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Drug Search by Year (Detail)

Side effect search by year (detail)

Drug:

Reaction: SOMNOLENCE

20250101 - 20251231

No. 101 - 200

Next page: 3 next page>>
No.
safetyreportid
occurcountry
patientonsetage
patientsex 1:M 2:F
Adverse reaction
Drug (openfda.generic_name, medicinalproduct)
101
25129279
US
2
Somnolence, Therapeutic product effect incomplete,
CETIRIZINE HYDROCHLORIDE, OMALIZUMAB,
102
25129392
US
1
Heart rate decreased, Agitation, Chest pain, Disturbance in attention, Feeling cold, Gastrointestinal disorder, Myocardial infarction, Cardiac flutter, Amnesia, Cerebrovascular accident, Muscle spasms, Pollakiuria, Tremor, Fatigue, Nausea, Abdominal distension, Bradycardia, Somnolence, Vertigo, Asthenia, Recalled product, Recalled product administered, Product substitution issue, Product impurity, Product solubility abnormal, Product physical issue,
LITHIUM CARBONATE,
103
25129409
FR
56 1
Malaise, Loss of consciousness, Somnolence, Muscle spasms, Toxicity to various agents, Drug abuse,
PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, CANNABIDIOL, PREGABALIN,
104
25129440
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,
105
25129652
FR
40 1
Mydriasis, Substance use disorder, Drug use disorder, Somnolence, Chest pain, Malaise, Hyperhidrosis,
PREGABALIN,
106
25129959
CA
73 2
Angioedema, Nervousness, Pain of skin, Paraesthesia, Peripheral swelling, Pneumonia, Pruritus, Respiratory rate increased, Rhinorrhoea, Somnolence, Sputum discoloured, Blood pressure systolic increased, Swelling, Tachypnoea, Urinary incontinence, Urticaria, Inappropriate schedule of product administration, Cardiac murmur, Cough, Dyspnoea exertional, Erythema, Headache, Heart valve incompetence, Hypertension, Productive cough, Pain,
OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, PREDNISONE, MONTELUKAST SODIUM, MONTELUKAST SODIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, DIPHENHYDRAMINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE, CETIRIZINE, CETIRIZINE HYDROCHLORIDE TABLETS, CETIRIZINE HYDROCHLORIDE ALLERGY, RANITIDINE,
107
25130406
US
Somnolence,
108
25130419
ES
86 2
Unresponsive to stimuli, Somnolence,
109
25130478
69
Somnolence, Dyspnoea, Brain fog, Anaemia, Off label use,
RUXOLITINIB,
110
25130555
US
Large intestine infection, Choking, Secretion discharge, Somnolence, Product size issue,
ELACESTRANT, ELACESTRANT,
111
25130757
US
2
Somnolence,
VALBENAZINE,
112
25130794
US
2
Fatigue, Somnolence, Product prescribing error,
NAPROXEN SODIUM, NAPROXEN SODIUM TABLET,
113
25130996
PL
43 2
Balance disorder, Somnolence, Suicide attempt, Drug abuse,
ZOLPIDEM TARTRATE, LORAZEPAM,
114
25131042
CN
36 2
Coma, Somnolence, Craniocerebral injury, Gastrointestinal haemorrhage, Cerebral infarction, Myocardial ischaemia, B-cell type acute leukaemia, Cerebral haemorrhage, Systemic inflammatory response syndrome, Brain herniation, Electrolyte imbalance, Diarrhoea, Platelet count decreased, Infection,
TIGECYCLINE, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE, MEROPENEM, VANCOMYCIN HYDROCHLORIDE, ERAVACYCLINE,
115
25131141
US
79 1
Somnolence, Off label use,
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL,
116
25131192
US
63 1
Diabetes mellitus inadequate control, Pruritus, Diarrhoea, Toothache, Bipolar disorder, Nasal discomfort, Weight decreased, Somnolence, Arthritis, Lacrimation increased, Dry mouth, Intentional product use issue, Product dose omission issue, Rhinorrhoea, Influenza, Blood glucose decreased, Wrong technique in product usage process, Drug ineffective, Inability to afford medication,
DEUTETRABENAZINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, MAGNESIUM, MELATONIN,
117
25131215
US
90 2
Somnolence, Hyperhidrosis, Gait disturbance, Fall, Insomnia, Intentional product use issue, Product use in unapproved indication,
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HCL,
118
25131348
65 1
Arthralgia, Myalgia, Fatigue, Headache, Restlessness, Somnolence, Injection site pain, Injection site bruising, Drug ineffective,
INSULIN LISPRO, ENALAPRIL, ROSUVASTATIN,
119
25131519
FR
77 2
Confusional state, Agitation, Hallucination, Somnolence, Aggression, Hypokalaemia, Hypophosphataemia, Persecutory delusion, Haemorrhage, Choking, Pulmonary congestion, Head injury, Fall, Encephalopathy, Clostridium difficile colitis,
METHYLPREDNISOLONE, OLANZAPINE, PREDNISONE, PREDNISONE, PREDNISONE, PREDNISONE, OXAZEPAM, OXAZEPAM, METHADONE HYDROCHLORIDE, METHADONE, METHADONE HYDROCHLORIDE, METHADONE, MORPHINE SULFATE, APIXABAN, IRBESARTAN, NALOXEGOL OXALATE, LANSOPRAZOLE, AMLODIPINE, HYDROCHLOROTHIAZIDE, LEVOTHYROXINE, BEVACIZUMAB, FLUOROURACIL, FLUOROURACIL, OXALIPLATIN,
120
25131598
US
73 2
Metastasis, Somnolence, Blood glucose decreased, Memory impairment, Weight increased, Dry mouth,
TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, PEMBROLIZUMAB, LENVATINIB, INSULIN ASPART,
121
25131870
US
70 2
COVID-19, Swollen tongue, Muscular weakness, Skin haemorrhage, Joint swelling, Blister rupture, Peripheral swelling, Heart rate irregular, Gait disturbance, Muscle spasms, Skin discolouration, Blister, Rash vesicular, Dizziness, Headache, Arthralgia, Somnolence, Paraesthesia, Rash, Myalgia, Dyspnoea,
LOSARTAN POTASSIUM, LOSARTAN, CLONIDINE HYDROCHLORIDE, CLONIDINE, LEVOTHYROXINE SODIUM,
122
25132026
US
14 2
Fatigue, Somnolence, Ocular hyperaemia,
DUPILUMAB,
123
25135839
37 2
Dizziness, Somnolence, Disturbance in attention,
ZURANOLONE,
124
25135840
29 2
Somnolence, Balance disorder,
ZURANOLONE,
125
25121585
PL
38 1
Suicide attempt, Somnolence, Toxicity to various agents,
QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, HYDROXYZINE,
126
25121724
HR
66 2
Somnolence, Disorientation,
POLATUZUMAB VEDOTIN,
127
25122015
US
33 1
Dysphagia, Cognitive disorder, Somnolence, Dizziness,
LACOSAMIDE, SERTRALINE HYDROCHLORIDE,
128
25122313
DE
75 1
Death, Anticonvulsant drug level increased, Somnolence,
PERAMPANEL, PERAMPANEL, PERAMPANEL, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, PREGABALIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG,
129
25122444
US
2
Off label use, Somnolence, Dizziness, Brain fog, Pain, Pain of skin, Pain in extremity, Alopecia, Renal failure, Abdominal pain,
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL HYDROCHLORIDE,
130
25122543
US
77 2
Somnolence,
OLOPATADINE HYDROCHLORIDE,
131
25122755
DE
45 2
Suicide attempt, Intentional self-injury, Blood pressure systolic decreased, Blood pressure diastolic decreased, Oxygen saturation decreased, Somnolence, Intentional overdose,
PANTOPRAZOLE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE,
132
25123077
PL
23 2
Toxicity to various agents, Somnolence, Vomiting,
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, KETOPROFEN,
133
25123139
US
Dementia, Confusional state, Somnolence, Drug ineffective, Wrong technique in product usage process,
VIBEGRON, VIBEGRON, MIRABEGRON,
134
25123287
US
18 2
Muscle tone disorder, Somnolence, Device malfunction,
BACLOFEN,
135
25123410
US
2
Fatigue, Intentional dose omission, Somnolence, Infusion site bruising,
LORAZEPAM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROCHLOROTHIAZIDE, GABAPENTIN, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, CALCIUM ACETATE, CALCIUM ACETATE CAPSULES 667 MG, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED,
136
25123469
US
71 2
Fatigue, Incorrect drug administration rate, Somnolence,
EPINEPHRINE, ADRENALINUM, AZITHROMYCIN, AZITHROMYCIN MONOHYDRATE, AZITHROMYCIN DIHYDRATE, ETHAMBUTOL HYDROCHLORIDE, RIFAMPIN, FLUTICASONE FUROATE, UMECLIDINIUM BROMIDE AND VILANTEROL TRIFENATATE,
137
25123580
US
1
Headache, Somnolence, Pruritus, Fatigue, Arthralgia,
OXYCODONE HYDROCHLORIDE, OXYCODONE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, INSULIN GLARGINE, INSULIN LISPRO-AABC, TORSEMIDE, ZOLPIDEM TARTRATE, CARVEDILOL, DICYCLOMINE HYDROCHLORIDE, ALBUTEROL SULFATE, GABAPENTIN, TAMSULOSIN HYDROCHLORIDE, COLCHICINE, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, TIOTROPIUM BROMIDE AND OLODATEROL, NAPROXEN, NAPROXEN SODIUM, FERROUS SULFATE, GLIMEPIRIDE, DIGOXIN, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, STANDARDIZED SENNA CONCENTRATE AND DOCUSATE SODIUM, ERGOCALCIFEROL, QUERCETIN, QUERCETIN,, DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, LIQUID FILLED, EPINEPHRINE, ADRENALINUM, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, NORMAL SALT TABLETS, CEPHALEXIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,
138
25123591
FR
91 1
Sinus bradycardia, Somnolence, Disorientation, Product prescribing error, Incorrect dose administered, Prescribed overdose,
OLANZAPINE,
139
25123747
US
Somnolence, Asthenia, Product dose omission in error, Incorrect dose administered,
RELUGOLIX, RELUGOLIX, APALUTAMIDE, GABAPENTIN, MELOXICAM, PSYLLIUM HUSK, ROSUVASTATIN CALCIUM, EZETIMIBE,
140
25123912
US
1
Pneumonia, Hospitalisation, Eating disorder, Somnolence, Carbon dioxide increased, Off label use, Overdose,
LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LEVETIRACETAM,
141
25123917
US
1
Sleep disorder, Somnolence,
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, ACALABRUTINIB, ATORVASTATIN CALCIUM, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROCHLOROTHIAZIDE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, ALLOPURINOL, PROCHLORPERAZINE, GABAPENTIN, FLUTICASONE PROPIONATE, TRIPROLIDINE HCL, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCL, ACYCLOVIR,
142
25124479
US
79 2
Burn oral cavity, Fatigue, Somnolence,
PALBOCICLIB,
143
25124891
US
0 2
Seizure, Involuntary vocalisation, Somnolence, Drug ineffective,
VIGABATRIN, VIGABATRIN, LACOSAMIDE, PHENOBARBITAL, PREDNISOLONE SODIUM PHOSPHATE, ERGOCALCIFEROL, PREDNISONE, FAMOTIDINE,
144
25125042
FR
91 1
Sinus bradycardia, Somnolence, Disorientation, Product prescribing error, Incorrect dose administered, Prescribed overdose,
OLANZAPINE,
145
25125220
US
1
Lennox-Gastaut syndrome, Tonic convulsion, Seizure, Hypersensitivity, Influenza, Pyrexia, Rash, Somnolence, Prescribed overdose, Drug ineffective,
VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, VIGABATRIN, BACLOFEN, CLONAZEPAM, LEVETIRACETAM, OXCARBAZEPINE, CLOBAZAM, ZONISAMIDE, IRON, ERGOCALCIFEROL, ERGOCALCIFEROL,
146
25125584
US
75 1
Somnolence, Fatigue,
HYDROCODONE BITARTRATE, LOSARTAN, METOPROLOL SUCCINATE, METOPROLOL SUCCINATE ER TABLETS, ROSUVASTATIN, LENVATINIB, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, VITAMIN C, PEMBROLIZUMAB, LEVOTHYROXINE,
147
25125672
FR
55 1
Somnolence, Drug interaction, Drug level decreased, Drug interaction,
CARBAMAZEPINE, MIRTAZAPINE, ABACAVIR SULFATE, DOLUTEGRAVIR SODIUM, LAMIVUDINE, ATAZANAVIR, RITONAVIR, PERAMPANEL,
148
25125954
CH
64 1
Overdose, Respiratory depression, Somnolence, Miosis, Dysarthria,
DIAZEPAM, METHADONE,
149
25115669
US
Somnolence, Abnormal dreams,
150
25115730
US
38 2
Somnolence,
ADALIMUMAB,
151
25116200
PL
28 2
Somnolence, Toxicity to various agents,
152
25116265
US
65 2
Somnolence, Feeling abnormal, Pain, Chills, Headache, Pyrexia, Influenza like illness, Insomnia, Back pain, Arthralgia, Asthenia, Nausea, Fatigue,
TIRZEPATIDE,
153
25116421
IT
Fatigue, Lethargy, Somnolence, Negative thoughts, Loss of personal independence in daily activities,
CABOTEGRAVIR, CABOTEGRAVIR, CABOTEGRAVIR,
154
25116435
US
58 2
Somnolence, Product tampering,
TIRZEPATIDE,
155
25116455
FR
56 1
Muscle spasms, Toxicity to various agents, Malaise, Loss of consciousness, Somnolence, Drug abuse,
DRONABINOL, CANNABIDIOL, PREGABALIN, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE,
156
25116812
HR
16 2
Somnolence, Suicide attempt, 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,
157
25116819
DE
45 2
Suicide attempt, Intentional self-injury, Somnolence, Blood pressure systolic decreased, Blood pressure diastolic decreased, Oxygen saturation decreased, Intentional overdose,
PANTOPRAZOLE, VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE,
158
25117576
US
56 2
Alanine aminotransferase increased, Aspartate aminotransferase increased, Hypoxia, Ischaemia, Overdose, Respiratory failure, Somnolence, Prescription drug used without a prescription,
159
25117646
FR
76 1
Somnolence, Product administration error, Wrong rate,
MORPHINE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE,
160
25117956
US
78 2
Somnolence,
LENALIDOMIDE,
161
25117986
US
48 2
Somnolence, Fatigue,
PALBOCICLIB,
162
25118027
JP
29 1
Status epilepticus, Oxygen saturation decreased, Somnolence, Prescribed underdose, Off label use,
VALPROATE SODIUM, PRIMIDONE, PHENOBARBITAL, STIRIPENTOL, PERAMPANEL,
163
25118073
US
Somnolence, Wrong technique in product usage process,
CETIRIZINE HYDROCHLORIDE,
164
25118295
DE
1
Pyrexia, Rash, Fatigue, Somnolence, S100 protein increased,
DABRAFENIB, TRAMETINIB,
165
25118296
CA
53
Abdominal discomfort, Accidental overdose, Adverse drug reaction, Alcohol poisoning, Arthritis, Bronchiectasis, Burns second degree, COVID-19, Cardiac murmur, Catarrh, Cerebrovascular accident, Colitis ulcerative, Condition aggravated, Confusional state, Deep vein thrombosis, Depression, Drug ineffective, Dysgeusia, Eczema, Fatigue, Frequent bowel movements, Gingival pain, Haematochezia, Headache, Hypopnoea, Impaired quality of life, Impaired work ability, Inappropriate schedule of product administration, Intentional product use issue, Loss of personal independence in daily activities, Loss of personal independence in daily activities, Medication error, Migraine, Nightmare, Off label use, Pain, Pain in extremity, Palpitations, Parosmia, Product use in unapproved indication, Pulmonary embolism, Pyrexia, Rash, Rectal haemorrhage, Rhinitis, Somnolence, Steroid dependence, Stress, Swollen tongue, Systemic lupus erythematosus, Tinnitus, Tubulointerstitial nephritis, Vertigo, Weight decreased,
ESOMEPRAZOLE, ESOMEPRAZOLE MAGNESIUM, ROSUVASTATIN, ROSUVASTATIN, ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM, ROSUVASTATIN CALCIUM, 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, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, 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, ALBENDAZOLE, ALBENDAZOLE, AMLODIPINE BESYLATE, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, BISOPROLOL FUMARATE, BISOPROLOL FUMARATE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, BUDESONIDE, CALCIUM CARBONATE, CALCIUM CARBONATE, MAGNESIUM CARBONATE, ERGOCALCIFEROL, CANDESARTAN, CITALOPRAM, CITALOPRAM HYDROBROMIDE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE, DAPAGLIFLOZIN, DAPAGLIFLOZIN, DESOXIMETASONE, DESOXIMETASONE, DESOXIMETASONE, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE, DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE, EMPAGLIFLOZIN, EMPAGLIFLOZIN, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, VEDOLIZUMAB, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, FELODIPINE, FELODIPINE EXTENDED-RELEASE TABLETS, FESOTERODINE FUMARATE, FOLIC ACID, FUROSEMIDE, GABAPENTIN, GABAPENTIN, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, ADALIMUMAB, 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, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB-DYYB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, INFLIXIMAB, LANSOPRAZOLE, LATANOPROST, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, PREGABALIN, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, MESALAMINE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, MINERAL OIL, NAPHAZOLINE HYDROCHLORIDE, NITROFURANTOIN, NITROFURANTOIN MONOHYDRATE/MACROCRYSTALS, NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OXYCODONE, PREDNISONE, PREDNISONE, PREDNISONE, RAMIPRIL, MESALAMINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, SULFASALAZINE, TAMSULOSIN HYDROCHLORIDE, ERGOCALCIFEROL, LISDEXAMFETAMINE DIMESYLATE, WARFARIN, WARFARIN, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, WARFARIN SODIUM, WARFARIN, TOFACITINIB, TOFACITINIB, TOFACITINIB, BUDESONIDE, BUDESONIDE, BUDESONIDE, LISDEXAMFETAMINE DIMESYLATE, LISDEXAMFETAMINE, LISDEXAMFETAMINE DIMESYLATE CAPSULES, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, OXYCODONE HYDROCHLORIDE, OXYCODONE, OXYCODONE HYDROCHLORIDE, OXYCODONE, RIVAROXABAN, TETRAHYDROZOLINE HYDROCHLORIDE,
166
25118387
TR
14 2
Anuria, Somnolence, Toxicity to various agents, Hypotension, Overdose,
AMLODIPINE,
167
25118598
US
20 2
Toxicity to various agents, Overdose, Cardiac arrest, Cardiac failure high output, Drug ineffective, Vasoplegia syndrome, Renal failure, Multiple organ dysfunction syndrome, Somnolence, Hypotension, Pulmonary oedema, Generalised oedema, Hypoxia,
AMLODIPINE, AMLODIPINE, AMLODIPINE, AMLODIPINE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, EPINEPHRINE, ADRENALINUM, EPINEPHRINE, ADRENALINUM, EPINEPHRINE, ADRENALINUM, EPINEPHRINE, ADRENALINUM, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, METHYLENE BLUE, METHYLENE BLUE, METHYLENE BLUE, METHYLENE BLUE, HYDROXOCOBALAMIN, HYDROXOCOBALAMIN, HYDROXOCOBALAMIN, HYDROXOCOBALAMIN, GLUCAGON, GLUCAGON, GLUCAGON, GLUCAGON, CALCIUM, CALCIUM, CALCIUM, CALCIUM,
168
25118656
HR
16 2
Suicide attempt, Somnolence,
ALPRAZOLAM,
169
25119076
US
75 1
Infusion related reaction, Oropharyngeal pain, Somnolence, Throat irritation, Restlessness, Headache,
DARATUMUMAB, INSULIN ASPART, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, METHYLPREDNISOLONE SODIUM SUCCINATE, FAMOTIDINE, MONTELUKAST SODIUM, PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE, ACYCLOVIR,
170
25119721
US
18 2
Seizure, Bicuspid aortic valve, Agitation, Somnolence,
FENFLURAMINE, FENFLURAMINE, FENFLURAMINE,
171
25120057
US
Neuropathy peripheral, Autoimmune disorder, Somnolence, Dyspnoea, Wheezing, Fall, Foot fracture, Ankle fracture, Muscle fatigue, Fatigue, Asthenia,
RAVULIZUMAB, GABAPENTIN,
172
25120137
DE
45 2
Suicide attempt, Intentional self-injury, Somnolence, Blood pressure systolic decreased, Blood pressure diastolic decreased, Oxygen saturation decreased, Intentional overdose,
PANTOPRAZOLE, VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE,
173
25120145
FR
56 1
Toxicity to various agents, Loss of consciousness, Malaise, Muscle spasms, Somnolence, Drug abuse,
PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, CANNABIDIOL, CANNABIDIOL, CANNABIDIOL, CANNABIDIOL, FENOFIBRATE, FENOFIBRATE, FENOFIBRATE, FENOFIBRATE, AMLODIPINE, AMLODIPINE, AMLODIPINE, AMLODIPINE, CANDESARTAN, CANDESARTAN, CANDESARTAN, CANDESARTAN, ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE AND PROGUANIL HYDROCHLORIDE,
174
25120380
JP
35 2
Pneumonia, Decreased appetite, Gastric fistula, Somnolence, Bronchitis, Muscular weakness, Prescribed underdose, Off label use,
VALPROATE SODIUM, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, POTASSIUM BROMIDE, RAMELTEON, MAGNESIUM OXIDE, TOPIRAMATE, TOPIRAMATE SPINKLE, VALPROATE SODIUM,
175
25120517
FR
74 2
Somnolence, Bradypnoea,
OXYCODONE HYDROCHLORIDE, OXYCODONE, DROPERIDOL, LEVOFLOXACIN, LEVOFLOXACIN IN 5% DEXTROSE, SUFENTANIL, MINOCYCLINE HYDROCHLORIDE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, CLOBAZAM, NEBIVOLOL, NEBIVOLOL HYDROCHLORIDE, ENOXAPARIN SODIUM, PANTOPRAZOLE,
176
25120572
US
44 2
Systemic lupus erythematosus, Injection site pain, Sleep disorder due to a general medical condition, Somnolence, Scar, Dry eye, Oral herpes, Product preparation error,
DUPILUMAB,
177
25120893
US
2
Somnolence,
CARIPRAZINE,
178
25123674
78 1
Drug ineffective, Asthenia, Fatigue, Asthenia, Somnolence, Loss of personal independence in daily activities, Apathy, Peripheral swelling, Erythema, Livedo reticularis, Cellulitis, Blood glucose increased,
METOPROLOL TARTRATE, METOROPROLOL TARTRATE, METOPROLOL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CLOPIDOGREL BISULFATE, ENALAPRIL, AMLODIPINE BESYLATE,
179
25124929
70 2
Somnolence, Illness, Asthenia, Incoherent, Blood sodium decreased, Blood phosphorus decreased, Blood potassium decreased,
AVACOPAN,
180
25109803
US
68 2
Fatigue, Somnolence,
DUPILUMAB,
181
25109825
GB
45 2
Sedation complication, Somnolence, Dizziness, Fall,
QUETIAPINE FUMARATE, QUETIAPINE,
182
25109829
GB
22 2
Somnolence, Vision blurred,
QUETIAPINE FUMARATE, QUETIAPINE,
183
25109861
GB
39 2
Fatigue, Somnolence,
QUETIAPINE FUMARATE, QUETIAPINE, PREGABALIN,
184
25110021
GB
Suicidal ideation, Seizure, Generalised tonic-clonic seizure, Depressive symptom, Somnolence, Mood altered, Depression, Off label use,
LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM, LEVETIRACETAM ORAL, LEVETIRACETAM INJECTION, LEVETIRACETAM IN SODIUM CHLORIDE,
185
25110223
US
80 2
Drug interaction, Dysstasia, Somnolence,
PIMAVANSERIN TARTRATE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, LETROZOLE, LETROZOLE TABLETS, CETIRIZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE, CARVEDILOL, GABAPENTIN, ESCITALOPRAM, ESCITALOPRAM OXALATE, ESCITSLOPRAM, ROPINIROLE,
186
25110357
US
70 1
Dyspnoea, Dyspnoea exertional, Flushing, Productive cough, Somnolence, Weight decreased, Headache, Abdominal discomfort, Dizziness, Nausea, Fatigue, Abdominal pain upper,
SEMAGLUTIDE, OXYGEN, 0XYGEN, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS,
187
25110397
IE
13 2
Somnolence, Sleep disorder, Blood pressure decreased, Blood pressure fluctuation, Restlessness, Insomnia, Head discomfort, Diarrhoea, Heart rate increased, Growth retardation, Scoliosis, Condition aggravated, Headache, Product use complaint,
LEVOTHYROXINE, LEVOTHYROXINE, LEVOTHYROXINE, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, SOMATROPIN, OXYCODONE HYDROCHLORIDE, MORPHINE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE,
188
25110505
CA
41 1
Anger, Apathy, Aphasia, Condition aggravated, Depression, Drug titration error, Fatigue, Hypersomnia, Off label use, Speech disorder, Therapeutic response unexpected, Depressed mood, Somnolence, Diplopia, Status epilepticus,
LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, BRIVARACETAM, CLOBAZAM, CLONAZEPAM, PANTOPRAZOLE, RISPERIDONE, OXCARBAZEPINE, ZONISAMIDE,
189
25111007
50 2
Drug ineffective, Abdominal distension, Abdominal pain, Dizziness, Somnolence, Fatigue, Musculoskeletal stiffness, Arthralgia, Rheumatoid arthritis, Swelling of eyelid,
METHOTREXATE, METHOTREXATE SODIUM, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, ADALIMUMAB-ADAZ, HYDROCORTISONE, HYDROCORTISONE, HYDROCORTISONE,
190
25111011
US
1
Fatigue, Somnolence,
PIMAVANSERIN TARTRATE, MELATONIN, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, HYDROXYZINE PAMOATE,
191
25111132
FR
28 1
Somnolence, Disorientation, Drug use disorder, Substance use disorder,
TOPIRAMATE, TOPIRAMATE SPINKLE, DIAZEPAM, LOXAPINE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, ZOLPIDEM TARTRATE,
192
25111170
JP
Acute kidney injury, Altered state of consciousness, Nephropathy toxic, Urinary retention, Feeling abnormal, Speech disorder, Renal disorder, Somnolence, Stupor, Urine output decreased, Toxicity to various agents, Inappropriate schedule of product administration, Prescribed overdose, Off label use,
VALACYCLOVIR HYDROCHLORIDE, TELMISARTAN, LUBIPROSTONE, SOLIFENACIN SUCCIATE, SOLIFENACIN SUCCINATE,
193
25111255
FR
Major depression, Delirium, Job dissatisfaction, Time perception altered, Confusional state, Apathy, Tremor, Somnolence, Depressed mood, Blepharospasm, Decreased appetite, Disturbance in attention, Salivary hypersecretion, Panic attack, Swelling, Emotional poverty, Feeling abnormal, Anxiety, Sleep disorder, Ageusia, Dry skin, Anosmia, Vision blurred, Speech disorder, Mutism, Hypersensitivity, Negative thoughts, Weight increased, Amnesia, Depression,
ARIPIPRAZOLE, LOXAPINE, OLANZAPINE, OLANZAPINE PAMOATE, OLANZAPINE, OLANZAPINE PAMOATE, OLANZAPINE, OLANZAPINE PAMOATE, OLANZAPINE, OLANZAPINE PAMOATE, OLANZAPINE, OLANZAPINE PAMOATE, OLANZAPINE, OLANZAPINE PAMOATE,
194
25111411
US
6 2
Seizure, Limb injury, Norovirus infection, Gastrointestinal infection, Somnolence, Vomiting, Product use complaint,
TROFINETIDE,
195
25111542
PL
23 2
Psychomotor retardation, Somnolence, Depressed mood, Dizziness,
ALPRAZOLAM,
196
25111555
US
Mood altered, Abdominal discomfort, Sleep disorder, Illness, Hyperhidrosis, Pain in extremity, Pain, Muscle twitching, Nausea, Constipation, Somnolence, Malaise, Insomnia,
PREGABALIN,
197
25111703
US
28 2
Myasthenia gravis, Somnolence, Maternal exposure during delivery, Off label use,
BUPIVACAINE, BUPIVACAINE HYDROCHLORIDE IN DEXTROSE, DEXTROSE MONOHYDRATE, DEXTROSE,
198
25111779
US
Diabetes mellitus, Somnolence, Fatigue,
RELUGOLIX, RELUGOLIX,
199
25111812
HR
16 2
Suicide attempt, Somnolence, Intentional overdose,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, OLANZAPINE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE,
200
25112127
BE
2
Somnolence, Vomiting, Intentional self-injury, Product use issue, Intentional overdose,
ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL,

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last_updated

2025-04-28

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