Medical Editor: John P. Cunha, DO, FACOEP
What Is Onzetra Xsail?
What Are Side Effects of Onzetra Xsail?
Common side effects of Onzetra Xsail include:
Dosage for Onzetra Xsail
The recommended dose of Onzetra Xsail is 22 mg, administered by use of one nosepiece (11 mg) in each nostril.
What Drugs, Substances, or Supplements Interact with Onzetra Xsail?
Onzetra Xsail may interact with ergot-containing drugs, monoamine oxidase inhibitors (MAOIs), other 5-HT1 agonists (e.g., triptans), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). Tell your doctor all medications and supplements you use.
Onzetra Xsail During Pregnancy and Breastfeeding
Onzetra Xsail is not recommended for use during pregnancy; it may harm a fetus. Onzetra Xsail passes into breast milk. Avoid breastfeeding for 12 hours after treatment with Onzetra Xsail.
Our Onzetra Xsail (sumatriptan nasal powder) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
The following serious adverse reactions are discussed in more detail in other sections of the prescribing information:
- Myocardial ischemia, myocardial infarction, and Prinzmetal's angina [see WARNINGS AND PRECAUTIONS]
- Arrhythmias [see WARNINGS AND PRECAUTIONS]
- Chest, throat, neck and/or jaw pain/tightness/pressure [see WARNINGS AND PRECAUTIONS]
- Cerebrovascular events [see WARNINGS AND PRECAUTIONS]
- Other vasospasm reactions [see WARNINGS AND PRECAUTIONS]
- Medication overuse headache [see WARNINGS AND PRECAUTIONS]
- Serotonin syndrome [see WARNINGS AND PRECAUTIONS]
- Increase in blood pressure [see WARNINGS AND PRECAUTIONS]
- Hypersensitivity reactions [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS]
- Seizures [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to the rates in the clinical trials of another drug, and may not reflect the rates observed in practice.
Table 1 lists adverse reactions that occurred in 2 placebo-controlled clinical trials in 301 patients with migraine who took at least 1 dose of ONZETRA Xsail or placebo. Only adverse reactions that occurred at a frequency of 2% or more with ONZETRA Xsail and that occurred at a frequency greater than the placebo group are included in Table 1.
Table 1: Adverse Reactions Reported by at Least 2% of Patients in 2 Controlled Migraine Trials
|Adverse Reaction||Percent of Patients Reporting|
|a Limited examinations of the nose and throat did not reveal any clinically noticeable injury in these patients.|
There is insufficient data with ONZETRA Xsail to assess the impact of age, gender, and race on adverse effects.
The following adverse reaction has been identified during post approval use of ONZETRA Xsail. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure.
Epistaxis has been identified during post approval use of ONZETRA Xsail as an adverse reaction.
Read the entire FDA prescribing information for Onzetra Xsail (Sumatriptan Nasal Powder Nasal Administration)