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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|
(N = 45)
(N = 44)
|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)|
|Ammonia increased||1 (2)||2 (5)|
|Metabolism and nutrition disorders|
|Decreased appetite||2 (4)||3 (7)|
|Nervous system disorders|
|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 Ravicti (glycerol phenylbutyrate oral liquid) Side Effects Center for a complete guide to possible side effects
Potential For Other Drugs To Affect Ammonia
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 UCD patients.
Potential For Other Drugs To Affect RAVICTI
Probenecid may inhibit the renal excretion of metabolites of RAVICTI including PAGN and PAA.
Last reviewed on RxList: 7/17/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Ravicti Information
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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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