Drug:
Reaction: SOMNOLENCE
20250101 - 20251231
No. 201 - 300
No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
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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, |
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BRIVARACETAM, BRIVARACETAM, TAURINE, |
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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, |
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DIROXIMEL FUMARATE, AMANTADINE, ATENOLOL, CYCLOBENZAPRINE, MECLIZINE HYDROCHLORIDE, MECLIZINE HCL, MECLIZINE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, |
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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, |
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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, |
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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, |
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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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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