ONZETRA XSAIL SIDE EFFECTS
- Generic Name: sumatriptan nasal powder nasal administration
- Brand Name: Onzetra Xsail
- Drug Class: Antimigraine Agents, Serotonin 5-HT-Receptor Agonists
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
- 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 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.
SRC: NLM .