Drug:
Reaction: INSOMNIA
20250101 - 20251231
No. 901 - 1000
| No. | safetyreportid |
occurcountry |
patientonsetage |
patientsex 1:M 2:F |
|---|---|---|---|---|
Adverse reaction |
||||
Drug (openfda.generic_name, medicinalproduct) |
||||
| 901 | 25017353 |
US |
2 | |
Insomnia, |
||||
TIRZEPATIDE, TIRZEPATIDE, |
||||
| 902 | 25017768 |
US |
72 | 2 |
Headache, Vision blurred, Dizziness, Fatigue, Insomnia, Eye pain, Foreign body sensation in eyes, Product delivery mechanism issue, Product dose omission in error, Wrong technique in product usage process, Inappropriate schedule of product administration, Liquid product physical issue, |
||||
BRIMONIDINE TARTRATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 903 | 25017796 |
SE |
68 | 2 |
Eye pain, Blindness, Paraesthesia, Cough, Peripheral coldness, Headache, Limb injury, Fall, Neuralgia, Ophthalmic migraine, Insomnia, Nausea, Dizziness, Muscle spasms, Hypoaesthesia, Visual impairment, Chest pain, Hypotension, |
||||
METOPROLOL TARTRATE, METOPROLOL, METOPROLOL TARTRATE, METOPROLOL, ALENDRONATE SODIUM, ALENDRONATE SODIUM TABLET, |
||||
| 904 | 25017918 |
DE |
70 | 1 |
Pneumonia, Hallucination, visual, Hallucination, Altered state of consciousness, Increased bronchial secretion, Acute kidney injury, Soliloquy, Insomnia, |
||||
MIRTAZAPINE, MIRTAZAPINE, AMLODIPINE, RISPERIDONE, RISPERIDONE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, |
||||
| 905 | 25017962 |
US |
2 | |
Abdominal pain upper, Initial insomnia, Insomnia, |
||||
TROFINETIDE, |
||||
| 906 | 25018018 |
US |
77 | 2 |
Body temperature increased, Blood pressure decreased, Neuropathy peripheral, Myalgia, Arthralgia, Insomnia, Fatigue, |
||||
| 907 | 25018024 |
US |
1 | |
Aspiration, Choking, Epiglottis dysfunction, Mood altered, Dysphagia, Insomnia, Vomiting, Loss of personal independence in daily activities, General physical health deterioration, |
||||
PIMAVANSERIN TARTRATE, QUETIAPINE, |
||||
| 908 | 25018187 |
|||
Cough, Productive cough, Tremor, Loss of consciousness, Dyspnoea, Wheezing, Depression, Decreased interest, Insomnia, Fatigue, Restlessness, Psychiatric symptom, Haemorrhage, Diverticulitis, |
||||
MACITENTAN, |
||||
| 909 | 25018215 |
|||
Cough, Productive cough, Tremor, Loss of consciousness, Dyspnoea, Wheezing, Depression, Decreased interest, Insomnia, Fatigue, Restlessness, Psychiatric symptom, Haemorrhage, Diverticulitis, Heart valve operation, |
||||
SILDENAFIL CITRATE, SILDENAFIL, SILDENAFIL POWDER,, |
||||
| 910 | 25018224 |
DE |
70 | 1 |
Hallucination, visual, Pneumonia, Insomnia, Altered state of consciousness, Increased bronchial secretion, Soliloquy, Acute kidney injury, |
||||
AMLODIPINE, MIRTAZAPINE, RISPERIDONE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, |
||||
| 911 | 25018307 |
US |
||
Tremor, Insomnia, |
||||
PIMAVANSERIN TARTRATE, |
||||
| 912 | 25018347 |
US |
45 | 1 |
Insomnia, Middle insomnia, Thirst, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 913 | 25018348 |
US |
2 | |
Insomnia, Product dose omission issue, |
||||
SODIUM OXYBATE, |
||||
| 914 | 25018350 |
US |
2 | |
Initial insomnia, Migraine, Feeling abnormal, Nasal congestion, Sinus congestion, Snoring, Insomnia, Dizziness, Nocturia, Somnolence, Feeling drunk, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, ATOGEPANT, PITOLISANT HYDROCHLORIDE, |
||||
| 915 | 25018367 |
US |
1 | |
Insomnia, Initial insomnia, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, PITOLISANT HYDROCHLORIDE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 916 | 25018370 |
US |
20 | 1 |
Hallucinations, mixed, Fear, Insomnia, Thinking abnormal, Brain fog, Wrong technique in product usage process, Intentional dose omission, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL, SOLRIAMFETOL, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, |
||||
| 917 | 25018371 |
US |
1 | |
Insomnia, Dizziness, Hypersensitivity, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, MODAFINIL, CETIRIZINE HYDROCHLORIDE, |
||||
| 918 | 25018373 |
US |
27 | 2 |
Bruxism, Insomnia, Fatigue, Nausea, |
||||
SODIUM OXYBATE, SOLRIAMFETOL, |
||||
| 919 | 25018375 |
US |
2 | |
Middle insomnia, Insomnia, Dry throat, Terminal insomnia, Nocturia, Nausea, Tremor, Headache, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 920 | 25018376 |
US |
2 | |
Fatigue, Insomnia, Terminal insomnia, Thirst, Maternal exposure during pregnancy, Nocturia, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 921 | 25018381 |
US |
2 | |
Insomnia, Retching, Vomiting, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 922 | 25018382 |
US |
1 | |
Feeling abnormal, Insomnia, Poor quality sleep, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 923 | 25018386 |
US |
2 | |
Insomnia, Sleep apnoea syndrome, Unevaluable event, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 924 | 25018389 |
US |
50 | 2 |
Insomnia, Feeling abnormal, Intentional dose omission, Wrong technique in product usage process, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL, MODAFINIL, |
||||
| 925 | 25018392 |
US |
45 | 2 |
Middle insomnia, Insomnia, Incorrect dose administered, |
||||
SODIUM OXYBATE, |
||||
| 926 | 25018396 |
US |
54 | 1 |
Middle insomnia, Insomnia, Hyperhidrosis, |
||||
SODIUM OXYBATE, |
||||
| 927 | 25018397 |
US |
72 | 1 |
Initial insomnia, Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 928 | 25018405 |
US |
2 | |
Insomnia, Peripheral swelling, |
||||
SODIUM OXYBATE, |
||||
| 929 | 25018415 |
US |
38 | 2 |
Initial insomnia, Insomnia, Feeling abnormal, Flatulence, Abdominal distension, Nasal congestion, Discomfort, Brain fog, Vertigo, Diarrhoea, Nocturia, Abdominal pain upper, Nausea, Dizziness, Headache, Memory impairment, Therapeutic response unexpected, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, ALPRAZOLAM, BACLOFEN, CETIRIZINE, CETIRIZINE HYDROCHLORIDE, CETIIRIZINE, FISH OIL, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, SOLRIAMFETOL, TERBINAFINE HYDROCHLORIDE, TERBINAFINE, VALACYCLOVIR, VALACYCLOVIR HYDROCHLORIDE, |
||||
| 930 | 25018417 |
US |
24 | 2 |
Eructation, Flatulence, Insomnia, Abdominal discomfort, Sinus disorder, Hypersensitivity, Abdominal pain upper, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, ARIPIPRAZOLE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, MESALAMINE, ALBUTEROL SULFATE, ONDANSETRON HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE, IRON, VILAZODONE HYDROCHLORIDE, ACETAMINOPHEN, ACETAMINOPHEN ORAL SOLUTION, ACETAMINOPHEN TABLET EXTENDED RELEASE, PAIN RELIEVER, ACETAMINOPHEN, DIPHENHYDRAMINE HCL, |
||||
| 931 | 25018423 |
US |
53 | 2 |
Fatigue, Insomnia, Feeling abnormal, Irritability, Memory impairment, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, PITOLISANT HYDROCHLORIDE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, PITOLISANT HYDROCHLORIDE, ERGOCALCIFEROL, METFORMIN HYDROCHLORIDE, METFORMIN, METFORMIN HYDROCHLORIDE EXTENDED-RELEASE TABLETS, METFORMIN HYDROCHLORIDE TABLET, METFORMIN HYDROCHLORIDE TABLETS, PROGESTERONE, CALCIUM, MAGNESIUM, POTASSIUM, AND SODIUM OXYBATES, |
||||
| 932 | 25018428 |
US |
2 | |
Insomnia, Vomiting, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 933 | 25018429 |
US |
1 | |
Insomnia, Middle insomnia, |
||||
SODIUM OXYBATE, |
||||
| 934 | 25018431 |
US |
16 | 2 |
Insomnia, Sedation, Crying, Feeling abnormal, Fatigue, Sleep deficit, Nausea, Fall, Drug ineffective, Wrong technique in product usage process, Product dose omission issue, Intentional dose omission, Hypophagia, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 935 | 25018433 |
US |
1 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 936 | 25018434 |
US |
35 | 2 |
Insomnia, Hangover, |
||||
SODIUM OXYBATE, |
||||
| 937 | 25018437 |
US |
2 | |
Loss of consciousness, Middle insomnia, Vertigo, Feeling abnormal, Insomnia, Initial insomnia, Hypophagia, Sleep deficit, Blood potassium decreased, Blood calcium increased, Fatigue, Restlessness, Drug interaction, Somnolence, Dizziness, Vomiting, Nausea, Weight decreased, Muscle spasms, Drug ineffective, Product dose omission issue, Wrong technique in product usage process, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, QUETIAPINE, QUETIAPINE EXTENDED-RELEASE, SEMAGLUTIDE, LITHIUM, LITHIUM BROMATUM, CLONAZEPAM, CLONAZEPAM, QUETIAPINE, PROPRANOLOL HYDROCHLORIDE, METHYLPHENIDATE, METHYLPHENIDATE HYDROCHLORIDE, MODAFINIL, PITOLISANT HYDROCHLORIDE, LITHIUM CARBONATE, VALACYCLOVIR HYDROCHLORIDE, PROMETHAZINE, PROMETHAZINE, PROMETHAZINE, HYOSCYAMINE SULFATE, HYOSCYAMINE SULFATE, HYOSCYAMINE SULFATE, LEVONORGESTREL, |
||||
| 938 | 25018440 |
US |
49 | 2 |
Insomnia, Balance disorder, Middle insomnia, Nocturia, |
||||
SODIUM OXYBATE, |
||||
| 939 | 25018442 |
US |
49 | 2 |
Insomnia, Heart rate decreased, Restlessness, Hallucination, Somnolence, Hyperhidrosis, Nausea, Arthralgia, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 940 | 25018444 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 941 | 25018448 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 942 | 25018449 |
US |
37 | 2 |
Insomnia, Fatigue, |
||||
SODIUM OXYBATE, |
||||
| 943 | 25018456 |
US |
2 | |
Middle insomnia, Insomnia, Fatigue, Restlessness, Tachyphrenia, Pain in jaw, Bruxism, Nausea, Vomiting, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, INSULIN LISPRO, FREMANEZUMAB-VFRM, RIMEGEPANT SULFATE, LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM ANHYDROUS, BUPROPION HYDROCHLORIDE, PANCRELIPASE, TIRZEPATIDE, GLYCOPYRRONIUM, FLUTICASONE PROPIONATE, MAGNESIUM, CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE OINTMENT USP, 0.05%, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, KETOROLAC TROMETHAMINE, ESCITALOPRAM, |
||||
| 944 | 25018460 |
US |
1 | |
Insomnia, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 945 | 25018468 |
US |
1 | |
Insomnia, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, METOPROLOL TARTRATE, METOPROLOL, ROPINIROLE, METFORMIN, METFORMIN ER 500 MG, METFORMIN ER 750 MG, EMPAGLIFLOZIN, SEMAGLUTIDE, GALCANEZUMAB-GNLM, ATOMOXETINE, MODAFINIL, TIOTROPIUM BROMIDE AND OLODATEROL, |
||||
| 946 | 25018469 |
US |
2 | |
Insomnia, Middle insomnia, Abnormal sleep-related event, Feeling hot, Contusion, Neck pain, Enuresis, Pain in extremity, Somnambulism, Tremor, Blood pressure increased, Drug effect less than expected, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 947 | 25018472 |
US |
2 | |
Middle insomnia, Insomnia, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 948 | 25018484 |
US |
2 | |
Suicidal ideation, Depression, Insomnia, Sedation, Unevaluable event, Therapeutic response unexpected, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 949 | 25018496 |
US |
2 | |
Retching, Insomnia, Middle insomnia, Fatigue, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 950 | 25018501 |
US |
2 | |
Insomnia, Middle insomnia, Enuresis, Drug ineffective, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 951 | 25018506 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 952 | 25018508 |
US |
1 | |
Insomnia, Fatigue, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 953 | 25018509 |
US |
66 | 2 |
Insomnia, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, MODAFINIL, ERGOCALCIFEROL, LOSARTAN POTASSIUM, LOSARTAN, FERROUS SULFATE, VENLAFAXINE HYDROCHLORIDE, PITOLISANT HYDROCHLORIDE, VITAMIN C, ERGOCALCIFEROL, MODAFINIL, OMEPRAZOLE, OMEPRAZOLE MAGNESIUM, AMLODIPINE BESYLATE, ROSUVASTATIN, |
||||
| 954 | 25018510 |
US |
2 | |
Hunger, Compulsions, Insomnia, Poor quality sleep, Middle insomnia, Heart rate abnormal, Fatigue, Brain fog, Decreased appetite, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, LITHIUM, LITHIUM BROMATUM, LAMOTRIGINE, CETIRIZINE HYDROCHLORIDE, |
||||
| 955 | 25018511 |
US |
2 | |
Insomnia, Distractibility, Fatigue, Disturbance in attention, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 956 | 25018515 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, PITOLISANT HYDROCHLORIDE, |
||||
| 957 | 25018521 |
US |
2 | |
Hypersomnia, Tachyphrenia, Crying, Fatigue, Thirst, Insomnia, Sleep-related eating disorder, Paraesthesia, Nocturia, Enuresis, Confusional state, Emotional disorder, Disorientation, Depressed mood, Unevaluable event, Wrong technique in product usage process, Intentional dose omission, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, PITOLISANT HYDROCHLORIDE, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL, |
||||
| 958 | 25018538 |
US |
1 | |
Insomnia, Sciatica, Feeling abnormal, Initial insomnia, Middle insomnia, Somnolence, Unevaluable event, Therapeutic response unexpected, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, TIZANIDINE HYDROCHLORIDE, PITOLISANT HYDROCHLORIDE, LISINOPRIL, LEVOTHYROXINE SODIUM, SOLRIAMFETOL, LORAZEPAM, |
||||
| 959 | 25018540 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 960 | 25018542 |
US |
1 | |
Gait inability, Middle insomnia, Fatigue, Gait disturbance, Insomnia, Arthralgia, Nocturia, Diarrhoea, Vomiting, Depression, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, BUPROPION HYDROCHLORIDE, SOLRIAMFETOL, ERGOCALCIFEROL, |
||||
| 961 | 25018546 |
US |
1 | |
Blood pressure decreased, Nail discolouration, Peripheral coldness, Insomnia, Cough, Heart rate increased, Nasopharyngitis, Nausea, Headache, Unevaluable event, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, MODAFINIL, ERGOCALCIFEROL, |
||||
| 962 | 25018556 |
US |
2 | |
Insomnia, Fatigue, |
||||
SODIUM OXYBATE, |
||||
| 963 | 25018568 |
US |
2 | |
Streptococcal urinary tract infection, Flushing, Flatulence, Abdominal distension, Urine abnormality, Flank pain, Escherichia urinary tract infection, Insomnia, Diarrhoea, Headache, Off label use, |
||||
SODIUM OXYBATE, MAGNESIUM CITRATE, MAJOR MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, CVS MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, CVS MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - LEMON, LEADER MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, BE HEALTH MAGNESIUM CITRATE ORAL SOLUTION - LEMON, FRESKARO MAGNESIUM CITRATE ORAL SOLUTION - CHERRY, LEADER MAGNESIUM CITRATE ORAL SOLUTION - GRAPE, HARRIS TEETER MAGNESIUM CITRATE ORAL SOLUTION - LEMON, ERGOCALCIFEROL, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, ALBUTEROL SULFATE, FLUTICASONE PROPIONATE AND SALMETEROL, CETIRIZINE HYDROCHLORIDE, LISINOPRIL, BUPRENORPHINE AND NALOXONE, BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE, DIVALPROEX SODIUM, BUPROPION HYDROCHLORIDE, |
||||
| 964 | 25018569 |
US |
1 | |
Abnormal sleep-related event, Fatigue, Muscular weakness, Restless legs syndrome, Insomnia, Joint swelling, Tendon pain, Arthralgia, Pain in extremity, Peripheral swelling, Memory impairment, Tremor, Somnolence, Muscle spasms, Fall, Therapeutic product effect incomplete, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 965 | 25018570 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 966 | 25018575 |
US |
1 | |
Initial insomnia, Fatigue, Insomnia, Drug ineffective, Nausea, Hangover, Unevaluable event, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, LISINOPRIL, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, ERGOCALCIFEROL, MAGNESIUM, PRAMIPEXOLE DIHYDROCHLORIDE, DESVENLAFAXINE, DESVENLAFAXINE SUCCINATE, AMPHETAMINE, AMPHETAMINE SULFATE, AMPHETAMINE SULFATE TABLETS, CHLORTHALIDONE, |
||||
| 967 | 25018577 |
US |
40 | 2 |
Initial insomnia, Insomnia, Stress, Somnolence, Unevaluable event, Drug ineffective, |
||||
SODIUM OXYBATE, |
||||
| 968 | 25018583 |
US |
2 | |
Middle insomnia, Insomnia, Poor quality sleep, Drug ineffective, |
||||
SODIUM OXYBATE, |
||||
| 969 | 25018590 |
US |
2 | |
Loss of consciousness, Insomnia, Restless legs syndrome, Somnolence, Nausea, Vomiting, Headache, Dizziness, Fall, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 970 | 25018595 |
US |
2 | |
Insomnia, |
||||
SODIUM OXYBATE, |
||||
| 971 | 25018599 |
US |
60 | 2 |
Insomnia, Middle insomnia, Snoring, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 972 | 25018605 |
US |
21 | 1 |
Insomnia, Stress, Decreased appetite, Somnolence, Anxiety, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 973 | 25018606 |
US |
2 | |
Terminal insomnia, Insomnia, Sluggishness, Somnolence, Drug ineffective, Wrong technique in product usage process, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, BUPROPION HYDROCHLORIDE, |
||||
| 974 | 25018609 |
US |
2 | |
Insomnia, Appetite disorder, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, BUSPIRONE HYDROCHLORIDE, |
||||
| 975 | 25018618 |
US |
1 | |
Poor quality sleep, Insomnia, Initial insomnia, Headache, Nausea, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 976 | 25018620 |
US |
2 | |
Insomnia, Muscle tightness, Alopecia, Myalgia, Decubitus ulcer, Sleep disorder, Hyperhidrosis, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, CALCIUM, IRON, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 977 | 25018633 |
US |
2 | |
Poor quality sleep, Insomnia, Feeling abnormal, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, IBUPROFEN, IBUPROFEN CAPSULES 200 MG, IBUPROFEN TABLETS USP, 200MG, IBUPROFEN ORAL, IBUPROFEN 200MG, IBUPFROFEN, IBUPROFEN TABLET, FILM-COATED, IBUPROFEN 200 MG, IBUPROFEN CAPSULE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, |
||||
| 978 | 25018635 |
US |
2 | |
Poor quality sleep, Insomnia, Asthenia, Nausea, Dizziness, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 979 | 25018638 |
US |
1 | |
Insomnia, Sedation, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 980 | 25018651 |
US |
2 | |
Insomnia, Drug ineffective, |
||||
SODIUM OXYBATE, MELATONIN, ERGOCALCIFEROL, MAGNESIUM, KETOTIFEN FUMARATE, VITAMIN C, ONDANSETRON HYDROCHLORIDE, PANTOPRAZOLE SODIUM, PANTOPRAZOLE, PANTOPRAZOLE SODIUM IN 0.9% SODIUM CHLORIDE, PANTOPRAZOLE SODIUM INJECTION, ATOGEPANT, METHYLPHENIDATE HYDROCHLORIDE, METHOCARBAMOL, METHOCARBAMOL TABLETS, NABUMETONE, RIZATRIPTAN, ALPRAZOLAM, HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE, CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE, AMITRIPTYLINE HYDROCHLORIDE, ESCITALOPRAM OXALATE, ESCITALOPRAM, BUPROPION HYDROCHLORIDE, SPIRONOLACTONE, MIDODRINE HYDROCHLORIDE, MONTELUKAST SODIUM, MONTELUKAST, GABAPENTIN ENACARBIL, |
||||
| 981 | 25018657 |
US |
2 | |
Insomnia, Fatigue, |
||||
SODIUM OXYBATE, |
||||
| 982 | 25018660 |
US |
49 | 2 |
Insomnia, Fatigue, Nausea, Anxiety, |
||||
SODIUM OXYBATE, |
||||
| 983 | 25018664 |
US |
2 | |
Respiration abnormal, Snoring, Gait disturbance, Abnormal sleep-related event, Feeling abnormal, Insomnia, Nocturia, Disorientation, Hyperhidrosis, Intentional dose omission, |
||||
SODIUM OXYBATE, ARMODAFINIL, |
||||
| 984 | 25018668 |
US |
1 | |
Insomnia, Fatigue, Stress, Sluggishness, Somnolence, Intentional dose omission, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, ALCOHOL, ETHYL ALCOHOL, ISOPROPYL ALCOHOL, |
||||
| 985 | 25018669 |
US |
2 | |
Insomnia, Performance status decreased, Poor quality sleep, Fatigue, Stress, Initial insomnia, Somnolence, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 986 | 25018675 |
US |
2 | |
Insomnia, Fatigue, Nausea, Nocturia, Tremor, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 987 | 25018682 |
US |
2 | |
Insomnia, Poor quality sleep, Initial insomnia, Nausea, Dizziness, Cataplexy, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 988 | 25018691 |
US |
1 | |
Terminal insomnia, Insomnia, Middle insomnia, Myoclonus, Skin odour abnormal, Abnormal sleep-related event, Palpitations, Peripheral swelling, Unevaluable event, Somnolence, Therapeutic product effect incomplete, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, ARMODAFINIL, |
||||
| 989 | 25018698 |
US |
48 | 2 |
Insomnia, Middle insomnia, Headache, Depression, Anxiety, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE ASPARTATE, DEXTROAMPHETAMINE SULFATE, AND AMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SACCHARATE, AMPHETAMINE SULFATE AND AMPHETAMINE ASPARTATE, LISDEXAMFETAMINE DIMESYLATE, |
||||
| 990 | 25018700 |
US |
35 | 2 |
Insomnia, Middle insomnia, Nocturia, Headache, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 991 | 25018702 |
US |
43 | 2 |
Insomnia, Middle insomnia, Enuresis, Disorientation, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 992 | 25018708 |
US |
78 | 2 |
Hallucination, Initial insomnia, Terminal insomnia, Herpes zoster, Feeling abnormal, Urinary tract infection, Insomnia, Hot flush, Middle insomnia, Nocturia, Hyperhidrosis, Unevaluable event, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 993 | 25018710 |
US |
2 | |
Poor quality sleep, Middle insomnia, Abnormal dreams, Myalgia, Insomnia, Emotional distress, Feeling guilty, Feeling abnormal, Nervous system disorder, Pain, Anxiety, Depressed mood, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 994 | 25018711 |
US |
22 | 1 |
Insomnia, Fatigue, Pharyngitis streptococcal, Performance status decreased, Drug ineffective, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 995 | 25018718 |
US |
2 | |
Insomnia, Product dose omission issue, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, SOLRIAMFETOL, |
||||
| 996 | 25018721 |
US |
53 | 2 |
Insomnia, Anxiety, Vomiting, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 997 | 25018723 |
US |
35 | 1 |
Insomnia, Middle insomnia, |
||||
SODIUM OXYBATE, |
||||
| 998 | 25018724 |
US |
1 | |
Initial insomnia, Insomnia, Somnolence, |
||||
SODIUM OXYBATE, |
||||
| 999 | 25018726 |
US |
39 | 2 |
Feeling abnormal, Abnormal dreams, Hunger, Thirst, Insomnia, Nightmare, Feeling hot, Poor quality sleep, Hot flush, Discomfort, Nocturia, Somnolence, Headache, Anxiety, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, |
||||
| 1000 | 25018727 |
US |
62 | 2 |
Terminal insomnia, Insomnia, Sinus disorder, Nasal congestion, Dyspnoea, Poor quality sleep, Sleep apnoea syndrome, Middle insomnia, Hypersensitivity, |
||||
SODIUM OXYBATE, SODIUM OXYBATE, SODIUM OXYBATE, ALBUTEROL SULFATE, HYDROCHLOROTHIAZIDE, LISINOPRIL, CEVIMELINE HYDROCHLORIDE, MELOXICAM, HYDROXYCHLOROQUINE SULFATE, |
||||
disclaimer
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