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Index of reports
> Cases with Somnolence (54)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Fentanyl where reactions include somnolence. The selected reports were submitted to the FDA during the sample period of about a year. Reports 1 - 30 of 54 Next >>
Possible Fentanyl side effects in 65 year old female
Reported by a health professional (non-physician/pharmacist) from Israel on 2012-08-24
Patient: 65 year old female
Reactions: Drug Tolerance, Respiratory Arrest, Somnolence
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fentanyl
Fentanyl
Fentanyl
Indication: Pain
Possible Fentanyl side effects in 3 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 3 year old male, weighing 16.8 kg (36.9 pounds)
Reactions: Oedema Peripheral, Somnolence, Lethargy, Blister
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Fentanyl
Possible Fentanyl side effects in female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-02
Patient: female
Reactions: Wrong Technique in Drug Usage Process, Overdose, Heart Rate Decreased, Pyrexia, Hyperhidrosis, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: changed q72h
Start date: 2012-06-01
End date: 2012-06-01
Fentanyl
Dosage: changed q72h
Indication: Arthralgia
Start date: 2012-06-01
Possible Fentanyl side effects in 61 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-30
Patient: 61 year old male, weighing 114.5 kg (251.9 pounds)
Reactions: Mental Status Changes, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: 75mcg per hour top
Administration route: Topical
Indication: Pain
Start date: 2012-06-27
End date: 2012-07-25
Morphine
Dosage: 30 mg qid po
Administration route: Oral
Indication: Pain
Start date: 2012-06-27
End date: 2012-07-27
Possible Fentanyl side effects in 41 year old female
Reported by a pharmacist from United States on 2012-07-27
Patient: 41 year old female, weighing 75.2 kg (165.4 pounds)
Reactions: Dysarthria, Somnolence, Accidental Overdose
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Diazepam
Dosage: chronic
Indication: Back Pain
Dilaudid
Dosage: chronic
Indication: Back Pain
Fentanyl
Dosage: chronic
Indication: Back Pain
Klonopin
Dosage: chronic
Indication: Back Pain
Lorazepam
Dosage: chronic
Indication: Back Pain
Morphine
Dosage: chronic
Indication: Back Pain
Tofranil
Dosage: chronic
Indication: Back Pain
Tramadol HCL
Dosage: chronic
Indication: Back Pain
Other drugs received by patient: Synthroid; Lotemax; Prednisone TAB; Reglan; Depakote; Restasis; Seasonale; Zofran; Colace
Possible Fentanyl side effects in male
Reported by a pharmacist from United States on 2012-07-17
Patient: male
Reactions: Product Quality Issue, Overdose, Pruritus, Insomnia, Drug Administration Error, Hyperhidrosis, Somnolence
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Vicodin
Possible Fentanyl side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female
Reactions: Somnolence
Drug(s) suspected as cause:
Fentanyl
Possible Fentanyl side effects in male
Reported by a physician from United States on 2012-07-09
Patient: male, weighing 102.0 kg (224.4 pounds)
Reactions: Blood Pressure Increased, Poor Quality Sleep, Tinnitus, Drug Ineffective, Asthenia, Somnolence
Drug(s) suspected as cause:
Ambien
Dosage: unk
Indication: Sleep Disorder
Amlodipine Besylate
Dosage: 10 mg, daily
Indication: Hypertension
Start date: 2011-11-01
Chantix
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2012-06-10
End date: 2012-01-01
Chantix
Dosage: unk, daily
Administration route: Oral
Start date: 2012-01-01
Chantix
Dosage: unk, 2x/day
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Fentanyl
Dosage: 100 ug two patch every two days
Indication: Pain
Morphine Sulfate
Dosage: 100mg two times a day with 30mg daily
Indication: Pain
Other drugs received by patient: Crestor; Hydrochlorothiazide; Tamsulosin Hydrochloride; Lortab; Glucophage; Flexeril; Valium; Valium; Lisinopril; Pravachol; Simvastatin; Zetia
Possible Fentanyl side effects in 48 year old female
Reported by a consumer/non-health professional from United States on 2012-07-03
Patient: 48 year old female
Reactions: Wrong Drug Administered, Somnolence
Drug(s) suspected as cause:
Cymbalta
Dosage: unk
Fentanyl
Dosage: 50 mg patch
Lyrica
Dosage: unk
Percocet
Dosage: unk
Rimadyl
Robaxin
Dosage: unk
Possible Fentanyl side effects in male
Reported by a consumer/non-health professional from United States on 2012-06-18
Patient: male, weighing 102.0 kg (224.4 pounds)
Reactions: Blood Pressure Increased, Poor Quality Sleep, Tinnitus, Drug Ineffective, Asthenia, Somnolence
Drug(s) suspected as cause:
Ambien
Dosage: unk
Indication: Sleep Disorder
Amlodipine Besylate
Dosage: 10 mg, daily
Indication: Hypertension
Start date: 2011-11-01
Chantix
Dosage: unk, daily
Administration route: Oral
Start date: 2012-01-01
Chantix
Dosage: 0.5 mg, daily
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2012-06-10
End date: 2012-01-01
Chantix
Dosage: unk, 2x/day
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Fentanyl
Dosage: 100 ug two patch every two days
Indication: Pain
Morphine Sulfate
Dosage: 100mg two times a day with 30mg daily
Indication: Pain
Other drugs received by patient: Diazepam; Tamsulosin Hydrochloride; Metformin; Diazepam; Lisinopril; Hydrocodone Bitartrate and Acetaminophen
Possible Fentanyl side effects in 32 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-18
Patient: 32 year old male
Reactions: Wrong Technique in Drug Usage Process, Unresponsive To Stimuli, Mental Status Changes, Toxicity To Various Agents, Somnolence, Respiratory Rate Decreased, Miosis, Dizziness, Multiple Drug Overdose Intentional, Depressed Level of Consciousness, Suicide Attempt, Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: po
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Fentanyl
Dosage: 2 df; 1x; po
Administration route: Oral
Other drugs received by patient: Methamphetamine
Possible Fentanyl side effects in 90 year old female
Reported by a health professional (non-physician/pharmacist) from France on 2012-06-13
Patient: 90 year old female
Reactions: Off Label Use, Hypothermia, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Lyrica; Doliprane (Phenacetyl); Aspirin; Nicorandil (Nicorandil); Clopidegrel; Lorazepam; Nebivolol HCL; Ranitidine Hydrochloride; Atorvastatin Calcium
Possible Fentanyl side effects in female
Reported by a physician from Japan on 2012-06-12
Patient: female, weighing 3.5 kg (7.7 pounds)
Reactions: Neonatal Hyponatraemia, Blood Lactate Dehydrogenase Increased, Inappropriate Antidiuretic Hormone Secretion, Neonatal Asphyxia, Feeding Disorder Neonatal, Maternal Exposure Timing Unspecified, Somnolence
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: 2 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Meilax
Dosage: 1 mg, 1x/day
Indication: Depression
Propofol
Dosage: 150 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Sevoflurane
Dosage: unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Succinylcholine Chloride INJ
Dosage: 80 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Zoloft
Dosage: 25 mg, 1x/day
Indication: Depression
Possible Fentanyl side effects in 32 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-11
Patient: 32 year old male
Reactions: Incorrect Route of Drug Administration, Intentional Overdose, Unresponsive To Stimuli, Neurological Examination Abnormal, Mental Status Changes, Toxicity To Various Agents, Somnolence, Suicide Attempt, Depressed Level of Consciousness, Dizziness, Bradycardia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: ingested 6-8mg
Administration route: Oral
Indication: Suicide Attempt
Fentanyl
Dosage: chewed, ingested 2x 50 microg transdermal patches
Administration route: Oral
Indication: Suicide Attempt
Possible Fentanyl side effects in 32 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-06-05
Patient: 32 year old male
Reactions: Incorrect Route of Drug Administration, Unresponsive To Stimuli, Mental Status Changes, Somnolence, Respiratory Rate Decreased, Miosis, Dizziness, Depressed Level of Consciousness, Bradycardia, Blood Pressure Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Alprazolam
Dosage: 6-8 mg
Fentanyl
Dosage: 2 patches of 50 ug, qh
Administration route: Oral
Other drugs received by patient: Benzodiazepines; Methamphetamine Hydrochloride; Opioids
Possible Fentanyl side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-31
Patient: male
Reactions: Rheumatoid Arthritis, Increased Upper Airway Secretion, Nasopharyngitis, Pruritus, Fistula, Nausea, Rash Erythematous, Oropharyngeal Pain, Somnolence, Cough
Drug(s) suspected as cause:
Celebrex
Dosage: unk
Enbrel
Dosage: 50 mg, qwk
Indication: Rheumatoid Arthritis
Start date: 2012-01-30
Fentanyl
Possible Fentanyl side effects in male
Reported by a consumer/non-health professional from China on 2012-05-03
Patient: male, weighing 60.0 kg (132.0 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Somnolence
Drug(s) suspected as cause:
Diazepam
Indication: Product Used FOR Unknown Indication
Fentanyl
Indication: Angina Pectoris
Start date: 2011-03-14
End date: 2011-03-15
Fentanyl
Indication: Cancer Pain
Start date: 2011-03-14
End date: 2011-03-15
Morphine
Indication: Product Used FOR Unknown Indication
Possible Fentanyl side effects in female
Reported by a physician from Japan on 2012-04-24
Patient: female, weighing 3.5 kg (7.7 pounds)
Reactions: Neonatal Hyponatraemia, Blood Lactate Dehydrogenase Increased, Inappropriate Antidiuretic Hormone Secretion, Neonatal Asphyxia, Feeding Disorder Neonatal, Maternal Exposure Timing Unspecified, Somnolence
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: 2 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Meilax
Dosage: 1 mg, 1x/day
Indication: Depression
Propofol
Dosage: 150 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Sevoflurane
Dosage: unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Succinylcholine Chloride INJ
Dosage: 80 mg, unk
Indication: General Anaesthesia
Start date: 2012-02-04
End date: 2012-02-04
Zoloft
Dosage: 25 mg, 1x/day
Indication: Depression
Possible Fentanyl side effects in female
Reported by a consumer/non-health professional from United States on 2012-04-19
Patient: female, weighing 107.5 kg (236.5 pounds)
Reactions: Hypotension, Muscular Weakness, Somnolence, Fall
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Bupivacaine HCL
Possible Fentanyl side effects in 68 year old male
Reported by a pharmacist from United States on 2012-04-10
Patient: 68 year old male, weighing 87.5 kg (192.5 pounds)
Reactions: Heart Rate Increased, Hypoxia, Snoring, Respiratory Depression, Somnolence, Pallor
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Fentanyl
Possible Fentanyl side effects in
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-03-20
Patient:
Reactions: Pruritus, Vomiting, Drug Ineffective, Nausea, Headache, Somnolence, Constipation, Delirium, Vertigo, Hallucination
Drug(s) suspected as cause:
Fentanyl
Indication: Cancer Pain
Hydromorphone HCL
Administration route: Oral
Indication: Cancer Pain
Morphine
Indication: Cancer Pain
Oxycodone HCL
Indication: Cancer Pain
Possible Fentanyl side effects in 44 year old female
Reported by a physician from United States on 2012-03-20
Patient: 44 year old female
Reactions: Unresponsive To Stimuli, Somatoform Disorder, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: 125 mg, single
Indication: Sedation
Midazolam HCL
Dosage: 4 mg, single
Indication: Sedation
Other drugs received by patient: Bupropion HCL; Propranolol
Possible Fentanyl side effects in 44 year old female
Reported by a physician from United Kingdom on 2012-02-29
Patient: 44 year old female
Reactions: Somatoform Disorder, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Dosage: 125mg
Midazolam HCL
Dosage: 4 mg
Other drugs received by patient: Bupropion HCL; Propranolol
Possible Fentanyl side effects in 44 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-27
Patient: 44 year old female
Reactions: Somatoform Disorder, Somnolence
Drug(s) suspected as cause:
Bupropion HCL
Fentanyl
Dosage: 125 mg
Indication: Sedation
Midazolam
Dosage: 4 mg
Indication: Sedation
Propranolol
Possible Fentanyl side effects in 90 year old female
Reported by a consumer/non-health professional from United States on 2012-02-27
Patient: 90 year old female, weighing 72.6 kg (159.7 pounds)
Reactions: Movement Disorder, Dyspnoea, Unresponsive To Stimuli, Mental Status Changes, Somnolence, Exercise Tolerance Decreased, Staring, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Tramadol HCL; Potassium Chloride; Zocor; Klonopin; Calcium; Trimethoprim; Clonidine; Aricept; Celexa; Coumadin; Lisinopril; Iron; Trental; Prilosec; Lanoxin
Possible Fentanyl side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-02-22
Patient: 50 year old female, weighing 74.4 kg (163.7 pounds)
Reactions: Product Quality Issue, Dyspnoea, Application Site Swelling, Application Site Erosion, Amnesia, Somnolence, Application Site Pruritus, Dysarthria, Application Site Erythema, Incorrect Dose Administered by Device, Hypersomnia
Drug(s) suspected as cause:
Fentanyl
Dosage: 1 patch;q27h;tder, 1 patch;q27h;tder
Indication: Back Pain
Start date: 2011-06-01
End date: 2012-01-15
Fentanyl
Dosage: 1 patch;q27h;tder, 1 patch;q27h;tder
Indication: Back Pain
Start date: 2012-01-24
Other drugs received by patient: Crestor; Neurontin; Roxicodone; Metformin HCL; Valium; Omeprazole
Possible Fentanyl side effects in 44 year old female
Reported by a physician from United States on 2012-02-17
Patient: 44 year old female
Reactions: Somatoform Disorder, Somnolence
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Indication: Sedation
Midazolam
Indication: Sedation
Other drugs received by patient: Bupropion HCL; Propranolol
Possible Fentanyl side effects in 72 year old female
Reported by a consumer/non-health professional from United States on 2012-02-09
Patient: 72 year old female, weighing 74.4 kg (163.7 pounds)
Reactions: Vomiting, Inadequate Analgesia, Blood Potassium Increased, Somnolence, Tremor, Verbal Abuse, Malaise, Renal Failure, Dialysis, Dehydration, Feeling Drunk, Hallucination, Hypersomnia, Blood Glucose Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Chemotherapy (Unspecified) (NO Pref. Name)
Indication: Hepatic Neoplasm Malignant
Start date: 2012-01-01
Fentanyl
Dosage: 1 patch; q72h; tder, 2 patches; q72j; tder
Indication: Back Pain
Start date: 2012-01-24
End date: 2012-01-25
Fentanyl
Dosage: 1 patch; q72h; tder, 2 patches; q72j; tder
Indication: Back Pain
Start date: 2012-01-23
End date: 2012-01-24
Other drugs received by patient: Unspecified Medications
Possible Fentanyl side effects in 50 year old female
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: 50 year old female
Reactions: Dyspnoea, Drug Effect Increased, Somnambulism, Somnolence
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Crestor; Roxicodone; Metformin HCL; Omeprazole; Neurontin; Valium
Possible Fentanyl side effects in 90 year old female
Reported by a consumer/non-health professional from United States on 2012-01-23
Patient: 90 year old female, weighing 72.6 kg (159.7 pounds)
Reactions: Dyspnoea, Unresponsive To Stimuli, Staring, Somnolence, Exercise Tolerance Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Fentanyl
Other drugs received by patient: Tramadol HCL; Calcium; Trental; Aricept; Coumadin; Lisinopril; Lanoxin; Trimethoprim; Iron; Zocor; Prilosec; Klonopin; Celexa; Potassium; Clonidine
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