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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: PRODUCT USE ISSUE

20260101 - 20261231

No. 201 - 300

Next page: 4 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
201
26534802
US
66 2
Sepsis, Product use issue, Upper limb fracture, Osteoporosis, Lung neoplasm, Hyperhidrosis, Nausea,
VORTIOXETINE,
202
26534928
SG
1
Disease progression, Product use issue,
DAROLUTAMIDE,
203
26535055
US
69
Product use issue, Device mechanical issue, Device malfunction,
FLUTICASONE PROPIONATE AND SALMETEROL,
204
26535130
CN
1
Acute kidney injury, Hepatitis acute, Cholecystitis, Pancreatitis, Product use issue,
SEMAGLUTIDE,
205
26535194
US
59 2
Hypertension, COVID-19, Impaired gastric emptying, Metabolic disorder, Postprandial hypoglycaemia, Illness, Body temperature decreased, Vomiting, Alopecia, Dehydration, Headache, Blood glucose increased, Autoimmune disorder, Antinuclear antibody positive, Psoriasis, Sinusitis, Influenza, Dumping syndrome, Inappropriate schedule of product administration, Therapeutic response decreased, Overdose, Drug ineffective, Product use issue,
IXEKIZUMAB, IXEKIZUMAB, IXEKIZUMAB, IXEKIZUMAB, TIRZEPATIDE, DULAGLUTIDE, LIRAGLUTIDE,
206
26535411
EU
69 2
Neutropenia, Anaemia, Infection, Product use issue, Toxicity to various agents,
IVOSIDENIB, AZACITIDINE, AZACITIDINE FOR, AZACITIDINE, AZACITIDINE FOR,
207
26526828
EU
81 2
Cardiac failure, Hyponatraemia, Rib fracture, Hip fracture, Product use issue, Fall, Multiple fractures,
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, SELINEXOR, POMALIDOMIDE,
208
26526839
US
1
Product use issue,
PIMAVANSERIN TARTRATE,
209
26526952
US
48 2
Product use issue,
LENALIDOMIDE,
210
26527057
EU
1
Product dose omission issue, Product use issue, Device issue, Liquid product physical issue,
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO,
211
26527125
US
26 2
Product use issue,
VIMSELTINIB,
212
26527182
US
Product use issue, Product dose omission issue, Product cleaning inadequate, Device use issue, Dyspnoea,
213
26527236
JP
Dysphagia, Product use issue,
OSIMERTINIB,
214
26527246
CA
45 1
Aspiration, Disseminated tuberculosis, Enteral nutrition, Gastrostomy, Hepatic enzyme increased, Intentional dose omission, Intercepted product prescribing error, Meningitis tuberculous, Pneumothorax, Product use issue, Surgical vascular shunt, Tracheostomy, Tuberculosis of central nervous system, Weaning failure,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG,
215
26527405
US
1
Bronchitis, Product use issue,
DAPAGLIFLOZIN,
216
26527589
CA
65 2
Abdominal pain, Alanine aminotransferase increased, Arthralgia, Arthritis, Arthropathy, Aspartate aminotransferase increased, Basal cell carcinoma, Blood parathyroid hormone decreased, Breath sounds abnormal, C-reactive protein increased, Condition aggravated, Drug eruption, Drug hypersensitivity, Drug intolerance, Drug tolerance decreased, Erythema, Granuloma skin, Headache, Hepatic enzyme increased, Hypercalcaemia, Hypersensitivity, Hypertension, Inflammation, Infusion related reaction, Insomnia, Joint swelling, Musculoskeletal stiffness, Pain, Panniculitis, Peripheral swelling, Pneumonia, Pruritus, Pulmonary fibrosis, Rash, Rash pruritic, Red blood cell sedimentation rate increased, Rheumatoid arthritis, Rheumatoid factor positive, Rheumatoid nodule, Skin necrosis, Skin ulcer, Synovitis, Ulcer, Deafness, Contraindicated product administered, Prescribed underdose, Product use issue, Product use in unapproved indication, Adverse event, Off label use, Treatment failure, Therapeutic product effect decreased, Therapeutic response decreased, Drug ineffective,
BUDESONIDE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, SULFASALAZINE, CYCLOSPORINE, AZATHIOPRINE, AZATHIOPRINE, AZATHIOPRINE, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, TOCILIZUMAB, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, ALENDRONATE SODIUM, MAGNESIUM OXIDE, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, ABATACEPT, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, TOFACITINIB, IXEKIZUMAB, SECUKINUMAB, IRON, ALENDRONATE SODIUM, ALPRAZOLAM, AMLODIPINE BESYLATE, ATENOLOL, BISOPROLOL FUMARATE, CELECOXIB, CYANOCOBALAMIN, ERGOCALCIFEROL, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, FOLIC ACID, GOLD, HYDROCHLOROTHIAZIDE, IRON SUCROSE, PREGABALIN, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, MORPHINE SULFATE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PAROXETINE HYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, PROPRANOLOL HYDROCHLORIDE, RAMIPRIL, RISEDRONATE SODIUM, SERTRALINE HYDROCHLORIDE, GOLIMUMAB, TELMISARTAN, SIMVASTATIN,
217
26527591
CA
63 2
Erythema, Pruritus, Anxiety, Chest discomfort, Hot flush, Hypotension, Hyperventilation, Malaise, Product use issue,
INFLIXIMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,
218
26527877
US
17 1
No adverse event, Product use issue, Circumstance or information capable of leading to medication error, Product physical issue,
LISDEXAMFETAMINE DIMESYLATE,
219
26527899
US
54 2
Headache, Nausea, Dizziness, Product use issue, Device information output issue, Device malfunction, Device infusion issue, Product leakage,
TREPROSTINIL, TREPROSTINIL, ERGOCALCIFEROL, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, FAMOTIDINE, VITAMIN C, METOLAZONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, TADALAFIL, FUROSEMIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, MACITENTAN, SOTATERCEPT-CSRK, OXYGEN, 0XYGEN, IRON, IPRATROPIUM BROMIDE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, GABAPENTIN, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, BENZONATATE, LORATADINE, LORATADINE ORAL, ONDANSETRON HYDROCHLORIDE,
220
26528135
US
2
Cough, Product dose omission issue, Device delivery system issue, Product packaging quantity issue, Product use issue, Wrong technique in product usage process,
ALBUTEROL SULFATE,
221
26528245
US
4
Urticaria, Product use issue,
CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, LEVALBUTEROL, LEVALBUTEROL HYDROCHLORIDE, DORNASE ALFA, BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, TOBRAMYCIN, TOBRAMYCIN SULFATE, TOBRAMYCIN SOLUTION, PANCRELIPASE LIPASE, PANCRELIPASE PROTEASE, PANCRELIPASE AMYLASE, ZINC, ZINC GLUCONATE, ZINC CHLORIDE,
222
26528579
2
Hyperammonaemia, Mental status changes, Product use issue, Inappropriate schedule of product administration,
TESTOSTERONE UNDECANOATE, TESTOSTERONE UNDECANOATE, TESTOSTERONE UNDECANOATE, TESTOSTERONE UNDECANOATE, TESTOSTERONE UNDECANOATE,
223
26528715
1
Haematological infection, Product use issue,
MOMELOTINIB,
224
26528823
US
Product dose omission issue, Off label use, Product use issue,
LENALIDOMIDE,
225
26528840
EU
22 2
Abdominal pain, Diarrhoea, Product use issue, Product use issue, Off label use,
TRAMETINIB, TRAMETINIB, PEMBROLIZUMAB, PEMBROLIZUMAB, ENCORAFENIB, ENCORAFENIB, BINIMETINIB, BINIMETINIB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, GABAPENTIN, QUETIAPINE, PREDNISONE, PREDNISONE, OXAZEPAM,
226
26528986
US
Product use issue, Fatigue,
TIRZEPATIDE,
227
26529031
US
Abdominal operation, Product use issue,
TOBRAMYCIN,
228
26529127
CA
64 2
Haematological infection, Pneumonia, Oedema, Asthenia, Product use issue, Walking aid user,
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB,
229
26529356
13 2
Vertigo, Headache, Blood test abnormal, Vomiting, Abdominal pain, Product use issue, Intentional overdose,
ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER,
230
26529580
EU
72 1
Acute respiratory distress syndrome, General physical condition abnormal, Interstitial lung disease, Pulmonary fibrosis, Pulmonary oedema, Hallucination, Neuropathy peripheral, Off label use, Product use issue,
PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND), CARBOPLATIN, NIVOLUMAB, NIVOLUMAB, NIVOLUMAB, PREGABALIN, DESLORATADINE, CELECOXIB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, CANDESARTAN, AMLODIPINE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE BITARTRATE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM CAPSULE, DELAYED RELEASE, ESOMEPRAZOLE MAGNESIUM DIHYDRATE, ESOMEPRAZOLE MAGNESIUM DELAYED RELEASE CAPSULES, CELECOXIB, FUROSEMIDE, SPIRONOLACTONE,
231
26529607
US
62 2
Diarrhoea, Nausea, Dizziness, Depression, Therapeutic product effect decreased, Mood altered, Abdominal pain upper, Restlessness, Vomiting, Insomnia, Inappropriate schedule of product administration, Product use issue,
DEUTETRABENAZINE, DEUTETRABENAZINE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, AMLODIPINE, ARIPIPRAZOLE, QUETIAPINE,
232
26529621
US
60 1
Product use issue,
MAVACAMTEN,
233
26529689
US
73 1
Adverse event, Product use issue,
234
26529732
US
84 2
Dizziness, Fall, Product use issue,
MAVACAMTEN,
235
26529921
US
51 2
Product use issue, Incorrect dose administered,
TIRZEPATIDE,
236
26530174
US
72 2
Cardiomyopathy, Pancreatitis, Hyperhidrosis, Product use issue, Discharge, Obstruction, Heart valve incompetence, Spleen disorder,
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE,
237
26530353
US
69 1
Balance disorder, Fall, Head injury, Haematological infection, Atrial fibrillation, Product use issue,
SEMAGLUTIDE, SEMAGLUTIDE,
238
26530515
US
66 2
Glycosylated haemoglobin increased, Product dose omission issue, Inability to afford medication, Insurance issue, Product use issue,
SITAGLIPTIN, EMPAGLIFLOZIN, AMLODIPINE, CALCITRIOL, CALCITRIOL CAPSULES 0.25 MCG, CALCITRIOL CAPSULES 0.5 MCG,
239
26530612
CA
2
Product use issue, Electrocardiogram QT prolonged, Schizoaffective disorder, Sinus rhythm, Insomnia,
ESTRADIOL, ERGOCALCIFEROL, VALPROIC ACID, CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, RANITIDINE, RANITIDINE, RANITIDINE, DIVALPROEX SODIUM, DIVALPROEX SODIUM, DIVALPROEX SODIUM, DIVALPROEX SODIUM, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN AND CAFFEINE, AMLODIPINE, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, BREXPIPRAZOLE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, BREXPIPRAZOLE, BREXPIPRAZOLE, CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPICAL, ALUMINUM HYDROXIDE, CONJUGATED ESTROGENS, ESTROGENS, CONJUGATED, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, VALPROATE SODIUM, PHENYLEPHRINE HYDROCHLORIDE,
240
26530685
US
2
Cardiac failure congestive, Product dose omission issue, Product use issue,
DAPAGLIFLOZIN,
241
26530690
US
87 1
Off label use, Product use issue,
NIRMATRELVIR AND RITONAVIR,
242
26530830
CA
44 2
Abdominal pain upper, Asthenia, Back pain, Body temperature increased, Diarrhoea, Ear pain, Headache, Insomnia, Muscle spasticity, Night sweats, Respiratory disorder, Stomatitis, Urticaria, Vomiting, Contraindicated product administered, Drug ineffective, Drug intolerance, Intentional product use issue, Medication error, Maternal exposure timing unspecified, Off label use, Product use issue, Therapeutic product effect decreased, Treatment failure,
OXYCODONE HYDROCHLORIDE, OXYCODONE, CORTISONE ACETATE, CORTISONE ACETATE, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, HYDROCORTISONE ACETATE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, INFLIXIMAB, ISOPROPYL ALCOHOL, 70%ISOPROPYL ALCOHOL, ALCOHOL PREP PADS, ALCOHOL, ISOPROPYL ALCOHOL SPRAY, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE, RITUXIMAB, TOFACITINIB, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, SULFAMETHOXAZOLE AND TRIMETHOPRIM, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,
243
26531057
US
2
Pain in extremity, Product use issue, Wrong technique in product usage process, Product container issue,
LATANOPROST,
244
26522697
US
1
Condition aggravated, Product use issue,
PIMAVANSERIN TARTRATE,
245
26522745
US
78 2
Product use issue,
RIPRETINIB,
246
26522909
US
1
Product use issue,
PIMAVANSERIN TARTRATE,
247
26522917
US
68 2
Product use issue, Dyspepsia,
TIRZEPATIDE,
248
26522965
US
1
Product dose omission issue, Product use issue, No adverse event,
SITAGLIPTIN,
249
26523031
US
No adverse event, Product use issue,
VORTIOXETINE,
250
26523140
US
Product use issue,
ISOTRETINOIN,
251
26523142
US
Product use issue,
ISOTRETINOIN,
252
26523273
CA
43 2
Sleep disorder, Sinusitis, Sciatica, Road traffic accident, Rheumatoid arthritis, Rheumatic fever, Respiratory disorder, Red blood cell sedimentation rate increased, Rectal haemorrhage, Rash, Psoriatic arthropathy, Porphyria acute, Pneumonia, Peripheral venous disease, Peripheral swelling, Pericarditis, Pemphigus, Paraesthesia, Pancreatitis, Pain in extremity, Pain, Overlap syndrome, Osteoarthritis, Onychomycosis, Onychomadesis, Oedema peripheral, Normal newborn, Obesity, Night sweats, Neck pain, Nasopharyngitis, Nail disorder, Musculoskeletal pain, Muscular weakness, Muscle spasms, Muscle injury, Mobility decreased, Migraine, Memory impairment, Lupus-like syndrome, Lung disorder, Lower respiratory tract infection, Lower limb fracture, Swelling, Liver injury, Swollen joint count increased, Synovitis, Systemic lupus erythematosus, Taste disorder, Ulcer haemorrhage, Underdose, Type 2 diabetes mellitus, Urticaria, Vomiting, Weight increased, Wheezing, White blood cell count increased, Wound, Wound infection, Abdominal discomfort, X-ray abnormal, Stomatitis, Therapeutic product effect incomplete, Treatment failure, Therapy non-responder, Therapeutic product effect decreased, Maternal exposure during pregnancy, Product use issue, Off label use, Product use in unapproved indication, Product quality issue, Prescribed underdose,
CANDESARTAN, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, ALENDRONATE SODIUM, ALENDRONATE SODIUM,
253
26523422
US
2
Product use issue, Product use in unapproved indication, Product administered at inappropriate site, Intentional product misuse,
254
26524030
US
42 2
Product dose omission in error, Product use issue, Product use issue, Insurance issue,
255
26524067
US
2
Hereditary angioedema, Product use issue,
ECALLANTIDE, ECALLANTIDE,
256
26524109
US
55 2
Suicidal ideation, Depression, Impaired work ability, Product use issue, Negative thoughts, Mood altered, Pruritus, Dyskinesia, Dysphonia,
DEUTETRABENAZINE, DEUTETRABENAZINE, DEUTETRABENAZINE, VALBENAZINE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE,
257
26524203
US
1
Renal failure, Product use issue,
DAPAGLIFLOZIN,
258
26524596
CO
20 2
Pyrexia, Allergy to immunoglobulin therapy, Infection, Insurance issue, Treatment noncompliance, Product use issue, Weight decreased, Body height increased,
259
26524675
CA
37 2
Dyspepsia, Product use issue,
ADALIMUMAB-BWWD,
260
26524768
CA
Migraine, Heart rate increased, Device leakage, Product use issue, Inappropriate schedule of product administration, Product knowledge deficit,
SEMAGLUTIDE, ORAL SEMAGLUTIDE,
261
26524966
US
2
Central nervous system lesion, Hospitalisation, Muscular weakness, Tremor, Headache, Musculoskeletal disorder, Insurance issue, Product use issue,
262
26524985
CA
74 2
Acute kidney injury, Drug ineffective, Rash erythematous, Renal disorder, Renal failure, Pruritus, Respiratory failure, Back pain, Contusion, Dermatitis exfoliative generalised, Psoriasis, Pulmonary oedema, Product use issue,
METHOTREXATE, METHOTREXATE SODIUM, ACITRETIN, CYCLOSPORINE, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, SECUKINUMAB, CYCLOSPORINE, 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,
263
26525065
EU
25 2
Furuncle, Product use issue,
OFATUMUMAB, OFATUMUMAB,
264
26525182
15 2
Neutropenia, Product use in unapproved indication, Product use issue,
GANCICLOVIR SODIUM, GANCICLOVIR, GANCICLOVIR SODIUM, GANCICLOVIR, GANCICLOVIR SODIUM, GANCICLOVIR,
265
26525205
US
66 1
Incontinence, Asthenia, Fall, Product use issue, Product availability issue,
RISPERIDONE, RISPERIDONE, RISPERIDONE,
266
26525610
US
2
Product use issue,
USTEKINUMAB, USTEKINUMAB,
267
26525635
US
67 1
Hospitalisation, Product use issue,
TRIENTINE HYDROCHLORIDE,
268
26525982
JP
85 2
Myocardial infarction, Product use issue,
BREXPIPRAZOLE, BREXPIPRAZOLE,
269
26526083
US
76 2
Lung disorder, Product use issue,
REGORAFENIB,
270
26526129
37 2
Product use issue, General physical health deterioration,
SOTATERCEPT-CSRK,
271
26526148
EU
12 2
Serotonin syndrome, Neuroleptic malignant syndrome, Product use issue,
HALOPERIDOL, HALOPERIDOL LACTATE, HALOPERIDOL, HALOPERIDOL LACTATE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, FLUOXETINE HYDROCHLORIDE, FLUOXETINE,
272
26526532
IL
55 2
International normalised ratio abnormal, Incorrect dose administered, Product use issue,
TIRZEPATIDE,
273
26526736
CA
43 2
Systemic lupus erythematosus, Rheumatoid factor positive, Mobility decreased, Off label use, Sinusitis, Therapy non-responder, Nasopharyngitis, Wound infection, Swelling, Therapeutic product effect decreased, Treatment failure, Sciatica, Irritable bowel syndrome, Rash, Rash pruritic, Joint range of motion decreased, Prescribed overdose, Muscle injury, Intentional product use issue, Live birth, Sleep disorder, Therapeutic response decreased, Lower respiratory tract infection, Synovitis, Lower limb fracture, Maternal exposure during pregnancy, Pruritus, Nausea, Prescribed underdose, Wound, Rheumatoid arthritis, Type 2 diabetes mellitus, Wheezing, Malaise, Lupus vulgaris, Product use issue, Ulcer haemorrhage, Vomiting,
DICLOFENAC SODIUM, RITUXIMAB, SECUKINUMAB, SECUKINUMAB, CALCIUM CARBONATE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, 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, 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, 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, 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, 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, APREMILAST, HYDROXYCHLOROQUINE, HYDROXYCHLOROQUINE, DOXYCYCLINE HYCLATE, DOXYCYCLINE, DOXYCLYCLINE HYCLATE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, CANDESARTAN, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM, FILM COATED, DICLOFENAC POTASSIUM TABLETS, LEFLUNOMIDE, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, GOLIMUMAB, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, NAPROXEN SODIUM, NAPROXEN SODIUM 220MG, NAPROXEN SODIUM, COATED TABLETS, NAPROXEN SODIUM TABLET, COATED, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, CERTOLIZUMAB PEGOL, PHENYLEPHRINE HYDROCHLORIDE, APREPITANT, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, LANSOPRAZOLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, ERENUMAB-AOOE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, CALCIUM GLUCONATE, ISOPROPYL ALCOHOL, 70%ISOPROPYL ALCOHOL, ALCOHOL PREP PADS, ALCOHOL, ISOPROPYL ALCOHOL SPRAY, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, PREGABALIN, ALENDRONATE SODIUM, ADALIMUMAB-ADAZ, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, ERGOCALCIFEROL, RAMIPRIL, MELOXICAM, LORAZEPAM, PIROXICAM, SULFASALAZINE, RISEDRONATE SODIUM, CYANOCOBALAMIN, LISINOPRIL, MAGNESIUM CARBONATE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, ERGOCALCIFEROL,
274
26526761
US
1
Feeling abnormal, Fatigue, Product use issue, Therapy interrupted, Product use in unapproved indication,
CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES,
275
26526766
US
2
Yellow skin, Depersonalisation/derealisation disorder, Fatigue, Dizziness, Headache, Therapy interrupted, Product use issue, Inability to afford medication,
DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, SERTRALINE, SERTRALINE, MELOXICAM, STANDARDIZED SENNA CONCENTRATE, PSYLLIUM HUSK,
276
26528524
66 2
Product use issue, Malaise,
ELVITEGRAVIR, COBICISTAT, EMTRICITABINE, AND TENOFOVIR ALAFENAMIDE, ALBUTEROL SULFATE, RILONACEPT, COLCHICINE, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, INDOMETHACIN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, RILONACEPT,
277
26528875
60 2
Knee arthroplasty, Vascular operation, Loss of consciousness, Fall, Back injury, Spinal column injury, Therapy interrupted, Product use issue,
BELIMUMAB,
278
26522040
CA
66 1
Cardiac disorder, Product dose omission issue, Off label use, Product use issue,
PATIROMER,
279
26522431
US
37 2
Migraine, Product use issue,
FREMANEZUMAB-VFRM, FREMANEZUMAB-VFRM,
280
26521244
US
2
Exposure during pregnancy, Off label use, Product use issue,
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE,
281
26521519
US
7 2
Lactic acidosis, Product use issue, Insurance issue, Iron deficiency, Vitamin D deficiency, Gastrointestinal microorganism overgrowth, Gastrooesophageal reflux disease, Weight decreased,
TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, TEDUGLUTIDE, FERROUS SULFATE, FERROUS SULFATE, METRONIDAZOLE, METRONIDAZOLE TOPICAL, CYANOCOBALAMIN, CYANOCOBALAMIN, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, CHOLESTYRAMINE, CIPROFLOXACIN HYDROCHLORIDE,
282
26521542
US
2
Lip discolouration, Lip pain, Product use issue, Lip swelling,
TIRZEPATIDE, TIRZEPATIDE,
283
26521708
EU
72
Death, Diffuse large B-cell lymphoma recurrent, B-lymphocyte count decreased, Cell marker decreased, Product use issue,
RITUXIMAB, RITUXIMAB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, LENALIDOMIDE, LONCASTUXIMAB TESIRINE, POLATUZUMAB VEDOTIN, POLATUZUMAB VEDOTIN, PREDNISONE, PREDNISONE, TOCILIZUMAB,
284
26517266
US
1
Urinary tract infection, Drug ineffective, Hypoproteinaemia, Product use issue,
ECULIZUMAB,
285
26517385
58
Blood glucose increased, Product use issue, Device mechanical issue,
INSULIN GLARGINE-YFGN, INSULIN GLARGINE, INSULIN GLARGINE-YFGN, INSULIN GLARGINE,
286
26517416
US
2
Exposure during pregnancy, Off label use, Product use issue,
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE,
287
26517512
55
Glycosylated haemoglobin increased, Device delivery system issue, Device breakage, Device mechanical issue, Product use issue,
288
26517517
52
Blood glucose increased, Product use issue, Device mechanical issue,
289
26517621
US
1
Product use issue,
PIMAVANSERIN TARTRATE,
290
26517691
US
70 2
Infusion site haemorrhage, Infusion site pain, Product adhesion issue, Product use issue,
TREPROSTINIL, TREPROSTINIL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, PREDNISONE, SODIUM CHLORIDE, SODIUM CHLORIDE TABLET, SODIUM CHLORIDE TABLETS, MACITENTAN, ALBUTEROL SULFATE, HYDROXYCHLOROQUINE SULFATE, FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE NASAL, MONTELUKAST SODIUM, MONTELUKAST, OXYGEN, 0XYGEN, CETIRIZINE HCL, CETIRIZINE, FUROSEMIDE, FLUTICASONE PROPIONATE AND SALMETEROL, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,
291
26517809
US
66 1
Inability to afford medication, Insurance issue, Product use issue, Therapy interrupted,
292
26517976
EU
16 2
Intentional overdose, Nausea, Abdominal pain, Suicide attempt, Product use issue,
ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER,
293
26517989
ZA
14 2
Liver injury, Pancreatitis, Type IV hypersensitivity reaction, Product use issue, Product administered to patient of inappropriate age,
294
26518005
EU
14 2
Suicide attempt, Intentional overdose, Product use issue, Nausea, Abdominal pain,
ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER,
295
26518006
EU
Cardiac failure, Multiple fractures, Hip fracture, Rib fracture, Fall, Hyponatraemia, Product use issue,
SELINEXOR, POMALIDOMIDE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG,
296
26518020
US
Insurance issue, Product use issue, Off label use,
297
26518116
GB
Stridor, Periorbital oedema, Product use issue,
SEVOFLURANE, FENTANYL, PROPOFOL, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, TRANEXAMIC ACID, MORPHINE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM,
298
26518122
US
63 2
Product use issue,
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, AMBRISENTAN, FUROSEMIDE, FLUTICASONE FUROATE AND VILANTEROL TRIFENATATE, ALBUTEROL SULFATE, LORAZEPAM, SILDENAFIL CITRATE,
299
26518272
US
2
Abdominal discomfort, Swelling, Product use issue,
SULFAMETHOXAZOLE AND TRIMETHOPRIM,
300
26518302
EU
16 1
Intentional overdose, Abdominal pain, Product use issue, Headache, Suicide attempt,
ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER,

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last_updated

2026-04-28

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