TRULANCE SIDE EFFECTS
- Generic Name: plecanatide tablets
- Brand Name: Trulance
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. |
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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
SRC: NLM .