Drug:
Reaction: INJECTION SITE PAIN
20260101 - 20261231
No. 201 - 300
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 201 | 26546893 |
US |
80 | 2 |
Dry mouth, Pollakiuria, Rhinorrhoea, Chromaturia, Injection site mass, Injection site pain, Injection site erythema, |
||||
SARILUMAB, |
||||
| 202 | 26546916 |
US |
61 | 1 |
Nasopharyngitis, Pharyngeal swelling, Condition aggravated, Injection site pain, |
||||
DUPILUMAB, |
||||
| 203 | 26546981 |
US |
63 | 2 |
Injection site pain, Incorrect dose administered, |
||||
DUPILUMAB, |
||||
| 204 | 26547024 |
US |
8 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 205 | 26547073 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 206 | 26547089 |
US |
62 | 1 |
Injection site pain, Off label use, |
||||
DUPILUMAB, |
||||
| 207 | 26547103 |
US |
59 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 208 | 26547156 |
US |
2 | 1 |
Pain in extremity, Pruritus, Dry skin, Eye pruritus, Injection site pain, |
||||
DUPILUMAB, |
||||
| 209 | 26547223 |
US |
4 | 2 |
Rash, Pruritus, Product dose omission issue, Injection site pain, |
||||
DUPILUMAB, |
||||
| 210 | 26547274 |
US |
25 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 211 | 26547335 |
US |
15 | 2 |
Injection site pain, Injection site erythema, |
||||
DUPILUMAB, |
||||
| 212 | 26547349 |
US |
65 | 2 |
Menopausal symptoms, Hot flush, Injection site pain, |
||||
DUPILUMAB, |
||||
| 213 | 26547399 |
|||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 214 | 26547430 |
|||
Injection site rash, Injection site erythema, Injection site pruritus, Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 215 | 26547437 |
US |
2 | |
Injection site pain, |
||||
SARILUMAB, |
||||
| 216 | 26547458 |
US |
76 | 2 |
Injection site haemorrhage, Gait inability, Injection site bruising, Injection site pain, Arthralgia, |
||||
DUPILUMAB, |
||||
| 217 | 26547580 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 218 | 26547616 |
US |
70 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 219 | 26547617 |
US |
76 | 2 |
Injection site pain, Device mechanical issue, |
||||
INSULIN GLARGINE, |
||||
| 220 | 26547645 |
US |
59 | 2 |
Anxiety, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 221 | 26547675 |
US |
60 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 222 | 26547677 |
US |
1 | |
Injection site pain, Product preparation error, |
||||
DUPILUMAB, |
||||
| 223 | 26547789 |
US |
45 | 1 |
Injection site reaction, Injection site pruritus, Injection site pain, Incorrect dose administered, |
||||
DUPILUMAB, |
||||
| 224 | 26547793 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 225 | 26547795 |
80 | ||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 226 | 26547835 |
US |
36 | 1 |
Paraesthesia, Diarrhoea, Insomnia, Injection site pain, |
||||
DUPILUMAB, |
||||
| 227 | 26547858 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 228 | 26547908 |
US |
2 | |
Depression, Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE, ALBUTEROL, IPRATROPIUM BROMIDE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, LISINOPRIL, ROFLUMILAST, SERTRALINE, SIMVASTATIN, |
||||
| 229 | 26548040 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, TIRZEPATIDE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, IRON, ESCITALOPRAM OXALATE, ESCITALOPRAM, |
||||
| 230 | 26548041 |
US |
1 | |
Injection site pain, Therapeutic response decreased, |
||||
DUPILUMAB, ACYCLOVIR, BRIMONIDINE, BRIMONIDINE TARTRATE, DORZOLAMIDE, EZETIMIBE, ATORVASTATIN CALCIUM, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, VALSARTAN, VALSARTAN ORAL, |
||||
| 231 | 26548053 |
US |
11 | 2 |
Urticaria, Pruritus, Injection site pain, |
||||
DUPILUMAB, |
||||
| 232 | 26548054 |
US |
29 | 1 |
Injection site rash, Injection site pain, |
||||
DUPILUMAB, |
||||
| 233 | 26548066 |
US |
42 | 2 |
Rash, Injection site pain, |
||||
DUPILUMAB, |
||||
| 234 | 26548145 |
US |
2 | |
Abdominal pain upper, Throat tightness, Injection site pain, |
||||
DUPILUMAB, |
||||
| 235 | 26548221 |
US |
33 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 236 | 26548237 |
US |
18 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 237 | 26548243 |
US |
5 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 238 | 26548245 |
US |
9 | 1 |
Rash, Product dose omission issue, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 239 | 26548284 |
US |
67 | 2 |
Injection site pain, Fall, Wrist fracture, Sleep disorder due to a general medical condition, Pruritus, Therapeutic response shortened, |
||||
DUPILUMAB, |
||||
| 240 | 26548290 |
US |
73 | 2 |
Pruritus, Injection site pain, |
||||
DUPILUMAB, |
||||
| 241 | 26548313 |
US |
2 | |
Rash, Injection site pain, Skin discolouration, Drug ineffective, |
||||
DUPILUMAB, ALBUTEROL SULFATE, ALBUTEROL, CLINDAMYCIN PHOSPHATE, CLINDAMYCIN, CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE OINTMENT USP, 0.05%, CLONAZEPAM, DONEPEZIL HYDROCHLORIDE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FUROSEMIDE, 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, LISINOPRIL, MIRTAZAPINE, MORPHINE SULFATE, MUPIROCIN, MUPIROCIN CALCIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, SPIRONOLACTONE, |
||||
| 242 | 26548334 |
US |
68 | 2 |
Injection site pain, Foreign body in eye, Sleep disorder due to a general medical condition, |
||||
DUPILUMAB, |
||||
| 243 | 26548386 |
US |
2 | |
Gastritis, Injection site pain, |
||||
DUPILUMAB, |
||||
| 244 | 26548397 |
US |
68 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 245 | 26548399 |
US |
42 | 2 |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, CETIRIZINE HYDROCHLORIDE, FAMOTIDINE, |
||||
| 246 | 26548401 |
US |
41 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 247 | 26548414 |
US |
55 | 1 |
Dizziness, Myalgia, Injection site urticaria, Injection site pain, |
||||
DUPILUMAB, |
||||
| 248 | 26548422 |
US |
4 | 1 |
Sleep disorder due to a general medical condition, Skin haemorrhage, Skin fissures, Pain of skin, Eczema, Injection site pain, |
||||
DUPILUMAB, |
||||
| 249 | 26548426 |
US |
50 | 2 |
Injection site erythema, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, |
||||
| 250 | 26548432 |
US |
55 | 2 |
Back pain, Injection site pain, |
||||
DUPILUMAB, |
||||
| 251 | 26548442 |
US |
51 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 252 | 26548451 |
US |
55 | 1 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, |
||||
| 253 | 26548468 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 254 | 26548471 |
US |
25 | 2 |
Injection site erythema, Injection site pain, Injection site discolouration, Pruritus, |
||||
DUPILUMAB, METOPROLOL TARTRATE, METOPROLOL, |
||||
| 255 | 26548520 |
US |
40 | 2 |
Injection site discolouration, Injection site pain, |
||||
IXEKIZUMAB, IXEKIZUMAB, RISANKIZUMAB-RZAA, |
||||
| 256 | 26548534 |
US |
1 | |
Injection site pain, Injection site swelling, |
||||
DUPILUMAB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, |
||||
| 257 | 26548567 |
US |
41 | 2 |
Injection site pain, |
||||
DUPILUMAB, EMPAGLIFLOZIN, SEMAGLUTIDE, ORAL SEMAGLUTIDE, RIVAROXABAN, VALSARTAN, VALSARTAN ORAL, VITAMIN C, FLUTICASONE PROPIONATE AND SALMETEROL, BETAMETHASONE DIPROPIONATE, |
||||
| 258 | 26548610 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, SIMVASTATIN, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, |
||||
| 259 | 26548611 |
US |
2 | |
Cellulitis, Arthralgia, Dermatitis atopic, Injection site pain, |
||||
DUPILUMAB, CEPHALEXIN, MAGNESIUM, NALTREXONE, PREDNISONE, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, ERGOCALCIFEROL, |
||||
| 260 | 26548625 |
US |
2 | |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, ALBUTEROL SULFATE, CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE OINTMENT USP, 0.05%, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LEVOTHYROXINE SODIUM, VILAZODONE HYDROCHLORIDE, |
||||
| 261 | 26548631 |
36 | ||
Injection site pain, Influenza, Product dose omission issue, Off label use, |
||||
BIMEKIZUMAB, |
||||
| 262 | 26548650 |
US |
1 | |
Injection site pruritus, Injection site pain, |
||||
DUPILUMAB, IRON, LOSARTAN POTASSIUM, LOSARTAN, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, |
||||
| 263 | 26548657 |
US |
7 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 264 | 26548682 |
US |
20 | 2 |
Injection site rash, Injection site pain, |
||||
DUPILUMAB, 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, NORELGESTROMIN AND ETHINYL ESTRADIOL, |
||||
| 265 | 26548686 |
US |
73 | 1 |
Dyspnoea, Hiccups, Injury associated with device, Injection site pain, Off label use, |
||||
INSULIN GLARGINE AND LIXISENATIDE, INSULIN GLARGINE AND LIXISENATIDE, |
||||
| 266 | 26548691 |
US |
44 | 1 |
Eye disorder, Pruritus, Dry skin, Therapeutic response decreased, Injection site pain, |
||||
DUPILUMAB, LEBRIKIZUMAB-LBKZ, LOTEPREDNOL ETABONATE, CYCLOSPORINE, CETIRIZINE HYDROCHLORIDE, |
||||
| 267 | 26548692 |
80 | ||
Injection site pain, Injection site pruritus, Dermatitis allergic, |
||||
OLEZARSEN SODIUM, EVOLOCUMAB, ERGOCALCIFEROL, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, GEMFIBROZIL, EZETIMIBE, CLOPIDOGREL, CLOPIDOGREL BISULFATE, METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, TELMISARTAN, EMPAGLIFLOZIN, ECHINACEA ANGUSTIFOLIA, HAMAMMELIS VIRGINIANA, CALCAREA PHOSPHORICA, HYDRASTIS CANADANESIS, SENEGA OFFICINALIS, SILICEA, CONIUM, AURUM MURIATICUM NATRONATUM, CALCAREA CARBONICA, FUCUS VESICULOSUS, LACHESIS MUTUS, FISH OIL, |
||||
| 268 | 26548693 |
US |
15 | 2 |
Injection site pain, Intentional dose omission, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
| 269 | 26548703 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 270 | 26548711 |
US |
77 | 1 |
Dyspnoea, Back disorder, Nasal polyps, Hernia, Asthma, Intervertebral disc operation, Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, DIPHENHYDRAMINE HYDROCHLORIDE, BUDESONIDE, HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM, LOSARTAN, MONTELUKAST, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 271 | 26548735 |
US |
49 | 1 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 272 | 26548750 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 273 | 26548777 |
US |
1 | |
Injection site rash, Injection site pain, |
||||
DUPILUMAB, |
||||
| 274 | 26548795 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, FLUOXETINE HYDROCHLORIDE, HYOSCYAMINE SULFATE, 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, LORAZEPAM, ESOMEPRAZOLE MAGNESIUM, PHENTERMINE AND TOPIRAMATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 275 | 26548826 |
US |
43 | 1 |
Product dose omission issue, Injection site injury, Injection site pain, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 276 | 26542040 |
US |
2 | |
Pain, Device issue, Injection site pain, Injection site coldness, Illness, Mucous stools, Vomiting, Abdominal rigidity, |
||||
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, |
||||
| 277 | 26542213 |
US |
15 | 1 |
Product dose omission issue, Device use issue, Injection site pain, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 278 | 26542589 |
US |
48 | 2 |
Surgery, Injection site pain, Incorrect dose administered, |
||||
RISANKIZUMAB-RZAA, |
||||
| 279 | 26542720 |
US |
72 | 2 |
Injection site pain, Drug ineffective, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 280 | 26542831 |
CA |
44 | 1 |
Death, Injection site pain, Mobility decreased, |
||||
| 281 | 26542992 |
US |
48 | |
Device defective, Injection site pain, Incorrect dose administered, Product dose omission issue, Injection site urticaria, |
||||
VEDOLIZUMAB, VEDOLIZUMAB, |
||||
| 282 | 26542998 |
US |
65 | 1 |
Spinal operation, Thrombosis, Eye infection, Depression, Somnolence, Dry skin, Weight decreased, Injection site pain, Dermatitis atopic, Product dose omission issue, |
||||
DUPILUMAB, DUPILUMAB, GABAPENTIN, |
||||
| 283 | 26543195 |
CN |
50 | 1 |
Injection site pain, Erythema multiforme, Blood pressure systolic increased, |
||||
INCLISIRAN, |
||||
| 284 | 26543241 |
US |
2 | |
Injection site pain, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
| 285 | 26543392 |
US |
19 | 2 |
Injection site pain, |
||||
TRALOKINUMAB-LDRM, |
||||
| 286 | 26543572 |
US |
27 | 1 |
Eczema, Injection site pain, |
||||
TRALOKINUMAB-LDRM, |
||||
| 287 | 26543641 |
US |
2 | |
Rash, Injection site erythema, Injection site pain, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE, |
||||
| 288 | 26543651 |
US |
71 | 2 |
Injection site pain, Injection site haemorrhage, |
||||
TIRZEPATIDE, |
||||
| 289 | 26544518 |
US |
61 | 2 |
Injection site pain, Injection site haemorrhage, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, RIMEGEPANT SULFATE, |
||||
| 290 | 26544624 |
US |
65 | 2 |
Incorrect dose administered, Illness, Injection site discomfort, Injection site pain, Drug ineffective, Weight increased, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 291 | 26545266 |
US |
1 | |
Injection site pain, |
||||
TESAMORELIN, |
||||
| 292 | 26545316 |
US |
40 | 1 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 293 | 26545419 |
KR |
7 | 1 |
Injection site pain, Incorrect dose administered by device, |
||||
SOMATROPIN, SOMATROPIN, SOMATROPIN, |
||||
| 294 | 26545502 |
EU |
2 | |
Needle issue, Patient-device incompatibility, Injection site pain, |
||||
ETANERCEPT, |
||||
| 295 | 26545504 |
BR |
9 | 1 |
Wrong technique in device usage process, Accidental overdose, Injection site mass, Injection site pain, |
||||
SOMATROPIN, SOMATROPIN, |
||||
| 296 | 26545532 |
US |
46 | 2 |
Memory impairment, Nausea, Diarrhoea, Abdominal discomfort, Injection site pain, Injection site erythema, Hunger, Binge eating, Drug ineffective, Food craving, Product dose omission issue, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 297 | 26545645 |
2 | ||
Injection site pain, Injection site bruising, Product dose omission issue, |
||||
| 298 | 26545743 |
US |
49 | 2 |
Systemic lupus erythematosus, Injection site pain, Haematoma, Fatigue, Illness, Product dose omission issue, |
||||
BELIMUMAB, |
||||
| 299 | 26546016 |
US |
45 | 2 |
Injection site pruritus, Injection site erythema, Injection site pain, |
||||
DUPILUMAB, |
||||
| 300 | 26546022 |
US |
68 | 1 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, 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