Symbravo Side Effects

Generic name: meloxicam / rizatriptan

Note: This document provides detailed information about Symbravo Side Effects associated with meloxicam / rizatriptan. Some dosage forms listed on this page may not apply specifically to the brand name Symbravo.

Applies to meloxicam / rizatriptan: oral tablet.

Important warnings This medicine can cause some serious health issues

You should not use this medicine if you have or have ever had: heart problems, stroke, transient ischemic attack (TIA or "mini-stroke"), blood circulation problems, certain types of migraines, uncontrolled high blood pressure, moderate to severe kidney problems or on dialysis, or a history of severe allergic reaction to aspirin or an NSAID.

Meloxicam and rizatriptan can increase your risk of fatal heart attack or stroke.

Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Meloxicam and rizatriptan may also cause stomach or intestinal bleeding, which can be fatal.

Some drugs should not be used with meloxicam and rizatriptan.

Your treatment plan may change if you also use: medications containing propranolol, other migraine headache medicine in the past 24 hours, certain antidepressants or have used them in the past 14 days.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using meloxicam and rizatriptan and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Stop taking this medicine and get emergency medical help if you have:

• signs of a heart attack or stroke--chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, feeling short of breath;

• blood circulation problems in legs and feet--pain, weakness, numbness, tingling, color changes (pale or blue-colored appearance), cramps, burning, coldness, or heavy feeling in toes, feet, or legs.

• severe stomach and intestinal problems--sudden severe stomach pain (including after eating), weight loss, constipation, diarrhea, nausea, vomiting; or

• signs of serotonin syndrome--agitation, hallucinations, coma, fast heart rate, changes in blood pressure, high body temperature, muscle stiffness, trouble walking.

Stop using meloxicam and rizatriptan and call your doctor at once if you have:

• tiredness, shortness of breath;

• severe headache, blurred vision, problems with balance, confusion;

• heart problems--irregular heartbeats, high blood pressure, heart failure (swelling, rapid weight gain);

• kidney problems--swelling, urinating less;

• liver problems--loss of appetite, stomach pain (upper right side), itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), flu-like symptoms;

• low red blood cells (anemia)--pale skin, feeling light-headed, cold hands and feet; or

• stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds.

Meloxicam and rizatriptan may worsen asthma attacks in people who have asthma. Talk with your doctor about your individual risk.

Common side effects may include:

• dizziness, feeling tired;

• stomach pain, constipation, diarrhea; or

• gas, heartburn, nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to meloxicam / rizatriptan: oral tablet.

General adverse events

The most common adverse reactions occurring with use of this combination drug included somnolence and dizziness.

Reported adverse effects include those occurring with use of this product, the individual components, other non-steroidal inflammatory drugs, and/or other 5-hydroxytryptamine 1 agonists.^[Ref]

Cardiovascular

• Frequency not reported: New onset/worsening hypertension, elevated blood pressure, hypertensive crisis, non-coronary vasospastic reactions, peripheral vascular ischemia, Raynaud's syndrome, cardiac rhythm disturbances, ventricular tachycardia, ventricular fibrillation, acute myocardial infarction, serious cardiac adverse reactions, coronary artery vasospasm (Prinzmetal's angina)

Dermatologic

• Frequency not reported: Drug reaction with eosinophilia and systemic symptoms
• Postmarketing reports: Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, fixed drug eruption, toxic epidermal necrolysis

Gastrointestinal

• Frequency not reported: Gastrointestinal vascular ischemia and infarction (presenting with abdominal pain and bloody diarrhea), inflammation, bleeding, ulceration, and perforation of the esophagus, stomach, small intestine, or large intestine

Hematologic

• Frequency not reported: Anemia, splenic infarction
• Postmarketing reports: Agranulocytosis

Hepatic

• Very common (10% or more): Increased AST/ALT (up to 15%)
• Postmarketing reports: Jaundice, liver failure, hepatotoxicity

Hypersensitivity

• Postmarketing reports: Allergic conditions including anaphylaxis/anaphylactic reaction (e.g., angioedema and shock)

Metabolic

• Frequency not reported: Increased serum potassium, hyperkalemia

Nervous system

• Common (1% to 10%): Somnolence, dizziness
• Frequency not reported: Cerebral hemorrhage, subarachnoid hemorrhage, stroke, serotonin syndrome, medication overuse headache
• Postmarketing reports: Seizure, dysgeusia

Ocular

• Frequency not reported: Transient/permanent blindness, significant partial vision loss

Other

• Frequency not reported: Fluid retention, edema, sensations of tightness, pain, pressure, and heaviness in the precordium, throat, neck and jaw
• Postmarketing reports: Female infertility

Psychiatric

• Postmarketing reports: Alterations in mood, elevated mood

Renal

• Frequency not reported: Renal papillary necrosis, renal insufficiency, acute renal failure, other renal injury
• Postmarketing reports: Acute urinary retention, interstitial nephritis

Respiratory

• Frequency not reported: Exacerbation of asthma related to aspirin sensitivity

Further information

Symbravo side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer