Drug:
Reaction: INJECTION SITE PAIN
20250101 - 20251231
No. 201 - 300
No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
201 | 25127018 |
US |
30 | 2 |
Injection site pain, Application site reaction, |
||||
BIMEKIZUMAB, |
||||
202 | 25127032 |
US |
2 | |
Injection site reaction, Injection site pain, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
203 | 25127060 |
US |
1 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
204 | 25127063 |
US |
53 | 2 |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
205 | 25127066 |
US |
2 | |
Injection site pain, Injection site reaction, Injection site swelling, Injection site erythema, Injection site warmth, |
||||
BIMEKIZUMAB, IXEKIZUMAB, |
||||
206 | 25127093 |
US |
53 | 1 |
Hidradenitis, Injection site pain, Fatigue, Hypersomnia, Therapeutic response shortened, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
207 | 25127094 |
US |
26 | 2 |
Hidradenitis, Injection site bruising, Injection site pain, Skin lesion, Injection site reaction, Inappropriate schedule of product administration, Product distribution issue, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
208 | 25127103 |
US |
2 | |
Injection site pain, |
||||
BIMEKIZUMAB, |
||||
209 | 25127123 |
US |
1 | |
Injection site pain, Wrong technique in product usage process, |
||||
BIMEKIZUMAB, |
||||
210 | 25127145 |
US |
2 | |
Injection site pain, Incorrect dose administered, |
||||
BIMEKIZUMAB, |
||||
211 | 25127205 |
US |
38 | 1 |
Injection site pain, Injection site bruising, Product storage error, Off label use, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
212 | 25127237 |
US |
1 | |
Injection site pain, Product dispensing error, |
||||
BIMEKIZUMAB, |
||||
213 | 25127239 |
US |
45 | 2 |
Injection site pain, Injection site swelling, |
||||
BIMEKIZUMAB, |
||||
214 | 25127244 |
US |
1 | |
Injection site pain, Drug ineffective, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, ZOLPIDEM TARTRATE, ROSUVASTATIN CALCIUM, EMPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE, EMPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, |
||||
215 | 25127245 |
US |
60 | 2 |
Injection site pain, Burning sensation, Injection site coldness, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, SEMAGLUTIDE, FUROSEMIDE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, |
||||
216 | 25127278 |
US |
18 | 1 |
Injection site pain, |
||||
OMALIZUMAB, |
||||
217 | 25127315 |
US |
55 | 2 |
Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
218 | 25127482 |
US |
39 | 2 |
Underdose, Injection site mass, Injection site bruising, Injection site pain, |
||||
GALCANEZUMAB-GNLM, SEMAGLUTIDE, |
||||
219 | 25127485 |
US |
54 | 1 |
Injection site pain, Injection site rash, Injection site hypersensitivity, |
||||
GALCANEZUMAB-GNLM, |
||||
220 | 25127807 |
GB |
56 | 2 |
Lower respiratory tract infection, Dysstasia, Feeding disorder, Oropharyngeal pain, Malaise, Hyperhidrosis, Pyrexia, Dyspnoea, Psoriasis, Axial spondyloarthritis, Condition aggravated, Toothache, Feeling abnormal, Influenza like illness, Cold sweat, Ageusia, Tonsillitis, Sinusitis, Hypoaesthesia, Musculoskeletal discomfort, Limb injury, Contusion, Injection site pain, Injection site pruritus, Injection site bruising, Anxiety, Migraine, Crying, Insomnia, Therapeutic product effect decreased, Viral infection, |
||||
ETANERCEPT, ETANERCEPT, METHOTREXATE SODIUM, |
||||
221 | 25127885 |
US |
71 | 2 |
Accidental underdose, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
222 | 25128022 |
US |
62 | 2 |
Off label use, Pain in extremity, Product colour issue, Injection site pain, Off label use, |
||||
OMALIZUMAB, OMALIZUMAB, |
||||
223 | 25128148 |
US |
||
Injection site pain, Device breakage, |
||||
SOMATROPIN, SOMATROPIN, |
||||
224 | 25128243 |
CA |
56 | 1 |
Blood pressure increased, Injection site pain, Grip strength decreased, Ankylosing spondylitis, Pain, Oropharyngeal pain, Musculoskeletal stiffness, Musculoskeletal pain, Palpitations, Pain in extremity, Diarrhoea, Drug ineffective, Arthralgia, Fatigue, |
||||
SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, METHOTREXATE, METHOTREXATE SODIUM, PREDNISONE, CALCIUM, CALCIUM, ERGOCALCIFEROL, ERGOCALCIFEROL, FOLIC ACID, FOLIC ACID, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, PANTOPRAZOLE, RISEDRONATE SODIUM, RISEDRONATE SODIUM, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, |
||||
225 | 25128317 |
IL |
9 | 1 |
Renal failure, Injection site pain, |
||||
SOMATROGON-GHLA, |
||||
226 | 25128630 |
US |
77 | 2 |
Accidental underdose, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
227 | 25128640 |
US |
46 | 2 |
Oesophageal candidiasis, Immunodeficiency, Oral candidiasis, Pyrexia, Injection site pain, Injection site induration, Injection site discolouration, Fatigue, Migraine, Psoriasis, Inappropriate schedule of product administration, |
||||
BIMEKIZUMAB, |
||||
228 | 25128681 |
US |
25 | 2 |
Presyncope, Hyperhidrosis, Asthenopia, Dizziness, Vision blurred, Headache, Injection site pain, |
||||
DUPILUMAB, |
||||
229 | 25128732 |
US |
1 | |
Injection site pain, Injection site swelling, |
||||
DUPILUMAB, |
||||
230 | 25128743 |
US |
68 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
231 | 25128814 |
US |
33 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
232 | 25128881 |
US |
62 | 1 |
Injection site pain, Asthenia, Lethargy, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
233 | 25128907 |
US |
29 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
234 | 25128983 |
US |
44 | 1 |
Dermatitis atopic, Pruritus, Dry skin, Skin exfoliation, Injection site pain, Therapeutic response shortened, |
||||
DUPILUMAB, |
||||
235 | 25129009 |
US |
35 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
236 | 25129098 |
US |
66 | 2 |
Injection site erythema, Injection site swelling, Injection site pain, Inflammation, Peripheral swelling, |
||||
237 | 25129114 |
US |
2 | |
Drug ineffective, Injection site erythema, Injection site pain, |
||||
238 | 25129115 |
US |
2 | |
Injection site pain, |
||||
239 | 25129200 |
US |
34 | 2 |
Incorrect dose administered, Injection site paraesthesia, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
240 | 25129208 |
US |
2 | |
Injection site pain, Product preparation error, |
||||
DUPILUMAB, |
||||
241 | 25129305 |
US |
47 | 1 |
Eczema, Swelling, Urticaria, Pruritus, Injection site pain, Condition aggravated, |
||||
DUPILUMAB, DUPILUMAB, |
||||
242 | 25129378 |
US |
74 | 2 |
Injection site pain, |
||||
SARILUMAB, |
||||
243 | 25129384 |
US |
25 | 2 |
Injection site irritation, Injection site pain, Injection site erythema, |
||||
DUPILUMAB, RESMETIROM, |
||||
244 | 25129607 |
US |
36 | 2 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
245 | 25129716 |
US |
67 | 2 |
Injection site haemorrhage, Injection site pain, Device issue, Blood glucose increased, Product storage error, |
||||
INSULIN GLARGINE AND LIXISENATIDE, |
||||
246 | 25129739 |
CA |
68 | 2 |
Condition aggravated, Dry eye, Fatigue, Flatulence, Impaired healing, Injection site pain, Nephrolithiasis, Pain in extremity, Sweat gland infection, Vitreous floaters, Intentional dose omission, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ATENOLOL, INDAPAMIDE, PANTOPRAZOLE, PREDNISONE, |
||||
247 | 25129744 |
US |
70 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
248 | 25129809 |
US |
48 | 1 |
Eczema, Injection site pain, |
||||
DUPILUMAB, |
||||
249 | 25129904 |
US |
1 | |
Injection site pain, Inappropriate schedule of product administration, |
||||
DUPILUMAB, |
||||
250 | 25129908 |
US |
69 | 2 |
Musculoskeletal stiffness, Pain in extremity, Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
251 | 25129970 |
US |
2 | |
Injection site pain, |
||||
DUPILUMAB, |
||||
252 | 25130105 |
US |
37 | 2 |
Injection site pruritus, Injection site pain, Asthma, Dyspnoea, Therapeutic response shortened, Off label use, |
||||
DUPILUMAB, DUPILUMAB, DUPILUMAB, |
||||
253 | 25130394 |
US |
1 | |
Erythema, Injection site pain, |
||||
DUPILUMAB, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, |
||||
254 | 25130697 |
US |
47 | 1 |
Psoriatic arthropathy, Injection site pain, Back pain, Arthralgia, Injection site vesicles, Therapeutic response unexpected, |
||||
BIMEKIZUMAB, BIMEKIZUMAB, |
||||
255 | 25130703 |
US |
75 | 1 |
Incorrect dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
256 | 25130875 |
CA |
12 | 1 |
Inflammatory bowel disease, Injection site pain, |
||||
ADALIMUMAB-AFZB, ADALIMUMAB-AFZB, SULFASALAZINE, |
||||
257 | 25131234 |
75 | 1 | |
Injection site pain, Injection site hypoaesthesia, Injection site pruritus, |
||||
258 | 25131348 |
65 | 1 | |
Arthralgia, Myalgia, Fatigue, Headache, Restlessness, Somnolence, Injection site pain, Injection site bruising, Drug ineffective, |
||||
INSULIN LISPRO, ENALAPRIL, ROSUVASTATIN, |
||||
259 | 25131593 |
US |
56 | 2 |
Injection site pain, Product dose omission issue, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
260 | 25131812 |
CA |
2 | |
Rheumatoid arthritis, Injection site pain, Injection site swelling, Injection site discolouration, Abnormal dreams, Alopecia, |
||||
CERTOLIZUMAB PEGOL, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, IBUPROFEN TABLET COATED, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, PANTOPRAZOLE, |
||||
261 | 25131836 |
US |
53 | 2 |
Product dose omission issue, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
262 | 25131841 |
US |
||
Injection site reaction, Injection site erythema, Injection site pain, |
||||
PEGVALIASE-PQPZ, |
||||
263 | 25131865 |
US |
36 | 2 |
Injection site pain, |
||||
GLATIRAMER ACETATE, |
||||
264 | 25131973 |
US |
48 | 2 |
Product dose omission issue, Injection site pain, |
||||
DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, DULAGLUTIDE, |
||||
265 | 25132014 |
US |
43 | 2 |
Injection site haemorrhage, Injection site coldness, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
266 | 25132016 |
US |
43 | 2 |
Product dose omission issue, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
267 | 25132019 |
US |
67 | 2 |
Drug dose omission by device, Injection site pain, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
268 | 25132027 |
US |
60 | 2 |
Injection site pain, |
||||
DUPILUMAB, DUPILUMAB, |
||||
269 | 25132036 |
US |
9 | 1 |
Injection site pain, |
||||
DUPILUMAB, |
||||
270 | 25134431 |
46 | 2 | |
Injection site pain, Injection site induration, |
||||
DUPILUMAB, |
||||
271 | 25121190 |
US |
2 | |
Injection site pain, Injection site bruising, Rash, |
||||
DUPILUMAB, |
||||
272 | 25121196 |
US |
78 | 2 |
Injection site pain, |
||||
DUPILUMAB, |
||||
273 | 25121231 |
US |
28 | 2 |
Injection site erythema, Injection site pain, Injection site swelling, |
||||
DUPILUMAB, |
||||
274 | 25121253 |
US |
2 | |
Injection site pain, Accidental exposure to product, Exposure via skin contact, |
||||
DUPILUMAB, CLONIDINE, LEVALBUTEROL TARTRATE, EPINEPHRINE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, DEXLANSOPRAZOLE, MOMETASONE FUROATE, FEXOFENADINE HYDROCHLORIDE, MONTELUKAST SODIUM, BUDESONIDE, GLYCOPYRROLATE, AND FORMOTEROL FUMARATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
275 | 25121344 |
US |
53 | 1 |
Injection site pain, Incorrect dose administered, |
||||
DUPILUMAB, |
||||
276 | 25121366 |
US |
66 | 2 |
COVID-19, Eye swelling, Periorbital pain, Skin hyperpigmentation, Injection site pain, |
||||
LEBRIKIZUMAB-LBKZ, DUPILUMAB, DUPILUMAB, IRON, CYANOCOBALAMIN, ERGOCALCIFEROL, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, |
||||
277 | 25121373 |
US |
63 | 1 |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
278 | 25121378 |
US |
56 | 2 |
Injection site bruising, Injection site pain, Injection site erythema, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
279 | 25121379 |
US |
70 | |
Injection site pain, |
||||
TIRZEPATIDE, |
||||
280 | 25121381 |
US |
59 | 2 |
Injection site pain, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
281 | 25121404 |
US |
35 | 2 |
Stress, Migraine, Injection site pain, Product preparation error, |
||||
DUPILUMAB, DUPILUMAB, |
||||
282 | 25121549 |
US |
43 | 2 |
Injection site pain, |
||||
DULAGLUTIDE, DULAGLUTIDE, |
||||
283 | 25121554 |
US |
64 | |
Incorrect dose administered, Injection site discomfort, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
284 | 25121556 |
US |
78 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
285 | 25121565 |
US |
65 | 2 |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
286 | 25121566 |
US |
22 | 2 |
Product dose omission issue, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
287 | 25121936 |
US |
90 | 2 |
Injection site pain, |
||||
DULAGLUTIDE, DULAGLUTIDE, |
||||
288 | 25121937 |
US |
52 | 2 |
Drug dose omission by device, Migraine, Injection site pain, Injection site urticaria, |
||||
GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, GALCANEZUMAB-GNLM, |
||||
289 | 25121941 |
US |
52 | |
Extra dose administered, Injection site pain, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
290 | 25122048 |
US |
38 | 2 |
Incorrect dose administered, Cough, Injection site pain, Injection site mass, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
291 | 25122049 |
US |
72 | |
Incorrect dose administered, Injection site pain, Injection site mass, |
||||
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, |
||||
292 | 25122089 |
US |
51 | 1 |
Pneumonia, Loss of personal independence in daily activities, Dyspnoea, Malaise, Injection site pain, Drug ineffective, Inappropriate schedule of product administration, |
||||
DUPILUMAB, DUPILUMAB, |
||||
293 | 25122152 |
CA |
69 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
294 | 25122153 |
CA |
77 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, |
||||
295 | 25122158 |
CA |
65 | 1 |
Injection site haemorrhage, Injection site pain, |
||||
LEUPROLIDE ACETATE, |
||||
296 | 25122160 |
CA |
81 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
297 | 25122164 |
CA |
84 | 1 |
Injection site pain, |
||||
LEUPROLIDE ACETATE, |
||||
298 | 25122169 |
CA |
62 | 1 |
Injection site pain, Injection site mass, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
299 | 25122170 |
CA |
83 | 1 |
Injection site pain, Fatigue, |
||||
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE, |
||||
300 | 25122223 |
US |
1 | |
Injection site pain, |
||||
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, |
disclaimer
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last_updated
2025-04-28