Index of reports
> Cases with Insomnia (28)
Below is the selection of side effect reports (a.k.a. adverse event reports) related to Vicodin (Hydrocodone / Acetaminophen) where reactions include insomnia. The selected reports were submitted to the FDA during the sample period of about a year.
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-03
Patient: female, weighing 99.8 kg (219.5 pounds)
Reactions: Hypersensitivity, Sensory Loss, Somnolence, Erythema, Gastric Ulcer, Mania, Fatigue, Balance Disorder, Dizziness, Clumsiness, Anger, Abdominal Distension, Skin Swelling, Psychomotor Hyperactivity, Musculoskeletal Discomfort, Alopecia, Insomnia, Withdrawal Syndrome, Feeling Abnormal
Drug(s) suspected as cause:
Codeine
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Gabapentin
Dosage: 300 mg, 1x/day
Administration route: Oral
Indication: Pain
Start date: 2012-06-18
Gabapentin
Dosage: 300 mg, 3x/day
End date: 2012-07-07
Gabapentin
Dosage: 300 mg, 2x/day
Start date: 2012-06-01
Ibuprofen
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: 300 mg, 2x/day
Start date: 2012-01-01
Neurontin
Dosage: 300 mg,daily
Indication: Ehlers-Danlos Syndrome
Start date: 2012-06-01
Tramadol HCL
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Vicodin
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenzaprine
Possible Vicodin side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2012-08-01
Patient: 29 year old female, weighing 99.8 kg (219.5 pounds)
Reactions: Hypersensitivity, Sensory Loss, Erythema, Somnolence, Gastric Ulcer, Mania, Arthropathy, Fatigue, Balance Disorder, Clumsiness, Dizziness, Abdominal Distension, Anger, Skin Swelling, Psychomotor Hyperactivity, Abnormal Behaviour, Insomnia, Alopecia, Withdrawal Syndrome
Drug(s) suspected as cause:
Codeine
Indication: Ehlers-Danlos Syndrome
Ibuprofen
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: two times a day
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
Neurontin
Dosage: thrice daily
Administration route: Oral
Indication: Ehlers-Danlos Syndrome
End date: 2012-07-07
Neurontin
Dosage: daily
Administration route: Oral
Start date: 2012-06-01
End date: 2012-01-01
Neurontin
Dosage: daily
Administration route: Oral
Start date: 2012-06-18
Neurontin
Dosage: two times a day
Administration route: Oral
Start date: 2012-06-01
NON Steroidal Anti-Inflammatory Drugs
Indication: Ehlers-Danlos Syndrome
Tramadol Hydrochloride
Indication: Ehlers-Danlos Syndrome
Vicodin
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenzaprine
Possible Vicodin side effects in 54 year old female
Reported by a consumer/non-health professional from United States on 2012-07-27
Patient: 54 year old female
Reactions: Off Label Use, Drug Ineffective FOR Unapproved Indication, Insomnia
Drug(s) suspected as cause:
Seroquel
Administration route: Oral
Indication: Insomnia
Vicodin
Indication: Nephrolithiasis
Other drugs received by patient: Clonazepam; Potassium Chloride
Possible Vicodin side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2012-07-20
Patient: 29 year old female, weighing 99.8 kg (219.5 pounds)
Reactions: Hypersensitivity, Sensory Loss, Erythema, Somnolence, Gastric Ulcer, Mania, Arthropathy, Fatigue, Balance Disorder, Abdominal Distension, Anger, Dizziness, Clumsiness, Skin Swelling, Psychomotor Hyperactivity, Abnormal Behaviour, Insomnia, Alopecia, Withdrawal Syndrome
Drug(s) suspected as cause:
Codeine Sulfate
Indication: Ehlers-Danlos Syndrome
Ibuprofen
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: daily
Administration route: Oral
Start date: 2012-06-18
Neurontin
Dosage: daily
Administration route: Oral
Start date: 2012-06-01
End date: 2012-01-01
Neurontin
Dosage: two times a day
Administration route: Oral
Start date: 2012-06-01
Neurontin
Dosage: thrice daily
Administration route: Oral
Indication: Ehlers-Danlos Syndrome
End date: 2012-07-07
Neurontin
Dosage: two times a day
Administration route: Oral
Start date: 2012-01-01
End date: 2012-01-01
NON Steroidal Anti-Inflammatory Drugs
Indication: Ehlers-Danlos Syndrome
Tramadol Hydrochloride
Indication: Ehlers-Danlos Syndrome
Vicodin
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenzaprine
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: female, weighing 99.8 kg (219.5 pounds)
Reactions: Hypersensitivity, Sensory Loss, Gastric Ulcer, Erythema, Somnolence, Mania, Fatigue, Balance Disorder, Clumsiness, Anger, Abdominal Distension, Dizziness, Skin Swelling, Psychomotor Hyperactivity, Musculoskeletal Discomfort, Alopecia, Insomnia, Withdrawal Syndrome, Feeling Abnormal
Drug(s) suspected as cause:
Codeine SUL TAB
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Gabapentin
Dosage: 300 mg, 2x/day
Start date: 2012-06-01
Gabapentin
Dosage: 300 mg, 1x/day
Administration route: Oral
Indication: Pain
Start date: 2012-06-18
Gabapentin
Dosage: 300 mg, 3x/day
End date: 2012-07-07
Ibuprofen
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: 300 mg,daily
Indication: Ehlers-Danlos Syndrome
Start date: 2012-06-01
Neurontin
Dosage: 300 mg, 2x/day
Start date: 2012-01-01
Tramadol HCL
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Vicodin
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenzaprine
Possible Vicodin side effects in 29 year old female
Reported by a consumer/non-health professional from United States on 2012-07-17
Patient: 29 year old female, weighing 100.0 kg (220.0 pounds)
Reactions: Hypersensitivity, Psychomotor Hyperactivity, Abnormal Behaviour, Gastric Ulcer, Mania, Balance Disorder, Alopecia, Insomnia, Clumsiness, Abdominal Distension, Dizziness
Drug(s) suspected as cause:
Codeine
Indication: Ehlers-Danlos Syndrome
Ibuprofen
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: daily
Indication: Ehlers-Danlos Syndrome
Start date: 2012-01-01
Neurontin
Dosage: daily
Start date: 2012-06-01
End date: 2012-01-01
Neurontin
Dosage: two times a day
Start date: 2012-01-01
End date: 2012-01-01
NON Steroidal Anti-Inflammatory Drugs
Indication: Ehlers-Danlos Syndrome
Tramadol HCL
Indication: Ehlers-Danlos Syndrome
Vicodin
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenazprine
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-11
Patient: female, weighing 100.0 kg (220.0 pounds)
Reactions: Hypersensitivity, Psychomotor Hyperactivity, Gastric Ulcer, Mania, Balance Disorder, Insomnia, Alopecia, Clumsiness, Dizziness, Abdominal Distension, Feeling Abnormal
Drug(s) suspected as cause:
Codeine
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Ibuprofen
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Neurontin
Dosage: 300 mg,daily
Indication: Ehlers-Danlos Syndrome
Start date: 2012-06-01
Tramadol HCL
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Vicodin
Dosage: unk
Indication: Ehlers-Danlos Syndrome
Other drugs received by patient: Cyclobenzaprine
Possible Vicodin side effects in 60 year old male
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: 60 year old male
Reactions: Retching, Insomnia, Pain, Cold Sweat
Drug(s) suspected as cause:
Advil PM
Dosage: 200/38 mg, as needed
Administration route: Oral
Indication: Insomnia
Start date: 2012-06-03
End date: 2012-06-04
Vicodin
Dosage: unk, 2x/day
Start date: 2012-06-03
Other drugs received by patient: Diovan; Simvastatin; Nexium; Tricor
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2012-05-17
Patient: male, weighing 39.0 kg (85.8 pounds)
Reactions: Personality Change, Weight Decreased, Femur Fracture, Hyperhidrosis, Constipation, Suicidal Ideation, Abnormal Dreams, Depression, Myocardial Infarction, Pneumonia, Amnesia, Convulsion, Antisocial Behaviour, Tremor, HIP Fracture, Grand MAL Convulsion, Insomnia, Feeling Abnormal
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ativan
Dosage: 25 mg at night
Indication: Sleep Disorder
Chantix
Dosage: 0.5 mg, 1x/day
Administration route: Oral
Indication: Smoking Cessation Therapy
Start date: 2007-01-01
Chantix
Dosage: unk
Start date: 2011-12-27
Chantix
Dosage: unk
Start date: 2007-01-01
End date: 2007-01-01
Chantix
Dosage: 1 mg, 2x/day
Chantix
Dosage: unk
Start date: 2012-05-01
End date: 2012-05-14
Vicodin
Dosage: unk
Indication: Femur Fracture
Start date: 2011-01-01
Other drugs received by patient: Morphine; Hydrocodone; Hydrochlorothiazide; Tamsulosin Hydrochloride; Halcion; Creon; Percodan-Demi
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2012-03-27
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Drug Ineffective, Insomnia, Musculoskeletal Discomfort, Eating Disorder, Discomfort
Drug(s) suspected as cause:
Lyrica
Dosage: 200 mg, 3x/day
Indication: Fibromyalgia
Lyrica
Dosage: 200 mg, 2x/day
Motrin
Dosage: unk
Indication: Fibromyalgia
Neurontin
Dosage: 600 mg, 3x/day
Neurontin
Dosage: unk
Indication: Fibromyalgia
Vicodin
Dosage: unk
Indication: Fibromyalgia
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-06
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Thrombosis, Vein Disorder, Haemorrhage, Cardiac Operation, Abdominal Pain Upper, Abdominal Discomfort, Malaise, Thinking Abnormal, Dyspepsia, Insomnia, Myocardial Infarction, Feeling Abnormal
Drug(s) suspected as cause:
Celebrex
Dosage: 200 mg, daily
Administration route: Oral
Indication: Back Pain
Start date: 2000-03-01
Celebrex
Indication: Neck Pain
Vicodin
Dosage: 17 tablets, daily
Administration route: Oral
Indication: Back Pain
Vicodin
Indication: Neck Pain
Wellbutrin
Dosage: unk
Administration route: Oral
Indication: Neuralgia
Wellbutrin
Indication: Depression
Other drugs received by patient: Ibuprofen (Advil); Oxycontin; Oxycontin; Ibuprofen (Advil)
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-03-05
Patient: female, weighing 63.5 kg (139.7 pounds)
Reactions: Inappropriate Schedule of Drug Administration, Thrombosis, Vein Disorder, Haemorrhage, Abdominal Pain Upper, Abdominal Discomfort, Thinking Abnormal, Malaise, Dyspepsia, Insomnia, Myocardial Infarction, Feeling Abnormal
Drug(s) suspected as cause:
Celebrex
Dosage: 200 mg, daily
Administration route: Oral
Indication: Back Pain
Start date: 2000-03-01
Celebrex
Indication: Neck Pain
Vicodin
Dosage: 17 tablets dailiy
Administration route: Oral
Indication: Back Pain
Vicodin
Indication: Neck Pain
Wellbutrin
Dosage: unk
Administration route: Oral
Indication: Neuralgia
Wellbutrin
Indication: Depression
Other drugs received by patient: Oxycontin; Ibuprofen (Advil); Oxycontin; Ibuprofen (Advil)
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2012-02-03
Patient: male, weighing 77.1 kg (169.6 pounds)
Reactions: Drug Ineffective, Insomnia, Musculoskeletal Discomfort, Discomfort, Eating Disorder
Drug(s) suspected as cause:
Lyrica
Dosage: 200 mg, 2x/day
Lyrica
Dosage: 200 mg, 3x/day
Indication: Fibromyalgia
Motrin
Dosage: unk
Indication: Fibromyalgia
Neurontin
Dosage: 600 mg, 3x/day
Indication: Fibromyalgia
Vicodin
Indication: Fibromyalgia
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: male, weighing 109.0 kg (239.7 pounds)
Reactions: Anxiety, Nausea, Feeling Jittery, Insomnia, Energy Increased, Nervousness
Drug(s) suspected as cause:
Testim
Indication: Blood Testosterone Decreased
Start date: 2011-01-22
Testim
Vicodin
Indication: Postoperative Analgesia
Start date: 2010-01-01
Victoza
Indication: Diabetes Mellitus
Other drugs received by patient: Celebrex; Janumet; Desvenlafaxine; Novolog; Lantus
Possible Vicodin side effects in 65 year old female
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: 65 year old female
Reactions: Agitation, Insomnia
Drug(s) suspected as cause:
Vicodin
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: female, weighing 118.0 kg (259.7 pounds)
Reactions: Psychomotor Hyperactivity, Insomnia
Drug(s) suspected as cause:
Vicodin
Possible Vicodin side effects in 76 year old female
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: 76 year old female
Reactions: Insomnia, Constipation
Drug(s) suspected as cause:
Vicodin
Possible Vicodin side effects in female
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: female
Reactions: Insomnia
Drug(s) suspected as cause:
Vicodin
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2012-01-09
Patient: male
Reactions: Anxiety, Insomnia
Drug(s) suspected as cause:
Vicodin
Other drugs received by patient: Nadolol; Glucosin; Other Supplements; Glucosin; Vitamin TAB; Lovastatin
Possible Vicodin side effects in 68 year old female
Reported by a consumer/non-health professional from United States on 2012-01-06
Patient: 68 year old female
Reactions: Nerve Injury, Pain, Ligament Pain, Chronic Obstructive Pulmonary Disease, Myalgia, Tendon Pain, Insomnia, Systemic Lupus Erythematosus, Influenza Like Illness
Drug(s) suspected as cause:
Lyrica
Dosage: 75 mg, unk
Meloxicam
Dosage: 7.5 mg, unk
Vicodin
Dosage: unk
Possible Vicodin side effects in male
Reported by a pharmacist from United States on 2012-01-04
Patient: male
Reactions: Agitation, Product Quality Issue, Weight Decreased, Respiratory Depression, Delusion, Brain Stem Syndrome, Brain Injury, Hypoacusis, Psychotic Disorder, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
End date: 2011-08-01
MS Contin
Dosage: 60 mg, unk
Start date: 2010-10-01
End date: 2011-08-01
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-16
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a pharmacist from United States on 2011-12-29
Patient: male
Reactions: Product Quality Issue, Agitation, Weight Decreased, Respiratory Depression, Delusion, Hypoacusis, Brain Stem Syndrome, Brain Injury, Psychotic Disorder, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
End date: 2011-08-01
MS Contin
Dosage: 60 mg, unk
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
End date: 2011-08-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-16
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-28
Patient: male
Reactions: Product Quality Issue, Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-12-22
Patient: male
Reactions: Weight Decreased, Agitation, Product Quality Issue, Respiratory Depression, Brain Injury, Hypoacusis, Brain Stem Syndrome, Hospitalisation, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-29
Patient: male
Reactions: Weight Decreased, Agitation, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Lorcet-HD
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-11-23
Patient: male
Reactions: Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-11
Patient: male
Reactions: Agitation, Weight Decreased, Respiratory Depression, Brain Stem Syndrome, Brain Injury, Hypoacusis, Insomnia, Product Taste Abnormal, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Lorcet-HD
Morphine Sulfate
Dosage: 60 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, 2x/day
Administration route: Oral
Indication: Pain
Start date: 2010-10-01
Vicodin
Dosage: 10/650 mg
Administration route: Oral
Indication: Pain
Start date: 2011-03-01
Possible Vicodin side effects in male
Reported by a consumer/non-health professional from United States on 2011-10-07
Patient: male
Reactions: Weight Decreased, Agitation, Respiratory Depression, Brain Injury, Hypoacusis, Brain Stem Syndrome, Product Taste Abnormal, Insomnia, Product Odour Abnormal, Hypersomnia
Drug(s) suspected as cause:
Lorcet-HD
Indication: Product Used FOR Unknown Indication
Morphine Sulfate
Dosage: 60 mg, q12h
Administration route: Oral
Indication: Pain
Start date: 2010-11-01
Opana
Dosage: 20 mg, bid
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2010-10-01
Vicodin
Dosage: unk, see text
Administration route: Oral
Indication: Product Used FOR Unknown Indication
Start date: 2011-03-01
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