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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: OFF LABEL USE

20260101 - 20261231

No. 101 - 200

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No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
101
26942520
US
Off label use,
ATOGEPANT, ATOGEPANT,
102
26942529
US
 52 2
Optic ischaemic neuropathy, Optic neuritis, Off label use,
ORAL SEMAGLUTIDE,
103
26942535
CA
 70 2
Death, Squamous cell carcinoma of the oral cavity, Off label use, Product ineffective for unapproved use,
ACITRETIN, UPADACITINIB, HYDROXYCHLOROQUINE, SECUKINUMAB, HUMAN IMMUNOGLOBULIN G, CYCLOSPORINE, METHOTREXATE, METHOTREXATE SODIUM, AZATHIOPRINE, SULFASALAZINE,
104
26942537
CA
 75 2
Hepatotoxicity, Off label use, Abdominal discomfort, Rash, Drug ineffective, Drug ineffective,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, UPADACITINIB, DIFLUPREDNATE OPHTHALMIC, DIFLUPREDNATE,
105
26942540
IN
 2
Neutropenia, Off label use,
RIBOCICLIB,
106
26942557
US
 25 2
Meningitis bacterial, Complications of transplanted kidney, Transplant failure, Off label use, Product ineffective for unapproved use,
ECULIZUMAB, CARVEDILOL, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES,
107
26942558
JP
 2 2
Purpura, Infection, Prescribed underdose, Off label use,
WARFARIN,
108
26942561
US
Drug intolerance, Off label use,
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE,
109
26942582
50 1
Kaposi^s sarcoma, Anaemia, Aplasia pure red cell, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, METHYLPREDNISOLONE,
110
26942584
Arteriospasm coronary, Cardiotoxicity, Off label use,
FLUOROURACIL CREAM, 0.5%, FLUOROURACIL, FLUOROURACIL CREAM, 0.5%, FLUOROURACIL,
111
26942585
Cardiotoxicity, Off label use, Arteriospasm coronary,
FLUOROURACIL CREAM, 0.5%, FLUOROURACIL, FLUOROURACIL CREAM, 0.5%, FLUOROURACIL,
112
26942586
30 2
Warm autoimmune haemolytic anaemia, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, ALLOPURINOL, BISOPROLOL FUMARATE,
113
26942587
47 2
Kaposi^s sarcoma, Anaemia, Cytomegalovirus colitis, Off label use,
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION,
114
26942603
56 2
Rectal prolapse, Off label use,
NALTREXONE, NALTREXONE,
115
26942655
US
 60 2
Illness, Off label use,
TIRZEPATIDE,
116
26942663
US
 89 1
Weight loss poor, Off label use, Constipation, Weight decreased,
ORAL SEMAGLUTIDE, ORAL SEMAGLUTIDE,
117
26942673
US
 67
Drug dose omission by device, Wrong technique in product usage process, Device delivery system issue, Off label use,
ALBUTEROL SULFATE,
118
26942678
US
 53
Wrong technique in product usage process, Off label use,
ALBUTEROL SULFATE,
119
26942690
US
 47
Oesophagitis, Headache, Inability to afford medication, Off label use,
120
26942694
CA
 45
Colitis, Arthralgia, Weight decreased, Intentional product use issue, Off label use, Inappropriate schedule of product administration,
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB,
121
26942718
US
 65
Wrong technique in product usage process performed in error, Off label use,
ALBUTEROL SULFATE, ALBUTEROL SULFATE,
122
26942754
US
 75 1
Off label use,
IVERMECTIN,
123
26942775
US
Erythema, Feeling hot, Skin irritation, Off label use, Rosacea,
IVERMECTIN,
124
26942801
US
 1
Off label use, Lice infestation,
IVERMECTIN,
125
26942844
US
 80 2
Blood glucose increased, Drug ineffective, Off label use,
INSULIN GLARGINE,
126
26942902
61 2
Neoplasm progression, Fatigue, Off label use,
ETOPOSIDE, ETOPOSIDE, ATEZOLIZUMAB, ATEZOLIZUMAB, CARBOPLATIN, CARBOPLATIN,
127
26942907
4 2
Deep vein thrombosis, Myelosuppression, Pancreatic enzymes increased, Off label use,
ETOPOSIDE, DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN, METHYLPREDNISOLONE,
128
26942931
IN
 2
Neutropenia, Off label use,
RIBOCICLIB,
129
26942937
EU
 17 2
Oculogyric crisis, Ileus paralytic, Agitation, Antipsychotic drug level increased, Drug interaction, Amenorrhoea, Off label use,
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, RISPERIDONE, CLOZAPINE,
130
26942954
US
 36
Impaired gastric emptying, Off label use, Emotional distress,
ORAL SEMAGLUTIDE,
131
26942977
CN
Off label use, Infection,
RITUXIMAB, BUSULFAN, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
132
26942985
CA
 38
Surgery, Off label use,
OMALIZUMAB,
133
26943034
US
 2
Off label use, Chronic obstructive pulmonary disease, Circumstance or information capable of leading to medication error, Pneumonia, Bronchitis, Hypoacusis,
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE,
134
26943055
CA
 34
Urticaria, Nausea, Injection site reaction, Off label use, Drug ineffective,
OMALIZUMAB, OMALIZUMAB, AZATHIOPRINE, DIPHENHYDRAMINE HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE,
135
26943075
US
 31 2
Serum sickness-like reaction, Overdose, Off label use,
IXEKIZUMAB, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, MONTELUKAST SODIUM,
136
26943104
64 2
Autoimmune disorder, Off label use,
PREDNISONE, PREDNISONE, PREDNISONE, MINOCYCLINE, MINOCYCLINE, TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE OINTMENT USP, 0.05%, DUPILUMAB, DUPILUMAB, IXEKIZUMAB, IXEKIZUMAB,
137
26943154
CA
 32 1
Ileal stenosis, Intestinal stenosis, Condition aggravated, Craniocerebral injury, Nervous system disorder, Rhinorrhoea, Road traffic accident, Weight decreased, Therapeutic response shortened, Off label use,
INFLIXIMAB, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE,
138
26943172
US
 33 2
Arthritis bacterial, Chronic kidney disease, End stage renal disease, Hypogammaglobulinaemia, Therapy partial responder, Off label use,
RITUXIMAB, RITUXIMAB, PREDNISONE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
139
26943228
US
 45 2
Ocular pemphigoid, Diarrhoea, Escherichia sepsis, Acute kidney injury, Rebound effect, Cytomegalovirus oesophagitis, Off label use, Product ineffective for unapproved use,
ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, RITUXIMAB, PREDNISONE, PREDNISONE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, DIFLUPREDNATE OPHTHALMIC, METHOTREXATE, METHOTREXATE SODIUM, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, SULFASALAZINE,
140
26943269
US
Thrombocytopenia, Off label use,
VALPROIC ACID, VALPROIC ACID,
141
26943351
US
Off label use,
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE,
142
26943377
JP
 4 2
Ascites, Renal impairment, Off label use,
TRAMETINIB, TRAMETINIB,
143
26943383
TH
 2
Renal impairment, Off label use,
EVEROLIMUS, EVEROLIMUS, EXEMESTANE,
144
26943387
TW
 64 2
Lung adenocarcinoma stage IV, Malignant neoplasm progression, Diarrhoea, Decreased appetite, Rash, Mucosal inflammation, Swelling of eyelid, Off label use,
TRAMETINIB, TRAMETINIB, TRAMETINIB, TRAMETINIB, GEFITINIB, GEFITINIB,
145
26943394
US
 68 1
Colitis ischaemic, Off label use,
HUMAN IMMUNOGLOBULIN G, PREDNISONE, AMLODIPINE, LISINOPRIL, METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE INJECTION, FAMOTIDINE, PANTOPRAZOLE,
146
26943402
48 1
Surgery, Off label use,
LENALIDOMIDE,
147
26943412
US
 68 1
End stage renal disease, Product ineffective for unapproved use, Off label use,
RITUXIMAB, RITUXIMAB, PREDNISONE, HYDROXYCHLOROQUINE,
148
26943431
US
 10
Off label use,
BOSENTAN,
149
26943445
US
Nightmare, Off label use,
HALOPERIDOL DECANOATE,
150
26943450
US
 2
Agranulocytosis, Weight increased, Off label use, Product prescribing issue,
CLOZAPINE, CLOZAPINE, PREDNISONE, OLANZAPINE, TOPIRAMATE, TOPIRAMATE, LITHIUM, LITHIUM BROMATUM, LITHIUM, LITHIUM BROMATUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROXYZINE, GABAPENTIN,
151
26943463
EU
 82
Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Off label use, Treatment failure,
HUMAN IMMUNOGLOBULIN G,
152
26943471
EU
 82
Chronic inflammatory demyelinating polyradiculoneuropathy, Condition aggravated, Off label use, Treatment failure,
HUMAN IMMUNOGLOBULIN G,
153
26943496
51 1
Disease progression, Off label use,
FAM-TRASTUZUMAB DERUXTECAN-NXKI, FAM-TRASTUZUMAB DERUXTECAN-NXKI,
154
26943515
BR
 54 2
Pathogen resistance, Off label use,
FLUCONAZOLE, FLUCONAZOLE, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, KETOCONAZOLE, KETOCONAZOLE FOAM, KETOCONAZOLE CREAM, 2%, ITRACONAZOLE, ITRACONAZOLE, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, BORIC ACID, BORIC ACID, VORICONAZOLE, VORICONAZOLE INJECTION, VORICONAZOLE, VORICONAZOLE INJECTION,
155
26943539
AU
 68 1
Hypotension, Feeling hot, Hyperhidrosis, Dry throat, Facial discomfort, Adverse drug reaction, Headache, Dysphagia, Hypoaesthesia, Fatigue, Throat tightness, Flushing, Head discomfort, Eyelid ptosis, Dizziness, Hyperhidrosis, Dyspnoea, Off label use,
HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, HUMAN IMMUNOGLOBULIN G, NASAL, SODIUM CHLORIDE, SALINE, SALINE NASAL SPRAY, (SALINE),
156
26943562
US
 53 2
Colitis ulcerative, Off label use,
RITUXIMAB, ADALIMUMAB, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB-FKJP, PREDNISONE,
157
26943605
US
 26 1
Off label use,
DUPILUMAB,
158
26943640
US
 1
Influenza like illness, Off label use,
DUPILUMAB,
159
26943669
IN
 77 2
Off label use, Macular oedema,
FARICIMAB,
160
26943688
ZA
 77 2
Off label use, Retinal thickening,
FARICIMAB,
161
26943716
US
 1
End stage renal disease, Injection site discomfort, Product preparation issue, Product storage issue, Off label use, Product dose omission issue,
SIBEPRENLIMAB, SIBEPRENLIMAB,
162
26943740
ZA
 2
Retinal thickening, Off label use, Optical coherence tomography abnormal, Visual impairment,
FARICIMAB, FARICIMAB,
163
26943860
US
 65 2
Nausea, Wrong technique in product usage process, Headache, Off label use,
164
26943862
US
 1
Urinary tract infection, Dementia with Lewy bodies, Off label use,
PIMAVANSERIN TARTRATE, EZETIMIBE, FESOTERODINE FUMARATE, ROSUVASTATIN, DONEPEZIL HYDROCHLORIDE,
165
26943863
US
 2
Off label use, Fatigue,
PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE, PALIPERIDONE PALMITATE,
166
26943864
CH
 56 1
Polyneuropathy, Off label use,
DURVALUMAB, DOCETAXEL, DOCETAXEL ANHYDROUS, FLUOROURACIL CREAM, 0.5%, FLUOROURACIL, OXALIPLATIN,
167
26943883
CA
 17 1
Cardiac arrest, Meningococcal sepsis, Multiple organ dysfunction syndrome, Purpura, Respiratory failure, Septic shock, Off label use,
RITUXIMAB, AMOXICILLIN, ECULIZUMAB, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PREDNISONE,
168
26943898
CA
 52 2
Pyrexia, Oral infection, Peripheral swelling, Pain, Rash macular, Optic neuritis, Inappropriate schedule of product administration, Off label use,
RITUXIMAB, RITUXIMAB, RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, METHYLPREDNISOLONE, PREDNISONE, PREDNISONE,
169
26943919
CA
 38 2
Discomfort, Ear pruritus, Pharyngitis streptococcal, Throat irritation, Inappropriate schedule of product administration, Off label use,
RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, METHYLPREDNISOLONE,
170
26943932
CA
 56 2
Dysphonia, Sensation of foreign body, Throat irritation, Incorrect drug administration rate, Off label use,
RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE,
171
26943938
CA
 28 2
Ear pruritus, Throat irritation, Off label use,
RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, METHYLPREDNISOLONE,
172
26943952
US
Off label use,
APIXABAN, CARBAMAZEPINE, PHENYTOIN,
173
26943975
US
 2
Productive cough, Off label use, Therapy interrupted,
BRENSOCATIB,
174
26943993
US
 1
Product use issue, Off label use,
CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, CABOTEGRAVIR AND RILPIVIRINE, LENACAPAVIR SODIUM,
175
26944078
US
 85 2
Rash erythematous, Off label use,
SUZETRIGINE, SUZETRIGINE,
176
26944084
US
 2
Off label use,
SUZETRIGINE, 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,
177
26944177
US
 4 2
Off label use,
DUPILUMAB,
178
26944191
US
 67 2
Off label use,
DUPILUMAB,
179
26944248
2
Disease progression, Off label use,
DATOPOTAMAB DERUXTECAN,
180
26944277
CA
 19 2
Gastrointestinal haemorrhage, Off label use, Crohn^s disease,
RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA, RISANKIZUMAB-RZAA,
181
26944338
US
Insomnia, Feeding disorder, Abdominal pain upper, Off label use,
182
26944393
US
 2
Infection, Dermatitis atopic, Off label use,
OMALIZUMAB, OMALIZUMAB,
183
26944403
EU
 94 2
Thyroid cancer, Malignant neoplasm progression, Dysphagia, Off label use,
TRAMETINIB, DABRAFENIB,
184
26944447
US
 24 2
Lupus nephritis, Drug effective for unapproved indication, Off label use,
RITUXIMAB, RITUXIMAB, HYDROXYCHLOROQUINE, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION, PREDNISONE,
185
26944453
Carditis, Gingival abscess, Cellulitis, Tooth infection, Off label use, Tooth erosion,
BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE,
186
26944459
US
Off label use,
IBRUTINIB,
187
26944467
US
 2
Weight increased, Off label use, Swelling,
188
26944496
US
 59 1
Off label use, Injection site rash, Injection site erythema, Injection site pruritus,
TIRZEPATIDE, FINASTERIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, CALCIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ATORVASTATIN CALCIUM, OXYBUTYNIN, LORATADINE, LORATADINE TABLET,
189
26944515
US
 35 1
Death, Weight decreased, Decreased appetite, Coordination abnormal, Fall, Off label use,
CANNABIDIOL, CANNABIDIOL,
190
26944528
KR
 58 2
Leukopenia, Off label use,
PEMBROLIZUMAB, BEVACIZUMAB, PACLITAXEL, PACLITAXEL (AIBUMIN-BOUND),
191
26944600
US
 49
Off label use,
INSULIN GLARGINE,
192
26944602
US
 67
Off label use,
INSULIN GLARGINE,
193
26944607
ZA
 78 1
Off label use, Retinal thickening,
FARICIMAB, FARICIMAB, FARICIMAB, FARICIMAB, FARICIMAB, FARICIMAB, FARICIMAB,
194
26944646
US
 24 2
Seizure, Off label use, Urinary tract infection, Pain,
FENFLURAMINE, FENFLURAMINE, FENFLURAMINE, FENFLURAMINE,
195
26944695
US
 2
Off label use,
BOSENTAN,
196
26944786
CN
White blood cell count decreased, Platelet count decreased, Off label use,
SELINEXOR, BORTEZOMIB, DEXAMETHASONE, DEXAMETHASONE 1.5 MG,
197
26944815
US
 65
Off label use,
RUXOLITINIB, SIROLIMUS, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TACROLIMUS,
198
26944816
EU
 47 2
Hypogammaglobulinaemia, Off label use,
DEXAMETHASONE, DEXAMETHASONE 1.5 MG, RITUXIMAB, CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
199
26944828
EU
 68 2
Eyelid irritation, Influenza like illness, Paraesthesia, Abdominal pain upper, Drug ineffective, Overdose, Off label use,
VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, LEVETIRACETAM, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, SUMATRIPTAN, SUMATRIPTAN SUCCINATE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, PREGABALIN, GABAPENTIN, PROPRANOLOL HYDROCHLORIDE, TOPIRAMATE, ZONISAMIDE,
200
26944837
US
 2
Product preparation issue, Off label use, Drug ineffective,
STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, STIRIPENTOL, CLOBAZAM, CLONAZEPAM, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), LEVETIRACETAM, CANNABIDIOL, ZONISAMIDE,

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last_updated

2026-07-30

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