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Drug Search by Year (Detail)

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Drug:

Reaction: INJECTION SITE ERYTHEMA

20260101 - 20261231

No. 301 - 400

Next page: 5 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
301
26484192
US
17 1
Viral infection, Pyrexia, Off label use, Lethargy, Dizziness, Injection site pain, Injection site erythema, Injection site warmth, Injection site bruising,
PEGVALIASE-PQPZ,
302
26484387
US
70 2
Constipation, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site swelling, Injection site discolouration, Gastrooesophageal reflux disease, Fatigue,
TIRZEPATIDE, TIRZEPATIDE, POLYETHYLENE GLYCOL 3350, HYDROCHLOROTHIAZIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, PSYLLIUM HUSK,
303
26484522
US
1
Injection site erythema,
TIRZEPATIDE,
304
26484561
US
2
Injection site erythema, Injection site pruritus, Injection site swelling, Drug ineffective,
DUPILUMAB, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED,
305
26484599
US
2
Injection site haemorrhage, Device issue, Injection site erythema,
ADALIMUMAB,
306
26485122
US
18
Injection site pruritus, Injection site erythema,
INFLIXIMAB-DYYB,
307
26485143
US
52
Injection site swelling, Injection site erythema,
INFLIXIMAB-DYYB,
308
26475970
43
Injection site erythema, Injection site induration, Injection site discolouration,
OLEZARSEN SODIUM, DICLOFENAC, DICLOFENAC SODIUM, EVOLOCUMAB, FENOFIBRATE, GABAPENTIN, INSULIN ASPART, INSULIN GLARGINE-YFGN, INSULIN GLARGINE, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, LOSARTAN, MECLIZINE HCL 12.5 MG, MECLIZINE HCL 25 MG, MECLIZINE HYDROCHLORIDE, MECLIZINE, MECLIZINE HCL 25MG, MECLIZINE HCL 12.5MG, NIACIN, CYCLOBENZAPRINE, NALOXONE HCL,
309
26476364
US
1
Injection site erythema,
OCRELIZUMAB AND HYALURONIDASE,
310
26477139
US
2
Injection site erythema, Injection site swelling, Injection site induration, Injection site discomfort,
ROMOSOZUMAB-AQQG,
311
26477720
US
58 2
Dizziness, Weight increased, Injection site erythema, Injection site pain,
312
26477728
US
30 1
Injection site erythema, Injection site pain, Injection site discolouration, Injection site discharge, Underdose,
313
26477750
US
39
Injection site pain, Injection site erythema, Injection site swelling,
INFLIXIMAB-DYYB,
314
26478676
US
74 2
Injection site pain, Injection site erythema,
TIRZEPATIDE,
315
26478741
US
Injection site pruritus, Injection site hypersensitivity, Injection site erythema,
TIRZEPATIDE,
316
26478893
US
83 1
Injection site erythema,
TIRZEPATIDE,
317
26479229
US
62 2
Injection site erythema, Off label use,
ADALIMUMAB-ADBM,
318
26479809
US
62 2
Injection site erythema,
TIRZEPATIDE,
319
26479872
US
1
Device alarm issue, Injection site erythema, Injection site injury,
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA,
320
26471481
US
Injection site pruritus, Injection site erythema,
TIRZEPATIDE,
321
26471542
US
59 2
Injection site hypersensitivity, Injection site warmth, Injection site erythema, Incorrect dose administered by device,
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM,
322
26471729
US
2
Injection site erythema,
TIRZEPATIDE, TIRZEPATIDE,
323
26472495
US
64 1
Drug ineffective, Injection site swelling, Injection site pain, Injection site erythema,
TRALOKINUMAB-LDRM,
324
26472603
US
79 2
Injection site rash, Injection site erythema, Injection site pain,
TIRZEPATIDE,
325
26472854
JP
76 2
Empyema, Needle track marks, Blood pressure decreased, Skin papilloma, Pyrexia, Hyperhidrosis, Pyrexia, Tympanic membrane perforation, Pharyngeal polyp, Injection site haemorrhage, Injection site swelling, Injection site erythema, Injection site pain, Vertigo,
ABALOPARATIDE, ABALOPARATIDE,
326
26473063
CN
28 2
Injection site erythema, Injection site swelling, Drug hypersensitivity,
CARBOPROST TROMETHAMINE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, CEFOXITIN SODIUM, OXYTOCIN,
327
26474061
US
60 2
Colitis ulcerative, Therapeutic reaction time decreased, Defaecation urgency, Diarrhoea, Flatulence, Injection site erythema, Injection site pruritus,
VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB,
328
26474194
US
2
Injection site erythema, Injection site pruritus,
329
26474444
US
48 2
Arthralgia, Peripheral swelling, Pain in extremity, Injection site erythema,
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ,
330
26474448
US
4 2
Injection site pruritus, Injection site erythema,
331
26474681
US
55 2
Rash papular, Injection site erythema,
TIRZEPATIDE, TIRZEPATIDE,
332
26475457
Injection site rash, Injection site erythema,
BIMEKIZUMAB,
333
26470634
US
33 2
Incorrect dose administered by device, Injection site pain, Injection site erythema,
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM,
334
26470688
US
60
Injection site pain, Injection site urticaria, Injection site erythema, Device delivery system issue,
SUMATRIPTAN SUCCINATE, BUPROPION, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, LOSARTAN,
335
26470707
US
60 2
Injection site pruritus, Injection site erythema, Injection site mass,
TIRZEPATIDE,
336
26470747
US
72 2
Injection site erythema, Injection site pruritus,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
337
26470753
US
67
Product administered at inappropriate site, Incorrect dose administered, Injection site erythema, Injection site bruising,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
338
26470776
US
51 2
Visual impairment, Injection site swelling, Injection site erythema,
INSULIN GLARGINE, INSULIN GLARGINE,
339
26470933
US
74 2
Injection site discolouration, Injection site haemorrhage, Injection site bruising, Injection site mass, Injection site erythema,
DULAGLUTIDE,
340
26470980
US
2
Injection site swelling, Injection site erythema,
GUSELKUMAB,
341
26471009
US
57 1
Injection site warmth, Injection site erythema,
PEGINTERFERON BETA-1A,
342
26471054
39
Injection site erythema, Injection site swelling, Pain, Erythema, Swelling, Illness,
BIMEKIZUMAB,
343
26470574
US
58 2
Injection site erythema, Injection site pain, Injection site swelling, Incorrect dose administered,
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM,
344
26466753
CA
45
Lower respiratory tract infection, Nasopharyngitis, Dizziness, Injection site swelling, Injection site erythema, Injection site pruritus, Product dose omission issue, Inappropriate schedule of product administration,
OMALIZUMAB, OMALIZUMAB, ALBUTEROL SULFATE, ALBUTEROL,
345
26467219
US
52 2
Injection site erythema, Injection site swelling, Injection site pain,
ABATACEPT, SARILUMAB,
346
26467560
US
36 2
Pyrexia, Injection site pain, Injection site erythema,
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, RIMEGEPANT SULFATE,
347
26468073
IL
2
Pneumonia, Injection site swelling, Injection site erythema, Injection site pruritus,
VEDOLIZUMAB,
348
26468204
IL
47 2
Osteoporosis, Injection site swelling, Injection site rash, Injection site pruritus, Accidental exposure to product, Device leakage, Migraine, Injection site erythema,
FREMANEZUMAB-VFRM,
349
26468271
US
44 1
Adverse drug reaction, Injection site rash, Injection site erythema, Injection site pain, Injection site warmth,
350
26468512
US
19 2
Injection site erythema,
351
26468517
US
22 2
Injection site hypersensitivity, Injection site erythema, Injection site swelling,
PEGVALIASE-PQPZ, FAMOTIDINE, CETIRIZINE HYDROCHLORIDE, MONTELUKAST, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER,
352
26468801
US
66 2
Injection site papule, Injection site erythema,
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA,
353
26469227
US
22 2
Injection site erythema,
GALCANEZUMAB-GNLM, CELECOXIB,
354
26460958
CA
Cataract, Death of relative, Diverticulitis, Drug eruption, Hepatic enzyme increased, Infusion site erythema, Infusion site urticaria, Injection site erythema, Injection site pruritus, Leiomyosarcoma, Ocular discomfort, Osteoarthritis, Pulmonary embolism, Reaction to excipient, Weight decreased, White coat hypertension, Inappropriate schedule of product administration, Off label use,
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, PREDNISONE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ESTRADIOL, EZETIMIBE, BIMATOPROST, RAMIPRIL, RAMIPRIL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE TABLETS, ROSUVASTATIN CALCIUM,
355
26461167
US
71 2
Injection site erythema,
TIRZEPATIDE,
356
26461301
US
36 2
Skin reaction, Injection site erythema,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
357
26461876
US
41 2
Injection site swelling, Injection site erythema,
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM,
358
26462003
US
44 2
Injection site erythema, Accidental exposure to product, Injection site swelling, Device malfunction,
FREMANEZUMAB-VFRM,
359
26462474
Hypersensitivity, Injection site pain, Injection site erythema, Injection site warmth, Injection site urticaria, Drug ineffective,
BIMEKIZUMAB,
360
26462690
76
Cataract, Cataract operation, Injection site hypersensitivity, Fall, Peripheral swelling, Pain in extremity, Injection site erythema, Injection site pruritus, Inappropriate schedule of product administration,
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, ROSUVASTATIN, INDAPAMIDE,
361
26462695
63 2
Injection site erythema, Injection site pruritus, Injection site warmth,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MODAFINIL, DULOXETINE HYDROCHLORIDE, DULOXETINE, BREXPIPRAZOLE, LIOTHYRONINE SODIUM, GABAPENTIN, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, CELECOXIB, IRON, ERGOCALCIFEROL, BIOTIN,
362
26462803
Injection site irritation, Injection site erythema,
BIMEKIZUMAB, SEMAGLUTIDE, ORAL SEMAGLUTIDE,
363
26463511
US
8 2
Apnoea, Nasal congestion, Injection site erythema, Injection site urticaria, Injection site erythema,
ERGOCALCIFEROL, FAMOTIDINE,
364
26463883
US
Injection site pain, Injection site bruising, Injection site erythema, Injection site warmth, Injection site inflammation, Cellulitis, Abdominal wall wound,
LENACAPAVIR SODIUM, LENACAPAVIR SODIUM, LENACAPAVIR SODIUM, LENACAPAVIR SODIUM, AMOXICILLIN,
365
26465068
US
55 2
Injection site warmth, Injection site erythema, Injection site pruritus, Injection site induration,
TIRZEPATIDE, TIRZEPATIDE,
366
26457686
US
72 2
Injection site erythema, Injection site irritation,
TIRZEPATIDE,
367
26457696
US
65 2
Injection site bruising, Injection site haemorrhage, Injection site erythema, Injection site pain, Device issue,
GABAPENTIN, CLONAZEPAM, PANTOPRAZOLE, CELECOXIB, CETIRIZINE HYDROCHLORIDE, BUPROPION, OXYCODONE, FAMOTIDINE, METOPROLOL TARTRATE, METOPROLOL, LOSARTAN, ATORVASTATIN CALCIUM, PROPRANOLOL HYDROCHLORIDE, LEVOTHYROXINE SODIUM,
368
26459939
US
55 1
Blindness unilateral, Peripheral swelling, Uveitis, Arthralgia, Conjunctivitis, Injection site pain, Injection site erythema, Arthritis,
ADALIMUMAB,
369
26460148
GB
Syncope, Emotional distress, Blood glucose decreased, Hypotension, Dizziness, Injection site erythema, Injection site pruritus, Injection site rash, Injection site inflammation, Dehydration, Abdominal pain upper, Asthenia, Malaise, Nausea, Eructation, Vomiting, Diarrhoea,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
370
26452854
US
2
Injection site erythema, Drug delivery system malfunction,
PEGINTERFERON BETA-1A, PEGINTERFERON BETA-1A, PEGINTERFERON BETA-1A, NAPROXEN, NAPROXEN SODIUM, ERGOCALCIFEROL,
371
26453074
Psoriasis, Surgery, Injection site erythema, Memory impairment, Skin fissures, Hordeolum, Therapeutic response shortened, Therapy interrupted, Insurance issue,
BIMEKIZUMAB, BIMEKIZUMAB,
372
26453076
US
76 2
Injection site swelling, Injection site erythema, Drug ineffective,
TIRZEPATIDE, TIRZEPATIDE,
373
26453207
US
81 2
Injection site erythema, Injection site swelling,
IXEKIZUMAB,
374
26453328
US
50 2
Injection site erythema, Injection site pruritus, Injection site urticaria,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
375
26453467
24
Injection site pain, Premature delivery, Pyrexia, Immunosuppression, Gastroenteritis, Leukopenia, Staphylococcal infection, Cholestasis of pregnancy, Hypersensitivity, Injection site erythema, Injection site bruising, Pain, Fungal infection, Ovarian cyst, Injection site haematoma, Headache, Myalgia, Photophobia, Caesarean section, Maternal exposure during pregnancy, Maternal exposure before pregnancy, Product use in unapproved indication,
CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, PREDNISONE, PREDNISONE, CAFFEINE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, METRONIDAZOLE, METRONIDAZOLE TOPICAL, MORPHINE, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN,
376
26453756
US
72 2
Injection site erythema, Nausea, Vomiting, Decreased appetite, White blood cell count increased,
GUSELKUMAB, VALPROIC ACID, QUETIAPINE,
377
26454962
Injection site erythema, Wrong technique in product usage process,
BIMEKIZUMAB, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LOSARTAN POTASSIUM, LOSARTAN, CALCIUM,
378
26455553
US
52 2
Injection site pain, Injection site swelling, Injection site erythema,
379
26455570
59 2
Illness, Injection site erythema, Injection site warmth, Injection site swelling, Injection site pruritus, Injection site pain,
REPOSITORY CORTICOTROPIN,
380
26455685
US
63 2
Injection site erythema, Injection site warmth, Injection site pain,
PREDNISONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, ERGOCALCIFEROL, PREDNISONE,
381
26455904
US
62 2
Injection site reaction, Injection site rash, Injection site erythema, Injection site bruising, Injection site pruritus,
PEGVALIASE-PQPZ,
382
26456094
US
87 2
Injection site pain, Product communication issue, Fear of injection, Device difficult to use, Drug dose omission by device, Injection site erythema,
EVOLOCUMAB, EVOLOCUMAB, CLOPIDOGREL,
383
26456262
US
2
Blister, Injection site bruising, Injection site erythema, Injection site irritation, Injection site pain, Off label use, Product quality issue,
METHOTREXATE, ADALIMUMAB,
384
26456339
GB
2
Food allergy, Injection site swelling, Injection site rash, Injection site pruritus, Drug hypersensitivity, Injection site erythema,
TIRZEPATIDE, TIRZEPATIDE,
385
26448446
US
Vomiting, Decreased appetite, Injection site erythema,
BUROSUMAB,
386
26448564
US
1
Injury associated with device, Injection site erythema, Injection site swelling,
ERENUMAB-AOOE,
387
26448797
US
40 2
Injection site bruising, Injection site erythema, Injection site rash,
BELIMUMAB,
388
26448938
US
54
Injection site erythema, Injection site pruritus, Injection site irritation,
TIRZEPATIDE, TIRZEPATIDE,
389
26449496
GB
32 2
Syncope, Pallor, Loss of consciousness, Eye movement disorder, Dystonia, Muscle rigidity, Bruxism, Disorientation, Illness, Vomiting, Nausea, Injection site erythema,
DUPILUMAB, DUPILUMAB,
390
26449957
US
Accidental overdose, Product preparation issue, Injection site pain, Injection site erythema, Injection site pruritus,
TESAMORELIN,
391
26450243
US
71 2
Injection site pruritus, Injection site erythema, Injection site inflammation,
TIRZEPATIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, AMLODIPINE, HYDROCHLOROTHIAZIDE, THYROID, PORCINE,
392
26450567
US
2
Sinusitis, Accidental exposure to product, Device use error, Drug dose omission by device, Device difficult to use, Product communication issue, Injection site erythema, Injection site haemorrhage,
EVOLOCUMAB, EVOLOCUMAB,
393
26450769
US
2
Injection site pruritus, Formication, Injection site erythema,
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ,
394
26450816
US
2
Injection site erythema, Injection site pruritus, Injection site swelling,
395
26451126
US
2
Injection site erythema, Injection site pruritus, Injection site nodule, Incorrect dose administered,
GUSELKUMAB,
396
26451615
6 1
Papule, Injection site erythema, Immunisation reaction, Injection site induration,
NIRSEVIMAB,
397
26451694
US
2
Wrong technique in product usage process, Injection site erythema, Injection site reaction, Injection site haemorrhage, Injection site bruising,
ADALIMUMAB, ETANERCEPT,
398
26451885
US
57 2
Injection site erythema, Injection site induration,
TIRZEPATIDE, ATENOLOL,
399
26452007
US
2
Injection site erythema, Injection site pruritus, Urticaria, Injection site mass,
TOCILIZUMAB,
400
26452196
US
53 1
Injection site pain, Injection site erythema,
NIVOLUMAB AND HYALURONIDASE-NVHY,

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.

terms

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license

https://open.fda.gov/license/

last_updated

2026-04-28

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