Drug:
Reaction: SOMNOLENCE
20250101 - 20251231
No. 1 - 100
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
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| 1 | 25491684 |
US |
42 | 1 |
Insomnia, Sleep disorder, Palpitations, Middle insomnia, Micturition urgency, White blood cell count increased, Gastroenteritis viral, Confusional arousal, Hyperhidrosis, Confusional state, Disorientation, Parasomnia, Memory impairment, Drug interaction, Anxiety, Feeling abnormal, Somnolence, Dry mouth, Heart rate increased, |
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TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, TIRZEPATIDE, SODIUM OXYBATE, SODIUM OXYBATE, PITOLISANT HYDROCHLORIDE, ACETYLCYSTEINE, FISH OIL, BUPROPION HYDROCHLORIDE, MAGNESIUM, NALTREXONE HYDROCHLORIDE, ERGOCALCIFEROL, MODAFINIL, CLOMIPHENE CITRATE, |
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| 2 | 25491782 |
HR |
54 | 2 |
Suicide attempt, Somnolence, Intentional overdose, |
||||
VENLAFAXINE, VENLAFAXINE HYDROCHLORIDE, ALPRAZOLAM, PREGABALIN, BISOPROLOL FUMARATE, OXAZEPAM, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, ZOLPIDEM TARTRATE, |
||||
| 3 | 25491950 |
IN |
29 | 2 |
Intentional overdose, Hypoxia, Dyspnoea, Tachypnoea, Hypotension, Somnolence, Lethargy, Dizziness, Metabolic acidosis, Acute pulmonary oedema, |
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AMLODIPINE BESYLATE, |
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| 4 | 25491959 |
SE |
48 | 2 |
Tremor, Heart rate increased, Product substitution issue, Muscle tightness, Anxiety, Psychomotor hyperactivity, Hallucination, Somnolence, Impaired quality of life, Hypertension, Confusional state, |
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METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, |
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| 5 | 25492102 |
US |
49 | 2 |
Dizziness, Somnolence, Balance disorder, Fall, |
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VALBENAZINE, LUMATEPERONE, LUMATEPERONE, |
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| 6 | 25492132 |
US |
44 | 1 |
Endotracheal intubation, Somnolence, Condition aggravated, Restlessness, Condition aggravated, Agitation, Condition aggravated, Yawning, Condition aggravated, Piloerection, Condition aggravated, |
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DROPERIDOL, FENTANYL, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, NALOXONE, |
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| 7 | 25492183 |
PL |
63 | 2 |
Altered state of consciousness, Somnolence, Psychomotor hyperactivity, |
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SERTRALINE, |
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| 8 | 25492747 |
US |
2 | |
Kidney infection, Device infusion issue, Somnolence, Inappropriate schedule of product administration, Memory impairment, Muscular weakness, Oropharyngeal pain, Infusion site mass, Migraine, Hypersensitivity, COVID-19, Illness, Wrong technique in product usage process, Abdominal discomfort, Malaise, Fatigue, |
||||
| 9 | 25493122 |
JP |
88 | 1 |
Epilepsy, Tremor, Blood pressure increased, Somnolence, Off label use, |
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LACOSAMIDE, LACOSAMIDE, BREXPIPRAZOLE, AZILSARTAN KAMEDOXOMIL, LINAGLIPTIN, |
||||
| 10 | 25493220 |
US |
2 | |
Seizure, Dizziness, Fatigue, Somnolence, Injection related reaction, Blood iron decreased, Temperature intolerance, |
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OFATUMUMAB, |
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| 11 | 25493383 |
DE |
76 | 1 |
Epistaxis, Somnolence, Product use in unapproved indication, Asthenia, General physical health deterioration, |
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PEMBROLIZUMAB, LENVATINIB, |
||||
| 12 | 25493525 |
US |
57 | 2 |
Sedation, Somnolence, Fatigue, Antipsychotic drug level increased, Drug interaction, |
||||
CLOZAPINE, CLOZAPINE, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, DIVALPROEX SODIUM, LATANOPROST, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, CEPHALEXIN, CEPHALEXIN, |
||||
| 13 | 25493672 |
PL |
55 | 1 |
Drug ineffective, Somnolence, Confusional state, Dizziness, Ataxia, Vision blurred, |
||||
CARBAMAZEPINE, PHENYTOIN, CLONAZEPAM, GABAPENTIN, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, |
||||
| 14 | 25493955 |
GB |
70 | 1 |
Completed suicide, Lethargy, Abnormal dreams, Somnolence, |
||||
FINASTERIDE, |
||||
| 15 | 25493980 |
IT |
21 | 1 |
Hypoventilation, Somnolence, Intentional overdose, Intentional product misuse, |
||||
OLANZAPINE, ALPRAZOLAM, |
||||
| 16 | 25493987 |
US |
82 | 1 |
Cardiac failure congestive, Blood pressure abnormal, Abnormal behaviour, Decreased appetite, Gait inability, Dyskinesia, Fatigue, Somnolence, Drug ineffective, Therapy interrupted, Product use in unapproved indication, |
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BREXPIPRAZOLE, BREXPIPRAZOLE, BREXPIPRAZOLE, |
||||
| 17 | 25494093 |
IT |
1 | |
Drug abuse, Somnolence, Intentional overdose, |
||||
ALPRAZOLAM, |
||||
| 18 | 25494159 |
HR |
14 | 1 |
Suicide attempt, Somnolence, |
||||
ALPRAZOLAM, |
||||
| 19 | 25494554 |
CA |
80 | 2 |
Pruritus, Diarrhoea, Vomiting, Urinary tract infection, COVID-19, Depression, Taste disorder, Vision blurred, Dyspnoea, Anxiety, Malaise, Somnolence, Headache, Productive cough, Dry eye, Skin exfoliation, Pain in extremity, Asthenia, Fatigue, Decreased appetite, Weight increased, Weight decreased, Dizziness, Balance disorder, Blood culture positive, Pyrexia, |
||||
| 20 | 25494594 |
IT |
21 | 1 |
Somnolence, Hypoventilation, Intentional overdose, Intentional product misuse, |
||||
ALPRAZOLAM, OLANZAPINE, |
||||
| 21 | 25494723 |
US |
||
Somnolence, |
||||
LEVOCETIRIZINE DIHYDROCHLORIDE, |
||||
| 22 | 25495055 |
US |
||
Respiratory arrest, Skin discolouration, Generalised tonic-clonic seizure, Seizure, Seizure, Somnolence, Visual impairment, Tremor, |
||||
TOPIRAMATE, OXCARBAZEPINE, |
||||
| 23 | 25495274 |
HR |
2 | |
Suicide attempt, Loss of consciousness, Somnolence, Intentional overdose, |
||||
CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE, |
||||
| 24 | 25495294 |
FR |
19 | 2 |
Poisoning deliberate, Disorientation, Somnolence, Confusional state, Rhabdomyolysis, |
||||
CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CHLORPROMAZINE, CHLORPROMAZINE, CHLORPROMAZINE, CHLORPROMAZINE, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, |
||||
| 25 | 25495420 |
DE |
25 | 1 |
Erectile dysfunction, Shock, Dependence, Dementia, Suicidal ideation, Poisoning, Constipation, Malaise, Vomiting, Language disorder, Disturbance in attention, Weight increased, Skin laceration, Abdominal distension, Agitation, Salivary hypersecretion, Urinary tract infection, Movement disorder, Visual impairment, Polydipsia, Staring, Exercise tolerance decreased, Feeling abnormal, Pain, Thinking abnormal, Thinking abnormal, Hypersomnia, Sluggishness, Dyspnoea, Somnolence, Hypersensitivity, Drug ineffective, |
||||
OLANZAPINE, PALIPERIDONE, |
||||
| 26 | 25495544 |
HR |
46 | 2 |
Suicide attempt, Somnolence, Intentional overdose, |
||||
CLOZAPINE, |
||||
| 27 | 25496197 |
US |
||
Somnolence, |
||||
| 28 | 25496212 |
CA |
40 | 2 |
Wound infection, Pruritus, Somnolence, Abdominal distension, Neck pain, Hepatitis, Dyspepsia, Muscular weakness, Back injury, Nail disorder, Coeliac disease, Mobility decreased, Derealisation, Wheezing, Headache, Depressed mood, Peripheral coldness, Adverse reaction, Gait inability, Condition aggravated, Temperature intolerance, Diarrhoea, Decreased appetite, Urticaria, Product label confusion, Malaise, Insomnia, Respiratory tract congestion, Heart rate increased, Weight increased, Blister, Suicidal ideation, Burning sensation, Feeling abnormal, Asthenia, Weight decreased, Gastrooesophageal reflux disease, Intentional product use issue, Hypoaesthesia, Fatigue, Grip strength decreased, Alopecia, Sleep disorder, Bursitis, Musculoskeletal stiffness, Pain in extremity, Nausea, Erythema, Fall, Off label use, Folliculitis, Gastrointestinal disorder, Finger deformity, Liver function test increased, Osteoarthritis, Injury, Pneumonia, |
||||
DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, DICLOFENAC SODIUM, DICLOFENAC SODIUM TOPICAL, DICLOFENAC SODIUM TOPICAL GEL, 1%, DICLOFENAC, DICLOFENAC SODIUM 1%, ERENUMAB-AOOE, CANDESARTAN, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, OMALIZUMAB, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, ADALIMUMAB, ADALIMUMAB-FKJP, ADALIMUMAB-AATY, SECUKINUMAB, SECUKINUMAB, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, LEFLUNOMIDE, OXYCODONE, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, RITUXIMAB, PHENYLEPHRINE HYDROCHLORIDE, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, METHOTREXATE, METHOTREXATE SODIUM, ERGOCALCIFEROL, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, TOPIRAMATE, TOPIRAMATE SPINKLE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM, GABAPENTIN, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, MONTELUKAST SODIUM, MONTELUKAST, MONTELUKAST SODIUM, MONTELUKAST, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, |
||||
| 29 | 25503797 |
29 | 1 | |
Somnolence, Hypersomnia, Vomiting, Gastrointestinal disorder, Dehydration, |
||||
SUZETRIGINE, SUZETRIGINE, |
||||
| 30 | 25491156 |
IN |
30 | 2 |
Toxicity to various agents, Non-cardiogenic pulmonary oedema, Bradycardia, Hypotension, Dyspnoea, Lethargy, Tachypnoea, Somnolence, Blood pressure decreased, Intentional overdose, |
||||
AMLODIPINE BESYLATE, |
||||
| 31 | 25491170 |
IN |
40 | 1 |
Intentional overdose, Somnolence, Blood pressure systolic increased, Lethargy, Oxygen saturation decreased, Blood pressure decreased, Heart rate increased, Hyperglycaemia, Toxicity to various agents, |
||||
AMLODIPINE BESYLATE, NIFEDIPINE, |
||||
| 32 | 25491540 |
FR |
93 | 2 |
Wrong patient received product, Urinary retention, Somnolence, |
||||
RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, RISPERIDONE, PANTOPRAZOLE, LISINOPRIL AND HYDROCHLOROTHIAZIDE, CALCIUM CARBONATE, ANTACID, |
||||
| 33 | 25499665 |
74 | 2 | |
Somnolence, Disturbance in attention, Judgement impaired, Hypophagia, Potentiating drug interaction, |
||||
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, LEVOTHYROXINE, PROPRANOLOL HYDROCHLORIDE, CALCIUM, ERGOCALCIFEROL, |
||||
| 34 | 25489935 |
US |
30 | 1 |
Impaired driving ability, Dysstasia, Drug diversion, Dysarthria, Somnolence, |
||||
OXYCODONE HYDROCHLORIDE, OXYCODONE, ALPRAZOLAM, |
||||
| 35 | 25490032 |
CA |
||
Blood pressure fluctuation, Somnolence, Dizziness, |
||||
INFLIXIMAB-DYYB, |
||||
| 36 | 25490102 |
US |
1 | |
Somnolence, |
||||
VIGABATRIN, |
||||
| 37 | 25490173 |
US |
2 | |
Rhinorrhoea, Malaise, Product dose omission issue, Hypokinesia, Stereotypy, Cough, Somnolence, Fatigue, Infection, |
||||
VIGABATRIN, VIGABATRIN, VIGABATRIN, |
||||
| 38 | 25490275 |
US |
||
Somnolence, |
||||
VIGABATRIN, |
||||
| 39 | 25490282 |
US |
1 | 1 |
Faeces discoloured, Somnolence, |
||||
VIGABATRIN, |
||||
| 40 | 25490646 |
US |
62 | 2 |
Fatigue, Somnolence, Myalgia, Dizziness, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 41 | 25490889 |
US |
2 | |
Arterial occlusive disease, Somnolence, |
||||
DUPILUMAB, VALBENAZINE, |
||||
| 42 | 25484686 |
32 | 2 | |
Somnolence, Headache, |
||||
DUPILUMAB, ACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE, |
||||
| 43 | 25486619 |
CO |
19 | 2 |
Immunosuppressant drug level increased, Discouragement, Pyrexia, Back pain, Somnolence, Feeling hot, Blood glucose increased, Pallor, Weight decreased, |
||||
TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, ENALAPRIL, MYCOPHENOLIC ACID, MYCOPHENILIC ACID, |
||||
| 44 | 25486657 |
40 | 2 | |
Drug interaction, Hyperammonaemia, Somnolence, Product use issue, |
||||
TOPIRAMATE, TOPIRAMATE SPINKLE, STIRIPENTOL, |
||||
| 45 | 25486745 |
FR |
14 | 2 |
Somnolence, Poisoning deliberate, Prothrombin time ratio decreased, Vomiting, |
||||
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 46 | 25486752 |
GB |
54 | 1 |
Neuropathy peripheral, Toothache, Urinary bladder haemorrhage, Lethargy, Trigeminal neuralgia, Hepatic function abnormal, Electric shock sensation, Tinnitus, Mental impairment, Immunosuppression, Hypothyroidism, Photophobia, Spinal pain, Lip swelling, Blindness, Brain fog, Gait disturbance, Pain in extremity, Suicidal ideation, Mouth swelling, Punctate keratitis, Facial pain, Hyponatraemia, Somnolence, Dyspnoea, Pyrexia, Feeling of despair, White blood cell disorder, Depression, Confusional state, Dizziness, Nausea, Amnesia, COVID-19, Headache, Urinary tract infection, Haematological infection, Cough, Paraesthesia, Carpal tunnel syndrome, Dry eye, Hypoaesthesia, Influenza like illness, Flushing, Anxiety, Rash vesicular, Chest pain, |
||||
PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, OXCARBAZEPINE, OXYCODONE HYDROCHLORIDE, OXYCODONE, EPTINEZUMAB-JJMR, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, CARBAMAZEPINE, CARBAMAZEPINE, BACLOFEN, BACLOFEN, PHENYTOIN, PHENYTOIN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MIRTAZAPINE, BUPRENORPHINE, NALTREXONE, NAPROXEN, NAPROXEN SODIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DULOXETINE HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, ACYCLOVIR, ONABOTULINUMTOXINA, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, MAGNESIUM, GABAPENTIN, GABAPENTIN, GABAPENTIN, |
||||
| 47 | 25486814 |
AU |
47 | 2 |
Acute respiratory failure, Depressed level of consciousness, Agitation, Somnolence, Hypomania, Off label use, |
||||
HALOPERIDOL, HALOPERIDOL LACTATE, HALOPERIDOL, HALOPERIDOL LACTATE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), MIDAZOLAM, MIDAZOLAM HYDROCHLORIDE, OLANZAPINE, PROPOFOL, ACETAMINOPHEN AND DIPHENHYDRAMINE HCL, ACETAMINOPHEN, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN AND PHENYLEPRINE HCL, |
||||
| 48 | 25486850 |
CN |
||
Epilepsy, Dizziness, Nausea, Vomiting, Somnolence, Vision blurred, Drug ineffective, |
||||
LACOSAMIDE, LACOSAMIDE, |
||||
| 49 | 25486859 |
FR |
14 | 2 |
Poisoning deliberate, Somnolence, Vomiting, Prothrombin time ratio decreased, |
||||
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 50 | 25487019 |
GB |
1 | |
Somnolence, |
||||
MELATONIN, |
||||
| 51 | 25487032 |
ES |
89 | 1 |
Mental impairment, Somnolence, Confusional state, |
||||
| 52 | 25487157 |
FR |
78 | 1 |
Pneumonia aspiration, Confusional state, Tremor, Somnolence, Dysphagia, |
||||
PREGABALIN, |
||||
| 53 | 25487453 |
US |
||
Somnolence, |
||||
| 54 | 25487470 |
GB |
1 | |
Somnolence, |
||||
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE ORAL, FEXOFENADINE HCL, |
||||
| 55 | 25487658 |
US |
||
Seizure cluster, Somnolence, |
||||
VIGABATRIN, VIGABATRIN, |
||||
| 56 | 25487851 |
US |
||
Somnolence, |
||||
FEXOFENADINE HYDROCHLORIDE, |
||||
| 57 | 25487941 |
CZ |
1 | |
Hyperthyroidism, Myalgia, Malaise, Somnolence, |
||||
CABOTEGRAVIR SODIUM, ROSUVASTATIN CALCIUM, |
||||
| 58 | 25487994 |
US |
||
Somnolence, Back pain, |
||||
RELUGOLIX, RELUGOLIX, |
||||
| 59 | 25487996 |
US |
||
Somnolence, Hot flush, |
||||
RELUGOLIX, RELUGOLIX, |
||||
| 60 | 25488184 |
US |
57 | 2 |
Sedation, Somnolence, Fatigue, Antipsychotic drug level increased, Drug interaction, |
||||
CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CIPROFLOXACIN, CIPROFLOXACIN HYDROCHLORIDE, CIPROFOLXACIN, CIPROFLOXACIN TABLETS, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, CLOZAPINE, DOXYCYCLINE, DOXYCYCLINE HYCLATE, VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN, CEFTRIAXONE, CEFTRIAXONE SODIUM, CEFAZOLIN SODIUM, CEFAZOLIN, TOBRAMYCIN, TOBRAMYCIN SULFATE, TOBRAMYCIN SOLUTION, ERTAPENEM, ERTAPENEM SODIUM, CEPHALEXIN, CEPHALEXIN, ALBUTEROL SULFATE, DIVALPROEX SODIUM, BETAMETHASONE DIPROPIONATE, LATANOPROST, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, |
||||
| 61 | 25488186 |
US |
43 | 1 |
Haematuria, Somnolence, Renal disorder, |
||||
| 62 | 25488450 |
US |
||
Somnolence, |
||||
| 63 | 25488469 |
US |
||
Somnolence, Dizziness, |
||||
| 64 | 25488480 |
US |
||
Somnolence, |
||||
| 65 | 25488530 |
IT |
21 | 1 |
Somnolence, Intentional overdose, Hypoventilation, Intentional product misuse, |
||||
OLANZAPINE, ALPRAZOLAM, |
||||
| 66 | 25488752 |
CA |
80 | 1 |
Pulmonary embolism, Sleep disorder, Sleep disorder therapy, Somnolence, Swelling, Thrombosis, Troponin increased, Ulcer, |
||||
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, ALLOPURINOL, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, CEFTRIAXONE SODIUM, DOBUTAMINE, DOBUTAMINE, DOBUTAMINE, GABAPENTIN, GABAPENTIN, GABAPENTIN, GABAPENTIN, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, HEPARIN SODIUM, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, METRONIDAZOLE, METRONIDAZOLE TOPICAL, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE (BITARTRATE), NOREPINEPHRINE, NOREPINEPHRINE BITARTRATE, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, ALBUTEROL SULFATE, ALBUTEROL, DOCUSATE SODIUM, DOCUSATE SODIUM 100MG, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, LANSOPRAZOLE, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, SODIUM BICARBONATE, SODIUM BICARBONATE INJECTION,, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, SIMVASTATIN, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, THEOPHYLLINE, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, VASOPRESSIN, ASCORBIC ACID, PHYTONADIONE, PHYTONADIONE, PHYTONADIONE, |
||||
| 67 | 25489048 |
FI |
33 | 2 |
Heart rate increased, Somnolence, Pharyngeal hypoaesthesia, Palatal disorder, Dysphagia, Nausea, Pharyngeal paraesthesia, Off label use, Paraesthesia oral, Fatigue, Vision blurred, Dry mouth, Respiratory failure, Hypoaesthesia oral, Dry eye, Dyspnoea, Dizziness, Hypotension, Cough, Headache, Muscular weakness, |
||||
ONABOTULINUMTOXINA, ONABOTULINUMTOXINA, |
||||
| 68 | 25489472 |
US |
2 | 2 |
Somnolence, |
||||
DUPILUMAB, |
||||
| 69 | 25489676 |
BR |
68 | 1 |
Decreased appetite, Somnolence, Nausea, Asthenia, Cough, Poor quality sleep, Somnambulism, Product use issue, |
||||
REGORAFENIB, REGORAFENIB, |
||||
| 70 | 25489825 |
US |
94 | 2 |
Dementia, Somnolence, |
||||
VALBENAZINE, |
||||
| 71 | 25490201 |
US |
2 | |
Urticaria, Somnolence, |
||||
LEVOCETIRIZINE DIHYDROCHLORIDE, |
||||
| 72 | 25490686 |
US |
12 | 2 |
Mood altered, Somnolence, |
||||
DUPILUMAB, DUPILUMAB, |
||||
| 73 | 25481541 |
CA |
34 | 2 |
Arthralgia, Feeling hot, Blood glucose decreased, Food craving, Low density lipoprotein decreased, Migraine, Pain, Alanine aminotransferase increased, Anxiety, Back pain, Biliary colic, Blood iron decreased, Cerebral disorder, Food aversion, Dyspnoea, Uterine haemorrhage, Uterine leiomyoma, Liver injury, Somnolence, Neck pain, Syncope, Lower respiratory tract infection, Flatulence, Fatigue, Malaise, Dehydration, Constipation, Dizziness, Nausea, Headache, Vomiting, Cholelithiasis, Contraindicated product prescribed, Drug dose titration not performed, Labelled drug-drug interaction issue, Product use complaint, Contraindicated product administered, Intentional product misuse, Lack of concomitant drug effect, Product use issue, Product dose omission issue, |
||||
LIRAGLUTIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE AND BUPROPION HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE, LORAZEPAM, MORPHINE, OXYMORPHONE HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE, |
||||
| 74 | 25481544 |
CN |
92 | 2 |
Asthenia, Somnolence, |
||||
CARBAMAZEPINE, |
||||
| 75 | 25481783 |
US |
15 | 2 |
Somnolence, Treatment noncompliance, |
||||
METHYLPHENIDATE HYDROCHLORIDE, |
||||
| 76 | 25481843 |
US |
71 | 2 |
Gait disturbance, Somnolence, Product dose omission issue, |
||||
TREPROSTINIL, TREPROSTINIL, TREPROSTINIL, INSULIN GLARGINE-YFGN, POLYETHYLENE GLYCOL 3350, SEVELAMER CARBONATE, ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM, FILM COATED, CLOPIDOGREL, CLOPIDOGREL BISULFATE, BISACODYL, BISACODYL SUPPOSITORIES, BISCODYL, SILDENAFIL CITRATE, SILDENAFIL, DULAGLUTIDE, CARVEDILOL, ENALAPRIL MALEATE, ENALAPRIL, MIDODRINE HYDROCHLORIDE, GABAPENTIN, |
||||
| 77 | 25481880 |
CN |
20 | 2 |
Mental impairment, Somnolence, Suicidal ideation, Affect lability, Off label use, |
||||
PERAMPANEL, PERAMPANEL, PERAMPANEL, |
||||
| 78 | 25481901 |
GB |
79 | 1 |
Somnolence, |
||||
RISANKIZUMAB-RZAA, TACROLIMUS, TACROLIMUS OINTMENT 0.1%, TACROLIMUS EXTENDED-RELEASE CAPSULES, TRIMETHOPRIM, AMOXICILLIN, AMOXICILLIN, ALBUTEROL SULFATE, ALBUTEROL, FOLIC ACID, DOXYCYCLINE, DOXYCYCLINE HYCLATE, DOXAZOSIN, DOXAZOSIN MESYLATE, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, SIMVASTATIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, LIRAGLUTIDE, BISOPROLOL FUMARATE, CANAGLIFLOZIN, WARFARIN, |
||||
| 79 | 25481948 |
FR |
14 | 2 |
Somnolence, Vomiting, Prothrombin time ratio decreased, Poisoning deliberate, |
||||
IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 80 | 25482230 |
GB |
54 | 1 |
Trigeminal neuralgia, Amnesia, Blindness, Brain fog, Gait disturbance, Confusional state, Suicidal ideation, Mouth swelling, Mental impairment, Pain in extremity, Photophobia, Lip swelling, Spinal pain, Tinnitus, Electric shock sensation, Dizziness, Nausea, Somnolence, Facial pain, Headache, Lethargy, Neuropathy peripheral, Depression, Feeling of despair, Toothache, COVID-19, Urinary bladder haemorrhage, Haematological infection, Dyspnoea, Urinary tract infection, Hepatic function abnormal, Hyponatraemia, Pyrexia, Hypothyroidism, White blood cell disorder, Immunosuppression, Punctate keratitis, Hypoaesthesia, Rash vesicular, Carpal tunnel syndrome, Dry eye, Anxiety, Flushing, Paraesthesia, Cough, Chest pain, Influenza like illness, |
||||
PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, OXCARBAZEPINE, EPTINEZUMAB-JJMR, OXYCODONE HYDROCHLORIDE, OXYCODONE, CARBAMAZEPINE, CARBAMAZEPINE, BACLOFEN, BACLOFEN, PHENYTOIN, PHENYTOIN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MIRTAZAPINE, BUPRENORPHINE, NALTREXONE, NAPROXEN, NAPROXEN SODIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DULOXETINE HYDROCHLORIDE, DULOXETINE, ACYCLOVIR, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, MAGNESIUM, GABAPENTIN, GABAPENTIN, GABAPENTIN, |
||||
| 81 | 25482686 |
GB |
||
COVID-19, Neuropathy peripheral, Feeling of despair, Toothache, Urinary tract infection, Hepatic function abnormal, Electric shock sensation, Tinnitus, Mental impairment, Immunosuppression, Hypothyroidism, White blood cell disorder, Photophobia, Spinal pain, Urinary bladder haemorrhage, Trigeminal neuralgia, Haematological infection, Hyponatraemia, Gait disturbance, Brain fog, Punctate keratitis, Blindness, Facial pain, Pyrexia, Dizziness, Nausea, Lip swelling, Pain in extremity, Amnesia, Headache, Depression, Suicidal ideation, Mouth swelling, Dyspnoea, Lethargy, Somnolence, Confusional state, Cough, Chest pain, Rash vesicular, Carpal tunnel syndrome, Flushing, Influenza like illness, Anxiety, Dry eye, Paraesthesia, Hypoaesthesia, |
||||
PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, PREGABALIN, OXCARBAZEPINE, OXYCODONE HYDROCHLORIDE, OXYCODONE, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, PREDNISOLONE, PREDNISOLONE ORAL, PREDNISOLONE ORAL SOLUTION, EPTINEZUMAB-JJMR, CARBAMAZEPINE, CARBAMAZEPINE, BACLOFEN, BACLOFEN, PHENYTOIN, PHENYTOIN, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, LAMOTRIGINE, LAMOTRIGINE EXTENDED-RELEASE, LAMOTRIGINE CHEWABLE DISPERSIBLE, LAMOTIRIGINE, MIRTAZAPINE, BUPRENORPHINE, NALTREXONE, NAPROXEN, NAPROXEN SODIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, LACOSAMIDE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), DULOXETINE HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, ACYCLOVIR, ONABOTULINUMTOXINA, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, LIDOCAINE, LIDOCAINE HYDROCHLORIDE, BURN RELIEF, MAXIMUM STRENGTH PAIN RELIEVER, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, LIDOCAINE 4%, LIDOCAINE, MENTHOL, MAGNESIUM, GABAPENTIN, GABAPENTIN, GABAPENTIN, |
||||
| 82 | 25482986 |
FR |
14 | 2 |
Prothrombin time ratio decreased, Poisoning deliberate, 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, |
||||
| 83 | 25483510 |
CA |
55 | 1 |
Acute kidney injury, Cognitive disorder, Confusional state, Delirium, Dementia, Gait disturbance, Glabellar reflex abnormal, Loss of personal independence in daily activities, Memory impairment, Rhabdomyolysis, Somnolence, Off label use, |
||||
NALOXONE HYDROCHLORIDE, NALOXONE, NALXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE, NALOXONE, NALXONE HYDROCHLORIDE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, BUPRENORPHINE, BUPRENORPHINE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, MIRTAZAPINE, MIRTAZAPINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETIN HYDROCHLORIDE, DULOXETINE, |
||||
| 84 | 25483572 |
US |
36 | 2 |
Somnolence, Fatigue, |
||||
ZURANOLONE, ZURANOLONE, SERTRALINE HYDROCHLORIDE, LEVOTHYROXINE SODIUM, |
||||
| 85 | 25483624 |
US |
76 | 2 |
Neuropathy peripheral, Nausea, Somnolence, |
||||
LENALIDOMIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE, PREGABALIN, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN 500MG, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, AFLIBERCEPT, ALBUTEROL SULFATE, ALBUTEROL, ASPIRIN, ASPIRIN 81 MG, ASPIRIN 325 MG, CALCIUM CARBONATE, ANTACID, CYANOCOBALAMIN, HYDROCHLOROTHIAZIDE, IRBESARTAN, LEVOTHYROXINE, LORATADINE, LORATADINE ORAL, MAGNESIUM, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, ONDANSETRON HYDROCHLORIDE, ONDANSETRON, ONDANSETRON TABLETS, POTASSIUM CHLORIDE, POTASSIUM CHLORIDE EXTENDED-RELEASE, POTASSIUM CHLORIDE, DEXTROSE MONOHYDRATE, POTASSIUM CHLORIDE ORAL, PROCHLORPERAZINE, SODIUM CHLORIDE, SODIUM CHLORIDE INJECTION, SODIUM CHLORIDE TABLET, |
||||
| 86 | 25483640 |
US |
33 | 2 |
Dizziness, Somnolence, |
||||
ZURANOLONE, |
||||
| 87 | 25483661 |
US |
2 | |
Adverse drug reaction, Feeling drunk, Sleep disorder, Dizziness, Somnolence, |
||||
FLIBANSERIN, |
||||
| 88 | 25483688 |
US |
45 | 2 |
Somnolence, Dizziness, |
||||
VALBENAZINE, |
||||
| 89 | 25484469 |
|||
Somnolence, |
||||
| 90 | 25485003 |
FR |
56 | 1 |
Drug abuse, Toxicity to various agents, Malaise, Loss of consciousness, Somnolence, Muscle spasms, |
||||
PAROXETINE HYDROCHLORIDE HEMIHYDRATE, PAROXETINE, PAROXETINE HYDROCHLORIDE, CANNABIDIOL, DRONABINOL, PREGABALIN, |
||||
| 91 | 25485014 |
FR |
91 | 1 |
Sinus bradycardia, Somnolence, Disorientation, Product prescribing error, Incorrect dose administered, Prescribed overdose, |
||||
OLANZAPINE, |
||||
| 92 | 25485153 |
US |
14 | 2 |
Blood glucose increased, Headache, Nausea, Somnolence, Abdominal pain upper, |
||||
INSULIN LISPRO, |
||||
| 93 | 25485296 |
CZ |
1 | |
Hyperthyroidism, Myalgia, Malaise, Somnolence, |
||||
CABOTEGRAVIR SODIUM, CABOTEGRAVIR SODIUM, CABOTEGRAVIR SODIUM, ROSUVASTATIN CALCIUM, |
||||
| 94 | 25485523 |
US |
||
Seizure, Somnolence, |
||||
VIGABATRIN, VIGABATRIN, |
||||
| 95 | 25485795 |
US |
||
Fatigue, Disturbance in attention, Somnolence, |
||||
NEMOLIZUMAB-ILTO, NEMOLIZUMAB-ILTO, |
||||
| 96 | 25485837 |
US |
||
Somnolence, Dermatitis atopic, Incorrect dose administered, |
||||
NEMOLIZUMAB-ILTO, |
||||
| 97 | 25486300 |
CA |
62 | 2 |
Abnormal faeces, Dysphagia, Dyspnoea, Dyspnoea exertional, Furuncle, Gait inability, Hydrothorax, Libido increased, Pain, Weight increased, Balance disorder, Uterine polyp, Uterine mass, Uterine haemorrhage, Menstrual disorder, Injection site vesicles, Blood urine present, Dysuria, Chest pain, Abdominal pain lower, Abdominal pain lower, Vaginal haemorrhage, Frequent bowel movements, Somnolence, Peripheral swelling, Abdominal pain upper, Vomiting, Injection site pain, Asthenia, Headache, Blood glucose abnormal, Fatigue, Dizziness, Nausea, Nausea, Abdominal pain, Abdominal discomfort, Hyperglycaemia, Incorrect route of product administration, |
||||
PASIREOTIDE, PASIREOTIDE, PASIREOTIDE, PANTOPRAZOLE, HYDROCORTISONE, CALCIUM, ERGOCALCIFEROL, IRON, UREA, UREA, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ROSUVASTATIN CALCIUM, CABERGOLINE, |
||||
| 98 | 25475900 |
CA |
55 | |
Acute kidney injury, Glabellar reflex abnormal, Gait disturbance, Confusional state, Delirium, Dementia, Rhabdomyolysis, Somnolence, Memory impairment, Loss of personal independence in daily activities, Cognitive disorder, Overdose, |
||||
CITALOPRAM, CITALOPRAM HYDROBROMIDE, CITALOPRAM, CITALOPRAM HYDROBROMIDE, DULOXETINE HYDROCHLORIDE, DULOXETINE, DULOXETINE HYDROCHLORIDE, DULOXETINE, BUPRENORPHINE, QUETIAPINE FUMARATE, QUETIAPINE, QUETIAPINE FUMARATE, QUETIAPINE, NALOXONE, MIRTAZAPINE, MIRTAZAPINE, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, ARIPIPRAZOLE ORALLY DISINTEGRATING, ARIPIPRAZOLE, ARIPIPRAZOLE ORAL, |
||||
| 99 | 25476239 |
ES |
43 | 1 |
Depressed level of consciousness, Tachycardia, Generalised tonic-clonic seizure, Long QT syndrome, Hypotension, Miosis, Disorientation, Psychomotor retardation, Hallucination, visual, Encephalopathy, Somnolence, Suicide attempt, |
||||
QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, DIAZEPAM, DIAZEPAM ORAL, DIAZEPAM ORAL SOLUTION (CONCENTRATE), BUPROPION HYDROCHLORIDE, LISINOPRIL, |
||||
| 100 | 25476357 |
US |
2 | |
Somnolence, Fatigue, Abdominal pain, Nausea, |
||||
TIRZEPATIDE, |
||||
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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
2025-07-29