Onzetra Xsail
- Generic Name: sumatriptan nasal powder nasal administration
- Brand Name: Onzetra Xsail
Onzetra Xsail (Sumatriptan Nasal Powder Nasal Administration) side effects drug center
Onzetra Xsail Side Effects Center
What Is Onzetra Xsail?
Onzetra Xsail (sumatriptan nasal powder) is a serotonin 5-HT1B/1D receptor agonist (triptan) indicated for the acute treatment of migraine with or without aura in adults.
What Are Side Effects of Onzetra Xsail?
Common side effects of Onzetra Xsail include:
- unusual taste in the mouth,
- runny or stuffy nose, and
- nasal or sinus irritation
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.
Additional Information
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.
Onzetra Xsail Consumer Information
Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Stop using sumatriptan and call your doctor at once if you have:
- sudden and severe stomach pain and bloody diarrhea;
- severe chest pain, shortness of breath, irregular heartbeats;
- a seizure (convulsions);
- severe headache, blurred vision, pounding in your neck or ears;
- blood circulation problems in your legs or feet--cramps, tight or heavy feeling, numbness or tingling, muscle weakness, burning pain, cold feeling, color changes (pale or blue), hip pain;
- heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
- high levels of serotonin in the body--agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, vomiting, diarrhea; or
- signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance.
Common side effects may include:
- pain or tight feeling in your chest, throat, or jaw;
- pressure or heavy feeling in any part of your body;
- numbness or tingling, feeling hot or cold;
- dizziness, drowsiness, weakness;
- unusual or unpleasant taste in your mouth after using the nasal medicine;
- pain, burning, numbness, or tingling in your nose or throat after using the nasal medicine; or
- runny or stuffy nose after using the nasal medicine.
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.
Read the entire detailed patient monograph for Onzetra Xsail (Sumatriptan Nasal Powder Nasal Administration)
Onzetra Xsail Professional Information
SIDE EFFECTS
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 | |
| ONZETRA N=151 | Placebo N=150 | |
| Abnormal Taste | 20 | 3 |
| Nasal Discomfort | 11a | 1 |
| Rhinorrhea | 5 | 2 |
| Rhinitis | 2 | 0 |
| 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.
Postmarketing Experience
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)
&Copy; Onzetra Xsail Patient Information is supplied by Cerner Multum, Inc. and Onzetra Xsail Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.