Applies to tasimelteon: oral capsule, oral suspension.

Serious side effects of Tasimelteon

Along with its needed effects, tasimelteon 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 immediately if any of the following side effects occur while taking tasimelteon:

More common

• Bladder, lower back, or side pain
• bloody or cloudy urine
• difficult, burning, frequent, or painful urination

Other side effects of Tasimelteon

Some side effects of tasimelteon 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

• Body aches or pain
• chills or fever
• cough
• ear congestion
• headache
• nightmares
• runny or stuffy nose
• sneezing

For Healthcare Professionals

Applies to tasimelteon: oral capsule, oral suspension.

Nervous system

Very common (10% or more): Headache (17%)

Frequency not reported: Somnolence^[Ref]

Hepatic

Very common (10% or more): Increased ALT (10%)^[Ref]

Psychiatric

Very common (10% or more): Nightmare/abnormal dreams (10%)

Genitourinary

Common (1% to 10%): Urinary tract infection^[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection^[Ref]