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Maxalt: Uses, Dosage & Safety Information

Maxalt

Maxalt

Maxalt

Rizatriptan benzoate
Maxalt is Organon's brand of rizatriptan, a triptan for treating migraine attacks in adults and children aged 6 to 17. It comes as a swallowed tablet and as Maxalt-MLT, a wafer that dissolves on the tongue without water and contains phenylalanine. Only the 10 mg strength is still sold under the brand. It is prescription-only.
  • ActiveIngredient: Rizatriptan benzoate
  • DosageForm: Tablet; orally disintegrating tablet (Maxalt-MLT)
  • Dosage: 10 mg
  • Indications: Migraine (acute treatment), adults and children 6–17 years
  • Manufacturer: Organon
  • Storage: Store at 15–30°C (59–86°F); keep Maxalt-MLT blisters in the outer pouch until use
  • Drug Status: Prescription Only
Drug Status: Prescription Only
Description

What is Maxalt?

A tablet that needs no water
Maxalt-MLT dissolves on the tongue and is swallowed with saliva, so no liquid is needed. Its blister stays inside the outer aluminium pouch until the moment of use, is peeled open with dry hands, and each wafer contains phenylalanine, which matters for people with phenylketonuria.1

Maxalt contains rizatriptan, a serotonin 5-HT1B/1D receptor agonist, and is taken to end a migraine attack rather than to prevent one. The dose rules that depend on propranolol and on a child’s weight belong to the molecule and are set out on the rizatriptan page.1

Both forms were approved on 29 June 1998, and the applications are now held by Organon. The lower-strength Maxalt tablet and wafer have since been discontinued, for reasons the FDA determined were not related to safety or effectiveness; the labelling itself notes that the lower strength remains available from other manufacturers.21

The two names are separate products in the FDA record rather than one product in two packs: Maxalt, the swallowed tablet, is approved under NDA 020864, and Maxalt-MLT, the wafer, under NDA 020865.2

Generic rizatriptan tablets and orally disintegrating tablets carry the FDA’s AB rating against Maxalt, meaning they are considered therapeutically equivalent and can be substituted.3

▶Clinical detailstablet versus wafer
How the Two Maxalt Forms Compare
Maxalt tabletMaxalt-MLT
Bioavailability and peak levelReferenceSimilar
Speed of absorptionPeak at about 1 to 1.5 hoursSomewhat slower; peak delayed by up to 0.7 hour
Adverse reaction profileReferenceSimilar
Used in the paediatric efficacy trialNoYes

Source: 1

General Instructions

How to Take Maxalt

The swallowed tablet

Maxalt tablets are swallowed once a migraine attack has started. In trials they were taken without regard to meals; food leaves the amount absorbed unchanged but delays the peak by about an hour.1

The dissolving wafer

Leave the Maxalt-MLT blister inside its aluminium pouch until you are ready. Peel it open with dry hands, place the wafer on your tongue, let it dissolve and swallow it with saliva; no water is needed.1

How often

Adults may take a further dose if the headache returns, no sooner than 2 hours after the first, up to 30 mg in 24 hours. Children aged 6 to 17 take a single dose in 24 hours; the brand’s 10 mg strength is the labelled dose for children of 40 kg or more. Lower doses, including those needed with propranolol, are set out on the rizatriptan page.1

What not to do

Do not remove the wafer blister from its pouch in advance or handle it with wet hands. Do not take a second dose for an attack that did not respond at all; the diagnosis is reviewed first.1

Side Effects

What Are the Side Effects of Maxalt?

The labelling states that Maxalt-MLT has a side-effect profile similar to the tablet. In children, reactions in the controlled trial occurred at similar rates on Maxalt-MLT and placebo.1

Adults After a Single 10 mg Tablet
FrequencyEffectLabelled figure
CommonPain or pressure sensations9% vs 3% placebo
CommonSleepiness8% vs 4% placebo
CommonWeakness or tiredness7% vs 2% placebo
CommonDizziness9% vs 5% placebo

Source: 1

Children 6 to 17 Using Maxalt
FrequencyEffectLabelled figure
CommonFatigue; abdominal discomfortFrequent: more than 1 in 100 of 1,068 exposed
UncommonReduced hearing (hypoacusis), poor coordination, trouble concentrating, near-fainting (presyncope), hallucinationInfrequent: 1 in 100 to 1 in 1,000

Source: 1

Reported Without a Rate
FrequencyEffectWhat the labelling says
Frequency not established (postmarketing report)Seizure, anaphylaxis, angioedema, wheezing, toxic epidermal necrolysis, taste changeSpontaneous reports; causation cannot be reliably determined

Source: 1

Seek immediate medical attention if:
  • Pain or pressure in the chest that is severe, or with breathlessness or palpitations
  • Weakness on one side or difficulty speaking
  • Bloody diarrhoea with abdominal pain
  • A seizure
  • Swelling of the lips or throat, or a peeling rash
Uses

What is Maxalt Used For?

Labelled Indication and the
GroupIndicationForm studied
AdultsAcute treatment of migraine with or without auraControlled trials in more than 3,700 adults took Maxalt tablets
Children 6 to 17 yearsAcute treatment of migraine with or without auraThe controlled paediatric study used Maxalt-MLT; 977 of 1,382 enrolled patients took at least one dose

Source: 1

The split matters when choosing a form. The adult evidence comes largely from the swallowed tablet, while the evidence in children comes from the dissolving wafer; the two forms deliver a similar amount of drug, and the labelling describes their side-effect profiles as similar.1

Maxalt treats an attack that has started. It is not for preventing migraine, it has no established role in cluster headache, and it is not for hemiplegic or basilar migraine. It should be used only once migraine has been clearly diagnosed; if the first attack treated does not respond, the diagnosis is reviewed before Maxalt is used again.1

No benefit or safety has been shown in children under 6.1

Safety Advice

Interactions Alcohol:

Use with caution
No alcohol study is reported for Maxalt. Drowsiness and dizziness from the attack or the tablet are the reason to be careful.

Interactions Other Medications:

Unsafe
MAO inhibitors, ergot-type drugs and other triptans are contraindicated with Maxalt, and propranolol requires a strength the brand no longer makes. See the Interactions table.

Special Groups Pregnancy:

Consult your doctor
The Maxalt pregnancy registry found no pattern of birth defects from 1998 to 2018, but reports were too few to be reassuring on their own.

Special Groups Breastfeeding:

Consult your doctor
Whether rizatriptan reaches human milk is unknown; discuss feeding plans with your prescriber.

Special Groups Elderly:

Use with caution
Older adults start at the low end of dosing and, with heart risk factors, are assessed before a first dose.

Special Groups Children:

Use with caution
Maxalt-MLT was the form tested in children aged 6 to 17; the 10 mg brand strength matches the labelled dose only for children of 40 kg or more.

Effects on Activities Driving:

Use with caution
Do not drive until you know whether Maxalt makes you drowsy or dizzy.

Effects on Activities Operating Machinery:

Use with caution
The same applies to machinery. No liver or kidney dose change is stated.
Warnings

Critical Warnings for Maxalt Use

Phenylketonuria

Maxalt-MLT contains phenylalanine from aspartame, 2.1 mg in each 10 mg wafer.1

Heart, brain and circulation

Maxalt is contraindicated with ischaemic or vasospastic coronary disease or other significant cardiovascular disease, a history of stroke or TIA, peripheral vascular disease, ischaemic bowel disease and uncontrolled hypertension. Serious heart events have occurred within hours of a dose, some in people with no known coronary disease.1

Hemiplegic or basilar migraine

These migraine types are contraindications.1

Hypersensitivity

Allergy to rizatriptan or to any ingredient of either form excludes use.1

Serotonin syndrome

Stop Maxalt if serotonin syndrome is suspected; symptoms can begin within minutes to hours of a new or higher serotonergic dose.1

Drugs that must not be combined with Maxalt are listed in Interactions.

Dosage

Dosage

Maxalt Presentations
FormulationActive IngredientsClinical Note
Maxalt tabletRizatriptan 10 mg (as benzoate)Pale pink, capsule-shaped, marked MAXALT and MRK 267; carton of 18
Maxalt-MLT orally disintegrating tabletRizatriptan 10 mg (as benzoate)White, round, peppermint-flavoured wafer marked with a modified square; 2.1 mg phenylalanine; 6 cases of 3 (18 wafers)
Maxalt 5 mg tablet and 5 mg MLT—Discontinued under the brand; 5 mg rizatriptan is listed by generic manufacturers
Hepatic impairmentRizatriptanNo dose change is stated
Renal impairmentRizatriptanNo dose change is stated

Source: 124

Exceeding the dose
In a long-term study in teenagers, a quarter took two 10 mg Maxalt-MLT doses within 24 hours, and three of them reported abdominal discomfort, tiredness or breathlessness. After a suspected overdose, gut decontamination may be considered and heart monitoring with ECG continues for at least 12 hours even without symptoms; high blood pressure or heart ischaemia could occur.1
Interactions

What Does Maxalt Interact With?

Interactions by Severity
Interacting SubstanceEffect and RiskSeverityDocumentation
Moclobemide and other MAO-A or non-selective MAO inhibitors, including use within the last 2 weeksHigher rizatriptan levels, with exposure to its active metabolite up by more than 400%ContraindicatedGood — pharmacokinetic study
Dihydroergotamine, methysergide and ergotamine products in the previous 24 hoursVasospasm that may last longerContraindicatedGood — labelled contraindication
Any other triptan in the previous 24 hoursVasospastic effects may add upContraindicatedGood — labelled contraindication
PropranololNeeds the 5 mg dose, which the brand no longer suppliesMajorGood — pharmacokinetic study
Antidepressants of the SSRI and SNRI classesCase reports of serotonin syndromeMajorFair — case reports

Source: 1

FAQs
Not any more. Maxalt and Maxalt-MLT are sold only at 10 mg; the 5 mg brand strengths were discontinued, but generic rizatriptan is still available at 5 mg.
No. It delivers a similar amount of drug, but absorption is slightly slower, with the peak up to about 40 minutes later. Its advantage is that it needs no water.
Generic rizatriptan tablets and orally disintegrating tablets are rated by the FDA as therapeutically equivalent to Maxalt, so substitution is permitted where local pharmacy rules allow it.
The brand is held by Organon. Both Maxalt forms were first approved in June 1998.
The wafer contains phenylalanine, so people with phenylketonuria need to know this before using it; the swallowed tablet is the alternative form of the brand.
Evidence and Reported Data

Evidence Scope

What we know
  • Maxalt-MLT gives a similar amount of rizatriptan to the swallowed tablet, a little more slowly.1
  • Effectiveness in children aged 6 to 17 was shown in a controlled study of the dissolving wafer.1
  • Generic rizatriptan tablets and wafers are rated therapeutically equivalent to Maxalt.3
What remains uncertain
  • Whether the adult tablet evidence transfers exactly to the wafer. Adult controlled trials used the tablet; the wafer is linked to it through pharmacokinetics and a similar side-effect profile rather than separate large adult trials.
  • Repeat dosing in children. Its efficacy and safety within 24 hours have not been established.
  • Pregnancy. The Maxalt registry had few prospective reports and substantial loss to follow-up.
  • What postmarketing reports can show. Spontaneous reports cannot establish how often an effect occurs or whether Maxalt caused it.

Reports in the FDA Adverse Event Reporting System

FDA adverse event reports are counted by active ingredient, not by brand, so the aggregate figures for Maxalt are those for rizatriptan as a whole. They are shown, with their limitations, on the rizatriptan page.

Who was this medicine studied in?

No FDA Drug Trials Snapshot exists: Maxalt was approved in 1998, and the programme began publishing in 2015.52 Adult controlled trials enrolled more than 3,700 patients taking tablets, and the paediatric trial enrolled 1,382 patients aged 6 to 17 using the wafer; the labelling reports no effect of age or sex on adult reaction rates and insufficient data on race.1

Who this is and is not appropriate for

Typically considered for: adults, and children aged 6 to 17 weighing 40 kg or more, with a clear migraine diagnosis; the wafer suits people who have difficulty swallowing tablets or have no water to hand.

Not appropriate for: people with phenylketonuria (the wafer), those needing a 5 mg dose, anyone with the heart, circulation or stroke-related contraindications, hemiplegic or basilar migraine, or recent MAO inhibitor use.1

Where to report and verify

Routing to Official Registries
What you needWhere to go
Report a side effectFDA MedWatch
Pregnancy-specific dataMotherToBaby
Full prescribing informationDailyMed
Verify a pharmacy websiteFDA BeSafeRx · LegitScript
References

References

  1. FDA Prescribing Information, Maxalt tablets and Maxalt-MLT orally disintegrating tablets (Organon, NDA 020864 and NDA 020865) — Indications and Usage, Dosage and Administration 2.1–2.4, Dosage Forms and Strengths, Contraindications, Warnings and Precautions, Adverse Reactions, Drug Interactions, Use in Specific Populations 8.1–8.6, Overdosage, Clinical Pharmacology 12.3, How Supplied, Patient Counseling Information
    Label effective 2026-01-29 · Accessed 2026-09-27
    Used for: the indication and the form used in each population; wafer handling and phenylalanine content; the appearance and packs of both forms; doses tied to the 10 mg strength; contraindications and warnings; adult and paediatric adverse reaction data; the interactions; pregnancy, breastfeeding and paediatric use; the paediatric overdose experience; and tablet-versus-wafer pharmacokinetics.
    dailymed.nlm.nih.gov — DailyMed
  2. Drugs@FDA — application records for Maxalt (NDA 020864) and Maxalt-MLT (NDA 020865)
    Records accessed 2026-09-27
    Used for: the 29 June 1998 approval of both forms, the current holder, and the discontinuation of the 5 mg brand strengths with the Federal Register finding that it was not for safety or effectiveness reasons.
    accessdata.fda.gov — Drugs@FDA
  3. FDA Orange Book — Approved Drug Products with Therapeutic Equivalence Evaluations, rizatriptan benzoate
    Current edition · Accessed 2026-09-27
    Used for: the AB therapeutic equivalence rating of generic rizatriptan tablets and orally disintegrating tablets against Maxalt.
    accessdata.fda.gov — Orange Book
  4. FDA National Drug Code Directory — listings for Maxalt, Maxalt-MLT and rizatriptan benzoate
    Directory current · Accessed 2026-09-27
    Used for: confirmation that Maxalt is listed only at 10 mg while generic rizatriptan is listed at 5 mg and 10 mg.
    accessdata.fda.gov — NDC Directory
  5. FDA — Drug Trials Snapshots programme scope
    Programme current · Accessed 2026-09-27
    Used for: confirmation of when the programme began publishing, used to explain the absence of a Snapshot for this product.
    fda.gov — Drug Trials Snapshots

How this page was sourced

This page describes the Maxalt products; dose rules that belong to the molecule, such as the propranolol limit, are kept on the rizatriptan page and linked rather than repeated.

The paediatric data are presented as data for the wafer, because that is the form the labelling reports the children’s study used.

Substitution is described through the FDA therapeutic equivalence rating rather than by comparing products ourselves.

Review cycle. Clinical review completed 28 September 2026. Next review due by 28 September 2027, or earlier if the labelling is revised.

Disclaimer

Disclaimer: The information on this site is provided for informational purposes only and is not medical advice. It does not replace professional medical consultation, diagnosis, or treatment. Do not self-medicate based on the information presented on this site. Always consult with a doctor or other qualified healthcare professional before making any decisions about your health.