Ravicti Side Effects Center

Last updated on RxList: 9/20/2022
Ravicti Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Ravicti?

Ravicti is a prescription medicine used in adults and children 2 years of age and older for long-term management of high blood levels of ammonia caused by a condition called a urea cycle disorder (UCD).

What Are Side Effects of Ravicti?

The most commonly observed side effects included:

  • headache,
  • passing gas, and
  • diarrhea

Ravicti is not available in generic form.

Ravicti may cause serious side effects including:

  • hives,
  • difficulty breathing,
  • swelling of your face, lips, tongue, or throat,
  • cough,
  • wheezing,
  • lightheadedness,
  • weakness,
  • lack of energy,
  • thinking problems,
  • changes in behavior,
  • irritableness,
  • feeding problems,
  • seizure,
  • drowsiness,
  • tiredness,
  • memory problems,
  • confusion,
  • ongoing headache,
  • vomiting,
  • numbness, tingling, or burning pain in your hands or feet,
  • altered sense or taste, and
  • hearing problems

Get medical help right away, if you have any of the symptoms listed above.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheartedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Ravicti

The total daily dosage is given in 3 equally divided dosages, rounded up to nearest 0.5 mL. The maximum daily dosage is 17.5 mL. Patients taking Ravicti must restrict protein in their diets. Ravicti should be taken with food.

What Drugs, Substances, or Supplements Interact with Ravicti?

Drugs containing corticosteroids, valproic acid, or haloperidol may interact with Ravicti and increase ammonia levels in the blood. Doctors should closely monitor ammonia levels in patients taking Ravicti.

Ravicti During Pregnancy or Breastfeeding

Ravicti has not been studied in pregnant women. However, based on animal data, Ravicti may cause fetal harm. In breastfeeding women, it should be decided whether a woman will nurse or take Ravicti. Nursing women should not do both.

Additional Information

Our Ravicti (glycerol phenylbutyrate) 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.

QUESTION

What is hemophilia? See Answer
Ravicti Consumer Information

Get emergency medical help if you have signs of an allergic reaction: hives; cough, wheezing, difficult breathing; feeling like you might pass out; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any signs of high blood levels of ammonia (hyperammonemia):

  • weakness, lack of energy;
  • thinking problems, changes in behavior, feeling irritable;
  • breathing problems;
  • feeding problems; or
  • seizure (convulsions).

Glycerol phenylbutyrate can affect your nervous system. Call your doctor at once if you have:

  • drowsiness, unusual tiredness;
  • memory problems;
  • a light-headed feeling, like you might pass out;
  • confusion, ongoing headache, vomiting;
  • numbness, tingling, or burning pain in your hands or feet;
  • altered sense of taste; or
  • hearing problems.

Common side effects may include:

  • occasional headache;
  • nausea, vomiting, diarrhea;
  • loss of appetite, gas, stomach pain;
  • dizziness, tiredness;
  • rash; or
  • (in children younger than 2 years) fever, cold or flu symptoms, cough, small bumps on the skin.

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.

SLIDESHOW

Anemia Symptoms and Signs, Types, Treatment and Causes See Slideshow
Ravicti Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Neurotoxicity [see WARNINGS AND PRECAUTIONS]
  • Pancreatic insufficiency or Intestinal Malabsorption [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 rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

Assessment of adverse reactions was based on exposure of 45 adult patients (31 female and 14 male) with UCD subtype deficiencies of ornithine transcarbamylase (OTC, n=40), carbamoyl phosphate synthetase (CPS, n=2), and argininosuccinate synthetase (ASS, n=1) in a randomized, double-blind, active-controlled (RAVICTI vs sodium phenylbutyrate), crossover, 4-week study (Study 1) that enrolled patients 18 years of age and older [see Clinical Studies]. One of the 45 patients received only sodium phenylbutyrate prior to withdrawing on day 1 of the study due to an adverse reaction.

The most common adverse reactions (occurring in at least 10% of patients) reported during short-term treatment with RAVICTI were diarrhea, flatulence, and headache. Table 1 summarizes adverse reactions occurring in 2 or more patients treated with RAVICTI or sodium phenylbutyrate (incidence of at least 4% in either treatment arm).

Table 1: Adverse Reactions Reported in 2 or More Adult Patients with UCDs (at least 4% in Either Treatment Arm) in Study 1

Number (%) of Patients in Study 1
Sodium Phenylbutyrate
(N = 45)
RAVICTI
(N = 44)
Diarrhea 3 (7) 7 (16)
Headache 4 (9) 6 (14)
Flatulence 1 (2) 6 (14)
Abdominal pain 2 (4) 3 (7)
Vomiting 2 (4) 3 (7)
Decreased appetite 2 (4) 3 (7)
Fatigue 1 (2) 3 (7)
Dyspepsia 3 (7) 2 (5)
Nausea 3 (7) 1 (2)
Dizziness 4 (9) 0
Abdominal discomfort 3 (7) 0

Other Adverse Reactions

RAVICTI has been evaluated in 77 patients with UCDs (51 adult and 26 pediatric patients ages 2 years to 17 years) in 2 open-label long-term studies, in which 69 patients completed 12 months of treatment with RAVICTI (median exposure = 51 weeks). During these studies there were no deaths.

Adverse reactions reported in at least 10% of adult patients were nausea, vomiting, diarrhea, decreased appetite, dizziness, headache, and fatigue.

Adverse reactions reported in at least 10% of pediatric patients ages 2 years to 17 years were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, and headache.

RAVICTI has been evaluated in 17 patients with UCDs ages 2 months to less than 2 years in 3 open-label studies. The median exposure was 6 months (range 0.2 to 20 months). Adverse reactions reported in at least 10% of pediatric patients aged 2 months to less than 2 years were neutropenia, vomiting, constipation, diarrhea, pyrexia, hypophagia, cough, nasal congestion, rhinorrhea, rash, and papule.

RAVICTI has been evaluated in 16 patients with UCDs less than 2 months of age (age range 0.1 to 2 months, median age 0.5 months) in a single, open-label study. The median exposure was 10 months (range 2 to 20 months). Adverse reactions reported in at least 10% of pediatric patients aged less than 2 months were vomiting, rash, gastroesophageal reflux, increased hepatic enzymes, feeding disorder (decreased appetite, hypophagia), anemia, cough, dehydration, metabolic acidosis, thrombocytosis, thrombocytopenia, neutropenia, lymphocytosis, diarrhea, flatulence, constipation, pyrexia, lethargy, and irritability/agitation.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of RAVICTI. 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:

  • Abnormal body odor, including from skin, hair and urine
  • Retching and gagging
  • Dysgeusia or burning sensation in mouth

DRUG INTERACTIONS

Potential For Other Drugs To Affect Ammonia

Corticosteroids

Use of corticosteroids may cause the breakdown of body protein and increase plasma ammonia levels. Monitor ammonia levels closely when corticosteroids and RAVICTI are used concomitantly.

Valproic Acid And Haloperidol

Hyperammonemia may be induced by haloperidol and by valproic acid. Monitor ammonia levels closely when use of valproic acid or haloperidol is necessary in patients with UCDs.

Potential For Other Drugs To Affect RAVICTI

Probenecid

Probenecid may inhibit the renal excretion of metabolites of RAVICTI including PAGN and PAA.

Potential For RAVICTI To Affect Other Drugs

Drugs With Narrow Therapeutic Index That Are Substrates Of CYP3A4

RAVICTI is a weak inducer of CYP3A4 in humans. Concomitant use of RAVICTI may decrease the systemic exposure to drugs that are substrates of CYP3A4. Monitor for decreased efficacy of drugs with narrow therapeutic index (e.g., alfentanil, quinidine, cyclosporine) [see CLINICAL PHARMACOLOGY].

Midazolam

Concomitant use of RAVICTI decreased the systemic exposure of midazolam. Monitor for suboptimal effect of midazolam in patients who are being treated with RAVICTI.

Read the entire FDA prescribing information for Ravicti (Glycerol Phenylbutyrate Oral Liquid)

© Ravicti Patient Information is supplied by Cerner Multum, Inc. and Ravicti Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

Health Solutions From Our Sponsors