Drug Search by Year (Detail)

25080857

US

Loss of consciousness, Fatigue, Large intestine perforation, Somnolence, Abdominal pain lower, Fall, Abdominal discomfort, Contusion, Scratch,

ADALIMUMAB, ADALIMUMAB, INSULIN ASPART, TAMSULOSIN HYDROCHLORIDE, ALLOPURINOL, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, ORAL SEMAGLUTIDE, INSULIN GLARGINE, DAPAGLIFLOZIN, METOPROLOL TARTRATE, METOPROLOL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL,

25081172

TR

Toxicity to various agents, Somnolence, Hypotension, Anuria,

AMLODIPINE BESYLATE,

25081183

DK

Lymphadenopathy, Fatigue, Feeling cold, Somnolence, Headache, Serum sickness, Product use in unapproved indication,

DUPILUMAB, DUPILUMAB, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, TRAMETINIB, DABRAFENIB,

25076970

IT

Cerebrovascular accident, Abdominal pain, Somnolence, Sleep attacks,

LETROZOLE, LETROZOLE TABLETS,

25077444

CA

Nephrolithiasis, Haematemesis, Burning sensation, Productive cough, Fall, Throat irritation, Vomiting, Nausea, Headache, Pyrexia, Pain, Somnolence, Influenza, Condition aggravated, Fatigue, Off label use, Intentional product use issue,

INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, PREDNISONE,

25077524

PT

Abdominal pain, Altered state of consciousness, Headache, Asthenia, Urinary tract disorder, Myalgia, Syncope, Malaise, Photophobia, Diplopia, Cough, Vision blurred, Decreased appetite, Vomiting, Somnolence, Pyrexia, Blood pressure increased, Presyncope, Generalised oedema, Tinnitus, Haematuria, Abdominal pain upper, Blindness, Haematemesis, Tachycardia, Pruritus, Asthenia, Arthralgia, Fatigue, Amaurosis fugax,

IMATINIB, NILOTINIB, BRINZOLAMIDE, ALISKIREN, ALISKIREN HEMIFUMARATE, LETROZOLE, LETROZOLE TABLETS, LETROZOLE, LETROZOLE TABLETS, FLUVASTATIN, ANASTROZOLE, ANASTROZOLE TABLETS, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, DUTASTERIDE, DUTASTERIDE, TELMISARTAN, DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE, ETANERCEPT, ETANERCEPT, EZETIMIBE, EZETIMIBE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PITAVASTATIN CALCIUM, PITAVASTATIN, PREGABALIN, PREGABALIN, SERTRALINE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, SIMVASTATIN, SIMVASTATIN, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, NITROGLYCERIN, SIMVASTATIN, ZOLEDRONIC ACID, SIMVASTATIN, SIMVASTATIN, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PENTOXIFYLLINE, PENTOXIFYLLINE, POTASSIUM IODIDE, POTASSIUM IODIDE, PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, RIBAVIRIN, RIBAVIRIN, RIBAVIRIN, SOFOSBUVIR, SOFOSBUVIR, TOCILIZUMAB, TOCILIZUMAB, TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE, VORTIOXETINE, VORTIOXETINE, ACETAMINOPHEN, ACETAMINOPHEN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ESCHERICHIA COLI, HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE, IODINE, IODINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, BISOPROLOL FUMARATE, DOCETAXEL, DOCETAXEL ANHYDROUS, DOCETAXEL, DOCETAXEL ANHYDROUS, CELECOXIB,

25078040

US

Exposure via skin contact, Injection site haemorrhage, Somnolence, Fatigue, Wrong technique in device usage process, Accidental exposure to product, Product complaint,

BELIMUMAB, BELIMUMAB,

25078059

US

Headache, Insomnia, Fatigue, Lethargy, Somnolence, Migraine, Multiple sclerosis relapse, Flushing, Nausea,

DIMETHYL FUMARATE, DIMETHYL FUMARATE, GABAPENTIN, PREDNISONE, DULOXETINE HYDROCHLORIDE,

25078209

US

Somnolence, Abdominal discomfort,

VENETOCLAX, FARICIMAB,

25078324

FR

Drug abuse, Somnolence, Suicidal ideation, Toxicity to various agents, Anxiety,

ALPRAZOLAM, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL,

25078451

GB

Swelling face, Somnolence, Coordination abnormal, Mydriasis,

DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, LANSOPRAZOLE,

25078749

US

Somnolence,

OXYBUTYNIN, TOFACITINIB, PANTOPRAZOLE, METOPROLOL TARTRATE, METOPROLOL,

25078754

US

Infantile spasms, Condition aggravated, Appetite disorder, Abdominal discomfort, Intentional dose omission, Somnolence, Vomiting, Diarrhoea, Drug ineffective,

VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN,

25078823

BE

Ataxia, Somnolence, Vertigo, Intentional overdose, Product use issue,

ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

25079411

CA

Abdominal discomfort, Body temperature decreased, Contusion, Cystitis, Drug hypersensitivity, Erythema, Headache, Heart rate increased, Hypotension, Migraine, Poor venous access, Somnolence,

FENTANYL, OCRELIZUMAB, OCRELIZUMAB, DIPHENHYDRAMINE HYDROCHLORIDE, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN,

25079469

US

Labelled drug-drug interaction medication error, Respiratory depression, Somnolence, Balance disorder, Limb discomfort, Paraesthesia, Hepatic pain, Chromaturia, Cough, Decreased appetite, Vomiting,

PALBOCICLIB, METHADONE,

25079515

US

Drug ineffective, Somnolence,

LEMBOREXANT, LEMBOREXANT,

25079530

FR

Somnolence, Wrong patient received product,

CLOZAPINE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), PYRIDOSTIGMINE BROMIDE, PROMETHAZINE HYDROCHLORIDE,

25079695

FR

Somnolence, Substance use disorder, Drug use disorder,

DIAZEPAM, CLONAZEPAM, TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE,

25079715

CA

Neurological symptom, White blood cell disorder, Eye disorder, Hepatomegaly, Heart rate irregular, Peripheral swelling, Muscle contractions involuntary, Feeling cold, Dry skin, Nocturia, Polyuria, Cognitive disorder, Muscular weakness, Pollakiuria, Palpitations, Dyspnoea, Thirst, Gait disturbance, Chest discomfort, Rash, Musculoskeletal stiffness, Heart rate increased, Drug hypersensitivity, Weight increased, Insomnia, Somnolence, Fatigue, Hypertension, Tardive dyskinesia, Headache, Dystonia, Tremor, Nausea, Adverse drug reaction, Pain, White blood cell count decreased,

ARIPIPRAZOLE, ARIPIPRAZOLE, ARIPIPRAZOLE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), VALPROIC ACID, LORAZEPAM, OLANZAPINE, HYDROCHLOROTHIAZIDE,

25079774

PR

Somnolence,

IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, CARFILZOMIB, DARATUMUMAB,

25079860

CA

Loss of personal independence in daily activities, Acute kidney injury, Dementia, Glabellar reflex abnormal, Confusional state, Gait disturbance, Delirium, Cognitive disorder, Memory impairment, Rhabdomyolysis, Somnolence, Overdose,

ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, BUPRENORPHINE, BUPRENORPHINE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, MIRTAZAPINE, MIRTAZAPINE, NALOXONE, NALOXONE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE,

25071605

US

Paralysis, Muscle fatigue, Swelling face, Urticaria, Strabismus, Rash, Acne, Hangover, Vomiting, Somnolence, Fatigue,

CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES,

25071692

CA

Angina pectoris, Somnolence, Dizziness, Headache, Intentional underdose,

RANOLAZINE, EXTENDED-RELEASE, RANOLAZINE, EXTENDED-RELEASE,

25071932

NO

Pharyngeal swelling, Somnolence, Insomnia, Dyspnoea, Myalgia, Nausea, Fatigue, Disturbance in attention, Dizziness, Musculoskeletal stiffness, Swollen tongue, Hypersensitivity,

ATOGEPANT, TIOTROPIUM BROMIDE INHALATION SPRAY, ALBUTEROL SULFATE, ALBUTEROL,

25072443

US

Blood sodium decreased, Somnolence,

DEUTETRABENAZINE,

25073201

NL

Hallucination, visual, Somnolence,

FENTANYL, HYDROXOCOBALAMIN,

25073263

FR

Hepatic failure, Poisoning deliberate, Vomiting, Somnolence, Abdominal pain,

ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

25073427

US

Hallucination, Visual impairment, Headache, Dehydration, Migraine, Night sweats, Weight increased, Delusion, Photosensitivity reaction, Menopausal symptoms, Nausea, Somnolence,

PIMAVANSERIN TARTRATE, NYSTATIN, NYSTATIN OINTMENT, NYSTATIN CREAM, CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPICAL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ERGOCALCIFEROL, FERROUS SULFATE, VITAMIN C, UMECLIDINIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HBR, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, DEXTROMETHORPHAN HBR GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESIN, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, HYDROCHLOROTHIAZIDE, GABAPENTIN, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, LISINOPRIL, PREDNISONE, BENZONATATE, ALPRAZOLAM, ALBUTEROL SULFATE, NICOTINE POLACRILEX, NICOTINE, NICOTINE POLACRILEX MINI, NICOTINE POLARILEX, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, LUMATEPERONE,

25073659

US

Somnolence, Diarrhoea,

ZURANOLONE,

25073913

US

Somnolence,

BACLOFEN,

25073966

CA

Asthenia, Asthma, Bladder pain, Blood pressure fluctuation, Blood pressure increased, Blood thyroid stimulating hormone increased, Bronchitis, Cataract, Concussion, Condition aggravated, Cough, Dizziness, Dyspnoea, Ear discomfort, Eye pruritus, Fall, Fatigue, Feeling hot, Gait disturbance, Gastroenteritis, Head banging, Headache, Hypersensitivity, Hypertension, Inappropriate schedule of product administration, Influenza, Lymphadenitis, Lymphadenopathy, Migraine, Mood altered, Nasal pruritus, Nasopharyngitis, Neck pain, Oral pruritus, Paraesthesia, Pneumonitis, Pruritus, Respiratory disorder, Respiratory syncytial virus infection, Respiratory tract congestion, Retinal tear, Salivary hypersecretion, Sensitivity to weather change, Sinusitis, Sneezing, Somnolence, Stress, Swelling, Swelling face, Throat irritation, Thyroid mass, Wound infection fungal, Wrong technique in product usage process,

OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, CICLESONIDE, DIPHENHYDRAMINE HYDROCHLORIDE, CANDESARTAN, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, TERBINAFINE HYDROCHLORIDE, MONTELUKAST SODIUM, TIOTROPIUM BROMIDE, ALBUTEROL SULFATE, ALBUTEROL SULFATE,

25073977

CA

Arthralgia, Pruritus, Skin burning sensation, Shock, Pustule, Mental disorder, Aphonia, Product dose omission issue, Myalgia, Alopecia, Back pain, Ligament sprain, Injection site pain, Pain, General physical condition abnormal, Influenza, Pain in extremity, Peripheral swelling, Burning sensation, Nausea, Weight increased, Diarrhoea, Somnolence, Urticaria, Blood pressure systolic increased, Fatigue, Bronchitis, COVID-19, Erythema, Feeling abnormal, Gait inability, Ill-defined disorder, Insomnia, Musculoskeletal stiffness, Osteoarthritis, Pyrexia, Skin plaque, Therapy partial responder, Swelling,

LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE AND DIMETHICONE, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, LORAZEPAM, LORAZEPAM, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, SUCRALFATE, SUCRALFATE ORAL SUSPENSION, SUCRALFATE ORAL, TIMOLOL,

25074077

ES

Unresponsive to stimuli, Somnolence, Eye disorder, Head discomfort, Asthenia, Fatigue, Nausea, Nausea, Headache,

EFGARTIGIMOD ALFA,

25074119

HR

Suicide attempt, Somnolence, Somnolence,

OXAZEPAM, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), QUETIAPINE, QUETIAPINE EXTENDED-RELEASE,

25074643

DK

Weight increased, Akathisia, Hyperprolactinaemia, Apathy, Somnolence, Sexual dysfunction, Drug ineffective,

ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, OLANZAPINE, RISPERIDONE,

25075413

US

Fatigue, Oropharyngeal pain, Somnolence, Feeling cold, Diarrhoea, Product dose omission in error,

PALBOCICLIB,

25075568

CO

Oral mucosal blistering, Tongue blistering, Lip blister, Depression, Somnolence, Myopia, Visual impairment, Depressed mood,

RIBOCICLIB, RIBOCICLIB,

25075729

Feeling hot, Somnolence, Infusion related reaction, Chills,

ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, FAMOTIDINE,

25076023

ES

Somnolence, Hallucination, Disorganised speech,

CYCLOPENTOLATE HYDROCHLORIDE,

25076346

US

Hypercapnia, Oxygen saturation decreased, Blood bicarbonate increased, Hypoxia, Somnolence, Off label use,

BUPIVACAINE HYDROCHLORIDE, DEXTROSE MONOHYDRATE, DEXTROSE,

25076442

FR

Poisoning deliberate, Hepatic failure, Vomiting, Somnolence, Abdominal pain,

ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

25078577

Anxiety, Somnolence, Memory impairment, Confusional state,

ZURANOLONE,

25066115

US

Loss of consciousness, Somnolence, Dehydration, Off label use,

VORTIOXETINE,

25066152

CN

Mental disorder, Rash, Somnolence,

CARBOPLATIN, PEMETREXED DISODIUM, PEMETREXED,

25066223

CA

Chest discomfort, Cognitive disorder, Drug hypersensitivity, Dyspnoea, Dystonia, Eye disorder, Feeling cold, Heart rate irregular, Muscle contractions involuntary, Hepatomegaly, Hypertension, Fatigue, Insomnia, Muscular weakness, Musculoskeletal stiffness, Neurological symptom, Nocturia, Peripheral swelling, Pollakiuria, Polyuria, Thirst, White blood cell disorder, Heart rate increased, Gait disturbance, Dry skin, Tardive dyskinesia, Weight increased, Palpitations, Somnolence, Rash, Tremor, Nausea, Headache,

VALPROIC ACID, ARIPIPRAZOLE, ARIPIPRAZOLE, HYDROCHLOROTHIAZIDE, LORAZEPAM, OLANZAPINE,

25066377

FR

Seizure, Somnolence, Drug interaction, Wrong patient,

AMISULPRIDE, RISPERIDONE, CLOBAZAM, PHENOBARBITAL, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LOXAPINE, VALPROATE SODIUM, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, VALPROATE SODIUM,

25066491

US

Somnolence, Feeling cold, Chills, Cough, Fatigue, Headache,

BENZONATATE,

25066523

US

Somnolence,

CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE,

25066734

US

Somnolence, Fatigue,

ASFOTASE ALFA,

25067176

JP

Drop attacks, Epilepsy, Foot fracture, Somnolence, Prescribed underdose, Off label use,

FENFLURAMINE, FENFLURAMINE, LACOSAMIDE, ZONISAMIDE, RUFINAMIDE, CLOBAZAM, VALPROATE SODIUM,

25067190

CN

Vasoplegia syndrome, Acute left ventricular failure, Left ventricular dysfunction, Pulmonary oedema, Acute kidney injury, Shock, Circulatory collapse, Cardiogenic shock, Tachypnoea, Lethargy, Myocardial depression, Lactic acidosis, Hypotension, Sinus tachycardia, Somnolence, Vomiting, Toxicity to various agents, Intentional overdose, Hypocalcaemia,

AMLODIPINE BESYLATE,

25067208

US

Hypersomnia, Somnolence,

PIMAVANSERIN TARTRATE,

25067292

US

Somnolence, Fatigue,

RELUGOLIX, RELUGOLIX,

25067463

US

Dysgeusia, Somnolence, Product taste abnormal, Off label use,

GABAPENTIN, MIRTAZAPINE,

25067482

FR

Somnolence, Product use in unapproved indication,

OXAZEPAM, OXAZEPAM, METHADONE HYDROCHLORIDE, METHADONE,

25067729

FR

Wrong patient received product, Oxygen saturation decreased, Hypotension, Somnolence,

RISPERIDONE, CLOBAZAM,

25067773

ES

Intestinal prolapse, Abnormal faeces, Chromaturia, Constipation, Cyst, Diarrhoea, Erythema, Faeces discoloured, Faeces hard, Hyperhidrosis, Haemorrhoids, Haemorrhoidal haemorrhage, Hot flush, Hepatic cyst, Limb discomfort, Nervousness, Pruritus, Peripheral swelling, Pain in extremity, Weight increased, Somnolence, Sleep disorder, Stress, Tooth fracture, Varicose vein, Anal fissure, Blood urine present, Urinary tract infection,

LETROZOLE, LETROZOLE TABLETS, ABEMACICLIB, ABEMACICLIB, ABEMACICLIB, APIXABAN,

25067888

JP

Glycosylated haemoglobin increased, Hepatic fibrosis, Hepatic steatosis, Viral hepatitis carrier, Somnolence, Depressive symptom, Urine ketone body present, Blood growth hormone decreased, Blood corticotrophin decreased, Cortisol decreased, Blood pressure increased, Insulin C-peptide increased, Blood lactic acid increased,

VALPROATE SODIUM, FAMOTIDINE, LINAGLIPTIN, CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE, SUVOREXANT, ESCITALOPRAM OXALATE, ESCITALOPRAM,

25067932

NL

Erectile dysfunction, Memory impairment, Ejaculation disorder, Libido decreased, Somnolence,

GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION,

25068008

FR

Somnolence, Wrong patient received product,

CLOZAPINE, PYRIDOSTIGMINE BROMIDE, PROMETHAZINE HYDROCHLORIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE),

25068177

US

Off label use, Somnolence,

NIFEDIPINE, SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,,

25068374

CA

Tubulointerstitial nephritis, Palpitations, Parosmia, Adverse drug reaction, Depression, Alcohol poisoning, Somnolence, Swollen tongue, Steroid dependence, Stress, Impaired work ability, Condition aggravated, Vertigo, Burns second degree, Arthritis, Weight decreased, Bronchiectasis, Impaired quality of life, Colitis ulcerative, Frequent bowel movements, Tinnitus, Loss of personal independence in daily activities, Migraine, Hypopnoea, Nightmare, Gingival pain, Deep vein thrombosis, Eczema, Catarrh, Cardiac murmur, Dysgeusia, Rhinitis, Haematochezia, Pulmonary embolism, Abdominal discomfort, Cerebrovascular accident, Confusional state, Headache, Systemic lupus erythematosus, Rectal haemorrhage, Rash, COVID-19, Pyrexia, Pain in extremity, Pain, Fatigue, Accidental overdose, Drug ineffective, Inappropriate schedule of product administration, Product use in unapproved indication, Medication error, Intentional product use issue, Off label use,

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, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, HYDROCORTISONE, HYDROCORTISONE, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, HYDROCORTISONE, ANTIPRURITIC (ANTI-ITCH), ANTI-ITCH CREAM, HYDROCORTISONE 1%, HYDROCORTISONE CONTINUOUS SPRAY, ANTI-PRURITIC, HYDROCORTISONE LOTION, HYDROCORTISONE ACETATE, HYDROCORTISONE LOTION KIT, ANTI ITCH, ANTI-ITCH, COOL RELIEF GEL WITH ALOE, HYDROCORTISONE CREAM 1%, HYDROCORTISONE SPRAY, DRS. HYDROCORTISONE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, DAPAGLIFLOZIN, DAPAGLIFLOZIN, PREDNISONE, PREDNISONE, ROSUVASTATIN, ROSUVASTATIN, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, CANDESARTAN, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, WARFARIN, WARFARIN, WARFARIN, WARFARIN, WARFARIN, WARFARIN, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, ADALIMUMAB, ADALIMUMAB, GABAPENTIN, FUROSEMIDE, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, EPINEPHRINE, ADRENALINUM, EPINEPHRINE, ADRENALINUM, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, LISDEXAMFETAMINE DIMESYLATE, MESALAMINE, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OXYCODONE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, AMLODIPINE BESYLATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, BISOPROLOL FUMARATE, DORZOLAMIDE, EMPAGLIFLOZIN, FESOTERODINE FUMARATE, FOLIC ACID, LATANOPROST, LANSOPRAZOLE, METHOTREXATE, METHOTREXATE SODIUM, NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), PRAVASTATIN SODIUM, RAMIPRIL, RIVAROXABAN, TETRAHYDROZOLINE HYDROCHLORIDE, TOFACITINIB,

25068891

US

Somnolence, Peripheral swelling, Erythema, Pruritus,

DUPILUMAB, DUPILUMAB, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES,

25069019

NL

Erectile dysfunction, Ejaculation disorder, Libido decreased, Somnolence, Memory impairment,

GABAPENTIN, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION,

25069182

US

Influenza like illness, Somnolence, Cough, Rhinorrhoea, Decreased appetite,

DUPILUMAB, DUPILUMAB, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,

25069408

US

Somnolence, Overdose, Hypotension,

ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, TRANEXAMIC ACID, ZOLPIDEM TARTRATE, CLONAZEPAM, AMLODIPINE,

25069515

US

Somnolence, Nausea,

PIMAVANSERIN TARTRATE,

25069628

CN

Depressed level of consciousness, Dizziness, Somnolence, Nausea, Vomiting,

OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE,

25069870

US

Lower limb fracture, Fall, Somnambulism, Somnolence,

CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, DOXEPIN, DOXEPIN HYDROCHLORIDE, CLONAZEPAM,

25069910

US

Dehydration, Somnolence,

LENVATINIB, LENVATINIB, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, FLUTICASONE PROPIONATE, TRIPROLIDINE HCL, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, PANTOPRAZOLE, POLYETHYLENE GLYCOL 3350, DOCUSATE SODIUM,SENNOSIDES, PEMBROLIZUMAB, APIXABAN, POLYETHYLENE GLYCOL,

25069982

PL

Hallucination, Apathy, Lethargy, Asthenia, Somnolence, Weight increased, Treatment noncompliance, Drug ineffective, Off label use,

ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, RISPERIDONE, RISPERIDONE, CARIPRAZINE, CARIPRAZINE,

25070256

Somnolence, Adverse drug reaction,

ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, OLMESARTAN MEDOXOMIL,

25070747

US

Chest pain, Hypotension, Hypertension, Bradycardia, Electrocardiogram QT prolonged, Electrocardiogram abnormal, Tachycardia, Conduction disorder, Depressed level of consciousness, Rhabdomyolysis, Syncope, Intentional product misuse, Electrolyte imbalance, Blood creatinine increased, Dizziness, Vertigo, Visual impairment, Somnolence, Lethargy, Agitation, Dysarthria, Tremor, Headache, Tinnitus, Muscular weakness, Neurological symptom, Vomiting, Nausea, Diarrhoea, Dyspnoea, Cyanosis, Erythema, Flushing, Hyperhidrosis, Drug ineffective, Adverse drug reaction, Therapeutic product effect incomplete, Accidental exposure to product, Accidental exposure to product by child, Medication error,

IVABRADINE,

25070934

HR

Suicide attempt, Somnolence, Intentional overdose,

IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, OLANZAPINE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

25070992

CA

Abdominal pain, Anaemia, Asthma, Benign uterine neoplasm, Blood iron decreased, Blood pressure systolic decreased, Bruxism, COVID-19, Cough, Discomfort, Dizziness, Drug ineffective, Ear pain, Fatigue, Feeling cold, Headache, Heart rate increased, Hypertension, Illness, Incorrect dose administered, Infection, Influenza, Kidney infection, Menstrual disorder, Mucosal discolouration, Nasopharyngitis, Nausea, Oropharyngeal pain, Pain, Pain in jaw, Peripheral swelling, Pneumonia, Productive cough, Pyrexia, Serum ferritin decreased, Sinusitis, Somnolence, Swelling, Temporomandibular pain and dysfunction syndrome, Urinary tract infection,

OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, FLUTICASONE PROPIONATE AND SALMETEROL XINAFOATE, CANDESARTAN, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN, MOMETASONE FUROATE, PREDNISONE, MONTELUKAST SODIUM, ALBUTEROL SULFATE,

25071005

US

Somnolence,

VALBENAZINE, LISDEXAMFETAMINE DIMESYLATE, LURASIDONE HYDROCHLORIDE,

25071141

US

Respiratory arrest, Headache, Fatigue, Pruritus, Anxiety, Hypotension, Dizziness, Cold sweat, Confusional state, Illness, Pain in extremity, Nausea, Skin burning sensation, Drug ineffective, Dyspepsia, Malaise, Abdominal distension, Feeling hot, Dry mouth, Visual impairment, Flushing, Dry skin, Diarrhoea, Neck pain, Hypoaesthesia, Inflammation, Pyrexia, Decreased appetite, Hypoaesthesia oral, Sinus disorder, Dysphagia, Angina pectoris, Head discomfort, Joint range of motion decreased, Somnolence,

UPADACITINIB,

25071225

US

Rectal haemorrhage, Drug dependence, Congenital anomaly, Mental disorder, Defaecation urgency, Nightmare, Panic attack, Loss of personal independence in daily activities, Impaired quality of life, Stress, Confusional state, Vision blurred, Dizziness, Asthenia, Constipation, Somnolence, Hypotension, Anal pruritus, Tremor, Hyperhidrosis, Pain, Mood altered, Insomnia,

OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE, OXYCODONE,

25071508

US

Somnolence, Dizziness, Pruritus,

EMPAGLIFLOZIN,

25071517

BR

Syncope, Dizziness, Hormone level abnormal, Blood cholesterol increased, Illness, Asthenia, Somnolence, Product odour abnormal,

LEVOTHYROXINE SODIUM,

25071541

US

Somnolence,

CETIRIZINE HYDROCHLORIDE,

25061411

US

Somnolence,

OXYBUTYNIN, METOPROLOL TARTRATE, METOPROLOL, PANTOPRAZOLE, TOFACITINIB,

25061467

CA

Chronic spontaneous urticaria, Fatigue, Influenza, Lip swelling, Malaise, Somnolence, Urticaria, Disease recurrence, Inappropriate schedule of product administration, Drug ineffective,

OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, MONTELUKAST, ROSUVASTATIN CALCIUM, MONTELUKAST SODIUM,

25061561

FR

Stridor, Salivary hypersecretion, Somnolence, Bradypnoea, Accidental poisoning,

RISPERIDONE, RISPERIDONE,

25061997

US

Somnolence, Fatigue,

NIROGACESTAT,

25062209

US

Somnolence, Middle insomnia, Fatigue,

TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,

25062380

US

Somnolence,

25062580

US

Somnolence, Perinatal depression,

ZURANOLONE,

25062583

US

Nephrolithiasis, Renal procedural complication, Kidney infection, Critical illness, Kidney infection, Loss of consciousness, Multiple fractures, Immunodeficiency, Hip fracture, Somnolence, Urinary tract infection pseudomonal, Urosepsis, Pneumonia, Accident at work, Allergy to chemicals, Nasopharyngitis, Eye infection, Insomnia, Occupational asthma, Reactive airways dysfunction syndrome, Product dose omission issue, Wrong technique in device usage process, Device malfunction,

BUDESONIDE AND FORMOTEROL FUMARATE DIHYDRATE, ALBUTEROL SULFATE, ALBUTEROL, IPRATROPIUM BROMIDE,

25062960

FR

Stevens-Johnson syndrome, Asthenia, Somnolence, Decreased appetite,

IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, TRAMADOL HYDROCHLORIDE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, SIMVASTATIN, ALLOPURINOL,

25063030

PL

Somnolence, Blood pressure decreased, Suicide attempt, Toxicity to various agents,

IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, AMLODIPINE BESYLATE,

25063042

FR

Drug abuse, Suicidal ideation, Anxiety, Toxicity to various agents, Somnolence,

ALPRAZOLAM, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL,

25063635

US

Mouth swelling, Swollen tongue, Somnolence,

PIMAVANSERIN TARTRATE,

25063793

GB

Somnolence,

CLOPIDOGREL, CLOPIDOGREL BISULFATE,

25063927

DE

Dysarthria, Loss of consciousness, Muscular weakness, Disturbance in attention, Somnolence, Movement disorder, Areflexia, Speech disorder, Paralysis, Confusional state, Stupor, Illusion, Disturbance in attention, Post-traumatic stress disorder, Suicidal ideation,

MORPHINE SULFATE, MORPHINE SULFATE, MORPHINE SULFATE, MORPHINE SULFATE, MORPHINE SULFATE, MORPHINE SULFATE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, IPRATROPIUM BROMIDE, OXYGEN, 0XYGEN, ALBUTEROL SULFATE, ALBUTEROL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION,

25063949

US

Somnolence, Hypotension, Intentional overdose,

TRANEXAMIC ACID, AMLODIPINE, CLONAZEPAM, ZOLPIDEM TARTRATE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

25064041

CA

Balance disorder, Depression, Drug hypersensitivity, Ear swelling, Feeling abnormal, Ill-defined disorder, Injection site pain, Insomnia, Malaise, Panic disorder, Papule, Quality of life decreased, Rash macular, Scab, Scratch, Skin haemorrhage, Skin hypertrophy, Skin plaque, Somnolence, Swelling, Swelling face, Urticaria, Weight decreased, Wrong technique in product usage process, Diarrhoea, Dizziness, Fatigue,

OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, MORPHINE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY,

25064412

HR

Suicide attempt, Stupor, Somnolence, Bradypnoea, Miosis,

OLANZAPINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE,

25064492

CA

Angioedema, Asthenia, Dizziness, Dry mouth, Fatigue, Feeling abnormal, Gait disturbance, Hypersomnia, Illness, Malaise, Nausea, Peripheral swelling, Postoperative wound infection, Pruritus, Sedation, Sepsis, Somnolence, Urticaria, Therapeutic product effect decreased, Drug ineffective,

OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, DOXEPIN, DOXEPIN HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, DOXEPIN, DOXEPIN HYDROCHLORIDE, HYDROXYZINE, DIPHENHYDRAMINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, LORATADINE, LORATADINE TABLET,