Drug:
Reaction: INJECTION SITE PAIN
20250101 - 20251231
No. 101 - 200
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 101 | 25138069 |
US |
63 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 102 | 25132161 |
US |
35 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 103 | 25132215 |
US |
68 | 1 |
Weight decreased, Muscle atrophy, Hypersensitivity, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 104 | 25132216 |
US |
37 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, |
||||
| 105 | 25132224 |
US |
35 | 2 |
Incorrect dose administered, Injection site pain, |
||||
GALCANEZUMAB-GNLM, |
||||
| 106 | 25132290 |
US |
32 | 2 |
Injection site pain, Dermatitis atopic, Therapeutic response decreased, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
| 107 | 25132302 |
US |
56 | 2 |
Influenza, Injection site pain, Rash, |
||||
DUPILUMAB, |
||||
| 108 | 25132313 |
US |
2 | |
Injection site pain, Drug ineffective, |
||||
DUPILUMAB, DUPILUMAB, THIAMINE HYDROCHLORIDE, RIBOFLAVIN 5 PHOSPHATE SODIUM, DEXPANTHENOL AND NIACINAMIDE, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, ERGOCALCIFEROL, VITAMIN C, MAGNESIUM, FEXOFENADINE HYDROCHLORIDE, ESOMEPRAZOLE MAGNESIUM, |
||||
| 109 | 25132355 |
US |
76 | 2 |
Injection site pain, Off label use, Kaleidoscope vision, Vitreous floaters, Product dose omission issue, |
||||
FARICIMAB, |
||||
| 110 | 25132622 |
US |
52 | 1 |
Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 111 | 25132631 |
US |
39 | 2 |
Injection site pain, Injection site paraesthesia, Injection site warmth, |
||||
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, |
||||
| 112 | 25132709 |
US |
60 | 1 |
Injection site cellulitis, Injection site erythema, Injection site pustule, Injection site induration, Injection site warmth, Infusion site infection, Device dislocation, Injection site pain, Injection site warmth, Injection site induration, |
||||
FOSCARBIDOPA/FOSLEVODOPA, FOSCARBIDOPA/FOSLEVODOPA, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, TADALAFIL, ERGOCALCIFEROL, VITAMIN C, |
||||
| 113 | 25132747 |
CA |
72 | 1 |
Supraventricular tachycardia, Heart rate increased, Supraventricular tachycardia, Myalgia, Pain, Arthralgia, Respiratory disorder, Injection site pain, Injection site discomfort, Headache, Ill-defined disorder, |
||||
INCLISIRAN, INCLISIRAN, INCLISIRAN, INCLISIRAN, |
||||
| 114 | 25132925 |
US |
66 | 2 |
Off label use, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 115 | 25132928 |
US |
2 | |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 116 | 25132999 |
US |
67 | 2 |
Gait disturbance, Injection site rash, Injection site pain, Injection site irritation, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 117 | 25133002 |
US |
50 | 2 |
Injection site bruising, Injection site pain, |
||||
GALCANEZUMAB-GNLM, SEMAGLUTIDE, |
||||
| 118 | 25133263 |
US |
53 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 119 | 25133265 |
US |
50 | 2 |
Injection site pain, Injection site mass, |
||||
GALCANEZUMAB-GNLM, |
||||
| 120 | 25133403 |
US |
36 | 2 |
Injection site urticaria, Inflammation, Injection site mass, Injection site pain, |
||||
DUPILUMAB, |
||||
| 121 | 25133572 |
US |
66 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 122 | 25133582 |
US |
53 | |
Gastrointestinal tract irritation, Abdominal discomfort, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 123 | 25133778 |
US |
57 | 2 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
| 124 | 25133780 |
US |
56 | |
Injection site pain, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 125 | 25133782 |
US |
53 | |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 126 | 25133800 |
US |
2 | |
Inflammatory bowel disease, Haemorrhoids, Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 127 | 25133865 |
US |
38 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 128 | 25133900 |
US |
45 | 2 |
Injection site pain, Therapeutic response unexpected, |
||||
DUPILUMAB, |
||||
| 129 | 25133916 |
US |
2 | |
Injection site pain, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 130 | 25133972 |
US |
49 | 1 |
Injection site pain, Injection site pruritus, |
||||
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, |
||||
| 131 | 25134039 |
US |
56 | 2 |
Lacrimation increased, Injection site pain, |
||||
DUPILUMAB, |
||||
| 132 | 25134045 |
US |
2 | |
Injection site pain, Product use in unapproved indication, |
||||
DUPILUMAB, AMLODIPINE BESYLATE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, GABAPENTIN, TIRZEPATIDE, MUPIROCIN, MUPIROCIN CALCIUM, FLUOXETINE HYDROCHLORIDE, |
||||
| 133 | 25134051 |
US |
2 | |
Injection site erythema, Injection site pain, Injection site swelling, |
||||
DUPILUMAB, |
||||
| 134 | 25134082 |
FR |
11 | 2 |
Screaming, Injection site pain, Incorrect dose administered, |
||||
SOMATROPIN, |
||||
| 135 | 25134160 |
US |
2 | |
Extra dose administered, Feeling abnormal, Taste disorder, Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 136 | 25134886 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, ADALIMUMAB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LIOTHYRONINE SODIUM, ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE, EPINEPHRINE, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, MAGNESIUM OXIDE, PANCRELIPASE, DICLOFENAC, DICLOFENAC SODIUM, TROSPIUM CHLORIDE, DIHYDROERGOTAMINE MESYLATE, MONTELUKAST SODIUM, MONTELUKAST, ALBUTEROL SULFATE, AZELASTINE HYDROCHLORIDE, AZELASTINE, ERYTHROMYCIN, BACLOFEN, ERGOCALCIFEROL, CYANOCOBALAMIN, INSULIN LISPRO, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, BUPROPION HYDROCHLORIDE, DEXLANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, TIRZEPATIDE, GRANISETRON HYDROCHLORIDE, ERENUMAB-AOOE, LORAZEPAM, |
||||
| 137 | 25134927 |
US |
2 | |
Blood glucose increased, Injection site pain, |
||||
DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, |
||||
| 138 | 25134935 |
US |
2 | |
Injection site pain, Abdominal pain upper, |
||||
SECUKINUMAB, |
||||
| 139 | 25135085 |
CA |
95 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 140 | 25135086 |
CA |
74 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 141 | 25135089 |
CO |
11 | 2 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 142 | 25135286 |
US |
38 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 143 | 25135372 |
US |
1 | |
Injection site pain, |
||||
BELIMUMAB, |
||||
| 144 | 25135509 |
US |
68 | 1 |
Pain in extremity, Injected limb mobility decreased, Iliac artery occlusion, Injection site bruising, Injection site pain, Injection site discolouration, Product administration error, |
||||
EVOLOCUMAB, |
||||
| 145 | 25135597 |
CN |
32 | 1 |
Device deployment issue, Injection site pain, Injection site haemorrhage, Accidental exposure to product, Product dose omission issue, |
||||
GUSELKUMAB, |
||||
| 146 | 25135648 |
CA |
92 | 1 |
Injection site pain, Fatigue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 147 | 25135654 |
CA |
74 | 1 |
Injection site pain, Arthralgia, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 148 | 25135660 |
CA |
82 | 1 |
Injection site pain, Hot flush, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
| 149 | 25135761 |
US |
2 | |
Injection site pain, |
||||
INSULIN GLARGINE AND LIXISENATIDE, |
||||
| 150 | 25135773 |
US |
75 | 1 |
Device difficult to use, Injection site pain, Drug dose omission by device, |
||||
EVOLOCUMAB, EVOLOCUMAB, |
||||
| 151 | 25135950 |
US |
60 | 2 |
Injection site pain, Injection site erythema, Injection site pruritus, |
||||
INSULIN LISPRO-AABC, INSULIN LISPRO-AABC, INSULIN GLARGINE, |
||||
| 152 | 25136022 |
US |
15 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 153 | 25136106 |
US |
56 | 1 |
Injection site pain, Underdose, |
||||
DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT), |
||||
| 154 | 25136406 |
US |
63 | 2 |
Injection site bruising, Injection site pain, Device difficult to use, |
||||
EVOLOCUMAB, |
||||
| 155 | 25136508 |
CN |
17 | 2 |
Dizziness, Palpitations, Pyrexia, Injection site pain, |
||||
ETANERCEPT, ETANERCEPT, |
||||
| 156 | 25136628 |
US |
2 | |
Skin weeping, Skin haemorrhage, Condition aggravated, Pruritus, Injection site pain, Drug ineffective, |
||||
DUPILUMAB, LATANOPROST, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, ZOLPIDEM TARTRATE, LEVOTHYROXINE SODIUM, AMOXICILLIN, AMLODIPINE BESYLATE, FUROSEMIDE, |
||||
| 157 | 25136640 |
US |
1 | |
Inflammatory bowel disease, Joint swelling, Blood creatinine increased, White blood cell count decreased, Injection site mass, Product dose omission issue, Product use issue, Injection site pain, Injection site erythema, Insomnia, Pruritus, |
||||
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, INFLIXIMAB-DYYB, |
||||
| 158 | 25136785 |
US |
22 | 2 |
Atypical pneumonia, Sensitive skin, Bronchitis, Injection site mass, Nasopharyngitis, Injection site induration, Injection site pain, |
||||
DUPILUMAB, |
||||
| 159 | 25136787 |
US |
32 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
| 160 | 25136832 |
US |
58 | 2 |
Incorrect dose administered, Injection site injury, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 161 | 25136993 |
US |
2 | |
Suicidal ideation, Dyspnoea, Blood glucose fluctuation, Nausea, Vomiting, Generalised oedema, Injection site rash, Injection site pain, Injection site swelling, Rash, |
||||
INSULIN LISPRO, INSULIN DETEMIR, |
||||
| 162 | 25137061 |
US |
2 | |
Cyst, Injection site pain, |
||||
RISANKIZUMAB-RZAA, |
||||
| 163 | 25137146 |
US |
54 | 2 |
Alopecia, Condition aggravated, Injection site erythema, Injection site swelling, Injection site pain, Injection site bruising, |
||||
DUPILUMAB, GABAPENTIN, PANTOPRAZOLE, |
||||
| 164 | 25126438 |
US |
72 | 2 |
Injection site pain, Device issue, Needle issue, Product complaint, |
||||
TOCILIZUMAB, |
||||
| 165 | 25126477 |
US |
25 | 1 |
Migraine, Product dose omission issue, Injection site pruritus, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 166 | 25126483 |
US |
18 | 1 |
Incorrect dose administered, Injection site pain, |
||||
GALCANEZUMAB-GNLM, |
||||
| 167 | 25126487 |
US |
71 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 168 | 25126488 |
US |
54 | 2 |
Injection site haemorrhage, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 169 | 25126491 |
US |
43 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
| 170 | 25126492 |
US |
54 | 2 |
Injection site pain, |
||||
DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, |
||||
| 171 | 25126517 |
US |
66 | 2 |
Accidental exposure to product, Device difficult to use, Product communication issue, Injection site pain, |
||||
EVOLOCUMAB, |
||||
| 172 | 25126609 |
US |
54 | 2 |
Pain in extremity, Blood glucose increased, Injection site erythema, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 173 | 25126749 |
US |
64 | 2 |
Product storage error, Diarrhoea, Retching, Vomiting, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 174 | 25126750 |
US |
53 | 2 |
Off label use, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 175 | 25126759 |
US |
40 | 2 |
Accidental underdose, Injection site pain, Injection site bruising, Injection site haemorrhage, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
| 176 | 25126769 |
US |
1 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 177 | 25126771 |
US |
||
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 178 | 25126774 |
US |
34 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 179 | 25126800 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 180 | 25126815 |
US |
1 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 181 | 25126827 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 182 | 25126829 |
US |
61 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, FLUOXETINE HYDROCHLORIDE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, PROPRANOLOL HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, ERGOCALCIFEROL, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, BUPROPION HYDROCHLORIDE, |
||||
| 183 | 25126842 |
US |
75 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 184 | 25126850 |
US |
60 | 2 |
Injection site pain, Illness, |
||||
BIMEKIZUMAB, |
||||
| 185 | 25126856 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 186 | 25126858 |
US |
43 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 187 | 25126861 |
US |
37 | 1 |
Injection site pain, Injection site reaction, |
||||
BIMEKIZUMAB, |
||||
| 188 | 25126869 |
US |
1 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 189 | 25126879 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 190 | 25126892 |
US |
58 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 191 | 25126902 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 192 | 25126910 |
US |
60 | 2 |
Injection site pain, Burning sensation, Feeling cold, |
||||
BIMEKIZUMAB, SEMAGLUTIDE, FUROSEMIDE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, |
||||
| 193 | 25126919 |
US |
1 | |
Injection site pain, Headache, |
||||
BIMEKIZUMAB, |
||||
| 194 | 25126922 |
US |
47 | 1 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 195 | 25126946 |
US |
53 | 2 |
Psoriasis, Injection site pain, Wrong technique in product usage process, Inappropriate schedule of product administration, |
||||
BIMEKIZUMAB, |
||||
| 196 | 25126950 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
| 197 | 25126996 |
US |
58 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 198 | 25126998 |
US |
2 | |
Injection site pain, Skin mass, |
||||
BIMEKIZUMAB, |
||||
| 199 | 25127004 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
| 200 | 25127013 |
US |
35 | 1 |
Injection site pain, Device issue, |
||||
BIMEKIZUMAB, |
||||
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
2025-04-28