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Phenobarbital Side Effects

The most commonly reported side effects of phenobarbital include seizure, off label use, and toxicity to various agents, based on 14,877 FDA adverse event reports from 2004 to 2025. 16.1% of reports found the drug to be ineffective.

Phenobarbital side effects

Percentages show how often each reaction appears relative to total reports for phenobarbital.

1
Drug Ineffective16.1%2,396
2
Seizure11.0%1,639
3
Off Label Use9.6%1,429
4
Toxicity To Various Agents4.3%633
5
Drug Interaction4.1%616
6
Status Epilepticus3.3%487
7
Multiple-drug Resistance3.1%455
8
Somnolence2.8%419
9
Epilepsy2.8%413
10
Condition Aggravated2.7%403
11
Product Use In Unapproved Indication2.6%389
12
Hypotension2.6%386
13
Fall2.5%377
14
Pyrexia2.4%351
15
Death2.2%332

These are voluntary reports and do not establish that phenobarbital caused these reactions.

Report severity

84.7%Serious12,607 reports
38.9%Hospitalizations5,793 reports
12.5%Fatal1,858 reports

Seriousness is determined by the reporter, not by OpenClaim.

Phenobarbital drug interactions

Other drugs that appear in adverse event reports alongside phenobarbital. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Levetiracetam27.6%4,110
2
Phenytoin17.9%2,665
3
Lacosamide12.0%1,783
4
Topiramate10.6%1,574
5
Carbamazepine9.8%1,454
6
Midazolam9.2%1,368
7
Clobazam9.1%1,348
8
Valproic-acid9.0%1,345
9
Vigabatrin8.9%1,318
10
Lamotrigine7.8%1,160
11
Clonazepam5.6%840
12
Propofol5.1%761
13
Lorazepam5.0%748
14
Diazepam4.8%716
15
Valproate-sodium4.5%674

Taken alongside

1
Levetiracetam12.3%1,830
2
Phenytoin9.7%1,450
3
Topiramate6.7%992
4
Clonazepam6.4%950
5
Clobazam6.3%942
6
Diazepam5.3%788
7
Carbamazepine5.3%785
8
Acetaminophen5.2%775
9
Lorazepam4.8%715
10
Lacosamide4.5%669
11
Midazolam4.4%657
12
Ergocalciferol4.3%642
13
Lamotrigine4.3%640
14
Levothyroxine-sodium4.3%637
15
Gabapentin4.0%589

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports phenobarbital side effects

46.9% of phenobarbital adverse event reports involve female patients and 39.5% involve male patients. The largest age group is adult at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female46.9%
Male39.5%
Unknown13.6%

Age group

< 218.5%
2–1115.2%
12–175.1%
18–6446.2%
65+15.0%

What is phenobarbital used for

Conditions and purposes for which patients were taking phenobarbital when the adverse event was reported.

Abdominal PainAbdominal Pain UpperAbnormal BehaviourAccidentAcute Encephalitis With Refractory, Repetitive Partial SeizuresAcute Respiratory Distress SyndromeAffective DisorderAggressionAgitationAgitation NeonatalAlcohol UseAlcohol Withdrawal SyndromeAlcoholic SeizureAlexander DiseaseAlternating Hemiplegia Of Childhood

Showing 15 of 523 indications

Phenobarbital brand names and reporting trend

Phenobarbital is sold under the brand name Sezaby.

Brand names

Sezaby17,283

Quarterly reports (20042025)

20052010201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking phenobarbital with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.