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Fioricet (Butalbital / Acetaminophen / Caffeine) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Fioricet 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 (19)
Death (1)
Life Threatening Events (2)
Disability (1)

Reports by Reaction Type

Drug Ineffective (7)Headache (4)Pain (3)Hallucination (3)Insomnia (3)Agitation (2)Vomiting Projectile (2)Constipation (2)Influenza Like Illness (2)Haemorrhoidal Haemorrhage (2)Anger (2)Vaginismus (2)

Possible Fioricet side effects in female

Reported by a physician from United States on 2012-05-07

Patient: female

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Ibuprofen
    Dosage: unk

Vicodin
    Dosage: unk

Ergocalciferol
    Dosage: unk

Dihydrotachysterol
    Dosage: unk

Fioricet
    Dosage: unk

Oxycodone HCL
    Dosage: unk

Aspirin
    Dosage: unk



Possible Fioricet side effects in female

Reported by a lawyer from United States on 2012-04-20

Patient: female

Reactions: Weight Decreased, Cleft LIP, Cleft Palate, Emotional Disorder

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Amitriptyline HCL
    Indication: Foetal Exposure During Pregnancy

Phenergan HCL
    Indication: Foetal Exposure During Pregnancy

Multi-Vitamins
    Indication: Foetal Exposure During Pregnancy

Inderal
    Indication: Foetal Exposure During Pregnancy

Fioricet
    Indication: Foetal Exposure During Pregnancy

Phenergan HCL

Topamax
    Indication: Foetal Exposure During Pregnancy
    Start date: 2002-12-11
    End date: 2004-12-09



Possible Fioricet side effects in

Reported by a physician from United States on 2012-04-16

Patient:

Reactions: Drug Hypersensitivity

Drug(s) suspected as cause:
Aspirin
    Dosage: unk

Dihydrotachysterol
    Dosage: unk

Fioricet
    Dosage: unk

Ibuprofen
    Dosage: unk

Ergocalciferol
    Dosage: unk

Oxycodone Hydrochloride
    Dosage: unk

Vicodin
    Dosage: unk



Possible Fioricet side effects in

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-06

Patient:

Reactions: Death

Adverse event resulted in: death

Drug(s) suspected as cause:
Fioricet



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-03-28

Patient: female, weighing 52.2 kg (114.7 pounds)

Reactions: Dysarthria, Thinking Abnormal

Drug(s) suspected as cause:
Lyrica
    Dosage: 75 mg, two times a day on every other day
    Administration route: Oral
    Indication: Migraine
    Start date: 2010-01-01

Fioricet
    Dosage: unk, alternate day
    Indication: Migraine
    Start date: 2006-01-01

Codeine Sulfate
    Dosage: 30 mg, alternate day
    Indication: Migraine
    Start date: 2006-01-01

Other drugs received by patient: Crestor; Levothyroxine



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-29

Patient: female

Reactions: Drug Ineffective, Headache

Drug(s) suspected as cause:
Imitrex
    Indication: Migraine

Fioricet
    Indication: Migraine

Imitrex
    Administration route: Oral



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: female

Reactions: Drug Ineffective, Pain, Musculoskeletal Disorder

Adverse event resulted in: disablity

Drug(s) suspected as cause:
Fioricet
    Indication: Migraine

Vicodin
    Dosage: 25 mg, daily
    Indication: Pain

Oxycodone HCL
    Dosage: 20 mg, tid
    Indication: Pain



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: female

Reactions: Vomiting, Drug Withdrawal Syndrome, Convulsion, Malaise, Dehydration, Respiratory Arrest, Blindness, Hallucination

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Morphine
    Dosage: 120 mg, q3h
    Indication: Pain

Fioricet
    Indication: Migraine

Ambien
    Indication: Insomnia

Morphine Sulfate
    Dosage: 800 mg, q8h
    Indication: Pain

Valium
    Indication: Muscle Spasms



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-02-14

Patient: female, weighing 74.8 kg (164.6 pounds)

Reactions: Nausea, Vomiting Projectile, Drug Ineffective, Headache, Aggression, Anger, Disturbance in Attention, Nervous System Disorder, Drug Administration Error, Memory Impairment

Drug(s) suspected as cause:
Pristiq
    Indication: Insomnia

Xanax
    Dosage: unk
    Indication: Insomnia

Zofran
    Indication: Nausea

Promethazine
    Indication: Nausea

Fioricet
    Dosage: unk
    Administration route: Oral
    Indication: Headache

Zofran
    Dosage: unk
    Indication: Vomiting Projectile

Pristiq
    Dosage: 100 mg, daily
    Indication: Stress AT Work
    Start date: 2011-06-01

Promethazine
    Dosage: unk
    Indication: Vomiting Projectile

Lortab
    Dosage: unk
    Indication: Headache



Possible Fioricet side effects in 58 year old female

Reported by a consumer/non-health professional from United States on 2012-01-29

Patient: 58 year old female

Reactions: Contusion, Pruritus, Tinnitus, Urine Output Decreased, Localised Oedema, Paraesthesia, Emotional Distress, Insomnia, Oedema Peripheral, Energy Increased

Drug(s) suspected as cause:
Humira
    Dosage: on day 15

Fioricet
    Dosage: 1 tab four times daily prn
    Indication: Migraine

Humira
    Dosage: 40 mg eow

Humira
    Dosage: on day 1
    Indication: Crohn's Disease
    Start date: 2011-08-02
    End date: 2011-08-02

Other drugs received by patient: Vitamin B-12; Buditrotrion SR; Imodium; Calcium; Loperamide HCL; Vitamin D; Ventolin; Omeprazole; Levothyroxine Sodium; Pamine; Pamine; Digestive Advantage (Lactose and Probiotics); Lorazepam; Losartan Potassium; Fish OIL; Lomotil; Verapamil Hydrochloride; Lorazepam; Butalb / Apap / Caffeine; Lorazepam; Wellbutrin



Possible Fioricet side effects in 62 year old female

Reported by a physician from United States on 2012-01-23

Patient: 62 year old female, weighing 73.6 kg (161.9 pounds)

Reactions: Rhabdomyolysis, Respiratory Depression, Multiple Drug Overdose, Renal Tubular Necrosis, Transaminases Increased, Drug Abuse, Prothrombin Level Increased

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Extra Strength Tylenol

Zonisamide
    Indication: Pain

Fentanyl
    Indication: Pain

Fluconazole
    Indication: Pain

Metaxalone
    Indication: Pain

Extra Strength Tylenol
    Indication: Pain

Alprazolam
    Indication: Pain

Diphenhydramine HCL
    Indication: Pain

Percocet
    Indication: Pain

Fioricet
    Indication: Pain



Possible Fioricet side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-12

Patient: female, weighing 74.8 kg (164.6 pounds)

Reactions: Nausea, Vomiting Projectile, Drug Ineffective, Hypoaesthesia, Headache, Aggression, Disturbance in Attention, Anger, Memory Impairment

Drug(s) suspected as cause:
Xanax
    Dosage: unk
    Administration route: Oral
    Indication: Sleep Disorder

Pristiq
    Dosage: unk
    Administration route: Oral
    Indication: Insomnia
    Start date: 2011-01-01

Lortab
    Dosage: unk
    Indication: Headache

Pristiq
    Dosage: 100 mg,daily
    Administration route: Oral
    Indication: Stress AT Work
    Start date: 2011-06-01
    End date: 2011-01-01

Fioricet
    Dosage: unk
    Indication: Headache

Zofran
    Indication: Nausea

Promethazine
    Indication: Vomiting Projectile

Zofran
    Dosage: unk
    Indication: Vomiting Projectile

Promethazine
    Dosage: unk
    Indication: Nausea



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-09

Patient: female

Reactions: Drug Ineffective

Drug(s) suspected as cause:
Vicodin
    Indication: Back Pain

Fioricet
    Dosage: 50/325/40mg up to three times a day
    Indication: Product Used FOR Unknown Indication

Motrin

Prozac
    Indication: Product Used FOR Unknown Indication

Motrin
    Indication: Product Used FOR Unknown Indication

Other drugs received by patient: Vicodin



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2012-01-03

Patient: female, weighing 90.7 kg (199.5 pounds)

Reactions: Migraine, Drug Ineffective, Pain, Injection Site Pain, Anal Spasm, Constipation, Faeces Hard, Haemorrhoidal Haemorrhage, Periproctitis, Dysstasia, Arthralgia, Photophobia, Vaginismus, Urethral Spasm, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Preparation H / 00611001 /
    Dosage: unk
    Indication: Haemorrhoids
    Start date: 2011-01-01

Preparation H / 00611001 /
    Indication: Swelling

Botox
    Dosage: unk, injection
    Indication: Migraine
    Start date: 2011-09-27

Preparation H / 00611001 /
    Indication: Pain

Preparation H / 00611001 /
    Indication: Faeces Hard

Unspecified Narcotic Pain Killers
    Dosage: unk
    Indication: Pain

Preparation H / 00611001 /
    Indication: Constipation

Fioricet
    Dosage: unk
    Administration route: Oral
    Indication: Tension Headache
    Start date: 2011-01-01

Other drugs received by patient: Lithium Carbonate; Clonidine



Possible Fioricet side effects in female

Reported by a consumer/non-health professional from United States on 2011-12-02

Patient: female, weighing 90.7 kg (199.5 pounds)

Reactions: Photosensitivity Reaction, Drug Ineffective, Pain, Constipation, Haemorrhoidal Haemorrhage, Anorectal Disorder, Vaginismus, Muscle Spasms, Migraine, Injection Site Pain, Faeces Hard, Discomfort, Bladder Spasm, Dysstasia, Arthralgia, Influenza Like Illness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Preparation H Hemorrhoidal Suppositories
    Indication: Constipation

Fioricet
    Dosage: unk
    Indication: Migraine
    Start date: 2011-01-01

Preparation H Hemorrhoidal Suppositories
    Dosage: unk
    Indication: Haemorrhoids
    Start date: 2011-01-01

Preparation H Hemorrhoidal Suppositories
    Indication: Pain

Preparation H Hemorrhoidal Suppositories
    Indication: Anorectal Disorder

Botox
    Dosage: unk
    Indication: Migraine
    Start date: 2011-09-27

Preparation H Hemorrhoidal Suppositories
    Indication: Faeces Hard

Other drugs received by patient: Lithium; Clonidine



Possible Fioricet side effects in female

Reported by a physician from United States on 2011-11-23

Patient: female, weighing 58.2 kg (128.0 pounds)

Reactions: Pneumothorax

Adverse event resulted in: life threatening event, hospitalization

Drug(s) suspected as cause:
Fioricet
    Dosage: 1 tab, oral, prn
    Administration route: Oral
    Indication: Headache
    Start date: 2010-05-31

Aspirin
    Dosage: 325 mg, qd

Calcium

Agomelatine
    Dosage: 1 mg, unk
    Indication: Major Depression
    Start date: 2010-08-24
    End date: 2011-08-22

Ascorbic Acid

Shark Cartilage

Ibuprofen
    Dosage: 400 mg, prn
    Administration route: Oral
    Start date: 1980-01-01

Vitamin E

Fish OIL



Possible Fioricet side effects in 42 year old female

Reported by a physician from United States on 2011-10-14

Patient: 42 year old female

Reactions: Agitation, Hallucination, Auditory, Insomnia, Withdrawal Syndrome, Hallucination

Drug(s) suspected as cause:
Fioricet



Possible Fioricet side effects in 42 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2011-10-04

Patient: 42 year old female

Reactions: Agitation, Insomnia, Withdrawal Syndrome, Hallucination

Drug(s) suspected as cause:
Fioricet



Possible Fioricet side effects in 39 year old female

Reported by a physician from United States on 2011-10-04

Patient: 39 year old female

Reactions: Headache, Drug Dependence

Drug(s) suspected as cause:
Fioricet

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