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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: SOMNOLENCE

20250101 - 20251231

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
25112426
US
38 1
Seizure, Aggression, Somnolence, Fatigue, Hunger, Feeling abnormal, Constipation, Head injury, Wrong technique in product usage process, Incorrect dose administered, Product use issue,
BRIVARACETAM, BRIVARACETAM, TAURINE,
202
25112569
US
2
Underdose, Tremor, Eye movement disorder, Dysarthria, Pain in extremity, Paraesthesia, Hypoaesthesia, Urinary incontinence, Constipation, Liver disorder, Reading disorder, Aphasia, Disturbance in attention, Balance disorder, Gait disturbance, Depressed mood, Hypersomnia, Initial insomnia, Slow speech, Restlessness, Somnolence, Illness,
DIROXIMEL FUMARATE, AMANTADINE, ATENOLOL, CYCLOBENZAPRINE, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL, MECLIZINE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL,
203
25113390
PT
Haemorrhagic stroke, Sepsis, Cardio-respiratory arrest, Altered state of consciousness, Headache, Diplopia, Pruritus, Sepsis, Haemorrhagic stroke, Fall, Diarrhoea, Blindness, Tachycardia, Fatigue, Pruritus, Asthenia, Urinary tract disorder, Haematemesis, Arthralgia, Myalgia, Syncope, Malaise, Photophobia, Cough, Vision blurred, Decreased appetite, Vomiting, Coma, Somnolence, Dizziness, Pyrexia, Somnolence, Blood pressure increased, Ocular discomfort, Head discomfort, Chills, Presyncope, Insomnia, Generalised oedema, Tinnitus, Amaurosis fugax, Dyspnoea, Ascites, Haematuria, Abdominal pain upper, Abdominal pain, Nausea, Drug interaction, Diplopia, Eye pain, Off label use,
MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, EZETIMIBE, EZETIMIBE, EZETIMIBE, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, ALENDRONATE SODIUM, ALENDRONATE SODIUM,
204
25113846
JP
6 2
Electrocardiogram QT prolonged, Somnolence, Off label use,
OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, OLANZAPINE, MIRTAZAPINE, MIRTAZAPINE, MIRTAZAPINE, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM,
205
25113918
US
2
Somnolence, Accidental exposure to product,
206
25114842
FR
44 2
Poisoning deliberate, Disorientation, Prothrombin time ratio decreased, Somnolence, Intentional overdose, Off label use,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, MORPHINE SULFATE,
207
25115059
US
1
Somnolence, Off label use,
XANOMELINE AND TROSPIUM CHLORIDE, XANOMELINE AND TROSPIUM CHLORIDE,
208
25115084
Cerebrovascular accident, Blood creatinine increased, Fatigue, Somnolence, Diarrhoea, Nightmare, Depression,
LISINOPRIL, BUPROPION HYDROCHLORIDE, BUPROPION,
209
25109373
US
Somnolence,
210
25107629
GR
73 2
Hypophagia, Mobility decreased, Mental disorder, Weight decreased, Fluid intake reduced, Somnolence,
RIFAXIMIN, SACCHAROMYCES CEREVISIAE,
211
25108268
US
26 1
Hospitalisation, Somnolence, Constipation,
CLOZAPINE, VENLAFAXINE HYDROCHLORIDE, LINACLOTIDE,
212
25108274
US
20 1
Somnolence, Intentional overdose,
TRANEXAMIC ACID, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), CLORAZEPATE DIPOTASSIUM,
213
25108519
FR
40 1
Substance use disorder, Drug use disorder, Malaise, Chest pain, Somnolence, Mydriasis, Hyperhidrosis,
PREGABALIN,
214
25108528
BE
18 1
Somnolence, Intentional overdose, Product use issue,
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, DICLOFENAC, DICLOFENAC SODIUM,
215
25108545
FR
33 1
Somnolence, Substance use disorder, Drug use disorder,
DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), CLONAZEPAM,
216
25108565
ES
36 1
Bradyphrenia, Somnolence, Toxicity to various agents, Atrial fibrillation,
CLORAZEPATE DIPOTASSIUM, FLUMAZENIL, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), ZOLPIDEM TARTRATE,
217
25108591
FR
Sinus bradycardia, Disorientation, Somnolence, Product prescribing error, Incorrect dose administered, Prescribed overdose,
OLANZAPINE,
218
25108592
FR
Loss of consciousness, Muscle spasms, Malaise, Somnolence, Toxicity to various agents, Drug abuse,
PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, CANNABIDIOL,
219
25108610
US
Somnolence,
CETIRIZINE HYDROCHLORIDE,
220
25108802
PL
17 2
Dysarthria, Suicide attempt, Psychomotor retardation, Somnolence, Product administered to patient of inappropriate age, Intentional overdose,
CITALOPRAM, CITALOPRAM HYDROBROMIDE, OLANZAPINE,
221
25108885
GR
67 1
Speech disorder, Urinary incontinence, Hyperkinesia, Somnolence, Asthenia,
222
25108910
US
21 2
Hypoaldosteronism, Hyperkalaemia, Somnolence, Electrocardiogram T wave peaked, Exposure during pregnancy, Respiratory rate decreased, Hypermagnesaemia,
MAGNESIUM SULFATE, MAGNESIUM SULFATE HEPTAHYDRATE, MAGNESIUM SULFATE IN WATER FOR,
223
25113454
73 2
Gait disturbance, Somnolence,
GABAPENTIN, CARBIDOPA AND LEVODOPA, AMANTADINE, RASAGILINE, RASAGILINE MESYLATE, FAMOTIDINE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, BLACK COHOSH, BRYONIA ALBA WHOLE, TOXICODENDRON PUBESCENS WHOLE, ARNICA MONTANA, CAUSTICUM, FERROSOFERRIC PHOSPHATE, SODIUM SULFATE ANHYDROUS, STRYCHNOS NUX-VOMICA SEED, RHODODENDRON AUREUM WHOLE, CITRULLUS COLOCYNTHIS WHOLE, SOLANUM DULCAMARA WHOLE, KALMIA LATIFOLIA WHOLE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, ARSENIC TRIOXIDE, AND TRIBASIC CALCIUM PHOSPHATE, BERBERIS VULGARIS ROOT BARK, BRYONIA ALBA ROOT, PHENOL, MILK THISTLE, CHELIDONIUM MAJUS, JUNIPER BERRY, LYCOPODIUM CLAVATUM SPORE, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE, SODIUM SULFATE, STRYCHNOS NUX-VOMICA SEED, PHOSPHORUS, LACTIC ACID, L-, TARAXACUM OFFICINALE, VISCUM ALBUM FRUITING TOP, AND YUCCA FILAMENTOSA, ARTEMISIA CINA PRE-FLOWERING TOP, TANACETUM VULGARE WHOLE, ARTEMISIA VULGARIS WHOLE, DRYOPTERIS FILIX-MAS ROOT, MERCURIC CHLORIDE, AND GRAPHITE, AMBROSIA ARTEMISIAEFOLIA, ARALIA RACEMOSA, ARNICA MONTANA, CALENDULA OFFICINALIS, CHROMICUM ACIDUM, ECHINACEA PURPUREA, EUCALYPTOL, KALI BICHROMICUM, KALI MURIATICUM, KALI SULPHURICUM, LAC VACCINUM, MERCURIUS IODATUS FLAVUS, MERCURIUS SULPHURATUS RUBER, NATRUM ARSENICICUM, ROSA DAMASCENA, SABADILLA, SANGUINARINUM NITRICUM, SYMPHYTUM OFFICINALE, NAJA NAJA WHOLE, SCROPHULARIA NODOSA, LACTIC ACID, DL-, AND RADIUM BROMIDE, APIS MELLIFERA, ASPARAGUS, BERBERIS VULGARIS ROOT BARK, LYTTA VESICATORIA, CHELIDONIUM MAJUS, JUNIPER BERRY, MAGNESIUM CHLORIDE, SODIUM CHLORIDE, POPULUS TREMULOIDES BARK, RHUS AROMATICA ROOT BARK, RUBIA TINCTORUM ROOT, SAW PALMETTO, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, AND ARCTOSTAPHYLOS UVA-URSI LEAF, AVENA SATIVA WHOLE, VALERIANA OFFICINALIS WHOLE, HUMULUS LUPULUS WHOLE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII WHOLE, ZINC VALERATE DIHYDRATE, AMMONIUM BROMIDE, CHAMOMILE, ESCHSCHOLZIA CALIFORNICA, AND PASSIFLORA INCARNATA WHOLE, APIS MELLIFICA, ARGENTUM NITRICUM, BADIAGA, BELLADONNA, CANTHARIS, CAUSTICUM, CHIMAPHILA UMBELLATA, COLOCYNTHIS, CUBEBA OFFICINALIS, CUCURBITA CITRULLUS, CUCURBITA PEPO FLOWER, ECHINACEA ANGUSTIFOLIA, EQUISETUM HYEMALE, ERYNGIUM AQUATICUM, FERRUM PHOSPHORICUM, MITCHELLA REPENS, OLEUM SANTALI, PETROSELINUM SATIVUM, PIPER METHYSTICUM, POPULUS TREMULOIDES BARK, SARSAPARILLA, TEREBINTHINA, UVA URSI, ACHILLEA MILLEFOLIUM, ARNICA MONTANA, HYPERICUM PERFORATUM, HORSE CHESTNUT, AND VISCUM ALBUM WHOLE, ACONITUM NAPELLUS, AMERICAN GINSENG, ARSENICUM IODATUM, BLATTA ORIENTALIS, CALCAREA SULPHURICA, CARPINUS BETULUS FLOWER, CUPRUM METALLICUM, GRINDELIA, HEPAR SULPHURIS CALCAREUM, IPECACUANHA, JUSTICIA ADHATODA, KALI IODATUM, LOBELIA INFLATA, NAPHTHALINUM, NARCISSUS PSEUDONARCISSUS, PINE TAR, POPULUS CANDICANS, TABACUM, THUJA OCCIDENTALIS, THYMUS SERPYLLUM, PASSIFLORA INCARNATA WHOLE, SMILAX ORNATA WHOLE, PHYTOLACCA AMERICANA ROOT, STILLINGIA SYLVATICA ROOT, TRIFOLIUM PRATENSE WHOLE, ARCTIUM LAPPA WHOLE, PRUNUS DULCIS WHOLE, FRANGULA PURSHIANA BARK, BERBERIS VULGARIS WHOLE, GLYCYRRHIZA GLABRA WHOLE, AND LARREA DIVARICATA WHOLE, ALOE, ACTIVATED CHARCOAL, COLCHICUM AUTUMNALE BULB, COLLINSONIA CANADENSIS ROOT, CUCURBITA PEPO FLOWER, DRYOPTERIS FILIX-MAS ROOT, INDOLE, SKIM MILK, LYCOPODIUM CLAVATUM SPORE, ACHILLEA MILLEFOLIUM, SODIUM SULFATE, FRANGULA PURSHIANA BARK, SCROPHULARIA NODOSA, SKATOLE, TARAXACUM OFFICINALE, TARTARIC ACID, ARANEUS DIADEMATUS, ARISAEMA TRIPHYLLUM ROOT, ASTERIAS RUBENS, BAPTISIA TINCTORIA, BARIUM IODIDE, ECHINACEA ANGUSTIFOLIA, FERROUS IODIDE, GOLDENSEAL, LACHESIS MUTA VENOM, PHYTOLACCA AMERICANA ROOT, PINUS SYLVESTRIS FLOWERING TOP, SCROPHULARIA NODOSA, SPONGIA OFFICINALIS SKELETON, ROASTED, AND TEUCRIUM SCORODONIA FLOWERING TOP, ALFALFA, ALLIUM SATIVUM, ASPARAGUS OFFICINALIS, AVENA SATIVA, BELLADONNA, BERBERIS VULGARIS, CHELIDONIUM MAJUS, GLYCYRRHIZA GLABRA, HYDRASTIS CANADENSIS, JUNIPERUS VIRGINIANA, NICCOLUM METALLICUM, PASSIFLORA INCARNATA, SARCOLACTICUM ACIDUM, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, ALNUS GLUTINOSA, APIS MELLIFICA, BERBERIS VULGARIS, CALCIUM SULFIDE, CROTON TIGLIUM, ECHINACEA ANGUSTIFOLIA, GRAPHITE, GRINDELIA HIRSUTULA, HYDROFLUORIC ACID, JUGLANS REGIA, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, MYRISTICA SEBIFERA, NITRICUM ACIDUM, PHOSPHORUS, RHUS TOXICODENDRON, SCROPHULARIA NODOSA, SOLIDAGO VIRGAUREA, SULPHUR, VINCA MINOR, FISH OIL,
224
25102624
PL
34 1
Somnolence, Balance disorder, Suicide attempt, Toxicity to various agents,
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE,
225
25102701
PL
50 2
Suicide attempt, Toxicity to various agents, Nausea, Somnolence,
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE,
226
25102952
US
65 2
Somnolence, Off label use,
GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, AMLODIPINE BESYLATE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
227
25103173
US
20 2
Loss of consciousness, Blood potassium decreased, Blood calcium increased, Vertigo, Feeling abnormal, Insomnia, Hypophagia, Sleep deficit, Initial insomnia, Poor quality sleep, Muscle spasms, Somnolence, Weight decreased, Fatigue, Dizziness, Nausea, Vomiting,
SEMAGLUTIDE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, LITHIUM, LITHIUM BROMATUM, QUETIAPINE, CLONAZEPAM, PROPRANOLOL HYDROCHLORIDE, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, MODAFINIL, PITOLISANT HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE, LEVONORGESTREL,
228
25103238
US
86 2
Somnolence, Malaise, Fatigue, Sinus headache, Off label use,
FLUTICASONE PROPIONATE, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, EZETIMIBE,
229
25103365
US
1
Somnolence, Brain fog, Product dose omission in error, Memory impairment,
OMAVELOXOLONE,
230
25103413
US
1
Fatigue, Somnolence,
AFLIBERCEPT, LATANOPROST,
231
25103776
US
Somnolence, Therapeutic product effect incomplete,
232
25103795
US
42 2
Somnolence, Intentional dose omission, Product after taste,
TRAZODONE HYDROCHLORIDE, CLONAZEPAM, ALPRAZOLAM, ZOLPIDEM TARTRATE, ALPRAZOLAM,
233
25103875
US
25 2
Unresponsive to stimuli, Apnoea, Sinus tachycardia, Hypotension, Mental status changes, Coma, Areflexia, Respiratory acidosis, Seizure, Respiratory depression, Toxicity to various agents, Intentional overdose, Somnolence,
BUPROPION HYDROCHLORIDE, BUPROPION, BUPROPION HYDROCHLORIDE, BUPROPION, FLUOXETINE HYDROCHLORIDE, FLUOXETINE, SERTRALINE,
234
25104084
PL
2 1
Pharyngitis, Pyrexia, Crying, Papule, Somnolence, Catarrh,
235
25104157
AU
Delirium, Somnolence, Tachycardia,
QUETIAPINE FUMARATE, QUETIAPINE, ESCITALOPRAM OXALATE, ESCITALOPRAM, VALPROATE SODIUM,
236
25104275
US
59 2
Somnolence,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE,
237
25104646
CA
Abdominal pain, Tremor, Somnolence, Poor venous access, Photophobia, Phonophobia, Pain in extremity, Cerebral thrombosis, Headache, Decreased appetite,
PEGASPARGASE,
238
25104723
US
2
Somnolence, Feeling abnormal,
VEDOLIZUMAB,
239
25104726
CH
34 1
Seizure like phenomena, Headache, Nightmare, Head discomfort, Feeling cold, Tremor, Feeling abnormal, Wrong technique in product usage process, Somnolence,
DARIDOREXANT, DARIDOREXANT, DARIDOREXANT, DARIDOREXANT, DARIDOREXANT, DARIDOREXANT,
240
25104732
ES
57 1
Mental impairment, Malaise, Somnolence, Concomitant disease aggravated, Fatigue, Poor quality sleep, Chest discomfort, Narcolepsy, Loss of personal independence in daily activities, Disturbance in attention,
DARIDOREXANT, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG,
241
25104788
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,
242
25104930
PR
12 1
Skin implant, Headache, Arthritis, Somnolence,
UPADACITINIB, FOLIC ACID, FLUTICASONE PROPIONATE, ERGOCALCIFEROL, METHOTREXATE SODIUM, IBUPROFEN SODIUM, IBUPROFEN, IBUPROFEN TABLETS, COATED, IBUPROFEN TABLET COATED,
243
25105324
US
53 2
Pilonidal disease, Fatigue, Cataract, Somnolence, Malaise, Pain, Blood glucose increased, Decreased appetite, Dizziness, Blood glucose decreased,
TIRZEPATIDE, INSULIN LISPRO-AABC, MIFEPRISTONE, MIFEPRISTONE, MIFEPRISTONE, MIFEPRISTONE, CHLORTHALIDONE, DAPAGLIFLOZIN, INDOMETHACIN, METOPROLOL TARTRATE, METOPROLOL, INSULIN DEGLUDEC, LORAZEPAM, EZETIMIBE, ALPRAZOLAM,
244
25105340
FR
25 1
Somnolence, Tachycardia, Vomiting, Hypotension, Wrong patient received product,
CLOZAPINE, LEVETIRACETAM, OXCARBAZEPINE,
245
25105747
US
2
Somnolence, Withdrawal syndrome,
BUPRENORPHINE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, FLUOXETINE HYDROCHLORIDE, ADALIMUMAB,
246
25105860
US
46 1
Vision blurred, Diplopia, Skin exfoliation, Diarrhoea, Hyperaesthesia teeth, Blood pressure increased, Burning sensation, Somnolence, Tinnitus,
LENVATINIB,
247
25105928
US
73 2
Dehydration, Somnolence, Dizziness, Blood glucose increased, Blood glucose decreased,
INSULIN LISPRO, INSULIN GLARGINE,
248
25106006
US
Somnolence,
249
25106038
US
4 1
Crying, Off label use, Somnolence, Decreased appetite,
VIGABATRIN, LEVETIRACETAM, TOPIRAMATE, TOPIRAMATE SPINKLE, CLOBAZAM, DIVALPROEX SODIUM, FAMOTIDINE,
250
25106087
IN
64 1
Death, Flatulence, Hyperchlorhydria, Dyspnoea exertional, Tremor, Hunger, Dizziness, Back pain, Diarrhoea, Gait disturbance, Paraesthesia, Asthenia, Coordination abnormal, Balance disorder, Hypersomnia, Dysuria, Somnolence, Waist circumference increased, Gait inability, Decreased activity, Abdominal distension, Blood glucose increased, Low density lipoprotein increased, Albumin globulin ratio increased, Serum ferritin decreased, Globulins increased, Musculoskeletal stiffness, Full blood count decreased, Joint range of motion decreased, Muscle tightness, Nasopharyngitis, Respiratory rate increased, Productive cough, Negative thoughts, Pyrexia, Cough, Swelling, Blood cholesterol increased, Blood triglycerides increased, Fatigue, Peripheral swelling, Weight increased, Irritability, Respiratory disorder, Anxiety, Pain in extremity, Pain, Decreased appetite, Haemoglobin decreased, Blood sodium decreased, Dizziness postural, Dyspnoea, Muscular weakness,
LORLATINIB, LORLATINIB, LORLATINIB, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE,
251
25106277
JP
65 2
Somnolence, Pollakiuria, Temporomandibular pain and dysfunction syndrome, Gastrointestinal motility disorder, Constipation, Proctalgia, Pain, Photopsia, Intentional dose omission, Arthralgia, Neck pain, Abdominal distension, Iron deficiency anaemia, Head discomfort, Myalgia, Headache, Eye pain, Palpitations, Malaise, Limb discomfort, Abdominal pain, Dizziness, Vomiting, Diarrhoea,
TADALAFIL, SELEXIPAG, SELEXIPAG, SELEXIPAG, SELEXIPAG, MACITENTAN, EDOXABAN TOSYLATE,
252
25106512
CA
67 2
Death, Fatigue, Somnolence, Hepatic enzyme increased, Vomiting, Nausea, Diarrhoea, Madarosis, Blood thyroid stimulating hormone increased,
RIBOCICLIB, RIBOCICLIB,
253
25106513
CO
39 2
Pyelocaliectasis, Dysgeusia, Application site discolouration, Papule, Skin exfoliation, Pain of skin, Pain, Somnolence, Treatment noncompliance, Therapy interrupted, Accidental exposure to product, Wrong technique in product usage process, Arthropathy, Osteoarthritis, Erythema, Pruritus,
MECHLORETHAMINE HYDROCHLORIDE, MECHLORETHAMINE HYDROCHLORIDE, MECHLORETHAMINE HYDROCHLORIDE, ESZOPICLONE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, ESCITALOPRAM OXALATE, ESCITALOPRAM, QUETIAPINE FUMARATE, QUETIAPINE, SERTRALINE HYDROCHLORIDE,
254
25106606
US
79 1
Pain in extremity, Lacrimation increased, Somnolence, Confusional state,
NICOTINE,
255
25106656
US
69 2
Fatigue, Somnolence,
FLUTICASONE FUROATE, LORAZEPAM, SERTRALINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, IRON,
256
25106804
GB
Seizure, Somnolence,
LEVOTHYROXINE, CARBAMAZEPINE, CLOBAZAM,
257
25107118
TN
30 1
Drug screen positive, Hypotonia, Lethargy, Blood pressure decreased, Somnolence, Toxicity to various agents, Accidental exposure to product by child,
DRONABINOL,
258
25107265
TN
10 2
Somnolence, Mydriasis, Coma, Depressed level of consciousness, Toxicity to various agents, Accidental exposure to product by child, Drug screen positive,
DRONABINOL,
259
25107267
TN
7 2
Accidental exposure to product by child, Depressed level of consciousness, Coma, Pyrexia, Toxicity to various agents, Somnolence, Drug screen positive,
DRONABINOL,
260
25107273
US
1
Dehydration, Blood pressure increased, Dysphonia, Heart rate increased, Contusion, Pyrexia, Asthenia, Initial insomnia, Emotional disorder, Anxiety, Tremor, Panic attack, Decreased appetite, Dizziness, Insomnia, Somnolence, Depression, Incorrect dose administered,
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, DULOXETINE HYDROCHLORIDE, DULOXETINE, MIRTAZAPINE, MECLIZINE HCL 12.5 MG, MECLIZINE, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL 25MG, MECLIZINE HCL 12.5MG, HYOSCYAMINE SULFATE, ARMODAFINIL, ERGOCALCIFEROL, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE,
261
25107339
US
14 2
Somnolence,
RITLECITINIB,
262
25097245
CA
20 1
Hospitalisation, Brain neoplasm, Somnolence, Drug interaction,
CANNABIDIOL,
263
25097331
US
1
Joint swelling, Neuropathy peripheral, Somnolence, Weight increased, Peripheral swelling, Myalgia, Arthralgia, Fatigue, Nasopharyngitis, Constipation, Diarrhoea, Rash,
IXAZOMIB, IXAZOMIB, IXAZOMIB, LENALIDOMIDE,
264
25097381
US
28 2
Somnolence, Memory impairment, Anxiety, Confusional state,
ZURANOLONE,
265
25097686
US
82 1
Somnolence,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, ESCITALOPRAM, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, OXYBUTYNIN, FINASTERIDE, NALTREXONE, LEVOTHYROXINE, RAMELTEON, CLONAZEPAM,
266
25097860
BE
2
Somnolence, Vomiting, Intentional overdose, Product use issue,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
267
25097938
US
Drug intolerance, Somnolence, Product use in unapproved indication,
ESLICARBAZEPINE ACETATE, ESLICARBAZEPINE ACETATE,
268
25098078
FR
3 2
Somnolence, Wrong product administered,
CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE,
269
25098355
PL
6 1
Overdose, Somnolence, Altered state of consciousness, Slow response to stimuli, Tachycardia, Heart sounds normal, Muscle strength normal, Toxicity to various agents,
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE,
270
25098513
CN
85 1
Gaze palsy, Somnolence, Tremor, Speech disorder, Drooling, Blood pressure increased, Drug interaction, Overdose,
ABIRATERONE ACETATE, PREDNISONE, PERPHENAZINE,
271
25098674
US
80 1
Abdominal discomfort, Somnolence,
VENETOCLAX, FARICIMAB,
272
25098756
US
2
Somnolence,
TIZANIDINE,
273
25098768
IE
1
Myoclonus, Toxicity to various agents, Somnolence,
OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE,
274
25098770
IE
1
Myoclonus, Toxicity to various agents, Respiratory rate decreased, Somnolence,
OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE,
275
25098773
IE
1
Toxicity to various agents, Respiratory rate decreased, Somnolence, Confusional state,
OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE,
276
25099584
BE
Somnolence, Vomiting, Intentional overdose, Product use issue,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
277
25099588
US
58 2
Somnolence,
GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, PANTOPRAZOLE, CLONAZEPAM, BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, SERTRALINE, ACETAMINOPHEN AND IBUPROFEN, ACETAMINOPHEN, IBUPROFEN,
278
25099740
NL
56 1
Somnolence,
PREGABALIN, OXYBUTYNIN, SOLIFENACIN, METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE,
279
25099942
FR
52
Incorrect dose administered, Palpitations, Somnolence, Wrong product administered,
QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE,
280
25100052
CN
37
Seizure, Somnolence, Asthenia, Dizziness, Urine abnormality,
TENOFOVIR ALAFENAMIDE,
281
25100124
US
1
Somnolence,
TREPROSTINIL, TREPROSTINIL, MACITENTAN, PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE OPHTHALMIC SOLUTION, MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, SERTRALINE HYDROCHLORIDE, GABAPENTIN, TADALAFIL, APIXABAN, ERGOCALCIFEROL, HYDROXYCHLOROQUINE SULFATE, OXYGEN, 0XYGEN,
282
25100259
US
2
Feeling abnormal, Somnolence,
PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE, PIMAVANSERIN TARTRATE,
283
25100286
PL
33 2
Somnolence, Suicide attempt, Toxicity to various agents,
CARBAMAZEPINE,
284
25100341
GB
88 1
Fall, Somnolence, Device related infection,
TAFAMIDIS MEGLUMINE,
285
25100503
US
1
Death, Somnolence, Hospitalisation,
PEMBROLIZUMAB,
286
25100677
CN
75 2
Somnolence, Sedation, Respiratory depression, Coma, Miosis, Pupillary reflex impaired,
OXYCODONE HYDROCHLORIDE,
287
25100711
CA
50 2
Abdominal distension, Abdominal pain, Dizziness, Drug ineffective, Somnolence, Fatigue, Injection site pain, Musculoskeletal stiffness, Arthralgia, Rheumatoid arthritis, Swelling of eyelid,
METHOTREXATE SODIUM, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE,
288
25100753
US
Ammonia increased, Fatigue, Somnolence, Confusional state, Asterixis, Circumstance or information capable of leading to medication error, Drug titration error, Lethargy,
DIVALPROEX SODIUM, LEVETIRACETAM,
289
25101059
ES
14 1
Anxiety, Aggression, Therapy non-responder, Somnolence, Product use in unapproved indication,
ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, SERTRALINE, OXAZEPAM, MELATONIN,
290
25101240
US
2
Cardiomyopathy, Glaucoma, Somnolence, Sleep apnoea syndrome, Hepatic lesion, Ejection fraction abnormal, Fatigue, Insomnia,
CARVEDILOL, CARVEDILOL, SACUBITRIL AND VALSARTAN, SACUBITRIL AND VALSARTAN, DAPAGLIFLOZIN, LATANOPROST, ROSUVASTATIN,
291
25101302
48 2
Altered state of consciousness, Somnolence, Heart rate increased, Blood pressure increased, Therapy interrupted, Unevaluable event,
CYCLOPHOSPHAMIDE FOR INJECTION, CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE INJECTION, SOLUTION,
292
25101309
FR
37 2
Hypotension, Somnolence, Paraesthesia, Maternal exposure during pregnancy,
LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, ROPIVACAINE HYDROCHLORIDE, SUFENTANIL,
293
25101445
US
70 2
Brain fog, Myalgia, Coronary artery occlusion, Injection site urticaria, Injection site pain, Somnolence, Therapy cessation,
EVOLOCUMAB,
294
25101490
NO
23 2
Impaired driving ability, Somnolence, Rash pruritic,
GABAPENTIN, GABAPENTIN,
295
25101494
FR
40 1
Drug use disorder, Substance use disorder, Chest pain, Malaise, Somnolence, Mydriasis, Hyperhidrosis,
PREGABALIN,
296
25101710
BE
1
Intentional self-injury, Abdominal pain, Somnolence, Intentional overdose,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
297
25101735
CA
60 2
Anxiety, Apathy, Bradykinesia, Fatigue, Loss of personal independence in daily activities, Mood swings, Somnolence, Tremor, Irritability, Depression,
DIVALPROEX SODIUM, QUETIAPINE, QUETIAPINE,
298
25101776
US
Somnolence, Feeling abnormal, Adverse event,
CETIRIZINE HYDROCHLORIDE,
299
25101829
75 2
Flushing, Dizziness, Asthenia, Loss of consciousness, Somnolence,
LINACLOTIDE,
300
25101951
EG
36 1
Pericardial effusion, Fatigue, Somnolence, Hypotension,
LORLATINIB,

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last_updated

2025-04-28

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