Drug:
Reaction: INJECTION SITE PAIN
20260101 - 20261231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 1 | 26555323 |
PR |
2 | |
Injection site pain, |
||||
OCRELIZUMAB AND HYALURONIDASE, |
||||
| 2 | 26555804 |
US |
50 | |
Injection site pain, Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, |
||||
| 3 | 26555805 |
US |
||
Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 4 | 26555896 |
US |
||
Injection site pain, Off label use, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 5 | 26555932 |
US |
||
Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 6 | 26555942 |
US |
2 | |
Injection site pain, Fatigue, Wrong technique in product usage process, Injection site pain, |
||||
LANREOTIDE ACETATE, |
||||
| 7 | 26556010 |
62 | ||
Spinal fracture, Injection site pain, Road traffic accident, Off label use, Incorrect dose administered, Product knowledge deficit, |
||||
BIMEKIZUMAB, |
||||
| 8 | 26556059 |
US |
1 | |
Injection site pain, Injection site injury, Device issue, Accidental exposure to product, Device leakage, Incorrect dose administered by device, |
||||
SECUKINUMAB, INSULIN GLARGINE, INSULIN ASPART, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, EMPAGLIFLOZIN, |
||||
| 9 | 26556121 |
US |
||
Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 10 | 26556177 |
US |
35 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 11 | 26556182 |
US |
46 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 12 | 26556251 |
62 | ||
Psoriatic arthropathy, Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 13 | 26556313 |
US |
||
Injection site mass, Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 14 | 26556328 |
US |
||
Injection site mass, Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 15 | 26556329 |
US |
||
Injection site pain, Injection site mass, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 16 | 26556330 |
US |
||
Injection site pain, Injection site mass, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 17 | 26556331 |
US |
||
Injection site pain, Off label use, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 18 | 26556354 |
US |
||
Injection site pain, Drug ineffective, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 19 | 26556701 |
US |
65 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 20 | 26556731 |
CA |
2 | |
Feeling abnormal, Gait inability, Movement disorder, Drug hypersensitivity, Injection site pain, Erythema, Myalgia, Insomnia, Cough, Gait disturbance, Nasopharyngitis, Pruritus, |
||||
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, OCTREOTIDE ACETATE, |
||||
| 21 | 26556883 |
|||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 22 | 26557082 |
GB |
58 | 1 |
Injection site pain, Sedation, Sedation complication, |
||||
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, CLOZAPINE, |
||||
| 23 | 26557219 |
US |
66 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 24 | 26557242 |
US |
48 | 2 |
Injection site pain, Product dose omission issue, |
||||
DUPILUMAB, |
||||
| 25 | 26557314 |
US |
1 | |
Injection site discomfort, Injection site pain, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 26 | 26557315 |
US |
31 | 1 |
Injection site pain, Dry eye, Eye irritation, |
||||
DUPILUMAB, |
||||
| 27 | 26557415 |
US |
13 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 28 | 26557419 |
US |
43 | 2 |
Hypoaesthesia, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 29 | 26557431 |
US |
9 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 30 | 26557446 |
US |
60 | 2 |
Injection site pain, Rash macular, Dry eye, Eye discharge, Eye pruritus, |
||||
DUPILUMAB, |
||||
| 31 | 26557582 |
US |
9 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 32 | 26557589 |
US |
72 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 33 | 26557629 |
US |
70 | 2 |
Dyspnoea, Injection site pain, |
||||
DUPILUMAB, |
||||
| 34 | 26557706 |
57 | 2 | |
Seizure, Muscular weakness, Dizziness, Taste disorder, Mobility decreased, Injection site pain, Headache, Decreased appetite, Mouth injury, Feeding disorder, |
||||
FAM-TRASTUZUMAB DERUXTECAN-NXKI, |
||||
| 35 | 26557819 |
US |
62 | |
Loss of consciousness, Heart rate decreased, Blood glucose decreased, Injection site discolouration, Throat tightness, Eye swelling, Injection site swelling, Injection site erythema, Injection site pruritus, Dyspnoea, Injection site pain, Off label use, |
||||
PRABOTULINUM TOXIN TYPE A, PRABOTULINUM TOXIN TYPE A, |
||||
| 36 | 26557965 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 37 | 26557981 |
US |
71 | 1 |
Dyspnoea, Injection site pain, |
||||
DUPILUMAB, |
||||
| 38 | 26558021 |
41 | ||
Injection site pain, Product dose omission issue, |
||||
BIMEKIZUMAB, |
||||
| 39 | 26558022 |
US |
2 | |
Injection site pain, |
||||
ETANERCEPT, TOCILIZUMAB, ADALIMUMAB, |
||||
| 40 | 26558035 |
US |
2 | |
Injection site bruising, Injection site pain, Needle issue, |
||||
ENOXAPARIN SODIUM, |
||||
| 41 | 26558057 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 42 | 26558137 |
US |
2 | |
Injection site pain, Injection site bruising, Injection site pruritus, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 43 | 26558139 |
US |
1 | |
Injection site pain, Skin swelling, Injection site irritation, |
||||
DUPILUMAB, CRISABOROLE, |
||||
| 44 | 26558142 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 45 | 26558171 |
US |
40 | 2 |
Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE AND BUDESONIDE, ALBUTEROL SULFATE, BETAMETHASONE DIPROPIONATE, BUDESONIDE AND FORMOTEROL FUMARATE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE NASAL, LORATADINE, LORATADINE ORAL, MONTELUKAST SODIUM, MONTELUKAST, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, |
||||
| 46 | 26558271 |
US |
30 | |
Injection site pain, |
||||
PRABOTULINUM TOXIN TYPE A, |
||||
| 47 | 26558289 |
US |
66 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 48 | 26558622 |
US |
83 | 2 |
Injection site pain, Product delivery mechanism issue, |
||||
ALIROCUMAB, |
||||
| 49 | 26558797 |
US |
46 | 2 |
Deafness unilateral, Foot fracture, Stress fracture, Pain, Neck pain, Back pain, Arthralgia, Arthralgia, Arthralgia, Injection site pain, Arthralgia, Fatigue, Upper-airway cough syndrome, Tinnitus, Haemochromatosis carrier, Inappropriate schedule of product administration, |
||||
ASFOTASE ALFA, |
||||
| 50 | 26558822 |
US |
65 | 2 |
Injection site urticaria, Injection site bruising, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 51 | 26558952 |
US |
54 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 52 | 26559165 |
61 | 2 | |
Injection site erythema, Injection site rash, Injection site urticaria, Injection site pain, Injection site pruritus, Injection site mass, |
||||
REPOSITORY CORTICOTROPIN, |
||||
| 53 | 26559166 |
2 | ||
Injection site pain, |
||||
REPOSITORY CORTICOTROPIN, REPOSITORY CORTICOTROPIN, |
||||
| 54 | 26559174 |
2 | ||
Somnolence, Fatigue, Injection site pain, |
||||
REPOSITORY CORTICOTROPIN, |
||||
| 55 | 26559175 |
60 | 2 | |
Injection site reaction, Injection site pain, Injection site pruritus, Injection site mass, |
||||
REPOSITORY CORTICOTROPIN, |
||||
| 56 | 26559200 |
48 | 2 | |
Injection site swelling, Injection site erythema, Injection site pain, |
||||
| 57 | 26559431 |
EU |
1 | |
Walking disability, Pain in extremity, Injection site irritation, Injection site rash, Injection site pain, |
||||
GLATIRAMER ACETATE, GLATIRAMER ACETATE INJECTION, GLATIRAMER, GLATIRAMER ACETATE, GLATIRAMER ACETATE INJECTION, GLATIRAMER, GLATIRAMER ACETATE, GLATIRAMER ACETATE INJECTION, GLATIRAMER, GLATIRAMER ACETATE, GLATIRAMER ACETATE INJECTION, GLATIRAMER, |
||||
| 58 | 26559545 |
US |
2 | |
T-cell lymphoma, Eczema, Rash pruritic, Rash, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, CALCIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, SIMVASTATIN, CETIRIZINE HYDROCHLORIDE, MINOXIDIL, |
||||
| 59 | 26559683 |
US |
62 | 2 |
Injection site bruising, Drug administered in wrong device, Device delivery system issue, Injection site pain, |
||||
GLATIRAMER ACETATE, |
||||
| 60 | 26559854 |
US |
27 | 2 |
Off label use, Injection site pain, |
||||
TIRZEPATIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, PRAZOSIN, GABAPENTIN, FLUOXETINE HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, |
||||
| 61 | 26559867 |
US |
2 | |
Injection site pain, |
||||
PEGVALIASE-PQPZ, PEGVALIASE-PQPZ, |
||||
| 62 | 26560011 |
|||
Injection site pain, Product dose omission issue, Device issue, |
||||
BIMEKIZUMAB, |
||||
| 63 | 26560223 |
US |
65 | 1 |
Peripheral swelling, Rash, Injection site pain, |
||||
DUPILUMAB, |
||||
| 64 | 26560231 |
US |
48 | 2 |
Injection site mass, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 65 | 26560282 |
US |
35 | 2 |
Rash, Dry eye, Injection site swelling, Injection site pain, |
||||
DUPILUMAB, |
||||
| 66 | 26560284 |
US |
2 | |
Injection site pain, Surgery, |
||||
DUPILUMAB, |
||||
| 67 | 26560324 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 68 | 26560356 |
US |
25 | 1 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 69 | 26560358 |
US |
55 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 70 | 26560365 |
US |
12 | 1 |
Hypoaesthesia oral, Injection site pain, |
||||
DUPILUMAB, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, ALBUTEROL SULFATE, |
||||
| 71 | 26560399 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ERGOCALCIFEROL, |
||||
| 72 | 26560403 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, ERGOCALCIFEROL, IRON, ROSUVASTATIN CALCIUM, ACYCLOVIR, |
||||
| 73 | 26560415 |
US |
52 | 1 |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 74 | 26560434 |
US |
1 | |
Injection site pain, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
| 75 | 26560452 |
US |
80 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 76 | 26560474 |
US |
66 | 2 |
Injection site bruising, Injection site pain, |
||||
DUPILUMAB, |
||||
| 77 | 26561502 |
US |
72 | |
Arthralgia, Joint stiffness, Limb discomfort, Nasopharyngitis, Head discomfort, Cough, Injection site pain, Product dose omission issue, Device malfunction, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 78 | 26550041 |
US |
67 | 1 |
Injection site pain, |
||||
DUPILUMAB, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, BUDESONIDE, 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, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, |
||||
| 79 | 26550043 |
US |
62 | 2 |
Rhinorrhoea, Cough, Throat irritation, Injection site pain, Incorrect dose administered, |
||||
SARILUMAB, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CALCIUM, CLOPIDOGREL, CLOPIDOGREL BISULFATE, FAMOTIDINE, DAPAGLIFLOZIN, GABAPENTIN, GABAPENTIN, IRON, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, NORTRIPTYLINE HYDROCHLORIDE, SEMAGLUTIDE, ORAL SEMAGLUTIDE, PROPRANOLOL HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE, |
||||
| 80 | 26550049 |
US |
2 | |
Injection site pain, Injection site vesicles, Injection site rash, Dermatitis atopic, |
||||
DUPILUMAB, BIOTIN, LEMBOREXANT, FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE ORAL, FEXOFENADINE HCL, 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, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, MELATONIN, PIMECROLIMUS, PROPRANOLOL HYDROCHLORIDE, NORGESTIMATE AND ETHINYL ESTRADIOL, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, ERGOCALCIFEROL, |
||||
| 81 | 26550068 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, CHLORPHENIRAMINE MALEATE, EPINEPHRINE, DEXMETHYLPHENIDATE HYDROCHLORIDE, MELATONIN, MONTELUKAST SODIUM, MONTELUKAST, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL, |
||||
| 82 | 26550094 |
US |
35 | 1 |
Brain fog, Feeling abnormal, Injection site bruising, Injection site pain, Product use in unapproved indication, |
||||
CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, CAPLACIZUMAB, |
||||
| 83 | 26550106 |
US |
56 | 2 |
Fatigue, Injection site pain, |
||||
DUPILUMAB, |
||||
| 84 | 26550129 |
US |
1 | |
Injection site pain, |
||||
DUPILUMAB, PANTOPRAZOLE SODIUM, |
||||
| 85 | 26550133 |
US |
2 | |
Injection site pain, Sinusitis, |
||||
DUPILUMAB, ALBUTEROL SULFATE, ALBUTEROL SULFATE, MEDROXYPROGESTERONE ACETATE, EPINEPHRINE, MONTELUKAST SODIUM, MONTELUKAST, MOMETASONE FUROATE, |
||||
| 86 | 26550194 |
US |
77 | 1 |
Injection site pain, Injection site haemorrhage, |
||||
DUPILUMAB, |
||||
| 87 | 26550198 |
US |
1 | |
Injection site pain, Off label use, |
||||
DUPILUMAB, |
||||
| 88 | 26550217 |
|||
Injection site pain, Nausea, Joint swelling, Off label use, |
||||
BIMEKIZUMAB, MAVACAMTEN, CALCIUM, ENALAPRIL MALEATE, ENALAPRIL, INSULIN LISPRO, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, VITAMIN C, ERGOCALCIFEROL, |
||||
| 89 | 26550241 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, ALBUTEROL SULFATE, ESCITALOPRAM, PANTOPRAZOLE SODIUM, MONTELUKAST SODIUM, |
||||
| 90 | 26550246 |
US |
2 | |
Blister, Condition aggravated, Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, DUPILUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, FISH OIL, GARLIC, SUMATRIPTAN, LISINOPRIL, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, PIMECROLIMUS, |
||||
| 91 | 26550257 |
CN |
||
Device deployment issue, Product dose omission issue, Injection site pain, |
||||
GUSELKUMAB, |
||||
| 92 | 26550285 |
US |
61 | 1 |
Device difficult to use, Incorrect dose administered by device, Product communication issue, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 93 | 26550444 |
US |
2 | |
Injection site pain, Device use error, Incorrect dose administered, |
||||
GUSELKUMAB, |
||||
| 94 | 26550482 |
US |
||
Injection site pain, |
||||
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, |
||||
| 95 | 26550709 |
CA |
43 | 1 |
Arthralgia, Blood glucose increased, Cellulitis, Headache, Hypersensitivity, Injection site pain, Joint dislocation, Psoriasis, Therapy interrupted, Drug ineffective, Product distribution issue, |
||||
METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, BRODALUMAB, BRODALUMAB, BRODALUMAB, |
||||
| 96 | 26550820 |
US |
59 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 97 | 26550933 |
US |
24 | 1 |
Injection site swelling, Injection site pain, Product use issue, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 98 | 26551106 |
53 | ||
Oesophageal candidiasis, Bronchitis, Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 99 | 26551242 |
US |
76 | 2 |
Cataract, Visual impairment, Injection site pain, Dry eye, Therapeutic product effect incomplete, |
||||
DUPILUMAB, |
||||
| 100 | 26551286 |
US |
52 | 2 |
Intestinal obstruction, Volvulus, Dyspnoea, Dry eye, 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
