Does Onzetra Xsail (sumatriptan) cause side effects?

Onzetra Xsail (sumatriptan inhalation powder) is a selective serotonin receptor agonist used for acute treatment of migraine headaches with or without an aura in adults. 

Migraine headaches are believed to result from dilatation of blood vessels in the brain. Onzetra Xsail relieves a migraine by stimulating serotonin receptors in the brain, which cause the muscles surrounding the blood vessels in the brain to contract and narrow the blood vessels. At the same time, it also reduces transmission of pain signals by nerves to the brain. 

While Onzetra Xsail is very effective in relieving migraine headaches, it does not prevent or reduce the number of headaches. Onzetra Xsail is not used for treatment of other types of headache pain.

Common side effects of Onzetra Xsail include

Serious side effects of Onzetra Xsail include

Drug interactions of Onzetra Xsail include monoamine oxidase inhibitors (MAOIs), which may reduce the breakdown of Onzetra Xsail in the liver, leading to increased blood levels and side effects of Onzetra Xsail.

  • Combining Onzetra Xsail with sibutramine, selective serotonin reuptake inhibitors (SSRIs), and serotonin and norepinephrine reuptake inhibitors (SNRIs) may increase the concentration of serotonin in the brain causing increased serotonin-related side effects.
  • Administering a dose of Onzetra Xsail within 24 hours of treatment with an ergot-containing medication is contraindicated because such combinations increase the likelihood of spasm of arteries. 

Safe use of Onzetra Xsail while pregnant has not been established.

Onzetra Xsail is excreted in breast milk. Infant exposure may be reduced by avoiding breastfeeding for 12 hours after administration of Onzetra Xsail.

What are the important side effects of Onzetra Xsail (sumatriptan)?

Common side effects include:

  1. Nausea
  2. Vomiting
  3. Abnormal taste
  4. Nasal discomfort
  5. Runny nose
  6. Common cold
  7. Other side effects include:
  8. Throat discomfort
  9. Dizziness

Possible serious side effects include:

  1. Heart attack, chest pain (myocardial ischemia/infarction and Prinzmetal's angina)
  2. Abnormal heart beats
  3. Chest, throat, neck and/or jaw pain/tightness/pressure
  4. Stroke
  5. Vasospasm reactions
  6. Medication overuse headache (rebound headache)
  7. Serotonin syndrome
  8. Increase in blood pressure
  9. Stomach and intestinal problems (GI ischemia and infarction events, peripheral vasospastic reactions)
  10. Seizures
  11. Cerebral hemorrhage, subarachnoid hemorrhage, and stroke

Onzetra Xsail (sumatriptan) side effects list for healthcare professionals

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
  • Arrhythmias
  • Chest, throat, neck and/or jaw pain/tightness/pressure
  • Cerebrovascular events
  • Other vasospasm reactions
  • Medication overuse headache
  • Serotonin syndrome
  • Increase in blood pressure
  • Hypersensitivity reactions
  • Seizures

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 ReactionPercent of Patients Reporting
Onzetra
N=151
Placebo
N=150
Abnormal Taste203
Nasal Discomfort11a1
Rhinorrhea52
Rhinitis20
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.

What drugs interact with Onzetra Xsail (sumatriptan)?

Ergot-Containing Drugs

Ergot-containing drugs have been reported to cause prolonged vasospastic reactions. Because these effects may be additive, use of ergotamine containing or ergot-type medications (like dihydroergotamine or methysergide) and Onzetra Xsail within 24 hours of each other is contraindicated.

Monoamine Oxidase Inhibitors

MAO-A inhibitors increase systemic exposure by up to 7-fold. Therefore, the use of Onzetra Xsail in patients receiving MAO-A inhibitors is contraindicated.

Other 5-HT1 Agonists

Because their vasospastic effects may be additive, co-administration of Onzetra Xsail and other 5-HT1 agonists (e.g., triptans) within 24 hours of each other is contraindicated.

Selective Serotonin Reuptake Inhibitors/Serotonin Norepinephrine Reuptake Inhibitors And Serotonin Syndrome

Cases of serotonin syndrome have been reported during co-administration of triptans and SSRIs, SNRIs, TCAs, and MAO inhibitors.

Summary

Onzetra Xsail (sumatriptan inhalation powder) is a selective serotonin receptor agonist used for acute treatment of migraine headaches with or without an aura in adults. Common side effects of Onzetra Xsail include nausea, vomiting, abnormal taste, nasal discomfort, runny nose, common cold, throat discomfort, and dizziness. Safe use of Onzetra Xsail while pregnant has not been established. Onzetra Xsail is excreted in breast milk.

Treatment & Diagnosis

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Medically Reviewed on 8/18/2020
References
FDA Prescribing Information

Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.