Elyxyb

What Is Elyxyb?

Elyxyb (celecoxib) is a nonsteroidal anti-inflammatory drug (NSAID) indicated for the acute treatment of migraine with or without aura in adults. Elyxyb is available as a generic.

What Are Side Effects of Elyxyb?

Side effects of Elyxyb include:

• changes in taste

Dosage for Elyxyb

The recommended dose of Elyxyb is 120 mg taken orally, with or without food.

Elyxyb In Children

Safety and effectiveness of Elyxyb in pediatric patients have not been established. Disseminated intravascular coagulation has occurred in pediatric patients.

What Drugs, Substances, or Supplements Interact with Elyxyb?

Elyxyb may interact with other medicines such as:

• anticoagulants,
• aspirin,
• selective serotonin reuptake inhibitors (SSRIs),
• serotonin–norepinephrine reuptake inhibitors (SNRIs),
• angiotensin converting enzyme (ACE) inhibitors,
• angiotensin receptor blockers (ARB),
• beta-blockers,
• diuretics,
• digoxin,
• lithium,
• methotrexate,
• cyclosporine,
• other NSAIDs or salicylates,
• pemetrexed,
• CYP2C9 inhibitors (e.g. fluconazole),
• CYP2C9 inducers (e.g. rifampin), and
• corticosteroids

Tell your doctor all medications and supplements you use.

Elyxyb During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Elyxyb; use of NSAIDs such as Elyxyb during the third trimester of pregnancy increases the risk of premature closure of the fetal ductus arteriosus. Avoid use of NSAIDs in pregnant women starting at 30 weeks of gestation. Elyxyb may pass into breast milk in small amounts. It is unknown how it might affect a nursing child. Consult your doctor before breastfeeding.

Additional Information

Our Elyxyb (celecoxib) Oral Solution Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

Elyxyb Consumer Information

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).

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, leg swelling, feeling short of breath.

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

• the first sign of any skin rash, no matter how mild;
• heart problems--swelling, rapid weight gain, feeling short of breath;
• signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
• liver problems--nausea, stomach pain (upper right side), itching, tiredness, dark urine, jaundice (yellowing of the skin or eyes);
• kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
• low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common side effects may include:

• stomach pain, heartburn, gas, diarrhea, constipation, nausea, vomiting;
• swelling in your hands or feet;
• dizziness; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Elyxyb (Celecoxib Oral Solution)

 

Elyxyb Professional Information

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
• GI Bleeding, Ulceration, and Perforation [see WARNINGS AND PRECAUTIONS]
• Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
• Hypertension [see WARNINGS AND PRECAUTIONS]
• Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
• Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
• Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
• Exacerbation of Asthma Related to Aspirin Sensitivity [see WARNINGS AND PRECAUTIONS]
• Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
• Medication Overuse Headache [see WARNINGS AND PRECAUTIONS]
• Premature Closure of Fetal Ductus Arteriosus [see WARNINGS AND PRECAUTIONS]
• Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]

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 the rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The safety of ELYXYB was evaluated in 815 patients who received at least one dose of ELYXYB in two, randomized, double-blind, placebo-controlled trials (Study 1 and 2) in adult patients with migraine [see Clinical Studies].

The most common (at least 2% of patients who received ELYXYB and greater than placebo) adverse reaction in Study 1 and Study 2 was dysgeusia, which occurred in 3% of patients who received ELYXB compared to 1% of patients who received placebo.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of celecoxib. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiovascular: Vasculitis, deep venous thrombosis

General: Anaphylactic reaction, angioedema

Liver and biliary: Liver necrosis, hepatitis, jaundice, hepatic failure

Hemic and lymphatic: Agranulocytosis, aplastic anemia, pancytopenia,leucopenia

Metabolic: Hypoglycemia, hyponatremia

Nervous: Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage

Renal: Interstitial nephritis

Read the entire FDA prescribing information for Elyxyb (Celecoxib Oral Solution)