Drug:
Reaction: SOMNOLENCE
20250101 - 20251231
No. 301 - 400
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 301 | 25102391 |
CA |
57 | 2 |
Cataract, Large intestine polyp, Crohn^s disease, Muscle spasms, Nausea, Somnolence, Fatigue, |
||||
RISANKIZUMAB-RZAA, PREDNISONE, |
||||
| 302 | 25092449 |
AU |
1 | |
Sepsis, Urinary tract infection, Mobility decreased, Urosepsis, Immunosuppression, Pemphigoid, Condition aggravated, Fatigue, Therapy cessation, Somnolence, Dehydration, Mouth ulceration, Odynophagia, Hypotension, Gout, |
||||
ABIRATERONE ACETATE, ALLOPURINOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, PHENYTOIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, THIAMINE HYDROCHLORIDE, DEGARELIX, METHYLPREDNISOLONE, |
||||
| 303 | 25092716 |
FR |
25 | 1 |
Hypotension, Tachycardia, Vomiting, Wrong patient received product, Somnolence, |
||||
CLOZAPINE, LEVETIRACETAM, OXCARBAZEPINE, |
||||
| 304 | 25092950 |
US |
60 | 1 |
Somnolence, Brain fog, Drug effective for unapproved indication, |
||||
PREGABALIN, PREGABALIN, |
||||
| 305 | 25093420 |
FR |
60 | 1 |
Somnolence, Respiratory acidosis, Drug use disorder, |
||||
DIAZEPAM, OXAZEPAM, |
||||
| 306 | 25093430 |
US |
||
Somnolence, Fatigue, Headache, Depression, Drug ineffective, Product quality issue, |
||||
BUPROPION HYDROCHLORIDE, |
||||
| 307 | 25093558 |
US |
1 | |
Fatigue, Somnolence, |
||||
BUPROPION HYDROCHLORIDE, LISINOPRIL, |
||||
| 308 | 25093681 |
US |
64 | 2 |
Dry eye, Fatigue, Somnolence, Vision blurred, |
||||
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE, CLONAZEPAM, CETIRIZINE HYDROCHLORIDE, |
||||
| 309 | 25093836 |
US |
||
Somnolence, Dizziness, Hot flush, |
||||
RELUGOLIX, RELUGOLIX, ENZALUTAMIDE, |
||||
| 310 | 25094335 |
US |
||
Flatulence, Somnolence, |
||||
RELUGOLIX, RELUGOLIX, AMLODIPINE BESYLATE, BICALUTAMIDE, |
||||
| 311 | 25094867 |
CA |
||
Behaviour disorder, Decreased appetite, Drooling, Dysarthria, Fatigue, Gait disturbance, Hyperammonaemic encephalopathy, Lethargy, Seizure, Sleep disorder, Somnolence, Tremor, Weight decreased, |
||||
STIRIPENTOL, CLOBAZAM, |
||||
| 312 | 25095469 |
DE |
8 | 2 |
Paralysis, Dysarthria, Somnolence, Muscular weakness, Illusion, Suicidal ideation, Post-traumatic stress disorder, Disturbance in attention, Loss of consciousness, Confusional state, Areflexia, Stupor, Speech disorder, Disturbance in attention, Movement disorder, |
||||
MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MORPHINE, OXYGEN, 0XYGEN, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, IPRATROPIUM BROMIDE, ALBUTEROL SULFATE, ALBUTEROL, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, |
||||
| 313 | 25095474 |
CA |
60 | 2 |
Foot operation, Somnolence, |
||||
UPADACITINIB, |
||||
| 314 | 25095605 |
US |
||
Somnolence, Fatigue, |
||||
| 315 | 25095618 |
US |
2 | |
Muscular weakness, Somnolence, Vertigo, Chills, Pain in extremity, Fatigue, Gait disturbance, |
||||
DALFAMPRIDINE, NATALIZUMAB, DALFAMPRIDINE, |
||||
| 316 | 25095987 |
US |
45 | 2 |
Fatigue, Somnolence, |
||||
DILTIAZEM HYDROCHLORIDE, FUROSEMIDE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, ESCITALOPRAM, ACETAMINOPHEN, ASPIRIN, AND CAFFEINE, SPIRONOLACTONE, OXYGEN, 0XYGEN, DIPHENHYDRAMINE HYDROCHLORIDE, MAGNESIUM, |
||||
| 317 | 25095989 |
IT |
46 | 1 |
Fatigue, Lethargy, Somnolence, Negative thoughts, Loss of personal independence in daily activities, |
||||
CABOTEGRAVIR, |
||||
| 318 | 25096110 |
JP |
||
Physical deconditioning, Somnolence, Product dose omission issue, |
||||
ABEMACICLIB, |
||||
| 319 | 25096328 |
JP |
||
Hyperprolactinaemia, Somnolence, Menstruation irregular, |
||||
LURASIDONE HYDROCHLORIDE, LURASIDONE HYDROCHLORIDE, |
||||
| 320 | 25096353 |
US |
2 | |
Somnolence, Fatigue, |
||||
DESVENLAFAXINE SUCCINATE, |
||||
| 321 | 25097187 |
GB |
||
Accident, Somnolence, |
||||
INFLIXIMAB, |
||||
| 322 | 25099669 |
|||
Somnolence, |
||||
| 323 | 25086684 |
FR |
14 | 1 |
Dependence, Drug withdrawal maintenance therapy, Somnolence, |
||||
PREGABALIN, CLONAZEPAM, |
||||
| 324 | 25086775 |
US |
||
Arthralgia, Neck pain, Back pain, Pain in extremity, Eye pruritus, Myalgia, Pain, Urticaria, Somnolence, |
||||
TEZEPELUMAB-EKKO, TEZEPELUMAB-EKKO, |
||||
| 325 | 25086860 |
BR |
||
Inguinal hernia repair, Sciatica, Gait inability, Headache, Fatigue, Pain, Somnolence, Intentional dose omission, |
||||
INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, LEFLUNOMIDE, |
||||
| 326 | 25087105 |
US |
2 | |
Thrombosis, Cataract, Confusional state, Respiratory tract congestion, Weight decreased, Cough, Productive cough, Headache, Back pain, Pain in extremity, Somnolence, Wrong technique in product usage process, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, NIFEDIPINE, RIVAROXABAN, RIVAROXABAN, SILDENAFIL CITRATE, SILDENAFIL, IRON, ZINC, ZINC GLUCONATE, ZINC CHLORIDE, TIZANIDINE HYDROCHLORIDE, ERGOCALCIFEROL, AMBRISENTAN, CLOPIDOGREL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, LOSARTAN POTASSIUM, LOSARTAN, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, SELEXIPAG, |
||||
| 327 | 25087111 |
US |
42 | 2 |
Tumour pain, Crying, Pruritus, Cough, Oropharyngeal pain, Fatigue, Productive cough, Illness, Somnolence, Diarrhoea, Hypophagia, Retching, Nausea, Headache, Feeling abnormal, Pain, Influenza like illness, Insomnia, Restless legs syndrome, Vomiting, Pyrexia, Chills, Migraine, Abdominal pain, Product dose omission issue, |
||||
ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, NIROGACESTAT, NIROGACESTAT, PROCHLORPERAZINE, PROCHLORPERAZINE, |
||||
| 328 | 25087251 |
US |
2 | |
Dyspnoea, Condition aggravated, Brain fog, Quality of life decreased, Loss of personal independence in daily activities, Fatigue, Feeling abnormal, Headache, Somnolence, Therapeutic product effect variable, Product use in unapproved indication, Drug ineffective, |
||||
LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE, |
||||
| 329 | 25087290 |
US |
89 | 1 |
Somnolence, |
||||
LENALIDOMIDE, |
||||
| 330 | 25087342 |
JP |
1 | |
Road traffic accident, Somnolence, |
||||
DARIDOREXANT, |
||||
| 331 | 25087356 |
CA |
||
Acquired epidermolysis bullosa, Condition aggravated, Somnolence, Fatigue, Malaise, Drug ineffective, Off label use, Intentional product use issue, |
||||
RITUXIMAB, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, DIPHENHYDRAMINE, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 332 | 25087638 |
US |
60 | 1 |
Brain fog, Somnolence, |
||||
PREGABALIN, |
||||
| 333 | 25087920 |
US |
41 | 1 |
Vision blurred, Somnolence, Off label use, |
||||
LENALIDOMIDE, |
||||
| 334 | 25088040 |
US |
67 | 2 |
Hospitalisation, Blood pressure decreased, Gait disturbance, Somnolence, Pain in extremity, Fatigue, |
||||
RIPRETINIB, |
||||
| 335 | 25088094 |
MX |
14 | 1 |
Toxicity to various agents, Vomiting, Somnolence, Pallor, Depression, Suicidal ideation, |
||||
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, DICLOFENAC, DICLOFENAC SODIUM, |
||||
| 336 | 25088102 |
IT |
64 | 1 |
SJS-TEN overlap, Irritability, Somnolence, Pyrexia, Conjunctivitis, Tissue rupture, Dysphagia, Eye irritation, Conjunctival hyperaemia, Mouth ulceration, Nasal mucosal disorder, Extravasation blood, Mucocutaneous disorder, Nail dystrophy, Dysuria, |
||||
LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, METHYLPREDNISOLONE, |
||||
| 337 | 25088110 |
US |
2 | |
Dizziness, Somnolence, Fall, |
||||
DUPILUMAB, DUPILUMAB, CALCIUM, CLOTRIMAZOLE, DRS. CLOTRIMAZOLE, FAMILY WELLNESS CLOTRIMAZOLE, CLOTRIMAZOLE TOPICAL, LOSARTAN POTASSIUM, DULOXETINE HYDROCHLORIDE, APIXABAN, LEVOTHYROXINE SODIUM, MAGNESIUM, MIRABEGRON, CLOPIDOGREL, OMEPRAZOLE MAGNESIUM, PANTOPRAZOLE SODIUM, MONTELUKAST SODIUM, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE, ALBUTEROL SULFATE, ALPRAZOLAM, |
||||
| 338 | 25088124 |
TR |
14 | 2 |
Suicide attempt, Toxicity to various agents, Anuria, Hypotension, Somnolence, |
||||
AMLODIPINE BESYLATE, |
||||
| 339 | 25088748 |
RU |
7 | 2 |
Seizure, Vomiting, Somnolence, Decreased appetite, |
||||
OSELTAMIVIR PHOSPHATE, OSELTAMIVIR PHOSPHATE, |
||||
| 340 | 25088818 |
HR |
16 | 2 |
Suicide attempt, Somnolence, Intentional overdose, |
||||
OLANZAPINE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, |
||||
| 341 | 25088917 |
FR |
23 | 2 |
Somnolence, Miosis, Tachycardia, Drug use disorder, Substance use disorder, |
||||
DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), MORPHINE SULFATE, |
||||
| 342 | 25088969 |
US |
||
Somnolence, Therapeutic product effect incomplete, |
||||
RISPERIDONE, |
||||
| 343 | 25089047 |
JP |
2 | |
Epilepsy, Somnolence, Diarrhoea, |
||||
FENFLURAMINE, ZONISAMIDE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, |
||||
| 344 | 25089425 |
US |
17 | 1 |
Somnolence, Prescription drug used without a prescription, Wrong technique in product usage process, |
||||
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE, |
||||
| 345 | 25089470 |
US |
2 | |
Surgery, Disability, Micturition urgency, Abnormal dreams, Disorientation, Feeling jittery, Insomnia, Somnolence, Vision blurred, Unevaluable event, Product administration interrupted, |
||||
CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, TICAGRELOR, LEVOTHYROXINE, NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE, PROGESTERONE, TRETINOIN, |
||||
| 346 | 25089520 |
US |
2 | |
Fatigue, Somnolence, |
||||
PROGESTERONE, |
||||
| 347 | 25090093 |
CN |
92 | 2 |
Disorganised speech, Depressed level of consciousness, Altered state of consciousness, Mental fatigue, Dyspnoea, Dyspnoea, Somnolence, Dysarthria, Dysphoria, Tremor, Confusional state, Muscle spasms, Cerebrovascular disorder, Logorrhoea, Product use in unapproved indication, |
||||
MONTELUKAST SODIUM, MONTELUKAST SODIUM, VORICONAZOLE, VORICONAZOLE, |
||||
| 348 | 25090230 |
US |
25 | 2 |
Somnolence, |
||||
FLUOXETINE HYDROCHLORIDE, FLUOXETINE, |
||||
| 349 | 25090568 |
US |
2 | |
Somnolence, |
||||
VALBENAZINE, |
||||
| 350 | 25090569 |
US |
48 | 2 |
Somnolence, |
||||
VALBENAZINE, VALBENAZINE, |
||||
| 351 | 25090779 |
|||
Somnolence, Lethargy, Brain fog, Bradyphrenia, Asthenopia, |
||||
OLANZAPINE, |
||||
| 352 | 25090953 |
FR |
25 | 1 |
Somnolence, Hypotension, Tachycardia, Vomiting, Wrong patient received product, |
||||
CLOZAPINE, LEVETIRACETAM, OXCARBAZEPINE, |
||||
| 353 | 25091109 |
PT |
||
Decreased appetite, Coma, Pyrexia, Somnolence, Somnolence, Vomiting, Dizziness, Myalgia, Syncope, Malaise, Photophobia, Diplopia, Cough, Vision blurred, |
||||
BISOPROLOL FUMARATE, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, TAMSULOSIN HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, FLUVASTATIN, PREGABALIN, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ESCITALOPRAM OXALATE, ESCITALOPRAM, BISOPROLOL FUMARATE, SERTRALINE HYDROCHLORIDE, ETANERCEPT, ETANERCEPT, ZOLEDRONIC ACID, PRAVASTATIN SODIUM, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, DONEPEZIL HYDROCHLORIDE, EZETIMIBE, EZETIMIBE, SIMVASTATIN, SIMVASTATIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, TELMISARTAN, LETROZOLE, LETROZOLE TABLETS, ANASTROZOLE, ANASTROZOLE TABLETS, NILOTINIB, DUTASTERIDE, HYDROCHLOROTHIAZIDE, BRINZOLAMIDE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, ALENDRONATE SODIUM, PITAVASTATIN CALCIUM, PITAVASTATIN, ALISKIREN, ALISKIREN HEMIFUMARATE, IMATINIB, DOCETAXEL, DOCETAXEL ANHYDROUS, DOCETAXEL, DOCETAXEL ANHYDROUS, CELECOXIB, POTASSIUM IODIDE, BUPRENORPHINE, PENTOXIFYLLINE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, INDOMETHACIN, IBANDRONATE SODIUM, FENOFIBRATE, CODEINE SULFATE, TOCILIZUMAB, ESCHERICHIA COLI, NITROGLYCERIN, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, ESCHERICHIA COLI, VORTIOXETINE, SOFOSBUVIR, EXEMESTANE, FLUOXETINE HYDROCHLORIDE, ENOXAPARIN SODIUM, RIBAVIRIN, RIBAVIRIN, HUMAN IMMUNOGLOBULIN G, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, TRAMADOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE, |
||||
| 354 | 25091144 |
BR |
27 | 2 |
Suicide attempt, Discomfort, Somnolence, Product use issue, Malaise, |
||||
IPRATROPIUM BROMIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, ALPRAZOLAM, AZITHROMYCIN DIHYDRATE, |
||||
| 355 | 25091267 |
US |
1 | |
Somnolence, Hypokalaemia, |
||||
DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE, |
||||
| 356 | 25091389 |
US |
2 | |
Fatigue, Somnolence, |
||||
DUPILUMAB, |
||||
| 357 | 25081773 |
ES |
||
Suicide attempt, Drug ineffective, Depression, Somnolence, Blood pressure increased, Dissociation, Vision blurred, Depersonalisation/derealisation disorder, Erythema, Dysgeusia, Vomiting, Dizziness, Paraesthesia, Treatment noncompliance, |
||||
ESKETAMINE HYDROCHLORIDE, |
||||
| 358 | 25081800 |
ES |
88 | 2 |
Delirium, Somnolence, |
||||
TAPENTADOL HYDROCHLORIDE, |
||||
| 359 | 25082036 |
US |
22 | 2 |
Salpingectomy, Somnolence, Gastroenteritis viral, Influenza, Ear infection, Product dose omission issue, Nausea, |
||||
ESKETAMINE HYDROCHLORIDE, ESKETAMINE HYDROCHLORIDE, ESKETAMINE HYDROCHLORIDE, |
||||
| 360 | 25082185 |
US |
68 | 2 |
Memory impairment, Thirst, Pruritus, Erythema, Somnolence, Fatigue, Asthenia, Decreased appetite, Blood glucose increased, Alopecia, |
||||
BEVACIZUMAB-AWWB, BEVACIZUMAB, PEMBROLIZUMAB, PACLITAXEL, CARBOPLATIN, PALONOSETRON, PALONOSETRON HYDROCHLORIDE, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, FOSAPREPITANT, FOSAPREPITANT DIMEGLUMINE, CETIRIZINE HYDROCHLORIDE, FAMOTIDINE, |
||||
| 361 | 25082320 |
FR |
21 | 1 |
Suicide attempt, Intentional overdose, Somnolence, |
||||
DARIDOREXANT, DARIDOREXANT, DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE, SERTRALINE HYDROCHLORIDE, |
||||
| 362 | 25082402 |
NL |
64 | 1 |
Post-injection delirium sedation syndrome, Hypertension, Sinus tachycardia, Electrocardiogram QT prolonged, Overdose, Toxicity to various agents, Antipsychotic drug level increased, Delirium, Agitation, Disorientation, Hyperhidrosis, Hallucination, Somnolence, Muscle rigidity, Dysarthria, |
||||
OLANZAPINE, OLANZAPINE, |
||||
| 363 | 25082542 |
BR |
33 | 2 |
Syncope, Malaise, Tremor, Lip discolouration, Hunger, Somnolence, Wrong technique in product usage process, Counterfeit product administered, |
||||
SEMAGLUTIDE, |
||||
| 364 | 25082574 |
CO |
87 | 2 |
Road traffic accident, Ankle fracture, Inflammation, Decreased appetite, Somnolence, Speech disorder, Depression, Cardiovascular disorder, Blister, Leg amputation, |
||||
INSULIN DETEMIR, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 365 | 25082642 |
US |
2 | |
Somnolence, |
||||
ZURANOLONE, |
||||
| 366 | 25082812 |
CA |
14 | 1 |
Vomiting, Somnolence, Drooling, Diarrhoea, Bradycardia, Agitation, Mental disorder, Accidental exposure to product by child, Medication error, Nodal rhythm, |
||||
DONEPEZIL HYDROCHLORIDE, |
||||
| 367 | 25082980 |
GB |
2 | |
Somnolence, Nightmare, Nausea, |
||||
VARENICLINE, VARENICLINE TARTRATE, |
||||
| 368 | 25083009 |
GB |
1 | |
Somnolence, |
||||
VARENICLINE, VARENICLINE TARTRATE, |
||||
| 369 | 25083040 |
FR |
||
Malaise, Chills, Hyperhidrosis, Somnolence, Confusional state, Hallucination, Hypotension, Accidental overdose, Wrong strength, |
||||
BACLOFEN, |
||||
| 370 | 25083081 |
FR |
||
Somnolence, Abdominal pain, Hepatic failure, Poisoning deliberate, Vomiting, |
||||
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, |
||||
| 371 | 25083291 |
US |
2 | |
Disturbance in attention, Somnolence, Asthenia, Product availability issue, |
||||
| 372 | 25083527 |
US |
2 | |
Hallucination, visual, Panic reaction, Sleep disorder, Somnolence, Therapeutic product effect incomplete, |
||||
PIMAVANSERIN TARTRATE, CARBIDOPA AND LEVODOPA, |
||||
| 373 | 25083758 |
FR |
23 | 2 |
Miosis, Tachycardia, Somnolence, Drug use disorder, Substance use disorder, |
||||
MORPHINE SULFATE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), |
||||
| 374 | 25083772 |
US |
||
Somnolence, Apathy, Product quality issue, Drug effect less than expected, |
||||
DEXTROAMPHETAMINE SULFATE, |
||||
| 375 | 25083791 |
KR |
2 | |
Depressed level of consciousness, Somnolence, Tremor, |
||||
GABAPENTIN, |
||||
| 376 | 25084228 |
US |
56 | 2 |
Blood glucose increased, Brain fog, Somnolence, Feeling abnormal, Product storage error, Incorrect dose administered, Vision blurred, Fatigue, |
||||
DULAGLUTIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, EMPAGLIFLOZIN, |
||||
| 377 | 25084571 |
FR |
77 | 2 |
Confusional state, Agitation, Hallucination, Somnolence, Aggression, Hypokalaemia, Hypophosphataemia, Persecutory delusion, Haemorrhage, Choking, Pulmonary congestion, Head injury, Fall, Encephalopathy, Clostridium difficile colitis, Off label use, |
||||
CLONAZEPAM, CLONAZEPAM, OLANZAPINE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, OXAZEPAM, OXAZEPAM, METHADONE HYDROCHLORIDE, METHADONE, METHADONE HYDROCHLORIDE, METHADONE, METHYLPREDNISOLONE, MORPHINE SULFATE, APIXABAN, IRBESARTAN, NALOXEGOL OXALATE, LANSOPRAZOLE, AMLODIPINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BEVACIZUMAB, FLUOROURACIL, FLUOROURACIL, OXALIPLATIN, |
||||
| 378 | 25084645 |
US |
65 | 1 |
Lower respiratory tract infection, Renal impairment, Somnolence, Hypometabolism, Constipation, Product supply issue, Therapy interrupted, |
||||
| 379 | 25084770 |
US |
||
Somnolence, |
||||
CARIPRAZINE, |
||||
| 380 | 25084822 |
US |
2 | |
Multiple sclerosis, Vision blurred, Paraesthesia, Weight increased, Limb discomfort, Brain fog, Somnolence, Influenza like illness, Pyrexia, Hot flush, Nausea, Injection site pain, Swelling of eyelid, Epistaxis, Fatigue, Condition aggravated, Feeling cold, Musculoskeletal stiffness, |
||||
OFATUMUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE, |
||||
| 381 | 25084859 |
AU |
||
Somnolence, Slow response to stimuli, Dysarthria, Sensory disturbance, |
||||
BUPRENORPHINE, DULOXETINE HYDROCHLORIDE, |
||||
| 382 | 25084891 |
PT |
||
Tinnitus, Haematuria, Abdominal pain upper, Abdominal pain, Asthenia, Urinary tract disorder, Myalgia, Syncope, Malaise, Photophobia, Diplopia, Cough, Vision blurred, Decreased appetite, Vomiting, Somnolence, Pyrexia, Blood pressure increased, Presyncope, Generalised oedema, Amaurosis fugax, Dyspnoea, Ascites, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, ALISKIREN, ALISKIREN HEMIFUMARATE, ANASTROZOLE, ANASTROZOLE TABLETS, ACETAMINOPHEN, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, BRINZOLAMIDE, BUPRENORPHINE, CELECOXIB, CODEINE SULFATE, DOCETAXEL, DOCETAXEL ANHYDROUS, DOCETAXEL, DOCETAXEL ANHYDROUS, DONEPEZIL HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, DUTASTERIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ETANERCEPT, ETANERCEPT, EZETIMIBE, EZETIMIBE, ENOXAPARIN SODIUM, ESCHERICHIA COLI, ESCHERICHIA COLI, EXEMESTANE, FLUVASTATIN, FENOFIBRATE, FLUOXETINE HYDROCHLORIDE, NITROGLYCERIN, HYDROCHLOROTHIAZIDE, IBANDRONATE SODIUM, IMATINIB, HUMAN IMMUNOGLOBULIN G, INDOMETHACIN, POVIDONE-IODINE, LETROZOLE, LETROZOLE TABLETS, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, NILOTINIB, NITROGLYCERIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PRAVASTATIN SODIUM, PREGABALIN, PENTOXIFYLLINE, PITAVASTATIN CALCIUM, PITAVASTATIN, POTASSIUM IODIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, PROPRANOLOL HYDROCHLORIDE, RIBAVIRIN, RIBAVIRIN, SERTRALINE HYDROCHLORIDE, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, SOFOSBUVIR, TAMSULOSIN HYDROCHLORIDE, TELMISARTAN, TOCILIZUMAB, TRAMADOL HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VORTIOXETINE, ZOLEDRONIC ACID, |
||||
| 383 | 25085042 |
US |
70 | 2 |
Somnolence, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 384 | 25085183 |
US |
15 | 2 |
Somnolence, Hypotension, Intentional overdose, |
||||
TRANEXAMIC ACID, AMLODIPINE, CLONAZEPAM, ZOLPIDEM TARTRATE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, |
||||
| 385 | 25085280 |
CO |
2 | |
Metastases to bone, Skull fracture, Vomiting, Somnolence, Gastritis, Mouth swelling, Abdominal pain upper, Ageusia, Decreased appetite, Product blister packaging issue, Drug hypersensitivity, Drug intolerance, Dyspnoea, Onychoclasis, Pruritus, Nail discolouration, Alopecia, Hypersensitivity, Pleural fibrosis, Fall, Neck injury, |
||||
RIBOCICLIB, RIBOCICLIB, LETROZOLE, LETROZOLE, FULVESTRANT, LETROZOLE, LETROZOLE TABLETS, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, |
||||
| 386 | 25085321 |
US |
73 | 2 |
Confusional state, Somnolence, Product dispensing error, |
||||
SUVOREXANT, |
||||
| 387 | 25085411 |
US |
74 | 1 |
Somnolence, Dizziness, Asthenia, |
||||
LENALIDOMIDE, GABAPENTIN, EMPAGLIFLOZIN, DULOXETINE HYDROCHLORIDE, DULOXETINE, DICLOFENAC, DICLOFENAC SODIUM, SITAGLIPTIN, TELMISARTAN, CARVEDILOL, VIBEGRON, DEXAMETHASONE, DEXAMETHASONE 1.5 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, |
||||
| 388 | 25085485 |
US |
61 | 2 |
Abdominal pain upper, Bile acid malabsorption, Fatigue, Bone pain, Joint swelling, Nausea, Feeding disorder, White blood cell count increased, Somnolence, Arthralgia, Product complaint, |
||||
BELIMUMAB, HYDROXYCHLOROQUINE, NALTREXONE, ESTRADIOL, ESTRADIOL GEL 0.1%, ESTRADIOL TRANSDERMAL, ESTRADIOL,, |
||||
| 389 | 25085713 |
JP |
8 | |
Pneumonia aspiration, Extrapyramidal disorder, Somnolence, Bradycardia, Off label use, |
||||
QUETIAPINE FUMARATE, QUETIAPINE, HALOPERIDOL, HALOPERIDOL LACTATE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 390 | 25085734 |
FR |
||
Urinary incontinence, Aphasia, Somnolence, Gait disturbance, |
||||
| 391 | 25086038 |
US |
28 | 2 |
Suicidal ideation, Visual impairment, Hot flush, Pain, Mania, Dizziness, Somnolence, Anxiety, |
||||
ZURANOLONE, |
||||
| 392 | 25086546 |
PL |
1 | 1 |
Swelling, Rash morbilliform, Rash, Hypersensitivity, Diarrhoea, Decreased appetite, Somnolence, |
||||
| 393 | 25086601 |
73 | 2 | |
Dysphagia, Bradykinesia, Asthenia, Irritability, Confusional state, Agitation, Somnolence, |
||||
| 394 | 25086667 |
PL |
4 | 2 |
Accidental overdose, Extrapyramidal disorder, Somnolence, Decreased appetite, Altered state of consciousness, Extrapyramidal disorder, Cogwheel rigidity, Opisthotonus, Eye movement disorder, Dystonia, Dystonic tremor, Dysphagia, Toxicity to various agents, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, |
||||
| 395 | 25088700 |
21 | 2 | |
Somnolence, Lethargy, Brain fog, |
||||
SERTRALINE, SERTRALINE, |
||||
| 396 | 25089231 |
79 | 1 | |
Diverticulitis, Large intestine infection, Ischaemia, Lethargy, Confusional state, Disorientation, Dysphagia, Somnolence, Osteomyelitis, Adverse drug reaction, Abdominal infection, Drug screen positive, Blood cannabinoids, Vitamin B12 decreased, Gastrointestinal wall thickening, |
||||
CEFEPIME HYDROCHLORIDE, |
||||
| 397 | 25081361 |
US |
1 | |
Deep vein thrombosis, Peripheral nerve operation, Palpitations, Somnolence, |
||||
CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, ATORVASTATIN CALCIUM, PENTOXIFYLLINE, DEXLANSOPRAZOLE, |
||||
| 398 | 25080457 |
PT |
||
Decreased appetite, Coma, Pyrexia, Somnolence, Somnolence, Vomiting, Dizziness, |
||||
ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB-ADAZ, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, ALISKIREN, ALISKIREN HEMIFUMARATE, ANASTROZOLE, ANASTROZOLE TABLETS, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, BRINZOLAMIDE, BUPRENORPHINE, CELECOXIB, CODEINE SULFATE, DOCETAXEL, DOCETAXEL ANHYDROUS, DOCETAXEL, DOCETAXEL ANHYDROUS, DONEPEZIL HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE EXTENDED-RELEASE TABLETS, DUTASTERIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ETANERCEPT, ETANERCEPT, EZETIMIBE, EZETIMIBE, ENOXAPARIN SODIUM, ESCHERICHIA COLI, ESCHERICHIA COLI, EXEMESTANE, FLUVASTATIN, FENOFIBRATE, FLUOXETINE HYDROCHLORIDE, NITROGLYCERIN, HYDROCHLOROTHIAZIDE, IBANDRONATE SODIUM, IMATINIB, HUMAN IMMUNOGLOBULIN G, INDOMETHACIN, LETROZOLE, LETROZOLE TABLETS, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, NILOTINIB, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PRAVASTATIN SODIUM, PREGABALIN, PENTOXIFYLLINE, PITAVASTATIN CALCIUM, PITAVASTATIN, POTASSIUM IODIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, PROPRANOLOL HYDROCHLORIDE, RIBAVIRIN, RIBAVIRIN, SERTRALINE HYDROCHLORIDE, SIMVASTATIN, SIMVASTATIN, SOFOSBUVIR, TAMSULOSIN HYDROCHLORIDE, TELMISARTAN, TOCILIZUMAB, TRAMADOL HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE, VORTIOXETINE, ZOLEDRONIC ACID, |
||||
| 399 | 25080636 |
FR |
26 | 1 |
Somnolence, Wrong patient received product, |
||||
CLOZAPINE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), PROMETHAZINE HYDROCHLORIDE, PYRIDOSTIGMINE BROMIDE, |
||||
| 400 | 25080810 |
US |
52 | 2 |
Illness, Arthritis, Hypotension, Visual impairment, Dizziness, Arrhythmia, Headache, Sinus disorder, Fatigue, Somnolence, Discomfort, Rheumatoid arthritis, Respiratory disorder, Neck pain, Diarrhoea, Dysphagia, Cold sweat, Decreased appetite, Hypoaesthesia oral, Dyspepsia, Skin burning sensation, Pyrexia, Feeling hot, Anxiety, Angina pectoris, |
||||
UPADACITINIB, |
||||
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Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.
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last_updated
2025-04-28