Meloxicamside effects

meloxicam 20 MG / rizatriptan 10 MG Oral Tablet [Symbravo]

Adverse reactions

The following adverse reactions are discussed in more detail in other sections of the labeling: Cardiovascular Thrombotic Events and Myocardial Infarction GI Bleeding, Ulceration, and Perforation Arrhythmias Cerebrovascular Events Anaphylactic Reactions Chest, Throat, Neck and/or Jaw Pain/Tightness/Pressure Other Vasospasm Reactions Hepatotoxicity Hypertension/Increase in Blood Pressure Heart Failure and Edema Renal Toxicity and Hyperkalemia Serious Skin Reactions Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) Fetal Toxicity Hematologic Toxicity Exacerbation of Asthma Related to Aspirin Sensitivity Medication Overuse Headache Serotonin Syndrome Most common adverse reactions (≥1% and greater than placebo) are dizziness and somnolence. To report SUSPECTED ADVERSE REACTIONS, contact Axsome Therapeutics at 1-800-484-1672 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. In two randomized, double-blind, controlled trials in adults with migraine, a total of 581 patients received a single dose of SYMBRAVO after the onset of a migraine attack (Studies 1 and 2). The most common adverse reactions from these two trials after treatment with SYMBRAVO (incidence ≥1% and greater than placebo) are provided in Table 1.

Table 1: Incidence (≥1% and Greater than Placebo) of Adverse Reactions after a Single Dose of SYMBRAVO in Adults (Study 1 and Study 2) SYMBRAVO N=581 a % Rizatriptan 10 mg N=434 b % Meloxicam 20 mg N=433 b % Placebo N=361 a % Somnolence 2 2 2 1 Dizziness 2 2 1 1 a Study 1 and Study 2 pooled b Data from Study 1 only; Study 2 did not include arms with each individual component Long-term safety was assessed in 706 patients dosing intermittently for up to 12 months in an open-label extension trial where patients treated at least 2 migraines per month with SYMBRAVO. Of these 706 patients, 496 patients were exposed to SYMBRAVO for at least 6 months, and 132 were exposed for at least 12 months, all of whom treated at least 2 migraine attacks per month, on average.

6.2 Postmarketing

Experience The following adverse reactions have been reported with the individual components of SYMBRAVO, meloxicam and rizatriptan, from postmarketing experience. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Meloxicam Blood and Lymphatic System Disorders: Agranulocytosis Hepatobiliary Disorders: Jaundice; liver failure Psychiatric Disorders: Alterations in mood (such as mood elevation) Renal and Urinary Disorders: Acute urinary retention; interstitial nephritis Reproductive System and Breast Disorders: Infertility female Skin and Subcutaneous Tissue Disorders: Anaphylactic reactions including shock; erythema multiforme; exfoliative dermatitis; Stevens-Johnson syndrome; fixed drug eruption (FDE); toxic epidermal necrolysis Rizatriptan General: Allergic conditions including anaphylaxis/ anaphylactic reaction, angioedema, wheezing, and toxic epidermal necrolysis Neurological/Psychiatric: Seizure Special Senses: Dysgeusia

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective November 21, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Contraindications

SYMBRAVO 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. Coronary artery vasospasm including Prinzmetal’s angina. In the setting of coronary artery bypass graft (CABG) surgery. History of stroke or transient ischemic attack (TIA). Hemiplegic or basilar migraine. Peripheral vascular disease (PVD). Ischemic bowel disease. Uncontrolled hypertension. Concomitant use of propranolol Recent use (i.e., within 24 hours) of an ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5-HT1 agonist (e.g., another triptan). Concurrent administration or recent discontinuation (i.e., within 2 weeks) of a MAO-A inhibitor. Known hypersensitivity (e.g., anaphylactic reactions and angioedema seen) to SYMBRAVO, meloxicam, rizatriptan, NSAIDs or any of the excipients in SYMBRAVO. History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs. Severe, sometimes fatal anaphylactic-like reactions to NSAIDs have been reported in such patients. Moderate to severe renal insufficiency in patients who are at risk for renal failure due to volume depletion or who are on dialysis. Ischemic coronary artery disease or other significant underlying cardiovascular disease Coronary artery vasospasm In the setting of CABG surgery History of stroke or transient ischemic attack Hemiplegic or basilar migraine Peripheral vascular disease Ischemic bowel disease Uncontrolled hypertension Concomitant use of propranolol Recent (within 24 hours) use of an ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), another 5-HT 1 agonist (e.g., another triptan) Concurrent administration or recent discontinuation (i.e., within the past 2 weeks) of a MAO-A inhibitor Known hypersensitivity to SYMBRAVO, meloxicam, rizatriptan, NSAIDs, triptans, or any of the excipients in SYMBRAVO History of asthma, urticaria, or other allergic-type reactions after taking aspirin or other NSAIDs Moderate to severe renal insufficiency in patients who are at risk for renal failure due to volume depletion or who are on dialysis

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