Drug:
Reaction: INJECTION SITE PAIN
20260101 - 20261231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 26546075 |
US |
66 | 2 |
Nausea, Injection site pain, Incorrect dose administered, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 302 | 26546076 |
US |
43 | 1 |
Injection site discomfort, Injection site pain, Therapeutic response decreased, |
||||
DUPILUMAB, |
||||
| 303 | 26546119 |
US |
57 | 2 |
Injection site pain, Exposure via skin contact, Accidental exposure to product, Product dose omission issue, Product complaint, |
||||
BELIMUMAB, |
||||
| 304 | 26546468 |
US |
2 | |
Pain, Injection site pain, Injection site haemorrhage, |
||||
INTERFERON BETA-1A, |
||||
| 305 | 26546506 |
US |
76 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 306 | 26546507 |
US |
78 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 307 | 26546508 |
US |
79 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 308 | 26546509 |
US |
1 | |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 309 | 26546510 |
US |
64 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 310 | 26546511 |
US |
67 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 311 | 26546512 |
US |
62 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 312 | 26546513 |
US |
1 | |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 313 | 26546514 |
US |
70 | 1 |
Injection site pain, |
||||
KIT FOR THE PREPARATION OF GALLIUM GA 68 GOZETOTIDE INJECTION, |
||||
| 314 | 26546654 |
|||
Dermo-hypodermitis, Nausea, Dysgeusia, Abdominal pain, Diarrhoea, Biliary colic, Gastrooesophageal reflux disease, Headache, Injection site pain, Arthralgia, Eosinophilia, Lipase increased, Lymphopenia, Fungal infection, Conjunctivitis, Oral herpes, Morphoea, Pruritus, Urticaria, Weight increased, |
||||
ZILUCOPLAN, |
||||
| 315 | 26554582 |
|||
Injection site pain, |
||||
FREMANEZUMAB-VFRM, |
||||
| 316 | 26535979 |
US |
45 | 2 |
Panic attack, Vomiting, Injection site rash, Injection site pain, Injection site pruritus, Nausea, Injection site erythema, Injection site irritation, Asthenia, |
||||
TIRZEPATIDE, ALPRAZOLAM, ALPRAZOLAM, ESCITALOPRAM, |
||||
| 317 | 26536071 |
US |
53 | 2 |
Injection site bruising, Injection site pain, Incorrect dose administered, |
||||
GALCANEZUMAB-GNLM, |
||||
| 318 | 26536143 |
US |
51 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 319 | 26536427 |
US |
||
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 320 | 26536429 |
US |
41 | 2 |
Injection site pain, Injection site bruising, |
||||
GALCANEZUMAB-GNLM, |
||||
| 321 | 26536567 |
US |
48 | 2 |
Injection site pain, Incorrect dose administered, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 322 | 26536780 |
US |
72 | 2 |
Injection site erythema, Injection site pruritus, Injection site pain, Injection site swelling, |
||||
TIRZEPATIDE, |
||||
| 323 | 26536920 |
CA |
2 | |
Psoriatic arthropathy, Injection site paraesthesia, Injection site pain, Condition aggravated, Fatigue, Dental caries, Product use issue, Joint deformity, Off label use, Treatment noncompliance, Disease recurrence, |
||||
PSEUDOEPHEDRINE HYDROCHLORIDE, PULSATILLA, EUPHORBIUM, ALLIUM CEPA, HISTAMINUM, LUFFA OPERCULATA, SABADILLA, HEPAR SULFUR., |
||||
| 324 | 26537022 |
US |
73 | 2 |
Neoplasm malignant, Respiratory disorder, Cough, Dyspnoea, Drug ineffective, Injection site pain, Injection site pruritus, |
||||
DUPILUMAB, |
||||
| 325 | 26537081 |
US |
74 | 2 |
COVID-19, Hypersensitivity, Injection site pain, |
||||
DUPILUMAB, |
||||
| 326 | 26537246 |
US |
57 | 1 |
Injection site discomfort, Injection site pain, |
||||
TRALOKINUMAB-LDRM, TRALOKINUMAB-LDRM, |
||||
| 327 | 26537329 |
US |
78 | |
Injection site pain, Injection site pruritus, Injection site rash, |
||||
DULAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 328 | 26537364 |
57 | ||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 329 | 26537567 |
US |
32 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 330 | 26537723 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 331 | 26537735 |
US |
39 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 332 | 26537805 |
US |
40 | 2 |
Rhinorrhoea, Condition aggravated, Product dose omission issue, Injection site pain, |
||||
DUPILUMAB, |
||||
| 333 | 26537983 |
US |
12 | 1 |
Injection site pain, Incorrect dose administered, |
||||
DUPILUMAB, |
||||
| 334 | 26538055 |
CA |
||
Eye haemorrhage, Injection site pain, |
||||
AFLIBERCEPT, |
||||
| 335 | 26538067 |
US |
21 | 2 |
Eczema, Injection site pain, |
||||
DUPILUMAB, |
||||
| 336 | 26538121 |
31 | ||
Injection site pain, Skin reaction, Insurance issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 337 | 26538128 |
US |
46 | 2 |
Injection site bruising, Injection site pain, Drug ineffective, Injection site discomfort, |
||||
TRALOKINUMAB-LDRM, |
||||
| 338 | 26538181 |
US |
2 | |
Depression, Platelet count abnormal, Injection site pain, |
||||
DUPILUMAB, TOPIRAMATE, TOPIRAMATE SPINKLE, |
||||
| 339 | 26538182 |
US |
1 | |
Peripheral swelling, Discharge, Injection site pain, Product preparation error, |
||||
DUPILUMAB, |
||||
| 340 | 26538188 |
US |
41 | 2 |
Pruritus, Skin fissures, Skin exfoliation, Dry skin, Injection site pain, Product dose omission issue, |
||||
DUPILUMAB, DUPILUMAB, OLANZAPINE, OLANZAPINE PAMOATE, |
||||
| 341 | 26538191 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, ATOMOXETINE HYDROCHLORIDE, FAMOTIDINE, GUANFACINE HYDROCHLORIDE, GUANFACINE, ERGOCALCIFEROL, ARIPIPRAZOLE, CETIRIZINE HYDROCHLORIDE, EPINEPHRINE, ERGOCALCIFEROL, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, HYDROXYZINE HYDROCHLORIDE ORAL, |
||||
| 342 | 26538192 |
US |
2 | |
Pruritus, Rash papular, Injection site pain, Product preparation error, Lacrimation increased, |
||||
DUPILUMAB, |
||||
| 343 | 26538393 |
US |
41 | 2 |
Incorrect route of product administration, Injection site pain, Injection site vesicles, |
||||
TIRZEPATIDE, |
||||
| 344 | 26538468 |
US |
71 | 2 |
Injection site pain, Injury associated with device, Product storage error, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, |
||||
| 345 | 26538743 |
US |
45 | 2 |
Injection site swelling, Injection site pain, Urticaria, Swelling, Pruritus, Therapeutic response shortened, |
||||
DUPILUMAB, |
||||
| 346 | 26538801 |
US |
||
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 347 | 26538924 |
45 | ||
Injection site pain, Product dose omission issue, Incorrect dose administered, Wrong technique in product usage process, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, LOSARTAN POTASSIUM, LOSARTAN, HYDRALAZINE HYDROCHLORIDE, CARVEDILOL, GABAPENTIN, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, NIFEDIPINE, LEFLUNOMIDE, CEFIXIME, LEVOCETIRIZINE DIHYDROCHLORIDE, IRON, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 348 | 26538975 |
TW |
53 | 2 |
Spinal cord compression, Injection site rash, Hereditary angioedema, Inappropriate schedule of product administration, Product availability issue, Fatigue, Injection site bruising, Injection site pain, Dizziness, Rash, |
||||
ICATIBANT, ICATIBANT, LANADELUMAB-FLYO, LANADELUMAB-FLYO, |
||||
| 349 | 26539009 |
1 | ||
Injection site pain, |
||||
REPOSITORY CORTICOTROPIN, |
||||
| 350 | 26539301 |
US |
80 | 2 |
Joint swelling, Arthralgia, Injection site pain, Device delivery system issue, Incorrect dose administered by device, Poor venous access, |
||||
ABATACEPT, ABATACEPT, |
||||
| 351 | 26539401 |
US |
50 | 1 |
Product storage error, Injection site bruising, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 352 | 26539421 |
US |
65 | 2 |
Ankle fracture, Dry eye, Injection site pain, |
||||
DUPILUMAB, |
||||
| 353 | 26539423 |
US |
65 | 2 |
Injection site irritation, Injection site pain, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 354 | 26539442 |
US |
51 | 1 |
Injection site induration, Rash, Injection site pain, |
||||
DUPILUMAB, |
||||
| 355 | 26539450 |
US |
24 | 2 |
Injection site bruising, Injection site swelling, Injection site pain, Pruritus, Dry skin, |
||||
DUPILUMAB, |
||||
| 356 | 26539457 |
US |
2 | |
Anxiety, Injection site pain, |
||||
DUPILUMAB, |
||||
| 357 | 26539856 |
US |
23 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 358 | 26539878 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, FUROSEMIDE, MONTELUKAST, TIOTROPIUM BROMIDE INHALATION SPRAY, SPIRONOLACTONE, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ERGOCALCIFEROL, |
||||
| 359 | 26540210 |
EU |
73 | 2 |
Injection site abscess, Vascular encephalopathy, Essential hypertension, Injection site infection, Dysarthria, Urinary incontinence, General physical health deterioration, Malnutrition, Injection site pain, Hypertonia, Reduced facial expression, Facial asymmetry, Dyscalculia, Speech disorder, Dysphonia, Dysarthria, Disorientation, Aggression, Sensory disturbance, Fall, Anxiety, Memory impairment, Depression, Affective disorder, Confusional state, Drug resistance, Balance disorder, Behaviour disorder, Dehydration, Dysdiadochokinesis, Sarcopenia, Paraesthesia, Delirium, Injection site cellulitis, Device issue, Silent sinus syndrome, Muscular weakness, Fine motor skill dysfunction, Hyperreflexia, Cogwheel rigidity, Bradykinesia, Dyskinesia, Aphasia, Muscle atrophy, Echolalia, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, CLOZAPINE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, RIVASTIGMINE, DALTEPARIN SODIUM, |
||||
| 360 | 26540375 |
US |
45 | 1 |
Injection site pain, |
||||
GOZETOTIDE, |
||||
| 361 | 26540376 |
US |
43 | 1 |
Injection site pain, |
||||
GOZETOTIDE, |
||||
| 362 | 26540384 |
US |
||
Injection site pain, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 363 | 26540527 |
US |
2 | |
Wrong technique in product usage process, Injection site bruising, Injection site pain, Device issue, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 364 | 26540694 |
34 | ||
Injection site pain, Pain, Off label use, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 365 | 26540921 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 366 | 26541021 |
US |
61 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 367 | 26541250 |
US |
51 | 2 |
Injection site pain, Injection site mass, Injection site bruising, |
||||
TIRZEPATIDE, |
||||
| 368 | 26541302 |
US |
2 | |
Injection site pain, Device issue, Injection site haemorrhage, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 369 | 26541675 |
US |
26 | 1 |
Swelling, Injection site pain, Device issue, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 370 | 26541796 |
US |
31 | 2 |
Injection site pain, Injection site pain, Injection site haemorrhage, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 371 | 26531143 |
US |
||
Poor quality product administered, Drug ineffective, Injection site pain, Product temperature excursion issue, |
||||
ONABOTULINUMTOXINA, |
||||
| 372 | 26531476 |
US |
27 | |
Incorrect dose administered, Injection site warmth, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 373 | 26531479 |
US |
53 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 374 | 26531597 |
US |
47 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 375 | 26531611 |
US |
66 | 1 |
Glycosylated haemoglobin increased, Arthralgia, Injection site pain, Illness, Decreased appetite, Product prescribing error, |
||||
EMPAGLIFLOZIN, INSULIN LISPRO, INSULIN LISPRO, INSULIN LISPRO, SITAGLIPTIN, INSULIN GLARGINE, |
||||
| 376 | 26531640 |
US |
||
Injection site pain, Drug ineffective, |
||||
ONABOTULINUMTOXINA, |
||||
| 377 | 26531842 |
55 | ||
Sinusitis, Influenza like illness, Injection site pain, Product dose omission issue, |
||||
BIMEKIZUMAB, CARVEDILOL, CARVEDILOL, ROSUVASTATIN, FOLIC ACID, METHOTREXATE, METHOTREXATE SODIUM, AMLODIPINE BESYLATE, DESVENLAFAXINE SUCCINATE, LEVOTHYROXINE SODIUM, VITAMIN A, SEMAGLUTIDE, HYDROXYCHLOROQUINE SULFATE, |
||||
| 378 | 26531913 |
US |
66 | 1 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 379 | 26532007 |
US |
2 | |
Blindness, Injection site pain, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 380 | 26532028 |
US |
2 | |
Rotator cuff syndrome, Breast cancer, Injection site discharge, Device related infection, Injection site pain, |
||||
ADALIMUMAB, |
||||
| 381 | 26532436 |
GB |
33 | 2 |
Lower respiratory tract infection, Neuralgia, Back pain, Pain, Dizziness, Decreased appetite, Feeling hot, Hyperhidrosis, Influenza like illness, Injection site pain, |
||||
OFATUMUMAB, OFATUMUMAB, OFATUMUMAB, |
||||
| 382 | 26532661 |
JP |
57 | 1 |
Hepatitis B, Hepatic function abnormal, Injection site pain, |
||||
CABOTEGRAVIR SODIUM, RILPIVIRINE, |
||||
| 383 | 26532745 |
US |
48 | 2 |
Off label use, Injection site bruising, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 384 | 26532762 |
26 | ||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 385 | 26532820 |
US |
56 | 2 |
Adverse event, Nerve injury, Injection site pain, |
||||
DUPILUMAB, |
||||
| 386 | 26533004 |
US |
||
Alopecia, Temperature regulation disorder, Wrong technique in product usage process, Headache, Injection site mass, Injection site pain, |
||||
LANREOTIDE ACETATE, |
||||
| 387 | 26533094 |
US |
7 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 388 | 26533106 |
US |
2 | |
Rash, Urticaria, Injection site pain, Injection site reaction, |
||||
DUPILUMAB, |
||||
| 389 | 26533107 |
US |
55 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 390 | 26533155 |
JP |
18 | 2 |
Hereditary angioedema, Hereditary angioedema, Hereditary angioedema, Swelling, Malaise, Hereditary angioedema, Hereditary angioedema, Hereditary angioedema, Hereditary angioedema, Hereditary angioedema, Hereditary angioedema, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, Injection site pain, |
||||
| 391 | 26533159 |
US |
65 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 392 | 26533162 |
US |
11 | 2 |
Injection site pain, Dry eye, |
||||
DUPILUMAB, |
||||
| 393 | 26533221 |
US |
57 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 394 | 26533225 |
US |
2 | |
Injection site reaction, Injection site pain, |
||||
DUPILUMAB, |
||||
| 395 | 26533251 |
US |
1 | |
Product dose omission issue, Illness, Arthralgia, Pain in extremity, Dry eye, Injection site pain, Injection site haemorrhage, Injection site swelling, Sensation of foreign body, Sleep disorder due to a general medical condition, |
||||
DUPILUMAB, |
||||
| 396 | 26533290 |
US |
44 | 1 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 397 | 26533402 |
US |
12 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 398 | 26533404 |
US |
66 | 2 |
Sunburn, Injection site pain, Acne, Product administered at inappropriate site, |
||||
TRALOKINUMAB-LDRM, |
||||
| 399 | 26533446 |
US |
62 | 1 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 400 | 26533482 |
US |
7 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
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
2026-04-28