Cardiovascular contraindications and interaction limits are essential.
Do not use with prohibited vascular disease, uncontrolled hypertension, another triptan/ergot within 24 hours, or a MAO-A inhibitor concurrently or within 2 weeks. Chest pain, stroke-like symptoms, severe abdominal pain or serotonin-syndrome symptoms require immediate assessment.
Warnings and precautionsIndications
Acute migraine treatment after a clear diagnosis.
Labeled use and limits
Acute migraine with or without aura in adults and pediatric patients 6–17 years. Not indicated for prevention; cluster-headache safety/effectiveness are unestablished. Hemiplegic or basilar migraine is contraindicated under the label’s terminology. If the first treated attack fails to respond, reconsider the diagnosis before subsequent treatment; do not assume every severe headache is migraine.
Dosage and administration
Adult redosing cannot be applied to children.
Selected oral regimens
| Population | Dose / limit |
|---|---|
| Adults | 5 or 10 mg orally; 10 mg may provide more benefit with more adverse effects. If headache recurs, a second dose may be taken ≥2 hours later. Maximum 30 mg in any 24 hours. Second-dose effectiveness was not established in placebo-controlled trials. |
| Ages 6–17 · weight <40 kg | 5 mg once; efficacy/safety of more than one dose in 24 hours unestablished. |
| Ages 6–17 · weight ≥40 kg | 10 mg once; more than one dose in 24 hours unestablished. |
| Adult taking propranolol | 5 mg per dose only; ≥2-hour spacing, maximum 3 doses (15 mg) in 24 hours. |
| Age 6–17 with propranolol · ≥40 kg | Single 5 mg dose; maximum 5 mg in 24 hours. |
| Age 6–17 with propranolol · <40 kg | Should not be prescribed under selected labeling. |
| Treatment-frequency boundary | Safety of treating more than 4 headaches in 30 days unestablished. This is distinct from medication-overuse headache at ≥10 acute-treatment days/month; neither is a permission to self-escalate. |
Administration and formulation
Tablet is swallowed orally. MLT: dry hands, leave blister in outer pouch until dose, peel open rather than push; place on tongue, dissolve and swallow with saliva, without fluid. The label notes brand 5 mg tablet and MLT strengths are no longer marketed; prescribed 5 mg regimens require exact appropriately labeled product selection rather than an improvised split 10 mg MLT. Generic appearance, excipients and packaging need package verification. No parenteral, intranasal or routine preventive regimen inferred.
Organ impairment and older adults
The selected label supplies exposure studies, not a universal renal/hepatic adjustment table: mild hepatic exposure was similar, moderate impairment increased levels about 30%; severe disease evidence is insufficient. CrCl 10–60 mL/min/1.73 m² did not significantly change exposure; hemodialysis patients (CrCl <2 in the same indexed units) had about 44% higher AUC. Do not invent a universal 5 mg ceiling or dialysis supplement from those observations. Older adults require cautious low-end selection, organ/medicine assessment and CV evaluation when risk factors apply.
Safety
Vasospasm, ischemia, serotonin toxicity and hypertension require recognition.
Warnings and precautions
- Rare MI, coronary vasospasm and serious arrhythmias have occurred. Evaluate triptan-naive patients with multiple cardiovascular risk factors before treatment. If evaluation is negative, consider supervised first dose and immediate ECG; periodic evaluation may be appropriate in long-term users with risk factors.
- Chest/throat/neck/jaw pressure is often noncardiac but warrants cardiac evaluation when suspected. Life-threatening arrhythmia requires discontinuation.
- Stroke/hemorrhage can be mistaken for migraine; exclude serious neurological causes in atypical headaches or symptoms. Do not treat a known stroke/TIA history.
- Peripheral or GI vasospasm, ischemic colitis, Raynaud effects and visual loss have been reported. Evaluate suspicious severe abdominal pain/bloody diarrhea or vascular symptoms before further doses.
- Serotonin syndrome may occur, especially with SSRIs, SNRIs, TCAs or MAO inhibitors; stop and urgently evaluate agitation, hyperthermia, autonomic instability, muscle incoordination or GI symptoms.
- Significant BP elevation and hypertensive crisis can occur; uncontrolled hypertension is contraindicated.
- Frequent acute treatment can worsen headache through medication overuse; clinician-directed withdrawal/prevention planning may be needed. Do not repeatedly dose an unresponsive atypical headache.
- MLT contains aspartame-derived phenylalanine: selected brand 10 mg MLT has 2.1 mg; exact generic strength content may differ, requiring PKU review.
Contraindications
Ischemic coronary artery disease or other significant underlying CV disease; coronary vasospasm; stroke/TIA history; peripheral vascular disease; ischemic bowel disease; uncontrolled hypertension; hemiplegic or basilar migraine; hypersensitivity including anaphylaxis/angioedema; another 5-HT1 agonist or ergot-containing medicine in the preceding 24 hours; concurrent MAO-A inhibitor or within 2 weeks of its discontinuation, including nonselective MAO inhibitors with MAO-A activity.
Boxed warning status
The selected Maxalt/MLT label has no boxed warning. Formal cardiovascular/vascular contraindications and potentially serious warnings still apply.
Adverse reactions and overdose
Common adult effects include fatigue, somnolence, dizziness and pain/pressure sensations; nausea and dry mouth can occur, with some dose dependence. Serious postmarketing reports include allergy, seizures and severe skin reactions with uncertain frequency. Overdose can cause syncope, bradycardia, vomiting, AV block, hypertension and coronary ischemia. Seek emergency/Poison Help (1-800-222-1222); clinical and ECG monitoring for at least 12 hours is advised even if asymptomatic. No specific antidote or known dialytic-removal benefit is established; no home gastric-emptying instructions.
Drug interactions
Separate prohibited combinations from adjusted propranolol dosing.
Propranolol and MAO metabolism
Propranolol increases rizatriptan exposure; use the exact adult/pediatric reduced regimens above. This adjustment is not automatically applied to every beta blocker. MAO-A inhibitors increase parent/active-metabolite exposure and are contraindicated concurrently or within 2 weeks after stopping; nonselective MAO inhibitors are included.
Other migraine and serotonergic drugs
Other triptans/5-HT1 agonists and ergot derivatives can produce additive vasospasm: avoid within 24 hours. SSRIs, SNRIs and other serotonergic drugs can cause serotonin syndrome; review the combination, counsel and monitor, while respecting formal MAO contraindications. No unsupported universal washout or CYP dose reduction is invented.
Use in specific populations
Pediatric evidence begins at age 6 and differs from adults.
Children and older adults
Ages 6–17 have weight-based single-dose labeling; below 6 safety/effectiveness unestablished. Pediatric propranolol restrictions are weight-specific, including no prescription below 40 kg. Older adults were underrepresented in trials; assess organ function, other drugs and cardiovascular risk, usually choosing the low end if appropriate.
Renal/hepatic and PKU considerations
Exposure data do not establish a universal adjustment algorithm; organ-specific limitations are described in dosage, and severe hepatic disease needs individual review. Preserve the label’s indexed renal units. PKU: check exact MLT phenylalanine amount; do not apply brand 10 mg content to all generic strengths.
Pregnancy and lactation
Human pregnancy data and the historical 1998–2018 registry were too limited for reliable major-risk estimates; animal developmental toxicity informs counseling. The historical registry is not presented as a currently enrolling program. Human-milk transfer and infant effects are unknown in this label; consider maternal treatment need and breastfeeding benefits/risks. No invented milk-discard interval or safety guarantee supplied.
Clinical pharmacology
Selective serotonin receptors mediate trigeminovascular effects.
Mechanism
Rizatriptan has high affinity for 5-HT1B/1D receptors. Actions on cranial vessels and trigeminal sensory nerves are proposed to cause vasoconstriction and reduce pro-inflammatory neuropeptide signaling. It is an acute migraine treatment rather than a general analgesic or preventive drug.
Pharmacokinetics
Oral bioavailability is about 45%; tablet peak time roughly 1–1.5 hours, MLT approximately 0.7 hour later. Food can delay absorption without materially changing bioavailability. Half-life is about 2–3 hours. Primary metabolism is MAO-A oxidative deamination; an active N-monodesmethyl metabolite exists. Renal/hepatic and propranolol effects require the separately stated clinical restrictions, not an inferred PK-based self-adjustment.
Monitoring and counseling
Check diagnosis, cardiovascular risks, medicines and treatment frequency.
Monitoring priorities
Assess CV/vascular history, BP, prior triptan response, age/weight, propranolol/MAO/ergot/other triptan and serotonergic medicines, organ function and PKU formulation content. Track headache days and acute-treatment days; reassess insufficient response or medication overuse. No universal routine laboratory or ECG schedule for all users is asserted.
Counseling
Use the prescribed single dose and population-specific limits. Children must not use adult repeat-dose instructions. Do not combine migraine medicines without review. Obtain urgent assessment for chest pain, stroke-like signs, severe abdominal pain/bloody diarrhea, severe allergy or serotonin toxicity. Dizziness/somnolence can impair driving; know individual effect. Keep MLT dry/in pouch until use, secure medicines from children and never share.
Product identification
Brand strength availability and generic products differ.
Representative Maxalt product
- 10 mg tablet
- Pale-pink capsule-shaped tablet, MAXALT / MRK 267.
- Selected package
- 18 tablets, NDC 78206-142-01.
- Status
- Prescription oral product; selected current label says brand 5 mg strengths no longer marketed.
Dosage forms and strengths
- Selected brand products
- Maxalt 10 mg oral tablet; Maxalt-MLT 10 mg orally disintegrating tablet. Label retains 5 mg dose information but marks brand 5 mg products no longer marketed.
- MLT identification
- White/off-white round tablet with modified-square marking; 18-tablet carrying-case carton NDC 78206-143-01.
- Ingredient versus salt
- 10 mg rizatriptan is supplied as 14.53 mg rizatriptan benzoate; clinical doses refer to rizatriptan.
- Other products
- Use exact generic 5 or 10 mg label/package for prescribed strength, imprint, phenylalanine and handling; no inventory or all-manufacturer appearance claim.
Storage and handling
Selected tablet and MLT products store at 15–30°C. Keep MLT in sealed blister/outer aluminum pouch until immediately before use; dry hands and peel blister, do not push through foil. Protect from children and follow exact generic packaging directions.
References
Original sources for the clinical and product information.
- DailyMed / official U.S. product labelingMaxalt and Maxalt-MLT · full Organon label
Clinical highlights and Patient Information revised June 2021; current January 2026 SPL does not imply new clinical revision; SPL v4 effective 20260129; API publication Feb 06, 2026. Clinical revision is distinct from publication. Checked October 1, 2026.