Drug:
Reaction: INJECTION SITE PAIN
20250101 - 20251231
No. 501 - 600
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 501 | 25114235 |
US |
37 | 2 |
Eczema, Rash, Pruritus, Injection site pain, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 502 | 25114289 |
US |
1 | |
Injection site pain, Product preparation error, Incorrect dose administered, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 503 | 25114292 |
US |
1 | |
Pruritus, Skin lesion, Therapeutic response decreased, Drug dose omission by device, Device operational issue, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 504 | 25114336 |
US |
2 | |
Injection site pain, Drug ineffective, |
||||
DUPILUMAB, |
||||
| 505 | 25114356 |
US |
78 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 506 | 25114358 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, PIOGLITAZONE, EMPAGLIFLOZIN, LOSARTAN POTASSIUM, LOSARTAN, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, FLUTICASONE PROPIONATE, MELOXICAM, BACLOFEN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, HYDROXYZINE, |
||||
| 507 | 25114364 |
US |
79 | 1 |
Glycosylated haemoglobin increased, Wrong technique in product usage process, Drug dose omission by device, Device difficult to use, Injection site pain, |
||||
EVOLOCUMAB, BUDESONIDE, TIOTROPIUM BROMIDE, INSULIN GLARGINE, EMPAGLIFLOZIN, |
||||
| 508 | 25114375 |
US |
15 | 2 |
Dyspnoea, Nasopharyngitis, Injection site pain, |
||||
DUPILUMAB, |
||||
| 509 | 25114429 |
US |
15 | 1 |
Injection site pain, Off label use, |
||||
DUPILUMAB, |
||||
| 510 | 25114527 |
US |
62 | 2 |
Injection site pain, Product preparation error, |
||||
DUPILUMAB, |
||||
| 511 | 25114530 |
US |
47 | 1 |
Sinus congestion, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
| 512 | 25114606 |
US |
||
Injection site pain, |
||||
DUPILUMAB, |
||||
| 513 | 25114609 |
US |
20 | 2 |
Dyspnoea, Asthenia, Pain in extremity, Arthralgia, Periorbital swelling, Loss of personal independence in daily activities, Injection site pain, Lack of injection site rotation, |
||||
DUPILUMAB, |
||||
| 514 | 25114628 |
US |
1 | |
Injection site mass, Injection site pain, |
||||
DUPILUMAB, |
||||
| 515 | 25114631 |
US |
5 | 1 |
Injection site pain, Conjunctivitis, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
| 516 | 25114744 |
US |
76 | 2 |
Gastrointestinal disorder, Hunger, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 517 | 25114769 |
US |
45 | 2 |
Injury associated with device, Injection site pain, Injection site bruising, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 518 | 25114778 |
US |
60 | 2 |
Food craving, Hunger, Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 519 | 25114850 |
BR |
55 | 1 |
Pain, Papule, Injection site pain, Off label use, |
||||
BOTULINUM TOXIN TYPE A, |
||||
| 520 | 25114851 |
US |
43 | 1 |
Superficial vein thrombosis, Injection site pain, Product commingling, Axillary vein thrombosis, |
||||
DICYCLOMINE HYDROCHLORIDE, |
||||
| 521 | 25115168 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, NIACIN, PRAVASTATIN SODIUM, TADALAFIL, TAMSULOSIN HYDROCHLORIDE, CARVEDILOL, |
||||
| 522 | 25115209 |
US |
2 | |
Injection site discharge, Injection site haemorrhage, Injection site pain, |
||||
ADALIMUMAB, |
||||
| 523 | 25115377 |
US |
11 | 1 |
Injection site pain, Liquid product physical issue, Product preparation error, Needle issue, Device use error, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 524 | 25115534 |
US |
74 | 2 |
Unresponsive to stimuli, Amnesia, Injection site bruising, Road traffic accident, Injection site haemorrhage, Injection site pain, |
||||
ADALIMUMAB, |
||||
| 525 | 25115535 |
US |
1 | |
Injection site pain, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 526 | 25109157 |
US |
21 | 2 |
Injection site irritation, Injection site pain, |
||||
DUPILUMAB, FISH OIL, BUPROPION HYDROCHLORIDE, FERROUS SULFATE, |
||||
| 527 | 25109168 |
US |
62 | 2 |
Dry eye, Injection site pain, |
||||
DUPILUMAB, |
||||
| 528 | 25109170 |
US |
45 | 1 |
Pulmonary mass, Flushing, Feeling hot, Paraesthesia, Renal disorder, Pain in extremity, Injection site pain, Inappropriate schedule of product administration, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 529 | 25109201 |
US |
67 | 1 |
Injection site pain, Dermatitis atopic, |
||||
DUPILUMAB, |
||||
| 530 | 25109202 |
US |
2 | |
Injection site pain, Product dose omission issue, |
||||
MEPOLIZUMAB, |
||||
| 531 | 25109259 |
US |
65 | 2 |
Injection site pain, |
||||
BELIMUMAB, |
||||
| 532 | 25109292 |
US |
61 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 533 | 25109293 |
US |
61 | 1 |
Injection site pain, Injection site discomfort, Injection site nodule, |
||||
CABOTEGRAVIR SODIUM, |
||||
| 534 | 25109367 |
US |
57 | 1 |
Product dose omission issue, Injection site pain, Injection site mass, Drug ineffective, Blood glucose increased, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 535 | 25109385 |
US |
7 | |
Leukaemia, Injection site pain, Incorrect dose administered, Skin tightness, Injection site haemorrhage, |
||||
ASFOTASE ALFA, |
||||
| 536 | 25109387 |
US |
61 | 1 |
Incorrect dose administered, Injection site pain, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 537 | 25109393 |
US |
66 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 538 | 25109426 |
US |
50 | 2 |
Urticaria, Injection site pain, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
| 539 | 25109456 |
US |
55 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 540 | 25109460 |
US |
1 | |
Injection site pain, Injection site pruritus, |
||||
DUPILUMAB, |
||||
| 541 | 25109523 |
US |
67 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 542 | 25109561 |
US |
1 | |
Injection site pain, Injection site pruritus, |
||||
DUPILUMAB, |
||||
| 543 | 25109566 |
US |
||
Device issue, Injection site swelling, Injection site erythema, Injection site pain, |
||||
RISANKIZUMAB-RZAA, |
||||
| 544 | 25109567 |
US |
56 | 2 |
Injection site pain, Neurodermatitis, |
||||
DUPILUMAB, DUPILUMAB, MORPHINE SULFATE, OXYCODONE HYDROCHLORIDE, OXYCODONE, GABAPENTIN, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), TIZANIDINE HYDROCHLORIDE, AMPHETAMINE, DEXTROAMPHETAMINE SULFATE, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ROSUVASTATIN CALCIUM, PROGESTERONE, TRIAMTERENE AND HYDROCHLOROTHIAZIDE, CYANOCOBALAMIN, DULOXETINE HYDROCHLORIDE, DULOXETINE, |
||||
| 545 | 25109621 |
US |
2 | |
Wrong technique in product usage process, Injection site pruritus, Injection site pain, Injection site induration, Injection site swelling, Injection site haemorrhage, Injection site erythema, Injection site warmth, |
||||
NALTREXONE, LITHIUM, LITHIUM BROMATUM, LEVOTHYROXINE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 546 | 25109673 |
US |
1 | |
Injection site pain, Injection site haemorrhage, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 547 | 25109682 |
US |
35 | 2 |
Incorrect dose administered, Hunger, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 548 | 25109689 |
US |
2 | |
Crohn^s disease, Injection site pain, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 549 | 25109733 |
US |
49 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 550 | 25107879 |
US |
7 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 551 | 25107886 |
US |
||
Injection site pain, |
||||
DUPILUMAB, |
||||
| 552 | 25107904 |
US |
73 | 2 |
Injection site mass, Injection site pain, |
||||
DUPILUMAB, |
||||
| 553 | 25107907 |
US |
30 | 2 |
Pain in extremity, Loss of personal independence in daily activities, Erythema, Injection site erythema, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 554 | 25107911 |
US |
74 | 1 |
Injection site pain, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 555 | 25107919 |
US |
65 | 2 |
Injection site erythema, Injection site pruritus, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 556 | 25107943 |
US |
40 | 1 |
Injection site pain, Dyspnoea, Headache, |
||||
DUPILUMAB, |
||||
| 557 | 25107967 |
US |
51 | 2 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 558 | 25107972 |
US |
38 | 2 |
Pruritus, Injection site pain, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 559 | 25107984 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 560 | 25107991 |
US |
54 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 561 | 25107996 |
US |
40 | 2 |
Injection site pain, Injection site bruising, |
||||
DUPILUMAB, |
||||
| 562 | 25107997 |
US |
65 | 1 |
Diarrhoea, Foreign body in skin or subcutaneous tissue, Injection site pain, Product preparation error, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 563 | 25108064 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 564 | 25108083 |
US |
2 | |
Injection site nodule, Injection site pain, Injection site pruritus, |
||||
DUPILUMAB, ALPRAZOLAM, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, IBUPROFEN TABLET COATED, ZOLPIDEM TARTRATE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, BUMETANIDE, SUCRALFATE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, METOPROLOL TARTRATE, METOPROLOL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 565 | 25108085 |
US |
63 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 566 | 25108121 |
US |
5 | 2 |
Injection site hypersensitivity, Injection site mass, Injection site erythema, Injection site pain, |
||||
DUPILUMAB, |
||||
| 567 | 25108129 |
US |
62 | 1 |
Urticaria, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 568 | 25108133 |
US |
9 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 569 | 25108177 |
US |
26 | 2 |
Urticaria, Myalgia, Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, UPADACITINIB, |
||||
| 570 | 25108192 |
US |
1 | |
Injection site pain, Lack of administration site rotation, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 571 | 25108197 |
US |
57 | 2 |
Hypoaesthesia oral, Injection site pain, |
||||
DUPILUMAB, |
||||
| 572 | 25108199 |
US |
13 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 573 | 25108230 |
US |
16 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 574 | 25108497 |
US |
54 | 2 |
Injection site nodule, Injection site pain, |
||||
DUPILUMAB, |
||||
| 575 | 25108567 |
US |
77 | 2 |
Back pain, Muscle spasms, Pain in extremity, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 576 | 25108739 |
CA |
||
Muscle haemorrhage, Injection site haemorrhage, Injection site pain, Muscle spasms, Rash, Drug ineffective, |
||||
ADALIMUMAB-AATY, ADALIMUMAB-AATY, ADALIMUMAB-AATY, |
||||
| 577 | 25108743 |
US |
56 | 2 |
Hypoglycaemia, Blood pressure increased, Eye pain, Injection site pain, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 578 | 25108759 |
US |
33 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 579 | 25108761 |
US |
36 | 2 |
Incorrect dose administered, Injection site bruising, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 580 | 25108769 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 581 | 25108947 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 582 | 25108973 |
US |
43 | 1 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 583 | 25108997 |
US |
77 | 2 |
Discomfort, Injection site pain, |
||||
DUPILUMAB, |
||||
| 584 | 25109078 |
US |
61 | 2 |
Injection site erythema, Injection site swelling, Injection site pain, |
||||
IXEKIZUMAB, IXEKIZUMAB, |
||||
| 585 | 25109140 |
US |
58 | 2 |
Injection site pain, Injection site papule, Injection site erythema, Device defective, |
||||
ADALIMUMAB, EZETIMIBE, FOLIC ACID, METHOTREXATE, METHOTREXATE SODIUM, APIXABAN, SEMAGLUTIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 586 | 25109145 |
US |
35 | 1 |
Injection site swelling, Injection site pain, Injection site bruising, |
||||
DUPILUMAB, |
||||
| 587 | 25102494 |
CA |
1 | |
Presyncope, Pallor, Dizziness, Injection site pain, General symptom, Autism spectrum disorder, Learning disability, Dizziness, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 588 | 25103064 |
US |
61 | 2 |
Extra dose administered, Injection site pain, |
||||
DULAGLUTIDE, |
||||
| 589 | 25103073 |
US |
52 | 1 |
Injection site bruising, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 590 | 25103263 |
US |
60 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 591 | 25103402 |
US |
47 | 1 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 592 | 25103455 |
US |
48 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, |
||||
| 593 | 25103458 |
US |
58 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 594 | 25103535 |
US |
76 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 595 | 25103640 |
CA |
81 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, |
||||
| 596 | 25103689 |
US |
59 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 597 | 25103700 |
US |
62 | 1 |
Hunger, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 598 | 25103753 |
US |
30 | 1 |
Injection site nodule, Injection site pain, Injection site pruritus, Product use in unapproved indication, |
||||
RISPERIDONE, |
||||
| 599 | 25103882 |
US |
56 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 600 | 25103885 |
US |
||
Injection site pain, |
||||
MIRIKIZUMAB-MRKZ, |
||||
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
license
last_updated
2025-04-28