What the label lists and what reports show
Rizatriptan side effects
Rizatriptan's FDA label: “The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co. …” FAERS holds 16,132 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (1,765 reports).
- Generic listed
Check it at the source: the rizatriptan FDA label on DailyMed (effective January 29, 2026); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of MAXALT?MAXALT may cause serious side effects. Call your doctor or go to the nearest hospital emergency room right away if you think you are having any of the serious side effects of MAXALT including: heart attack. Symptoms of a heart attack may include: chest discomfort in the center of your chest that lasts for more than a few minutes or that goes away and comes back chest discomfort that feels like uncomfortable pressure, squeezing, fullness or pain pain or discomfort in your arms, back, neck, jaw or stomach shortness of breath with or without chest discomfort breaking out in a cold sweat nausea or vomiting feeling lightheaded stroke. […]
Source: FDA drug label, Organon LLC, effective January 29, 2026 (SPL set 007b4644-e0e7-4863-9ae3-fe09676b3f5f), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1: Incidence (≥2% and Greater than Placebo) of Adverse Reactions After a Single Dose of MAXALT Tablets or Placebo in Adults
| Adverse Reactions | MAXALT 5 mg (N=977) | MAXALT 10 mg (N=1167) | Placebo (N=627) |
|---|---|---|---|
| Atypical Sensations | 4 | 5 | 4 |
| Paresthesia | 3 | 4 | <2 |
| Pain and other Pressure Sensations | 6 | 9 | 3 |
| tightness/pressure and/or heaviness | <2 | 3 | 1 |
| pain/tightness/pressure | <2 | 2 | 1 |
| tightness/pressure and/or heaviness | <1 | 2 | 0 |
| Pain, location unspecified | 3 | 3 | <2 |
| Digestive | 9 | 13 | 8 |
| Dry Mouth | 3 | 3 | 1 |
| Nausea | 4 | 6 | 4 |
| Neurological | 14 | 20 | 11 |
| Dizziness | 4 | 9 | 5 |
| Headache | <2 | 2 | <1 |
| Somnolence | 4 | 8 | 4 |
| Asthenia/fatigue | 4 | 7 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following adverse reactions are discussed in more detail in other sections of the labeling: Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina [see Warnings and Precautions (5.1) ]. Arrhythmias [see Warnings and Precautions (5.2) ]. Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure [see Warnings and Precautions (5.3) ]. Cerebrovascular Events [see Warnings and Precautions (5.4) ]. Other Vasospasm Reactions [see Warnings and Precautions (5.5) ]. Medication Overuse Headache [see Warnings and Precautions (5.6) ]. Serotonin Syndrome [see Warnings and Precautions (5.7) ]. Increase in Blood Pressure [see Warnings and Precautions (5.8) ]. The most common adverse reactions in adults were (incidence ≥5% and greater than placebo): asthenia/fatigue, somnolence, pain/pressure sensation and dizziness ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Organon LLC, a subsidiary of Organon & Co., at 1-844-674-3200 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, Organon LLC, effective January 29, 2026 (SPL set 007b4644-e0e7-4863-9ae3-fe09676b3f5f), via openFDA; the full label on DailyMed
What do FAERS reports show?
16,132 reports list rizatriptan among the medicines taken, each a report of something that happened, not proof the medicine caused it; 328 are coded as a death and 3,300 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 7 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Rizatriptan: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions