EGATEN SIDE EFFECTS
- Generic Name: triclabendazole tablets
- Brand Name: Egaten
- Drug Class: Anthelmintics
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. 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 Reactions | Triclabendazole 10 mg/kg N = 186, n (%) |
Triclabendazole 20 mg/kg in two divided doses1 N = 28, n (%) |
| Abdominal pain2 | 105 (56) | 26 (93) |
| Hyperhidrosis | 42 (23) | 7 (25) |
| Vertigo | 16 (9) | 0 |
| Nausea | 15 (8) | 5 (18) |
| Urticaria | 12 (7) | 3 (11) |
| Vomiting | 11 (6) | 2 (7) |
| Headache | 11 (6) | 4 (14) |
| Dyspnea | 9 (5) | 0 |
| Pruritus | 8 (4) | 1 (4) |
| Asthenia | 7 (4) | 0 |
| Musculoskeletal chest pain | 7 (4) | 1 (4) |
| Cough | 7 (4) | 0 |
| Decreased appetite | 6 (3) | 5 (18) |
| Chest pain | 6 (3) | 0 |
| Pyrexia | 4 (2) | 0 |
| Jaundice3 | 4 (2) | 0 |
| Chest discomfort | 4 (2) | 0 |
| Diarrhea | 0 | 2 (7) |
| 1 Divided doses were given 6-48 hours apart 2 Abdominal pain upper and abdominal pain 3 Jaundice and ocular icterus |
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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.
SRC: NLM .