TRULANCE SIDE EFFECTS

  • Generic Name: plecanatide tablets
  • Brand Name: Trulance
Last updated on MDtodate: 10/12/2022

Table 1 provides the incidence of adverse reactions reported in at least 2% of IBS-C patients treated with TRULANCE and at an incidence that was greater than in the placebo group.

Table 1: Most Common Adverse Reactionsa in Two Placebo-Controlled Trials of TRULANCE [Study 3 and Study 4] in Patients with IBS-C

Adverse Reaction TRULANCE, 3 mg
(N = 723)
%
Placebo
(N = 726)
%
Diarrheab 4.3 1
a: Reported in at least 2% of TRULANCE-treated patients with IBS-C and at an incidence greater than placebo.
b: Verbatim reports of diarrhea were recorded as adverse reactions; reports of loose stools and increase in stool frequency were recorded as adverse reactions if they were also reported to be bothersome to the patient.

 

Diarrhea

The majority of reported cases of diarrhea occurred within 4 weeks of treatment initiation. Severe diarrhea was reported in 1% of TRULANCE-treated patients compared to 0.1% of placebo-treated patients. Severe diarrhea was reported to occur within the first day of treatment.

Adverse Reactions Leading to Discontinuation

Discontinuations due to adverse reactions occurred in 2.5% of TRULANCE-treated patients and 0.4% of placebo-treated patients. The most common adverse reaction leading to discontinuation was diarrhea: 1.2% of TRULANCE-treated patients and 0% of placebo-treated patients withdrew due to diarrhea.

Less Common Adverse Reactions

Adverse reactions reported in 1% or more but less than 2% of TRULANCE-treated patients and at an incidence greater than placebo were: nausea, nasopharyngitis, upper respiratory tract infection, urinary tract infection, and dizziness. Two patients reported increased liver biochemical tests (alanine aminotransferase (ALT) greater than 5 to 15 times the upper limit of normal).

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of TRULANCE. 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 TRULANCE exposure.

Hypersensitivity Reactions: skin itching, hives, rash

Vomiting

 

SRC: NLM .