Egaten

Last updated on RxList: 9/8/2020
Egaten Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Egaten?

Egaten (triclabendazole) is an anthelmintic indicated for the treatment of fascioliasis in patients 6 years of age and older.

What Are Side Effects of Egaten?

Common side effects of Egaten include:

Dosage for Egaten

The recommended dose of Egaten is 2 doses of 10 mg/kg given 12 hours apart in patients 6 years of age and older. Egaten may interact with CYP2C19 substrates. Tell your doctor all medications and supplements you use.

What Drugs, Substances, or Supplements Interact with Egaten?

Egaten During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Egaten; it is unknown how it would affect a fetus. It is unknown if Egaten passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Egaten (triclabendazole) Tablets, for Oral Use 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.

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Egaten Professional Information

SIDE EFFECTS

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 clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of triclabendazole was evaluated in 208 adult and pediatric patients 5 years of age and older who participated in 6 clinical trials for the treatment of fascioliasis and received 10 mg/kg or 20 mg/kg of triclabendazole; of these, 6 patients failed the 10 mg/kg dose and were retreated with 20 mg/kg. The 10 mg/kg dosing regimen is not approved [see DOSAGE AND ADMINISTRATION]. In these trials, 186 patients received a single dose of 10 mg/kg and 28 patients received a dose of 20 mg/kg as two divided doses. Pooled data for adverse reactions reported in more than 2% of the patients in these clinical trials for the 10 mg/kg and 20 mg/kg dosing regimens are presented in Table 1.

Table 1: Adverse Reactions Occurring in >2% of Patients Who Received a Total of 10 mg/kg or 20 mg/kg Triclabendazole for Fascioliasis Treatment (Pooled across 6 studies)

Adverse ReactionsTriclabendazole 10 mg/kg
N = 186, n (%)
Triclabendazole 20 mg/kg in two
divided doses1
N = 28, n (%)
Abdominal pain2105 (56)26 (93)
Hyperhidrosis42 (23)7 (25)
Vertigo16 (9)0
Nausea15 (8)5 (18)
Urticaria12 (7)3 (11)
Vomiting11 (6)2 (7)
Headache11 (6)4 (14)
Dyspnea9 (5)0
Pruritus8 (4)1 (4)
Asthenia7 (4)0
Musculoskeletal chest pain7 (4)1 (4)
Cough7 (4)0
Decreased appetite6 (3)5 (18)
Chest pain6 (3)0
Pyrexia4 (2)0
Jaundice34 (2)0
Chest discomfort4 (2)0
Diarrhea02 (7)
1 Divided doses were given 6-48 hours apart
2 Abdominal pain upper and abdominal pain
3 Jaundice and ocular icterus

Adverse reactions reported in less than or equal to 2% of patients who received a total of 10 mg/kg of triclabendazole were constipation, biliary colic, arthralgia, back pain, spinal pain, and chromaturia. Some adverse reactions associated with triclabendazole treatment in fascioliasis, e.g. abdominal pain, biliary colic, and jaundice, could be secondary to the infection and may be more frequent and/or severe in patients with a heavy worm burden.

The safety profile of triclabendazole 20 mg/kg in divided doses in a non-hepatic parasitic infection (N = 104) was generally similar to the safety profile in fascioliasis, except for a lower incidence of post-treatment abdominal pain.

Liver Enzyme Elevations

In clinical studies, up to one third of patients had liver enzyme elevations at baseline, which generally improved post-treatment. Of those with normal liver enzyme values at baseline, 6.8%, 4.5%, 4.2% and 3% of patients had post-treatment elevations in bilirubin, aspartate aminotransferase (AST), alkaline phosphatase (ALP) and alanine aminotransferase (ALT), respectively. Transient increases in liver enzymes and total bilirubin in fascioliasis patients receiving triclabendazole are reported in the literature.

Postmarketing Experience

Resistance to triclabendazole has been reported outside the United States [see Microbiology].

Read the entire FDA prescribing information for Egaten (Triclabendazole Tablets)

SLIDESHOW

Hepatitis C, Hep B, Hep A: Symptoms, Causes, Treatment See Slideshow

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

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