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Butalbital and Acetaminophen (Butalbital / Acetaminophen) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Butalbital and Acetaminophen (Butalbital / 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 (6)
Death (3)

Reports by Reaction Type

Completed Suicide (3)Dyskinesia (2)Intentional Drug Misuse (2)Somnolence (2)Multiple Drug Overdose (2)Vomiting (1)Nausea (1)Hyperhidrosis (1)Abdominal Discomfort (1)Impaired Gastric Emptying (1)

Possible Butalbital and Acetaminophen side effects in 31 year old female

Reported by a physician from United States on 2012-07-09

Patient: 31 year old female, weighing 90.9 kg (200.0 pounds)

Reactions: Dyskinesia, Multiple Drug Overdose, Somnolence

Adverse event resulted in: hospitalization

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

Paracetamol / Dextromethorphan
    Indication: Product Used FOR Unknown Indication

Butalbital and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Oxycodone and Acetaminophen
    Indication: Product Used FOR Unknown Indication

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

Zolpidem
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication

Acetaminophen

Other drugs received by patient: Paroxetine; Lamotrigine; Promethazine



Possible Butalbital and Acetaminophen side effects in 55 year old female

Reported by a consumer/non-health professional from United States on 2012-05-18

Patient: 55 year old female

Reactions: Abdominal Discomfort, Vomiting, Nausea, Impaired Gastric Emptying, Hyperhidrosis

Drug(s) suspected as cause:
Butalbital and Acetaminophen

Other drugs received by patient: Tylenol; Reglan; Compazine



Possible Butalbital and Acetaminophen side effects in 31 year old female

Reported by a physician from United States on 2012-03-02

Patient: 31 year old female, weighing 90.9 kg (200.0 pounds)

Reactions: Dyskinesia, Multiple Drug Overdose, Somnolence

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Acetaminophen

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

Acetaminophen
    Indication: Product Used FOR Unknown Indication

Paracetamol / Dextromethorphan
    Indication: Product Used FOR Unknown Indication

Zolpidem
    Indication: Product Used FOR Unknown Indication

Butalbital and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Oxycodone HCL
    Indication: Product Used FOR Unknown Indication

Oxycodone and Acetaminophen
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Lamotrigine; Promethazine; Paroxetine



Possible Butalbital and Acetaminophen side effects in 47 year old female

Reported by a physician from United States on 2012-01-24

Patient: 47 year old female

Reactions: Completed Suicide

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral

Hydroxyzine Pamoate
    Administration route: Oral

Levothyroxine Sodium
    Administration route: Oral

Alprazolam
    Administration route: Oral

Pregabalin
    Administration route: Oral

Butalbital and Acetaminophen
    Administration route: Oral

Mirtazapine
    Administration route: Oral



Possible Butalbital and Acetaminophen side effects in 47 year old female

Reported by a physician from United States on 2012-01-13

Patient: 47 year old female

Reactions: Completed Suicide, Intentional Drug Misuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Butalbital and Acetaminophen
    Dosage: unk
    Administration route: Oral

Pregabalin
    Dosage: unk
    Administration route: Oral

Levothyroxine Sodium
    Dosage: unk
    Administration route: Oral

Alprazolam
    Dosage: unk
    Administration route: Oral

Hydroxyzine
    Dosage: unk
    Administration route: Oral

Baclofen
    Dosage: unk
    Administration route: Oral

Mirtazapine
    Dosage: unk
    Administration route: Oral



Possible Butalbital and Acetaminophen side effects in 47 year old female

Reported by a physician from United States on 2012-01-13

Patient: 47 year old female

Reactions: Completed Suicide, Intentional Drug Misuse

Adverse event resulted in: death

Drug(s) suspected as cause:
Baclofen
    Administration route: Oral

Butalbital and Acetaminophen
    Administration route: Oral

Pregabalin
    Administration route: Oral

Alprazolam
    Administration route: Oral

Hydroxyzine Pamoate
    Administration route: Oral

Mirtazapine
    Administration route: Oral

Levothyroxine Sodium
    Administration route: Oral

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