US |
29 | 2 |
Injection site pain, Injection site dryness, Injection site erythema, Injection site exfoliation, Dyspnoea, |
||||
DUPILUMAB, |
||||
| 147 | 26933768 |
US |
43 | 2 |
Injection site erythema, |
||||
DUPILUMAB, |
||||
| 148 | 26933779 |
US |
||
Fatigue, Headache, Injection site erythema, |
||||
DUPILUMAB, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, |
||||
| 149 | 26933810 |
US |
60 | 2 |
Injection site rash, Injection site erythema, Injection site pruritus, Product use in unapproved indication, Incorrect dose administered, |
||||
DUPILUMAB, DENOSUMAB, |
||||
| 150 | 26933899 |
US |
79 | 2 |
Injection site erythema, Injection site pruritus, |
||||
TIRZEPATIDE, |
||||
| 151 | 26933914 |
US |
72 | 2 |
Injection site bruising, Injection site erythema, Device use error, Wrong technique in product usage process, |
||||
EVOLOCUMAB, |
||||
| 152 | 26934018 |
US |
2 | |
Device difficult to use, Injection site erythema, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 153 | 26934023 |
US |
64 | 1 |
Injection site papule, Device issue, Injection site erythema, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 154 | 26938110 |
49 | 2 | |
Injection site erythema, Injection site swelling, Injection site mass, Injection site atrophy, Limb deformity, Lipodystrophy acquired, |
||||
TIRZEPATIDE, |
||||
| 155 | 26926883 |
US |
75 | 1 |
Urticaria, Injection site swelling, Injection site pruritus, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 156 | 26927275 |
US |
1 | |
Injection site erythema, |
||||
DUPILUMAB, |
||||
| 157 | 26927359 |
EU |
66 | 2 |
Dyspnoea exertional, Angina pectoris, Injection site urticaria, Injection site pain, Injection site erythema, |
||||
| 158 | 26927521 |
US |
75 | 1 |
Rash, Injection site pain, Injection site erythema, Injection site rash, Injection site swelling, Injection site pruritus, Injection site bruising, |
||||
DUPILUMAB, |
||||
| 159 | 26927596 |
US |
25 | 2 |
Device defective, Device malfunction, Device leakage, Injection site erythema, Drug dose omission by device, |
||||
| 160 | 26927705 |
US |
39 | 2 |
Injection site pruritus, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 161 | 26927707 |
US |
67 | 2 |
Hunger, Visual impairment, Palpitations, Dry mouth, Heart rate increased, Injection site pain, Injection site pruritus, Injection site swelling, Injection site erythema, Injection site urticaria, Injection site rash, Fatigue, Injection site mass, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 162 | 26927987 |
US |
40 | 2 |
Rash erythematous, Injection site erythema, Injection site pain, Injection site rash, Injection site pruritus, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 163 | 26928296 |
US |
2 | |
Ear swelling, Rash, Injection site erythema, Lip swelling, Swelling face, |
||||
TIRZEPATIDE, |
||||
| 164 | 26928783 |
US |
||
Injection site discharge, Injection site erythema, |
||||
OCRELIZUMAB AND HYALURONIDASE, |
||||
| 165 | 26929479 |
US |
1 | |
Skin pressure mark, Injection site erythema, Injection site discomfort, |
||||
| 166 | 26929927 |
US |
74 | 2 |
Anxiety, Injection site erythema, |
||||
DUPILUMAB, ALBUTEROL SULFATE, BUPROPION HYDROCHLORIDE, MOMETASONE FUROATE AND FORMOTEROL FUMARATE DIHYDRATE, EPINEPHRINE, ADRENALINUM, FAMOTIDINE, FLUTICASONE PROPIONATE, PANTOPRAZOLE, TIOTROPIUM BROMIDE, |
||||
| 167 | 26930235 |
US |
58 | 2 |
Injection site erythema, Injection site swelling, Injection site pruritus, Injection site warmth, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 168 | 26930391 |
US |
63 | 2 |
Injection site warmth, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 169 | 26930396 |
US |
3 | 1 |
Injection site reaction, Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 170 | 26921629 |
US |
75 | 2 |
Off label use, Injection site erythema, Injection site bruising, |
||||
TIRZEPATIDE, |
||||
| 171 | 26921672 |
JP |
2 | |
Cataract, Rash, Injection site erythema, Injection site rash, Injection site pain, Injection site pruritus, Urticaria, Pruritus, Erythema, Inappropriate schedule of product administration, |
||||
INCLISIRAN, INCLISIRAN, |
||||
| 172 | 26921711 |
US |
2 | |
Injection site erythema, Fatigue, |
||||
DUPILUMAB, DUPILUMAB, ALBUTEROL SULFATE, AMIKACIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, ETHAMBUTOL HYDROCHLORIDE, GABAPENTIN, HYDROCHLOROTHIAZIDE, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 173 | 26922191 |
US |
2 | |
Injection site erythema, Urticaria, Inflammation, |
||||
GUSELKUMAB, |
||||
| 174 | 26922233 |
US |
56 | 2 |
Injection site erythema, |
||||
EVOLOCUMAB, |
||||
| 175 | 26922424 |
CN |
41 | 2 |
Abscess, Pruritus, Injection site erythema, Injection site swelling, Injection site pruritus, Injection site pain, Product preparation issue, |
||||
DUPILUMAB, FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE ORAL, FEXOFENADINE HCL, |
||||
| 176 | 26922611 |
US |
47 | |
Crohn^s disease, Device deployment issue, Injection site warmth, Injection site erythema, Injection site swelling, Injection site irritation, |
||||
GUSELKUMAB, GUSELKUMAB, |
||||
| 177 | 26923043 |
US |
52 | 2 |
Injection site erythema, Injection site injury, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 178 | 26923380 |
GB |
64 | |
Stoma creation, Injection site mass, Injection site erythema, Injection site inflammation, Wrong technique in product usage process, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, LOSARTAN, SERTRALINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 179 | 26923543 |
US |
44 | 2 |
Urticaria, Injection site pruritus, Injection site erythema, Injection site warmth, |
||||
IXEKIZUMAB, |
||||
| 180 | 26923548 |
US |
45 | 2 |
Injection site pain, Injection site erythema, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 181 | 26923744 |
US |
27 | 1 |
Weight increased, Injection site erythema, Injection site bruising, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 182 | 26924028 |
US |
60 | 1 |
Injection site erythema, Injection site pain, Drug ineffective, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 183 | 26924221 |
GB |
62 | 2 |
Medication error, Injection site swelling, Injection site pain, Injection site erythema, Hypersensitivity, |
||||
TIRZEPATIDE, |
||||
| 184 | 26924242 |
US |
66 | 2 |
Memory impairment, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site bruising, |
||||
TIRZEPATIDE, |
||||
| 185 | 26924549 |
US |
52 | 2 |
Rheumatoid arthritis, Product ineffective for unapproved use, Injection site inflammation, Injection site warmth, Injection site erythema, Injection site pruritus, Pain, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 186 | 26924570 |
US |
||
Injection site papule, Injection site erythema, Injection site pain, Injection site warmth, |
||||
ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, |
||||
| 187 | 26924818 |
US |
0 | 2 |
Sinus tachycardia, Hypovolaemia, Dyspnoea, Fatigue, Injection site erythema, Injection site pain, |
||||
ZOPAPOGENE IMADENOVEC, ZOPAPOGENE IMADENOVEC, ZOPAPOGENE IMADENOVEC, ZOPAPOGENE IMADENOVEC, SERTRALINE, NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, |
||||
| 188 | 26924936 |
US |
79 | 2 |
Injection site warmth, Injection site mass, Injection site swelling, Injection site erythema, Injection site pruritus, Inappropriate schedule of product administration, |
||||
DUPILUMAB, ALBUTEROL SULFATE AND BUDESONIDE, AMLODIPINE BESYLATE, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, ESCITALOPRAM OXALATE, ESCITALOPRAM, GABAPENTIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, TIZANIDINE HYDROCHLORIDE, ERGOCALCIFEROL, BUPROPION HYDROCHLORIDE, |
||||
| 189 | 26925002 |
US |
75 | 2 |
Injection site pruritus, Injection site erythema, |
||||
EVOLOCUMAB, |
||||
| 190 | 26925435 |
EU |
60 | 2 |
Injection site erythema, Injection site pruritus, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 191 | 26925455 |
EU |
2 | |
Injection site pruritus, Injection site erythema, |
||||
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM, |
||||
| 192 | 26925811 |
US |
50 | 2 |
Product dose omission issue, Injection site irritation, Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 193 | 26925996 |
US |
52 | 2 |
Injection site bruising, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 194 | 26914665 |
US |
70 | 2 |
Off label use, Injection site erythema, Injection site mass, Injection site rash, Injection site pruritus, |
||||
TIRZEPATIDE, |
||||
| 195 | 26914712 |
US |
75 | 2 |
Injection site urticaria, Injection site swelling, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 196 | 26915009 |
US |
58 | 2 |
Injection site erythema, Injection site bruising, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 197 | 26915029 |
US |
2 | |
Injection site erythema, Injection site swelling, Injection site irritation, |
||||
CLOPIDOGREL, CLOPIDOGREL, |
||||
| 198 | 26915661 |
US |
||
Shoulder fracture, Limb injury, Injection site haemorrhage, Injection site erythema, Injection site pain, |
||||
ALIROCUMAB, |
||||
| 199 | 26915978 |
US |
79 | 2 |
Injection site bruising, Injection site erythema, Injection site swelling, Device difficult to use, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 200 | 26916051 |
US |
79 | 2 |
Off label use, Injection site pruritus, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
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
2026-07-30