OpenClaim

Pitolisant Side Effects

The most commonly reported side effects of pitolisant include anxiety, nausea, and headache, based on 2,106 FDA adverse event reports from 2015 to 2025. 11.4% of reports found the drug to be ineffective.

Pitolisant side effects

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

1
Drug Ineffective11.4%241
2
Anxiety10.8%227
3
Nausea10.7%226
4
Headache10.0%211
5
Insomnia10.0%211
6
Product Administration Interrupted9.3%196
7
Somnolence8.4%176
8
Fatigue7.9%166
9
Product Dose Omission Issue7.9%166
10
Dizziness5.5%116
11
Depression5.5%116
12
Middle Insomnia5.5%116
13
Surgery4.9%103
14
Feeling Abnormal4.4%92
15
Vomiting4.1%87

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

Report severity

48.7%Serious1,025 reports
12.2%Hospitalizations257 reports
0.5%Fatal10 reports

Seriousness is determined by the reporter, not by OpenClaim.

Pitolisant drug interactions

Other drugs that appear in adverse event reports alongside pitolisant. 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
Sodium-oxybate55.0%1,159
2
Calcium-oxybate17.0%359
3
Magnesium-oxybate17.0%359
4
Potassium-oxybate17.0%359
5
Solriamfetol3.6%75
6
Methylphenidate3.1%65
7
Dextroamphetamine2.9%61
8
Amphetamine2.8%60
9
Modafinil2.7%57
10
Venlafaxine2.1%44
11
Armodafinil1.4%30
12
Dupilumab1.4%30
13
Bupropion0.9%18
14
Levonorgestrel0.7%14
15
Lisdexamfetamine-dimesylate0.6%13

Taken alongside

1
Dextroamphetamine19.0%401
2
Amphetamine17.8%375
3
Ergocalciferol14.3%301
4
Modafinil13.0%273
5
Albuterol11.1%234
6
Fluticasone10.9%230
7
Acetaminophen10.7%225
8
Methylphenidate10.6%223
9
Omeprazole10.2%214
10
Armodafinil9.6%203
11
Solriamfetol9.6%203
12
Gabapentin9.0%189
13
Bupropion8.0%168
14
Levothyroxine-sodium7.6%161
15
Ondansetron7.4%156

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 pitolisant side effects

62.4% of pitolisant adverse event reports involve female patients and 26.7% involve male patients. The largest age group is adult at 91%. These figures reflect who reports side effects, not underlying risk.

Sex

Female62.4%
Male26.7%
Unknown10.9%

Age group

< 20.3%
2–110.8%
12–172.8%
18–6491.4%
65+4.7%

What is pitolisant used for

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

Attention Deficit Hyperactivity DisorderCataplexyCataplexyDeep Vein ThrombosisEhlers-danlos SyndromeFatigueFatigueHypersomniaHypersomniaInsomniaNarcolepsyNocturiaNarcolepsyObstructive Sleep Apnoea SyndromePrader-willi Syndrome

Showing 15 of 23 indications

Pitolisant brand names and reporting trend

Pitolisant is sold under the brand name Pitolisant.

Brand names

Pitolisant175

Quarterly reports (20152025)

2015202020242025

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

Taking pitolisant with another medication?

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