Riluzole Side Effects

Brand Names: Rilutek

Please note - some side effects for Riluzole may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Riluzole - for the Consumer

Riluzole

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Riluzole:

Abnormal skin sensations around the mouth; diarrhea; dizziness; drowsiness; headache; loss of appetite; muscle weakness; nausea; stomach pain; vomiting; weakness.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); cough, shortness of breath, or trouble breathing; fast or irregular heartbeat; frequent or painful urination; signs of infection (eg, fever, chills, sore throat); swelling of the hands or feet; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

Side Effects by Body System - for Healthcare Professionals

Hepatic

At least one elevation in ALT has occurred in 50% of patients receiving riluzole. An ALT greater than 5 times the upper limit of normal has occurred in approximately 2% of patients. These elevations tend to occur within the first 3 months of treatment, are usually transient if less than 5 times the upper limit of normal, and may return to normal within 2 to 6 months if therapy is continued. There is little experience in the management of patients whose ALT exceeds 5 times the upper limit of normal. The manufacturer recommends discontinuing the drug if ALT exceeds 10 times the upper limit of normal or if jaundice occurs.

In one patient receiving riluzole for epilepsy and concurrently taking phenobarbital and carbamazepine, clinical jaundice developed four months after starting riluzole (ALT 26 X ULN, AST 17 X ULN, and bilirubin 11 X ULN). Liver function tests returned to normal 7 weeks after discontinuing riluzole therapy.

Hepatic side effects including elevations in alanine aminotransferase (ALT), aspartate aminotransferase (AST), and jaundice have been reported. Cases of clinical hepatitis associated with riluzole have been reported, including one with a fatal outcome.

Gastrointestinal

Most gastrointestinal side effects have been dose-related. Nausea and abdominal pain commonly resulted in discontinuation of riluzole during clinical trials.

Gastrointestinal side effects have included nausea (16.3%), abdominal pain (5.1%), vomiting (4.2%), anorexia (3.2%), and diarrhea (2.9%). Two cases of pancreatitis have also been reported.

Musculoskeletal

Musculoskeletal side effects including asthenia (which appears to be dose-related) (19.2%) and muscle stiffness have been reported.

Respiratory

Respiratory side effects including cases of interstitial lung disease have been reported in patients treated with riluzole, some of them severe. Upon further investigation, many of these cases were hypersensitivity pneumonitis.

Nervous system

Nervous system side effects including dizziness (3.8%), vertigo (1.9%), circumoral paresthesias (1.6%) and somnolence (1.9%) have been reported.

Nervous system side effects appear to be dose-related. Dizziness occurred more frequently in female patients.

Hematologic

Hematologic side effects including anemia and neutropenia (absolute neutrophil count less than 500/mm3) have rarely been reported. A case of methemoglobinemia has also been reported.

Cardiovascular

Cardiovascular side effects including mild to moderate increases in blood pressure have been reported.

Hypersensitivity

Hypersensitivity side effects including anaphylaxis have been reported.

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.