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Phenobarbital (Phenobarbital) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

The following adverse reactions have been reported:

CNS Depression- Residual sedation or "hangover", drowsiness, lethargy, and vertigo. Emotional disturbances and phobias may be accentuated. In some persons, barbiturates such as Phenobarbital repeatedly produce excitement rather than depression, and the patient may appear to be inebriated. Irritability and hyperactivity can occur in children. Like other nonanalgesic hypnotic drugs, barbiturates such as Phenobarbital, when given in the presence of pain, may cause restlessness, excitement, and even delirium. Rarely, the use of barbiturates results in the localized or diffuse myalgic, neuralgic, or arthritic pain, especially in psychoneurotic patients with insomnia. The pain may appear in paroxysms, is most intense in the early morning hours, and is most frequently located in the region of the neck, shoulder girdle, and upper limbs. Symptoms may last for days after the drug is discontinued.

Respiratory/Circulatory- Respiratory depression, apnea, circulatory collapse.

Allergic- Acquired hypersensitivity to barbiturates consists chiefly in allergic reactions that occur especially in persons who tend to have asthma, urticaria, angioedema, and similar conditions. Hypersensitivity reactions in the category include localized swelling, particularly of the eyelids, cheeks or lips, and erythematous dermatitis. Rarely exfoliative dermatitis (e.g., Stevens-Johnson syndrome and toxic epidermal necrolysis) may be caused by Phenobarbital and can prove fatal. The skin eruption may be associated with fever, delirium, and marked degenerative changes in the liver and other parenchymatous organs. In a few cases, megaloblastic anemia has been associated with the chronic use of phenobarbital.

Other- Nausea and vomiting; headache, osteomalacia.

The following adverse reactions and their incidence were compiled from surveillance of thousands of hospitalized patients who received barbiturates. Because such patients may be less aware of the milder adverse effects of barbiturates, the incidence of these reactions may be somewhat higher in fully ambulatory patients.

More than 1 in 100 Patients

The most common adverse reaction, estimated to occur at a rate of 1 to 3 patients per 100, is:

Nervous System: Somnolence

Less than 1 in 100 Patients

Adverse reactions estimated to occur at a rate of less than 1 in 100 patients are listed below, grouped by organ system and by decreasing order of occurrence:

Nervous System: Hypoventilation, apnea

Cardiovascular System: Bradycardia, hypotension, syncope

Digestive System: Nausea, vomiting, constipation

Other Reported Reactions: Headache, injections site reactions, hypersensitivity reactions (angioedema, skin rashes, exfoliative dermatitis), fever, liver damage, megaloblastic anemia following chronic phenobarbital use.



REPORTS OF SUSPECTED PHENOBARBITAL SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Phenobarbital. The information is not vetted and should not be considered as verified clinical evidence.

Possible Phenobarbital side effects / adverse reactions 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

Suspect drug(s):
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



Possible Phenobarbital side effects / adverse reactions 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

Suspect drug(s):
Halcion
    Dosage: unk
    Administration route: Oral

Phenobarbital
    Dosage: unk
    Administration route: Oral

Flunitrazepam
    Dosage: unk
    Administration route: Oral



See index of all Phenobarbital side effect reports >>

Drug label data at the top of this Page last updated: 2011-07-09

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