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Ganaxolone Side Effects

The most commonly reported side effects of ganaxolone include seizure, product dose omission issue, and somnolence, based on 621 FDA adverse event reports from 2004 to 2025. 14.2% of reports found the drug to be ineffective.

Ganaxolone side effects

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

1
Seizure31.1%193
2
Product Dose Omission Issue15.8%98
3
Drug Ineffective14.2%88
4
Somnolence7.2%45
5
Change In Seizure Presentation6.9%43
6
Pneumonia4.5%28
7
Off Label Use3.7%23
8
Vomiting3.7%23
9
Illness2.4%15
10
Weight Decreased2.3%14
11
Fatigue2.1%13
12
Urinary Tract Infection1.8%11
13
Alopecia1.6%10
14
Death1.6%10
15
Pyrexia1.4%9

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

Report severity

53.5%Serious332 reports
16.9%Hospitalizations105 reports
2.4%Fatal15 reports

Seriousness is determined by the reporter, not by OpenClaim.

Ganaxolone drug interactions

Other drugs that appear in adverse event reports alongside ganaxolone. 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
Perampanel1.9%12
2
Lacosamide1.8%11
3
Midazolam1.6%10
4
Cannabidiol1.4%9
5
Felbamate1.3%8
6
Pentobarbital1.3%8
7
Levetiracetam1.3%8
8
Lorazepam1.0%6
9
Anakinra1.0%6
10
Phenobarbital-sodium0.8%5
11
Pyridoxine0.8%5
12
Valproic-acid0.8%5
13
Brivaracetam0.8%5
14
Ketamine-hydrochloride0.6%4
15
Fenfluramine0.6%4

Taken alongside

1
Clobazam4.8%30
2
Levetiracetam4.7%29
3
Cannabidiol4.2%26
4
Clonazepam2.3%14
5
Lamotrigine2.1%13
6
Valproic-acid1.9%12
7
Perampanel1.9%12
8
Lacosamide1.8%11
9
Felbamate1.8%11
10
Diazepam1.6%10
11
Rufinamide1.6%10
12
Zonisamide1.6%10
13
Phenobarbital-sodium1.6%10
14
Polyethylene-glycol-33501.3%8
15
Vigabatrin1.3%8

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 ganaxolone side effects

11.8% of ganaxolone adverse event reports involve female patients and 3.9% involve male patients. The largest age group is child at 46%. These figures reflect who reports side effects, not underlying risk.

Sex

Female11.8%
Male3.9%
Unknown84.4%

Age group

< 28.7%
2–1145.7%
12–1717.4%
18–6421.7%
65+6.5%

What is ganaxolone used for

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

Acquired Epileptic AphasiaAutism Spectrum DisorderCdkl5 Deficiency DisorderCardiac AmyloidosisDrug DependenceEncephalopathyEpilepsyFebrile Infection-related Epilepsy SyndromeLennox-gastaut SyndromeNeck PainParkinson's DiseasePcdh19 Gene-related EpilepsyProduct Used For Unknown IndicationProduct Used For Unknown IndicationProphylaxis

Showing 15 of 20 indications

Ganaxolone brand names and reporting trend

Ganaxolone is sold under the brand name Ztalmy.

Brand names

Ztalmy227

Quarterly reports (20042025)

20042025

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

Taking ganaxolone with another medication?

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