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),
Hyperhidrosis (1),
Abdominal Discomfort (1),
Vomiting (1),
Nausea (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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