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Phenobarbital (Phenobarbital) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Phenobarbital 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 (5)

Reports by Reaction Type

Toxicity To Various Agents (2)LIP Swelling (1)Rhabdomyolysis (1)Drug Ineffective (1)Loss of Consciousness (1)Sensation of Foreign Body (1)Cough (1)Renal Failure Acute (1)Drug Hypersensitivity (1)Drug Rash With Eosinophilia and Systemic Symptoms (1)Convulsion (1)Dehydration (1)

Possible Phenobarbital side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-07-05

Patient: female, weighing 56.2 kg (123.7 pounds)

Reactions: Drug Hypersensitivity, Toxicity To Various Agents

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

Dilantin
    Dosage: unk



Possible Phenobarbital side effects in female

Reported by a consumer/non-health professional from United States on 2012-06-08

Patient: female, weighing 61.0 kg (134.2 pounds)

Reactions: Drug Ineffective, Convulsion

Drug(s) suspected as cause:
Keppra
    Dosage: unk
    Indication: Convulsion

Lyrica
    Dosage: 150 mg, 4x/day
    Administration route: Oral
    Indication: Convulsion
    Start date: 2005-01-01

Phenobarbital
    Dosage: 260 mg daily
    Indication: Convulsion
    Start date: 1997-01-01

Other drugs received by patient: Lactic Acid Bacillus Probiotic; Iron



Possible Phenobarbital side effects in male

Reported by a consumer/non-health professional from United States on 2012-03-29

Patient: male

Reactions: LIP Swelling, Sensation of Foreign Body, Cough

Drug(s) suspected as cause:
Dilantin
    Dosage: five capsules of 100mg a day
    Administration route: Oral

Phenobarbital
    Dosage: 60 mg, 2x/day

Robitussin Lingering Cold Long-Acting Cough
    Dosage: unk
    Administration route: Oral
    Indication: Nasopharyngitis
    Start date: 2012-03-24

Robitussin Lingering Cold Long-Acting Cough
    Indication: Cough



Possible Phenobarbital side effects in 45 year old male

Reported by a physician from Japan on 2012-02-02

Patient: 45 year old male

Reactions: Rhabdomyolysis, Dehydration, Toxicity To Various Agents, Renal Failure Acute, Loss of Consciousness

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Halcion
    Dosage: unk
    Administration route: Oral

Phenobarbital
    Dosage: unk
    Administration route: Oral

Flunitrazepam
    Dosage: unk
    Administration route: Oral



Possible Phenobarbital side effects in 11 year old male

Reported by a physician from Japan on 2012-01-05

Patient: 11 year old male

Reactions: Drug Rash With Eosinophilia and Systemic Symptoms

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Diazepam
    Dosage: 5 mg, unk
    Administration route: Oral
    Start date: 2010-06-22
    End date: 2010-07-01

Acetaminophen
    Dosage: 300 mg, 1x/day
    Administration route: Oral
    Indication: Pyrexia
    Start date: 2010-06-27
    End date: 2010-07-16

Clindamycin Phosphate
    Dosage: 100 mg, 3x/day
    Start date: 2010-06-08
    End date: 2010-07-10

Depas
    Dosage: 1 df, uid/qd
    Administration route: Oral
    Start date: 2010-07-01
    End date: 2010-07-01

Decadron
    Dosage: 2 mg
    Start date: 2010-06-17
    End date: 2010-06-22

Atropine Sulfate
    Dosage: 0.5 mg, uid/qd
    Start date: 2010-06-17
    End date: 2010-06-22

Glycerin
    Dosage: unk
    Indication: Constipation
    Start date: 2010-06-27

Tricloryl
    Dosage: 20 ml, uid/qd
    Administration route: Oral
    Start date: 2010-06-28
    End date: 2010-07-05

Panthenol
    Dosage: 25 mg, 2x/day
    Start date: 2010-06-04
    End date: 2010-07-05

Piperacillin Sodium
    Dosage: 375 mg, qid
    Start date: 2010-07-15
    End date: 2010-07-16

Nicardipine HCL
    Dosage: unk

Cefazolin Sodium
    Dosage: 500 mg, 2x/day
    Start date: 2010-06-22
    End date: 2010-06-24

Famotidine
    Dosage: 8 mg,
    Start date: 2010-06-17
    End date: 2010-06-26

Diazepam
    Dosage: 4 ml
    Administration route: Oral
    Start date: 2010-07-02
    End date: 2010-07-22

Heparin
    Dosage: 5 iu/kg, uid/qd
    Start date: 2010-08-08
    End date: 2010-08-12

Heparin Sodium
    Dosage: 2 df, uid/qd
    Start date: 2010-06-17

Calcium Carbonate
    Dosage: 10 ml, uid/qd
    Start date: 2010-06-21
    End date: 2010-06-21

Dexmedetomidine Hydrochloride
    Dosage: unk
    Start date: 2010-07-04
    End date: 2010-07-05

Flurbiprofen
    Dosage: 3.5 ml, 1x/day
    Start date: 2010-07-09
    End date: 2010-07-09

Midazolam
    Dosage: 10 mg, 1x/day
    Start date: 2010-06-17
    End date: 2010-07-09

Cefazolin Sodium
    Dosage: 1g, unk
    Administration route: Oral
    Start date: 2010-07-11
    End date: 2010-07-18

Cefazolin Sodium
    Dosage: 1 g, unk
    Administration route: Oral
    Start date: 2010-07-11
    End date: 2010-07-18

Omeprazole
    Dosage: 7.5 mg, 2x/day
    Start date: 2010-07-16
    End date: 2010-07-21

Fentanyl
    Dosage: unk
    Start date: 2010-06-21
    End date: 2010-07-08

Ultiva
    Dosage: unk
    Start date: 2010-06-21
    End date: 2010-07-08

Acetaminophen
    Dosage: unk
    Start date: 2010-06-30
    End date: 2010-07-16

Risperdal
    Dosage: 0.3 ml, 1x/day
    Administration route: Oral
    Start date: 2010-07-02
    End date: 2010-07-14

Morphine Hydrochloride
    Dosage: 2 mg/kg, 1x/day
    Start date: 2010-06-21
    End date: 2010-07-09

Lactobacillus Casei
    Dosage: 500 mg
    Administration route: Oral
    Start date: 2010-07-02
    End date: 2010-07-09

Laxoberon
    Dosage: 10 ml, uid/qd
    Administration route: Oral
    Start date: 2010-06-20
    End date: 2010-06-20

Epinephrine
    Dosage: 10 mg, uid/qd
    Start date: 2010-06-21
    End date: 2010-06-21

Rocuronium Bromide
    Dosage: 50 mg, 1x/day
    Start date: 2010-06-17
    End date: 2010-07-06

Xylocaine
    Dosage: 10 ml, 1x/day
    Start date: 2010-06-21
    End date: 2010-07-09

Hyalein
    Dosage: unk
    Start date: 2010-07-23
    End date: 2010-08-21

Midazolam
    Dosage: 10 mg uid/qd
    Start date: 2010-06-21
    End date: 2010-06-21

Phenobarbital
    Dosage: 50 mg, 2x/day
    Administration route: Oral
    Start date: 2010-06-22
    End date: 2010-07-09

Ampicillin
    Dosage: 375 mg, 1x/day
    Start date: 2010-07-15
    End date: 2010-07-16

Lasix
    Dosage: 2.5 mg qid
    Administration route: Oral
    Start date: 2010-06-26
    End date: 2010-07-06

Atarax
    Dosage: 25 mg, 1x/day
    Start date: 2010-07-09
    End date: 2010-07-09

Lansoprazole
    Dosage: 7.5 mg, 2x/day
    Administration route: Oral
    Start date: 2010-06-28
    End date: 2010-07-28

Famotidine
    Dosage: 15 mg, unk
    Administration route: Oral
    Start date: 2010-06-26
    End date: 2010-07-15

Rocephin
    Dosage: 2000 mg, 1x/day
    Indication: Infection
    Start date: 2010-06-30
    End date: 2010-07-07

Aldactone
    Dosage: 2.5 mg qid
    Administration route: Oral
    Start date: 2010-06-26
    End date: 2010-07-06

Glyceol
    Dosage: 200 ml
    Start date: 2010-06-17
    End date: 2010-06-18

Ofloxacin
    Dosage: unk
    Start date: 2010-07-28
    End date: 2010-07-29

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