Drug:
Reaction: INJECTION SITE ERYTHEMA
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26510110 |
CA |
61 | 2 |
Pneumonia, Pyrexia, Sensitive skin, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, ALBUTEROL SULFATE, LEVOTHYROXINE SODIUM, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, |
||||
| 202 | 26510148 |
US |
59 | 1 |
Injection site rash, Injection site pruritus, Injection site erythema, Injection site mass, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 203 | 26510331 |
US |
68 | 2 |
Pruritus, Injection site pruritus, Injection site pain, Injection site erythema, Injection site urticaria, |
||||
TIRZEPATIDE, |
||||
| 204 | 26510575 |
62 | ||
Product dose omission issue, Injection site pain, Injection site erythema, Injection site rash, Injection site pain, Injection site reaction, Injection site bruising, |
||||
BIMEKIZUMAB, |
||||
| 205 | 26510600 |
US |
2 | |
Injection site erythema, |
||||
| 206 | 26510849 |
US |
57 | 2 |
Nausea, Gastrooesophageal reflux disease, Injection site erythema, Injection site swelling, |
||||
TIRZEPATIDE, |
||||
| 207 | 26512124 |
US |
61 | 2 |
Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 208 | 26502921 |
US |
||
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 209 | 26503342 |
US |
23 | 2 |
Injection site erythema, Injection site rash, |
||||
EPOPROSTENOL, AMBRISENTAN, RIOCIGUAT, SOTATERCEPT-CSRK, |
||||
| 210 | 26503461 |
CH |
45 | 2 |
Injection site pruritus, Injection site erythema, Hot flush, Palpitations, |
||||
OCRELIZUMAB, |
||||
| 211 | 26503555 |
US |
46 | |
Nausea, Injection site erythema, Injection site irritation, |
||||
TIRZEPATIDE, |
||||
| 212 | 26503600 |
US |
||
Injection site reaction, Injection site erythema, Injection site papule, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 213 | 26503775 |
US |
69 | 2 |
Injection site rash, Injection site erythema, Incorrect dose administered by device, |
||||
TERIPARATIDE, TERIPARATIDE, TERIPARATIDE, |
||||
| 214 | 26504488 |
47 | ||
Urticaria, Injection site pain, Injection site erythema, Injection site rash, Injection site swelling, Injection site pruritus, Injection site bruising, Gallbladder disorder, |
||||
BIMEKIZUMAB, |
||||
| 215 | 26504950 |
US |
51 | 2 |
Headache, Irritability, Malaise, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 216 | 26504955 |
US |
82 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 217 | 26505200 |
US |
62 | 2 |
Injection site erythema, Injection site pruritus, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 218 | 26505622 |
US |
82 | 2 |
Injection site bruising, Injection site erythema, |
||||
| 219 | 26505637 |
US |
78 | 2 |
Injection site erythema, Injection site bruising, |
||||
| 220 | 26505651 |
US |
79 | 2 |
Injection site pruritus, Injection site pain, Injection site erythema, Urinary tract infection, |
||||
| 221 | 26505703 |
US |
74 | 2 |
Injection site erythema, Injection site bruising, |
||||
| 222 | 26505789 |
US |
65 | 2 |
Injection site erythema, Injection site swelling, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 223 | 26505850 |
US |
35 | 2 |
Pneumonia, Injection site erythema, Influenza like illness, |
||||
OFATUMUMAB, OFATUMUMAB, |
||||
| 224 | 26506477 |
US |
2 | |
Injection site erythema, Injection site swelling, Injection site bruising, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 225 | 26506672 |
US |
43 | 2 |
Wrong technique in product usage process, Blood glucose increased, Injection site pain, Injection site erythema, |
||||
INSULIN LISPRO-AABC, |
||||
| 226 | 26506724 |
US |
17 | 2 |
Injection site erythema, Injection site irritation, Device malfunction, |
||||
FREMANEZUMAB-VFRM, |
||||
| 227 | 26497910 |
US |
65 | 1 |
Vision blurred, Injection site erythema, Injection site pruritus, Injection site swelling, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 228 | 26497979 |
US |
58 | 1 |
Injection site erythema, Injection site swelling, Injection site bruising, |
||||
EVOLOCUMAB, |
||||
| 229 | 26498436 |
US |
48 | 2 |
Insomnia, Pruritus, Injection site irritation, Injection site erythema, Injection site mass, Injection site warmth, Injection site pain, Injection site induration, |
||||
GALCANEZUMAB-GNLM, |
||||
| 230 | 26498493 |
US |
68 | 2 |
Nightmare, Abnormal dreams, Constipation, Injection site erythema, Injection site pruritus, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 231 | 26498528 |
US |
2 | |
Injection site erythema, Device use error, Injection site pain, |
||||
ADALIMUMAB, |
||||
| 232 | 26499108 |
US |
24 | 2 |
Injection site erythema, Injection site pruritus, Injection site swelling, |
||||
TIRZEPATIDE, |
||||
| 233 | 26499542 |
IN |
||
Kounis syndrome, Injection site erythema, Bundle branch block left, |
||||
DICLOFENAC, DICLOFENAC SODIUM, |
||||
| 234 | 26500418 |
US |
||
Injection site mass, Injection site erythema, |
||||
INCOBOTULINUMTOXINA, |
||||
| 235 | 26500783 |
US |
3 | 2 |
Injection site erythema, Eczema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 236 | 26500902 |
US |
46 | 2 |
Fall, Rib fracture, Memory impairment, Injection site irritation, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 237 | 26500992 |
US |
18 | 2 |
Injection site rash, Injection site erythema, Drug delivery system issue, |
||||
FREMANEZUMAB-VFRM, |
||||
| 238 | 26501011 |
US |
65 | 2 |
Injection site swelling, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 239 | 26501082 |
US |
78 | 2 |
Limb operation, Illness, Feeling abnormal, Injection site pain, Injection site erythema, Product dose omission issue, Incorrect disposal of product, Device difficult to use, Migraine, |
||||
ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, ERENUMAB-AOOE, |
||||
| 240 | 26501112 |
GB |
33 | 2 |
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 241 | 26501170 |
US |
17 | 1 |
Injection site cellulitis, Injection site reaction, Injection site pain, Injection site swelling, Injection site warmth, Injection site bruising, Injection site erythema, Erythema, Hypersensitivity, Influenza, Pyrexia, Lethargy, Pain, Dizziness, Off label use, |
||||
PEGVALIASE-PQPZ, FAMOTIDINE, LORATADINE, LORATADINE TABLET, PREDNISONE, |
||||
| 242 | 26501729 |
74 | 2 | |
Injection site bruising, Injection site swelling, Injection site warmth, Injection site erythema, Injection site pain, Urinary tract infection, Gait disturbance, Erythema, Chills, Injection site pain, Swelling, Pruritus, Contusion, |
||||
CEPHALEXIN, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CREAM 1%, ANTI-PRURITIC, HYDROCORTISONE CONTINUOUS SPRAY, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, |
||||
| 243 | 26506233 |
2 | ||
Chest pain, Electrocardiogram abnormal, Impaired gastric emptying, Injection site erythema, Gastrointestinal inflammation, Therapy partial responder, Hereditary angioedema, |
||||
ICATIBANT ACETATE, |
||||
| 244 | 26497656 |
US |
2 | |
Anxiety, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 245 | 26497674 |
US |
71 | 2 |
Injection site rash, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 246 | 26496684 |
US |
56 | 1 |
Incorrect dose administered, Injection site haemorrhage, Injection site erythema, |
||||
IXEKIZUMAB, IXEKIZUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 247 | 26496834 |
EU |
69 | 2 |
Injection site warmth, Injection site erythema, Malaise, Cold sweat, Blood pressure decreased, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, BISOPROLOL FUMARATE, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE NASAL, MONTELUKAST SODIUM, MONTELUKAST, TIOTROPIUM BROMIDE INHALATION SPRAY, ESTRADIOL, |
||||
| 248 | 26497262 |
IN |
40 | 2 |
Kounis syndrome, Bundle branch block left, Injection site erythema, |
||||
DICLOFENAC, DICLOFENAC SODIUM, |
||||
| 249 | 26492450 |
EU |
40 | |
Hypokalaemia, Blood cholesterol increased, Blood triglycerides increased, Injection site erythema, Injection site swelling, |
||||
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, METHOTREXATE, METHOTREXATE SODIUM, ACITRETIN, |
||||
| 250 | 26492541 |
US |
79 | 2 |
Injection site bruising, Injection site erythema, Injection site swelling, Incorrect disposal of product, Product communication issue, Device use error, |
||||
EVOLOCUMAB, |
||||
| 251 | 26493361 |
GB |
||
Death, Injection site erythema, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 252 | 26494605 |
41 | 2 | |
Injection site reaction, Injection site erythema, Injection site pruritus, Drug ineffective, Dry skin, |
||||
TIRZEPATIDE, TIRZEPATIDE, TELMISARTAN, BUPROPION, |
||||
| 253 | 26494630 |
US |
30 | 2 |
Product dose omission issue, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 254 | 26494889 |
US |
6 | 2 |
Injection site reaction, Injection site erythema, Injection site swelling, Injection site warmth, Off label use, |
||||
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, |
||||
| 255 | 26495305 |
US |
2 | |
Injection site erythema, Device leakage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 256 | 26495532 |
US |
55 | 2 |
Injection site erythema, Injection site pain, |
||||
ROMOSOZUMAB-AQQG, |
||||
| 257 | 26495920 |
US |
33 | 2 |
Injection site erythema, Injection site pruritus, Injection site urticaria, |
||||
SIBEPRENLIMAB, |
||||
| 258 | 26496235 |
US |
2 | |
Injection site erythema, Injection site swelling, |
||||
ASFOTASE ALFA, |
||||
| 259 | 26485378 |
US |
2 | |
Oesophagitis, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 260 | 26485502 |
US |
2 | |
Injection site rash, Injection site pruritus, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 261 | 26485709 |
US |
2 | 2 |
Injection site irritation, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 262 | 26486411 |
63 | ||
Injection site erythema, |
||||
OLEZARSEN SODIUM, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, HYDROCHLOROTHIAZIDE, LISINOPRIL, POLYETHYLENE GLYCOL 3350, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, RIZATRIPTAN, ROSUVASTATIN, ICOSAPENT ETHYL, CETIRIZINE HYDROCHLORIDE, FENOFIBRATE, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 263 | 26486531 |
US |
1 | |
Injection site swelling, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 264 | 26486720 |
US |
7 | 1 |
Injection site erythema, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE, ALBUTEROL, FLUTICASONE PROPIONATE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, TIOTROPIUM BROMIDE, MONTELUKAST SODIUM, |
||||
| 265 | 26487222 |
US |
63 | 2 |
Incorrect dose administered, Injection site injury, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 266 | 26487357 |
US |
2 | |
Nasal congestion, Eczema, Injection site swelling, Injection site pain, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 267 | 26487895 |
EU |
20 | 2 |
Somatic hallucination, Somatic hallucination, Hallucination, auditory, Hallucination, auditory, General physical health deterioration, Depressed mood, Hepatosplenomegaly, Gastrointestinal disorder, Malaise, Hypotension, Injection site erythema, Injection site induration, Sedation, Fatigue, Vomiting, Nausea, Incorrect dose administered, |
||||
ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, |
||||
| 268 | 26488047 |
US |
||
Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 269 | 26488169 |
US |
2 | |
Injection site pain, Injection site erythema, Injection site bruising, Injection site discharge, |
||||
| 270 | 26488826 |
US |
64 | 2 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 271 | 26488853 |
US |
1 | |
Injection site erythema, |
||||
INCLISIRAN, INCLISIRAN, |
||||
| 272 | 26489161 |
US |
2 | |
Injection site rash, Abdominal pain upper, Bacterial infection, Irritable bowel syndrome, Bronchitis, Infection parasitic, Bronchitis, Injection site pain, White blood cell count decreased, Injection site erythema, Abdominal pain upper, |
||||
ADALIMUMAB, AMLODIPINE, TIZANIDINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, EZETIMIBE, PREDNISONE, GABAPENTIN, CYCLOSPORINE, METOPROLOL TARTRATE, METOPROLOL, |
||||
| 273 | 26489312 |
US |
68 | 2 |
Injection site erythema, Injection site irritation, Injection site pruritus, Injection site swelling, |
||||
TIRZEPATIDE, |
||||
| 274 | 26489641 |
US |
16 | 1 |
Dry skin, Skin discolouration, Skin hypertrophy, Skin exfoliation, Pruritus, Injection site pain, Injection site erythema, Dermatitis atopic, |
||||
DUPILUMAB, |
||||
| 275 | 26489837 |
US |
65 | 1 |
Injection site erythema, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 276 | 26489919 |
US |
36 | 2 |
Injection site erythema, Injection site pruritus, Injection site bruising, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, |
||||
| 277 | 26489996 |
US |
13 | 1 |
Injection site erythema, |
||||
DUPILUMAB, |
||||
| 278 | 26490461 |
US |
8 | 2 |
Injection site erythema, Injection site swelling, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 279 | 26490709 |
US |
||
Injection site erythema, Injection site inflammation, |
||||
AMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT), |
||||
| 280 | 26490831 |
33 | ||
Injection site erythema, Abdominal pain, |
||||
DONIDALORSEN, |
||||
| 281 | 26490986 |
48 | ||
Injection site erythema, Product dose omission issue, Device malfunction, |
||||
BIMEKIZUMAB, |
||||
| 282 | 26491094 |
US |
||
Injection site mass, Injection site erythema, Injection site swelling, |
||||
INCOBOTULINUMTOXINA, |
||||
| 283 | 26491122 |
US |
||
Injection site mass, Injection site erythema, Injection site swelling, |
||||
INCOBOTULINUMTOXINA, |
||||
| 284 | 26491151 |
US |
1 | |
Taste disorder, Paraesthesia oral, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 285 | 26494321 |
60 | 2 | |
Injection site erythema, Injection site pruritus, Therapeutic product effect decreased, |
||||
TIRZEPATIDE, |
||||
| 286 | 26480669 |
US |
28 | |
Fatigue, Injection site erythema, Injection site bruising, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, |
||||
| 287 | 26480687 |
AU |
79 | 2 |
Cholestatic liver injury, Pyrexia, Chills, Injection site pain, Injection site erythema, Injection site swelling, |
||||
ROMOSOZUMAB-AQQG, ROMOSOZUMAB-AQQG, APIXABAN, BUMETANIDE, METHENAMINE HIPPURATE, PANTOPRAZOLE, SPIRONOLACTONE, |
||||
| 288 | 26480727 |
US |
39 | |
Injection site mass, Injection site erythema, Injection site swelling, Injection site pain, |
||||
INFLIXIMAB-DYYB, |
||||
| 289 | 26480929 |
CN |
||
Death, Adverse drug reaction, Spinal fracture, Phosphorus metabolism disorder, Musculoskeletal cancer, Surgery, Medical procedure, Central nervous system haemorrhage, Cerebrovascular accident, Bone operation, Joint surgery, Therapeutic procedure, Endocrine gland operation, Myocardial infarction, Dislocation of vertebra, Cardiac failure, Artery dissection, Metastasis, Spinal cord disorder, Bone disorder, Joint dislocation, Limb fracture, Calcium metabolism disorder, Tooth infection, Oral infection, Product storage error, Bone metabolism disorder, Magnesium metabolism disorder, Skeletal injury, Joint injury, Benign bone neoplasm, Musculoskeletal disorder, Connective tissue disorder, Metabolic disorder, Malnutrition, Noninfective gingivitis, Coronary artery disease, Injection site reaction, Fracture, Fall, Aneurysm, Nervous system disorder, Injection site urticaria, Injection site erythema, Muscle disorder, Musculoskeletal deformity, Intervertebral disc disorder, Skeletal survey abnormal, Soft tissue disorder, Blood electrolytes abnormal, Laboratory test abnormal, Cardiac valve disease, Parathyroid disorder, Benign endocrine neoplasm, Endocrine disorder, Benign gastrointestinal neoplasm, Endocrine test abnormal, Lipids abnormal, Radiculopathy, Tooth disorder, Gingival disorder, Neck injury, Administration site reaction, Enzyme level abnormal, Myalgia, Musculoskeletal pain, Pain in extremity, Off label use, |
||||
DENOSUMAB, DENOSUMAB, DENOSUMAB, DENOSUMAB, ROMOSOZUMAB-AQQG, ROMOSOZUMAB-AQQG, ROMOSOZUMAB-AQQG, ROMOSOZUMAB-AQQG, |
||||
| 290 | 26481362 |
67 | ||
Injection site erythema, Injection site warmth, |
||||
OLEZARSEN SODIUM, |
||||
| 291 | 26481700 |
US |
69 | 2 |
Injection site erythema, Injection site warmth, Injection site swelling, Injection site pain, Injection site mass, Malaise, |
||||
TIRZEPATIDE, |
||||
| 292 | 26481994 |
US |
74 | 2 |
Injection site erythema, Injection site urticaria, Injection site pruritus, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 293 | 26482663 |
US |
55 | 2 |
Rash erythematous, Rash pruritic, Injection site swelling, Injection site pruritus, Injection site erythema, Injection site pain, Maternal exposure during pregnancy, Eosinophilic oesophagitis, Gastrooesophageal reflux disease, Oropharyngeal pain, |
||||
DUPILUMAB, DUPILUMAB, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN TABLET, FILM COATED, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 294 | 26482863 |
US |
59 | 2 |
Panic attack, Injection site pain, Injection site erythema, Off label use, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 295 | 26482869 |
US |
2 | |
Injection site erythema, Injection site pain, |
||||
ROMOSOZUMAB-AQQG, |
||||
| 296 | 26483058 |
US |
64 | 2 |
Incorrect dose administered, Injection site erythema, |
||||
TIRZEPATIDE, |
||||
| 297 | 26483096 |
US |
75 | 2 |
Injection site swelling, Visual impairment, Back pain, Arthralgia, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 298 | 26483107 |
US |
51 | 1 |
Injection site erythema, Nasopharyngitis, Paranasal sinus hypersecretion, Cough, |
||||
DUPILUMAB, |
||||
| 299 | 26483177 |
US |
32 | |
Bronchitis, Injection site scab, Injection site rash, Injection site erythema, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 300 | 26483577 |
US |
||
Injection site erythema, Injection site swelling, Treatment failure, |
||||
GLATIRAMER ACETATE, |
||||
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last_updated
2026-04-28