Note: This document contains side effect information about edaravone. Some dosage forms listed on this page may not apply to the brand name Radicava.

Applies to edaravone: intravenous solution. Other dosage forms:

• oral suspension

Serious side effects of Radicava

Along with its needed effects, edaravone (the active ingredient contained in Radicava) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur while taking edaravone:

More common

• Blistering, crusting, irritation, itching, or reddening of the skin
• blue lips, fingernails, or skin
• chest pain or tightness
• change in walking and balance
• clumsiness or unsteadiness
• cough
• confusion
• cracked, dry, scaly skin
• difficult or troubled breathing
• dizziness
• fast heartbeat
• hives, itching, rash, or swelling
• irregular, fast or slow, or shallow breathing
• skin rash, encrusted, scaly and oozing
• unusual bruising
• weakness

Less common

• Sugar in the urine

Other side effects of Radicava

Some side effects of edaravone may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Headache
• itching in genital or other skin areas

For Healthcare Professionals

Applies to edaravone: intravenous solution, oral suspension.

General

The most common adverse reactions (incidence of at least 10% and greater than placebo) are contusion, gait disturbance, and headache.^[Ref]

Dermatologic

Very common (10% or more): Contusion (15%)

Common (1% to 10%): Dermatitis, eczema, tinea infection^[Ref]

Nervous system

Very common (10% or more): Gait disturbance (13%), headache (10%)^[Ref]

Renal

Common (1% to 10%): Glycosuria^[Ref]

Respiratory

Common (1% to 10%): Respiratory failure/respiratory disorder/hypoxia^[Ref]

Hypersensitivity

Postmarketing reports: Hypersensitivity reactions, anaphylaxis^[Ref]