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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

OXITRIPTAN: 100 Adverse Event Reports & Safety Profile

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100
Total FAERS Reports
5 (5.0%)
Deaths Reported
34
Hospitalizations
100
As Primary/Secondary Suspect
2
Life-Threatening
4
Disabilities
Energique, Inc.
Manufacturer

Route: ORAL · Manufacturer: Energique, Inc. · HUMAN OTC DRUG · FDA Label: Available

First Report: 20120101 · Latest Report: 20221114

What Are the Most Common OXITRIPTAN Side Effects?

#1 Most Reported
Serotonin syndrome
22 reports (22.0%)
#2 Most Reported
Anxiety
21 reports (21.0%)
#3 Most Reported
Insomnia
19 reports (19.0%)

All OXITRIPTAN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Serotonin syndrome 22 22.0% 0 18
Anxiety 21 21.0% 0 1
Insomnia 19 19.0% 0 1
Atrial fibrillation 18 18.0% 0 1
Bradycardia 18 18.0% 0 1
Gastric ph increased 18 18.0% 0 1
Somnolence 18 18.0% 0 12
Drug interaction 10 10.0% 0 9
Myoclonus 10 10.0% 0 5
Off label use 8 8.0% 1 3
Diarrhoea 7 7.0% 0 0
Migraine 7 7.0% 0 1
Product use in unapproved indication 7 7.0% 0 3
Headache 6 6.0% 0 1
Condition aggravated 5 5.0% 0 0
Drug ineffective 5 5.0% 0 2

Who Reports OXITRIPTAN Side Effects? Age & Gender Data

Gender: 58.6% female, 41.4% male. Average age: 52.2 years. Most reports from: US. View detailed demographics →

Is OXITRIPTAN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 3 0 2
2013 1 0 1
2014 1 0 0
2015 3 0 1
2016 4 0 3
2018 1 0 0
2019 4 0 0
2020 1 0 0
2021 3 0 2
2022 2 1 0

View full timeline →

What Is OXITRIPTAN Used For?

IndicationReports
Product used for unknown indication 38
Tonic convulsion 10
Migraine 6
Dopa-responsive dystonia 5
Post-traumatic epilepsy 5

OXITRIPTAN vs Alternatives: Which Is Safer?

OXITRIPTAN vs OXOMEMAZINE OXITRIPTAN vs OXY TAB OXITRIPTAN vs OXYBATE OXITRIPTAN vs OXYBUTYNIN OXITRIPTAN vs OXYBUTYNIN\OXYBUTYNIN OXITRIPTAN vs OXYCODONE OXITRIPTAN vs OXYCODONE TEREPHTHALATE OXITRIPTAN vs OXYCODONE\OXYCODONE OXITRIPTAN vs OXYCONTIN OXITRIPTAN vs OXYGEN

Official FDA Label for OXITRIPTAN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

INDICATIONS: May temporarily relieve symptoms associated with reactions to 5-HTP.** **Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Dosage & Administration

DIRECTIONS: Adults and children 5 to 10 drops orally, 1 time daily or as otherwise directed by a health care professional. If symptoms persist for more than 7 days, consult your health care professional. Consult a physician for use in children under 12 years of age.

Warnings

WARNINGS: If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Do not use if tamper evident seal is broken or missing. Store in a cool, dry place.

Active Ingredient

ACTIVE INGREDIENT: (in each drop): 25% of 5-Hydroxytryptophan 12X, 30X, 12C, 30C; 0.10% of 5-Hydroxytryptophan 6X.

Inactive Ingredients

INACTIVE INGREDIENTS: Demineralized water, 20% Ethanol.