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Plenity

Last reviewed on RxList: 4/24/2019
Plenity Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 4/24/2019

Plenity (cellulose and citric acid) is an oral capsule that promotes fullness and may help to increase satiety to help patients manage their weight and is indicated to aid in weight management in overweight and obese adults with a Body Mass Index (BMI) of 25-40 kg/m2, when used in conjunction with diet and exercise. Common side effects of Plenity are mild and include:

  • abdominal distension,
  • abdominal pain,
  • bloating,
  • irregular bowel movements,
  • changes in frequency and consistency of bowel movements,
  • constipation,
  • cramping,
  • diarrhea,
  • indigestion,
  • difficulty swallowing,
  • belching,
  • gas,
  • gastroesophageal reflux disease (GERD), and
  • vomiting

Plenity is supplied in double blister packs that, together, provide the two doses patients take daily. Each individual blister pack holds a single dose of three (3) capsules, to be administered with water before lunch and dinner. Plenity may interact with other oral medications taken at the same time. Tell your doctor all medications and supplements you use. Plenity is not recommended for use during pregnancy. Consult your doctor before breastfeeding.

Our Plenity (cellulose and citric acid) 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.

SLIDESHOW

Surprising Reasons for Weight Gain See Slideshow
Plenity Professional Information

SIDE EFFECTS

Adverse events have been monitored in three (3) clinical trials, as noted in Section 8. In the GLOW pivotal trial, during the 24-week assessment period, the overall incidence of adverse events in the Plenity treatment group was no different than placebo (71% in both groups). In both treatment groups, most (>95%) adverse events were assessed by the investigator as mild or moderate in intensity. There were no serious adverse events (SAEs) in the Plenity treatment group, whereas there was one (1) SAE in the placebo treatment group. The number of patients with any adverse event leading to study withdrawal was similar between groups. No deaths occurred during the trial.

Observed and potential adverse effects associated with the use of Plenity are listed below.

Table 1. Potential Adverse Events

Potential adverse events (rates observed compared to placebo)*
Greater than placebo Equivalent to placebo Not observed
  • All GI-related adverse events combined (98% mild or moderate)
  • Abdominal distension
  • Abdominal pain
  • Bloating
  • Bowel movement irregularity
  • Changes to frequency and consistency of bowel movements
  • Constipation
  • Cramping
  • Diarrhea
  • Dyspepsia
  • Dysphagia
  • Eructation
  • Flatulence
  • Gastroesophageal reflux disease
  • Vomiting
  • Adverse health consequences resulting from weight loss
  • Allergic Reaction
  • Bowel obstruction
  • Choking
  • Death
  • Dehydration
  • Electrolyte abnormalities
  • Fecal incontinence
  • GI atonia or hypomotility
  • Interactions with absorption of other ingested medication
  • Need for emergency surgery
*Rates observed in GLOW pivotal study.

Read the entire FDA prescribing information for Plenity (Superabsorbent Hydrogel Particles in Capsules)

Related Resources for Plenity

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

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