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Ravicti

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Ravicti

Ravicti Side Effects Center

Pharmacy Editor: Melissa Conrad Stöppler, MD

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). The most commonly observed side effects included headache, passing gas, and diarrhea. Ravicti is not available in generic form.

The total daily dosage is given in 3 divided dosages, with a maximum daily dosage of 17.5 mL. Patients taking Ravicti must restrict protein in their diets. Ravicti should be taken with food. 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 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.

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.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Ravicti FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

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), carbamyl 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 [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.

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

Table 1: Adverse Reactions Reported in ≥ 2 Adult UCD Patients in Study 1

  Number (%) of Patients in Study 1
Sodium Phenylbutyrate
(N = 45)
RAVICTI
(N = 44)
Gastrointestinal disorders
  Abdominal discomfort 3 (7) 0
  Abdominal pain 2 (4) 3 (7)
  Diarrhea 3 (7) 7 (16)
  Dyspepsia 3 (7) 2 (5)
  Flatulence 1 (2) 6 (14)
  Nausea 3 (7) 1 (2)
  Vomiting 2 (4) 3 (7)
General disorders and administration site conditions
  Fatigue 1 (2) 3 (7)
Investigations 
  Ammonia increased 1 (2) 2 (5)
Metabolism and nutrition disorders
  Decreased appetite 2 (4) 3 (7)
Nervous system disorders
  Dizziness 4 (9) 0
  Headache 4 (9) 6 (14)

Other Adverse Reactions

RAVICTI has been evaluated in 77 UCD patients (51 adult and 26 pediatric) 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 occurring in ≥ 10% of adult patients were nausea, vomiting, diarrhea, decreased appetite, hyperammonemia, dizziness, headache, and fatigue.

Adverse reactions occurring in ≥ 10% of pediatric patients were upper abdominal pain, rash, nausea, vomiting, diarrhea, decreased appetite, hyperammonemia, and headache.

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

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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