Trulance

Last updated on RxList: 4/23/2021
Trulance Side Effects Center

What Is Trulance?

Trulance (plecanatide) tablets, for oral use is a guanylate cyclase-C agonist indicated in adults for treatment of chronic idiopathic constipation (CIC).

What Are Side Effects of Trulance?

Common side effects of Trulance include:

Dosage for Trulance

The recommended adult dosage of Trulance is 3 mg taken orally once daily.

What Drugs, Substances, or Supplements Interact with Trulance?

Trulance may interact with other drugs. Tell your doctor all medications and supplements you use.

Trulance During Pregnancy and Breastfeeding

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

Additional Information

Our Trulance (plecanatide) 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.

QUESTION

You are constipated if you don't have a bowel movement every day. See Answer
Trulance Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Diarrhea is a common side effect of plecanatide. Stop using plecanatide and call your doctor at once if your diarrhea is severe.

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.

Read the entire detailed patient monograph for Trulance (Plecanatide Tablets)

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Trulance Professional Information

SIDE EFFECTS

Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Demographic characteristics were comparable between the TRULANCE and placebo groups in all studies [see Clinical Studies].

Chronic Idiopathic Constipation (CIC)

The safety data described below reflect data from 1,733 adult patients with CIC randomized in two double-blind, placebo-controlled clinical trials (Study 1 and Study 2) to receive placebo or 3 mg of TRULANCE once daily for 12 weeks.

Most Common Adverse Reactions

Table 1 provides the incidence of adverse reactions reported in at least 2% of CIC patients in the TRULANCE-treated group 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 1 and Study 2] in Patients with CIC

Adverse Reaction TRULANCE, 3 mg
(N = 863)
%
Placebo
(N = 870)
%
Diarrheab 5 1
a: Reported in at least 2% of TRULANCE-treated patients with CIC 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 0.6% of TRULANCE-treated patients compared to 0.3% of placebo-treated patients. Severe diarrhea was reported to occur within the first 3 days of treatment [see WARNINGS AND PRECAUTIONS].

Adverse Reactions Leading to Discontinuation

Discontinuations due to adverse reactions occurred in 4% of TRULANCE-treated patients and 2% of placebo-treated patients. The most common adverse reaction leading to discontinuation was diarrhea: 2% of TRULANCE-treated patients and 0.5% of placebo-treated patients withdrew due to diarrhea.

Less Common Adverse Reactions

Adverse reactions reported in less than 2% of TRULANCE-treated patients and at an incidence greater than placebo were: sinusitis, upper respiratory tract infection, abdominal distension, flatulence, abdominal tenderness, and increased liver biochemical tests (2 patients with alanine aminotransferase (ALT) greater than 5 to 15 times the upper limit of normal and 3 patients with aspartate aminotransferase (AST) greater than 5 times the upper limit of normal).

Irritable Bowel Syndrome With Constipation (IBS-C)

The safety data described below reflect data from 1,449 adults patients with IBS-C randomized in two double-blind, placebo-controlled clinical trials (Study 3 and Study 4) to receive placebo or 3 mg TRULANCE once daily for 12 weeks.

Most Common Adverse Reactions

Table 2 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 2: 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 [see WARNINGS AND PRECAUTIONS]. 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

DRUG INTERACTIONS

No Information Provided

Read the entire FDA prescribing information for Trulance (Plecanatide Tablets)

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

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