Ravicti Side Effects

Generic Name: glycerol phenylbutyrate

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

In Summary

Common side effects of Ravicti include: dizziness, fatigue, headache, nausea, and vomiting. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to glycerol phenylbutyrate: oral solution

Along with its needed effects, glycerol phenylbutyrate (the active ingredient contained in Ravicti) 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 glycerol phenylbutyrate:

• Continuing nausea or vomiting
• increase in the frequency of seizures
• loss of appetite
• swelling of the face
• tiredness and weakness

Some side effects of glycerol phenylbutyrate 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:

• Bloated or full feeling
• diarrhea
• excess air or gas in the stomach or intestines
• headache
• nausea
• passing gas
• rash
• upper abdominal or stomach pain
• vomiting

• Acid or sour stomach
• belching
• heartburn
• indigestion
• stomach discomfort or upset

For Healthcare Professionals

Applies to glycerol phenylbutyrate: oral liquid

General

The most frequently reported side effects included diarrhea, flatulence, and headache.^[Ref]

Nervous system

Very common (10% or more): Headache (14%), dizziness^[Ref]

Gastrointestinal

Very common (10% or more): Diarrhea (16%), flatulence (14%), upper abdominal pain (pediatric patients), nausea , vomiting
Common (1% to 10%): Abdominal pain (adults) dyspepsia^[Ref]

Metabolic

Very Common (10% or more): Decreased appetite, hyperammonemia^[Ref]

Other

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

Dermatologic

Very common (10% or more): Rash (pediatric patients)^[Ref]

Some side effects of Ravicti may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

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