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Vicodin ES (Hydrocodone / Acetaminophen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Vicodin ES (Hydrocodone / Acetaminophen) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (14)

Reports by Reaction Type

Dyspnoea (4)Drug Hypersensitivity (4)Drug Ineffective (3)Pain (3)Metabolic Acidosis (3)Diarrhoea (3)Asthenia (3)Abdominal Pain (2)Impaired Work Ability (2)Fall (2)Loss of Consciousness (2)Impaired Driving Ability (2)

Possible Vicodin ES side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: female, weighing 81.7 kg (179.8 pounds)

Reactions: Nerve Injury, Ruptured Cerebral Aneurysm, Drug Effect Decreased, Impaired Work Ability, Pain, Drug Hypersensitivity, Hypoaesthesia, Fall, Cerebrovascular Accident, Impaired Driving Ability, Speech Disorder, Spinal Fusion Surgery, Depressed Level of Consciousness, Intracranial Aneurysm, Neurostimulator Implantation, Feeling Abnormal

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vicodin ES
    Indication: Procedural Pain
    Start date: 2011-01-01

Morphine
    Indication: Spinal Fusion Surgery
    Start date: 2001-01-01

Codeine
    Indication: Procedural Pain
    Start date: 2011-01-01

Neurontin
    Indication: Intracranial Aneurysm

Lyrica
    Indication: Intracranial Aneurysm
    Start date: 2011-01-01
    End date: 2012-05-01

Neurontin
    Indication: Nerve Injury
    Start date: 2011-10-01

Tegretol
    Indication: Nerve Injury
    Start date: 2011-10-01

Tegretol
    Indication: Intracranial Aneurysm

Lyrica
    Indication: Nerve Injury
    Start date: 2011-05-01
    End date: 2011-11-01

Lyrica
    Start date: 2012-05-07

Morphine
    Indication: Procedural Pain

Vicodin ES
    Indication: Spinal Fusion Surgery

Codeine
    Indication: Spinal Fusion Surgery

Other drugs received by patient: Xanax; Paxil



Possible Vicodin ES side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-10

Patient: female, weighing 81.6 kg (179.5 pounds)

Reactions: Aneurysm Ruptured, Drug Ineffective, Impaired Work Ability, Pain, Drug Hypersensitivity, Cerebrovascular Accident, Fall, Impaired Driving Ability, Feeling Abnormal, Back Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Lyrica
    Dosage: 300 mg, 2x/day
    Indication: Occipital Neuralgia
    Start date: 2011-05-01

Morphine Sulfate
    Dosage: unk

Codeine Sulfate
    Dosage: unk

Neurontin
    Dosage: unk
    Indication: Occipital Neuralgia
    Start date: 2011-10-01
    End date: 2011-01-01

Tegretol
    Dosage: unk
    Indication: Occipital Neuralgia
    Start date: 2011-10-01
    End date: 2011-01-01

Vicodin ES
    Dosage: unk, 2x/day
    Indication: Pain
    Start date: 2011-01-01

Lyrica
    Indication: Intracranial Aneurysm

Neurontin
    Indication: Intracranial Aneurysm

Tegretol
    Indication: Intracranial Aneurysm

Other drugs received by patient: Xanax; Paxil



Possible Vicodin ES side effects in female

Reported by a physician from United States on 2012-04-25

Patient: female

Reactions: Diarrhoea, Pain, Bronchitis

Drug(s) suspected as cause:
Vicodin ES
    Dosage: take 1 tab by mouth every 4-6 hours
    Indication: Neck Pain

Duragesic-100
    Indication: Neck Pain

Other drugs received by patient: Zithromax; Zovirax; Rhinocort; Robitussin AC; Ventolin; Effexor; Soma; Lotrimin; Amitiza; Bactroban; Bisacodyl; Lyrica; Seroquel; Lidoderm; Klonopin; Nexium; Kenalog



Possible Vicodin ES side effects in 50 year old female

Reported by a physician from United States on 2012-04-17

Patient: 50 year old female

Reactions: Metabolic Acidosis, Dyspnoea, Pyroglutamate Increased, Asthenia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Clonazepam
    Indication: Product Used FOR Unknown Indication

Albuterol Sulfate and Ipratropium Bromide
    Indication: Product Used FOR Unknown Indication

Vicodin ES
    Indication: Product Used FOR Unknown Indication

Metoprolol Tartrate
    Indication: Product Used FOR Unknown Indication



Possible Vicodin ES side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-22

Patient: female

Reactions: Abdominal Pain, Vomiting, Diarrhoea, Drug Hypersensitivity, Loss of Consciousness

Drug(s) suspected as cause:
Elavil
    Indication: Product Used FOR Unknown Indication

Ultram
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Vicodin ES
    Indication: Product Used FOR Unknown Indication

Glucophage
    Indication: Product Used FOR Unknown Indication

Codeine
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Glipizide; Naproxen Sodium; Lisinopril; Cetirizine HCL; Ranitidine; Cyclobenzaprine HCL; Ibuprofen (Advil); Furosemide; Levothyroxine Sodium; Trazodone HCL; Trazodone HCL; Docusate Sodium; Meclizine; Lantus; Cyclobenzaprine HCL; Omeprazole; Lisinopril; Lipitor; Trazodone HCL; Hydroxyzine Pamoate; Triamcinolone Acetonide



Possible Vicodin ES side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-16

Patient: female

Reactions: Abdominal Pain, Vomiting, Diarrhoea, Drug Hypersensitivity, Loss of Consciousness

Drug(s) suspected as cause:
Elavil
    Indication: Product Used FOR Unknown Indication

Glucophage
    Indication: Product Used FOR Unknown Indication

Vicodin ES
    Indication: Product Used FOR Unknown Indication

Ultram
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Codeine Sulfate
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lantus; Levothyroxine Sodium; Lisinopril; Trazodone HCL; Cyclobenzaprine HCL; Ibuprofen (Advil); Meclizine; Ranitidine; Hydroxyzine Pamoate; Triamcinolone Acetonide; Cyclobenzaprine HCL; Naproxen Sodium; Glipizide; Lipitor; Trazodone HCL; Trazodone HCL; Omeprazole; Lisinopril; Furosemide; Cetirizine HCL; Docusate Sodium



Possible Vicodin ES side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-03-06

Patient: 50 year old female

Reactions: Dyspnoea, Metabolic Acidosis, Laboratory Test Abnormal, Anion GAP Increased, Asthenia, Haemodialysis, Renal Failure Acute

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Vicodin ES
    Indication: Product Used FOR Unknown Indication

Clonazepam
    Indication: Product Used FOR Unknown Indication

Albuterol Sulfate and Ipratropium Bromide
    Indication: Product Used FOR Unknown Indication

Metoprolol Succinate
    Indication: Product Used FOR Unknown Indication



Possible Vicodin ES side effects in

Reported by a individual with unspecified qualification from United States on 2011-12-17

Patient:

Reactions: Medication Error, Product Label Issue

Drug(s) suspected as cause:
Vicodin ES



Possible Vicodin ES side effects in male

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-12

Patient: male

Reactions: Dyspnoea, Malaise

Drug(s) suspected as cause:
Cinryze
    Indication: Prophylaxis

Vicodin ES
    Indication: Back Pain

Cinryze
    Indication: Hereditary Angioedema



Possible Vicodin ES side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-12

Patient: female, weighing 54.5 kg (119.9 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Vicodin ES

Other drugs received by patient: Imitrex



Possible Vicodin ES side effects in

Reported by a pharmacist from United States on 2011-12-12

Patient:

Reactions: Nightmare

Drug(s) suspected as cause:
Vicodin ES



Possible Vicodin ES side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-12

Patient: female, weighing 59.9 kg (131.8 pounds)

Reactions: Nausea, Vasoconstriction, Dizziness

Drug(s) suspected as cause:
Vicodin ES
    Dosage: 1/4 tablet
    Indication: Toothache
    Start date: 2011-04-01
    End date: 2011-04-01

Vicodin ES
    Dosage: es
    Administration route: Oral
    Start date: 1998-01-01
    End date: 1998-01-01

Vicodin
    Indication: Product Used FOR Unknown Indication
    Start date: 1998-01-01
    End date: 1998-01-01



Possible Vicodin ES side effects in male

Reported by a consumer/non-health professional from United States on 2011-12-12

Patient: male, weighing 73.5 kg (161.8 pounds)

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Vicodin ES

Other drugs received by patient: Elavil; Zanaflex; Zantac; Oxycontin



Possible Vicodin ES side effects in 50 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-11-09

Patient: 50 year old female

Reactions: Dyspnoea, Malaise, Metabolic Acidosis, Pyroglutamate Increased, Asthenia, Hyperchloraemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Ipratropium Bromide and Albuterol Sulfate
    Dosage: ipratropium bromide 18 mcg and albuterol 90 mcg 1 puff every 8 hrs

Vicodin ES
    Dosage: hydrocodone bitartrate 7.5 mg and acetaminophen 750 mg every 8 hours as needed
    Administration route: Oral
    Indication: Pain

Other drugs received by patient: Klonopin; Lopressor

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