Nurtec Odt: adverse event reports filed with FDA

9,415

reports as suspect product

0.1% of all reports · about 1,508 a year

712

reports, 12 months to June 2026

1,204 in the 12 months before

11.6%

marked serious by the reporter

20.9% across the class

0.9%

record death among outcomes, as reported

85 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Nurtec Odt reports recording the termmedian drug in calcitonin gene-related peptide receptor antagonist

1. Drug ineffectivethe medicine did not work as expected39.3%3,700
2. Nauseafeeling sick9.2%866
3. Therapeutic product effect incomplete6.3%595
4. Migrainemigraine4.8%449
5. Headachehead pain4.7%441
6. Off label useused for a purpose or in a way not on the label3.8%360
7. Dizzinesslight-headedness or unsteadiness3.2%299
8. Vomitingbeing sick2.5%240
9. Feeling abnormalfeeling odd or not right2.5%235
10. Therapeutic product effect decreased2.2%209
11. Abdominal pain upperupper stomach pain2.1%202
12. Somnolencedrowsiness2.1%198
13. Fatiguetiredness2.1%196
14. Rashskin rash2%191
15. Therapeutic product effect variable1.9%176
16. Hypersensitivityan allergic-type reaction1.8%166
17. Abdominal discomfortstomach discomfort1.5%145
18. Exposure during pregnancythe medicine was taken during pregnancy1.5%138
19. Pruritusitching1.4%131
20. Therapeutic product effect delayed1.3%123
21. Dyspepsiaindigestion1.3%118
22. Malaisegeneral feeling of being unwell1.2%114
23. Painpain, site not specified1.2%114
24. Anxietyanxiety1.2%110
25. Constipationconstipation1.2%110
26. Drug ineffective for unapproved indication1.2%109
27. Dyspnoeashortness of breath1.2%109
28. Diarrhoealoose or frequent stools1.1%103
29. Inappropriate schedule of product administrationthe product was taken at the wrong times1%97
30. Urticariahives1%95

Top 30 of 558 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 5 drugs in the calcitonin gene-related peptide receptor antagonist class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 18,311 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 99.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 9,415 reports.

Drugs most often listed in the same reports

Other products listed in reports where Nurtec Odt is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the calcitonin gene-related peptide receptor antagonist class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Nurtec Odt as a suspect or interacting product; reports listing it only as a concomitant medication (3,144) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.