Benzoate

Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. MAXALT presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

• MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established.ICD-10: G43.909

• MAXALT is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1) ] .contraindicated

Although rizatriptan benzoate 5 mg tablets and orally disintegrating tablets are available in the marketplace, MAXALT Tablets and MAXALT-MLT Orally Disintegrating Tablets are no longer marketed in the 5 mg strength. Adults: 5 or 10 mg single dose; separate repeat doses by at least two hours; maximum dose in a 24-hour period: 30 mg ( 2.1 ) Pediatric patients 6 to 17 years: 5 mg single dose in patients less than 40 kg (88 lb); 10 mg single dose in patients 40 kg (88 lb) or more ( 2.2 ) Adjust dose if co-administered with propranolol ( 2.4 ) 2.1 Dosing Information in Adults The recommended starting dose of rizatriptan benzoate is either 5 mg or 10 mg for the acute treatment of migraines in adults. The 10-mg dose may provide a greater effect than the 5-mg dose, but may have a greater risk of adverse reactions [see Clinical Studies (14.1) ] . Redosing in Adults Although the effectiveness of a second dose or subsequent doses has not been established in placebo-controlled trials, if the migraine headache returns, a second dose may be administered 2 hours after the first dose. The maximum daily dose should not exceed 30 mg in any 24-hour period. The safety of treating, on average, more than four headaches in a 30-day period has not been established. 2.2 Dosing Information in Pediatric Patients (Age 6 to 17 Years) Dosing in pediatric patients is based on the patient's body weight. The recommended dose of rizatriptan benzoate is 5 mg in patients weighing less than 40 kg (88 lb), and 10 mg in patients weighing 40 kg (88 lb) or more.

Myocardial ischemia, myocardial infarction, and Prinzmetal's angina: Perform cardiac evaluation in patients with multiple cardiovascular risk factors ( 5.1 ) Arrhythmias: Discontinue dosing if occurs ( 5.2 ) Chest/throat/neck/jaw pain, tightness, pressure, or heaviness; Generally not associated with myocardial ischemia; Evaluate patients at high risk ( 5.3 ) Cerebral hemorrhage, subarachnoid hemorrhage, and stroke: Discontinue dosing if occurs ( 5.4 ) Gastrointestinal ischemic events, peripheral vasospastic reactions: Discontinue dosing if occurs ( 5.5 ) Medication overuse headache: Detoxification may be necessary ( 5.6 ) Serotonin syndrome: Discontinue dosing if occurs ( 5.7 ) 5.1 Myocardial Ischemia, Myocardial Infarction, and Prinzmetal's Angina MAXALT should not be given to patients with ischemic or vasospastic coronary artery disease. There have been rare reports of serious cardiac adverse reactions, including acute myocardial infarction, occurring within a few hours following administration of MAXALT. Some of these reactions occurred in patients without known coronary artery disease (CAD). 5-HT 1 agonists, including MAXALT may cause coronary artery vasospasm (Prinzmetal's Angina), even in patients without a history of CAD. Triptan-naïve patients who have multiple cardiovascular risk factors (e.g., increased age, diabetes, hypertension, smoking, obesity, strong family history of CAD) should have a cardiovascular evaluation prior to receiving MAXALT.

The 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. Adults Incidence in Controlled Clinical Trials Adverse reactions to MAXALT were assessed in controlled clinical trials that included over 3700 adult patients who received single or multiple doses of MAXALT Tablets.

Pregnancy: Based on animal data, may cause fetal harm ( 8.1 ) Phenylketonurics: MAXALT-MLT contains phenylalanine ( 8.6 ) 8.1 Pregnancy Risk Summary Available human data on the use of MAXALT in pregnant women are not sufficient to draw conclusions about drug-associated risk for major birth defects and miscarriage. In animal studies, developmental toxicity was observed following oral administration of rizatriptan during pregnancy (decreased fetal body weight in rats) or throughout pregnancy and lactation (increased mortality, decreased body weight, and neurobehavioral impairment in rat offspring) at maternal plasma exposures greater than that expected at therapeutic doses in humans [see Animal Data ] . In the U.S. general population, the estimated background risk of major birth defects and of miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. The reported rate of major birth defects among deliveries to women with migraine range from 2.2% to 2.9% and the reported rate of miscarriage was 17%, which are similar to rates reported in women without migraine. Clinical Considerations Disease-Associated Maternal and/or Embryo/Fetal Risk In women with migraine, there is an increased risk of adverse perinatal outcomes in the mother, including pre-eclampsia and gestational hypertension.

Metabolism

Absorption Rizatriptan is completely absorbed following oral administration. The mean oral absolute bioavailability of the MAXALT Tablet is about 45%, and mean peak plasma concentrations (C max ) are reached in approximately 1-1.5 hours (T max ).

No overdoses of MAXALT were reported during clinical trials in adults. Some adult patients who received 40 mg of MAXALT either a single dose or as two doses with a 2-hour interdose interval had dizziness and somnolence. In a clinical pharmacology study in which 12 adult subjects received MAXALT, at total cumulative doses of 80 mg (given within four hours), two of the subjects experienced syncope, dizziness, bradycardia including third degree AV block, vomiting, and/or incontinence. In the long-term, open label study, involving 606 treated pediatric migraineurs 12 to 17 years of age (of which 432 were treated for at least 12 months), 151 patients (25%) took two 10-mg doses of MAXALT-MLT within a 24-hour period. Adverse reactions for 3 of these patients included abdominal discomfort, fatigue, and dyspnea. In addition, based on the pharmacology of MAXALT, hypertension or myocardial ischemia could occur after overdosage. Gastrointestinal decontamination, (i.e., gastric lavage followed by activated charcoal) should be considered in patients suspected of an overdose with MAXALT.

• Jun 29, 1998NDANDA020864Organon Llc
• Jun 29, 1998NDANDA020865Organon
• Dec 31, 2012ANDAANDA077263Teva Pharms
• Dec 31, 2012ANDAANDA202047Creekwood Pharms
• Dec 31, 2012ANDAANDA202490Aurobindo Pharma Ltd
• Jan 25, 2013NDANDA022426Takeda Pharms Usa
• Jun 10, 2021NDANDA215025Maia Pharms Inc
• Apr 14, 2023NDANDA205394Gensco

Recent PubMed references pinned to Benzoate as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

• A retrospective cohort study comparing treatment persistence between rimegepant and lasmiditan for the acute treatment of migraine in the US.
  Cephalalgia : an international journal of headache · 2026 · Tepper SJ, Jenkins A, Dagenais S, et al.
  PMID 42273779DOI 10.1177/03331024261447187
• Glutamyl-tRNA synthetase 2 regulates mitochondrial biogenesis and reactive oxygen species homeostasis mediatingenzalutamide resistance by targeting striatin 4 in prostate cancer cells.
  Journal of physiology and pharmacology : an official journal of the Polish Physiological Society · 2026 · Wang BQ, Wang X, Liu W, et al.
  PMID 42272283DOI 10.26402/jpp.2026.2.07
• Exogenous Syringic Acid Mitigates Arsenic Toxicity in Lettuce Plants: A Physiological, Antioxidant, and Metabolomics Investigation.
  Physiologia plantarum · 2026 · Salehi H, Alp-Turgut FN, Zengin G, et al.
  PMID 42259367DOI 10.1111/ppl.70964
• Multi-level assessment of chronic toxicity of the insect growth regulator lufenuron in the non-target aquatic organism Daphnia magna.
  Environmental geochemistry and health · 2026 · Dane H, Aksakal Ö, Şişman T, et al.
  PMID 42257755DOI 10.1007/s10653-026-03279-5
• Eltrombopag Combined With Cyclosporine A in the Treatment of Pediatric Patients With SAA: Establishing the Range for Eltrombopag Concentrations.
  Clinical and translational science · 2026 · Li F, Li N, Tang X, et al.
  PMID 42257533DOI 10.1111/cts.70631
• The Protective Role of Salicylic Acid-Conjugated Chitosan Nanoparticles Against Cryodamage in Buffalo Semen.
  Reproduction in domestic animals = Zuchthygiene · 2026 · Khalil WA, Ismail AA, Hassan MAE, et al.
  PMID 42257507DOI 10.1111/rda.70247
• Spectroscopic Analysis of Salicylate Dianion Generated during Aspirin Titration Based on the Japanese Pharmacopoeia Method.
  Chemical & pharmaceutical bulletin · 2026 · Shimozono S, Konno H, Kishimoto Y, et al.
  PMID 42252189DOI 10.1248/cpb.c26-00113
• Gallic acid attenuates LPS-induced acute kidney injury with accompanying changes in inflammatory and redox-related signaling pathways.
  Molecular biology reports · 2026 · Altuntas A, Asci H, Tepebasi MY, et al.
  PMID 42247065DOI 10.1007/s11033-026-12056-7

The 10 most recently updated of 1,811 ClinicalTrials.gov registrations naming Benzoate as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Optimization of Beta-lactam Dosing in Critically Ill Patients With Cystatin C (OPTIMIZE-GNI)
  Recruiting · Phase 4 · Interventional · 200 enrolled · National Institute of Allergy and Infectious Diseases (NIAID)
  NCT06709521updated 2026-06-12
• A Study to Compare Standard Therapy to Treat Hodgkin Lymphoma to the Use of Two Drugs, Brentuximab Vedotin and Nivolumab
  Recruiting · Phase 3 · Interventional · 1,875 enrolled · National Cancer Institute (NCI)
  NCT05675410updated 2026-06-12
• Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
  Not yet recruiting · Phase 4 · Interventional · 264 enrolled · Faisalabad Medical University
  NCT07638527updated 2026-06-11
• Fluorescent Probe for Assessment of Renal Elimination
  Not yet recruiting · Phase 4 · Interventional · 200 enrolled · Aaron Cook
  NCT07643467updated 2026-06-11
• Role of the Foregut in Nutrient Metabolism in Lean and Obese Humans
  Completed · Phase 1 · Interventional · 27 enrolled · Vanderbilt University Medical Center
  NCT02537314updated 2026-06-11
• Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer
  Recruiting · Phase 3 · Interventional · 718 enrolled · SWOG Cancer Research Network
  NCT07383441updated 2026-06-11
• NEPC Study: An Exploratory Safety and Efficacy Study With PSMA, SSTR2 and GRPR Targeted Radioligand Therapy in Metastatic Neuroendocrine Prostate Cancer.
  Active not recruiting · Phase 1 · Interventional · 31 enrolled · Novartis Pharmaceuticals
  NCT06379217updated 2026-06-10
• A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma
  Recruiting · Phase 2 · Interventional · 65 enrolled · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  NCT07015242updated 2026-06-10
• Asciminib Roll-over Study
  Recruiting · Phase 4 · Interventional · 347 enrolled · Novartis Pharmaceuticals
  NCT04877522updated 2026-06-10
• Intravenous Metoclopramide Versus Intravenous Acetaminophen for Acute Concussion Treatment
  Not yet recruiting · Phase 4 · Interventional · 200 enrolled · Montefiore Medical Center
  NCT07634393updated 2026-06-10

Frequently asked questions

How does Benzoate work?

Rizatriptan binds with high affinity to human cloned 5-HT 1B/1D receptors. MAXALT presumably exerts its therapeutic effects in the treatment of migraine headache by binding to 5-HT 1B/1D receptors located on intracranial blood vessels and sensory nerves of the trigeminal system.

What is Benzoate used for?

According to FDA labeling, Benzoate carries indications including: MAXALT ® and MAXALT-MLT ® are indicated for the acute treatment of migraine with or without aura in adults and in pediatric patients 6 to 17 years old. Limitations of Use MAXALT should only be used where a clear diagnosis of migraine has been established.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What are the brand names for Benzoate?

Benzoate is marketed under brand names including Ammonul, Hyophen, Prosed DS, Provita Combat, Uribel Tabs.

What are the contraindications for Benzoate?

Benzoate labeling lists contraindications including: MAXALT is contraindicated in patients with: Ischemic coronary artery disease (angina pectoris, history of myocardial infarction, or documented silent ischemia), or other significant underlying cardiovascular disease [see Warnings and Precautions (5.1) ] . Coronary artery vasospasm including Prinzmetal's angina [see Warnings and Precautions (5.1) ] .. Always consult the full prescribing information and a clinician.