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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

METHYLCELLULOSE: 95 Adverse Event Reports & Safety Profile

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95
Total FAERS Reports
8 (8.4%)
Deaths Reported
12
Hospitalizations
95
As Primary/Secondary Suspect
6
Life-Threatening
6
Disabilities
Haleon US Holdings LLC
Manufacturer

Route: ORAL · Manufacturer: Haleon US Holdings LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 1995 · Latest Report: 20250215

What Are the Most Common METHYLCELLULOSE Side Effects?

#1 Most Reported
Off label use
18 reports (18.9%)
#2 Most Reported
Drug ineffective
16 reports (16.8%)
#3 Most Reported
Incorrect product administration duration
14 reports (14.7%)

All METHYLCELLULOSE Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Off label use 18 19.0% 5 7
Drug ineffective 16 16.8% 4 5
Incorrect product administration duration 14 14.7% 0 0
Product complaint 13 13.7% 0 0
Product use in unapproved indication 13 13.7% 5 5
Diabetes mellitus 11 11.6% 6 6
Dyspnoea 11 11.6% 6 8
Rectal haemorrhage 11 11.6% 0 0
Constipation 10 10.5% 5 5
Abdominal pain 9 9.5% 5 5
Choking 9 9.5% 0 0
Condition aggravated 9 9.5% 5 5
Nausea 9 9.5% 5 5
Sleep disorder 8 8.4% 6 6
Blood cholesterol increased 7 7.4% 5 5
Drug hypersensitivity 7 7.4% 6 6
Vomiting 7 7.4% 5 6
Abdominal discomfort 6 6.3% 0 1
Abdominal distension 6 6.3% 5 5
Anaemia 6 6.3% 6 6

Who Reports METHYLCELLULOSE Side Effects? Age & Gender Data

Gender: 58.2% female, 41.8% male. Average age: 71.3 years. Most reports from: US. View detailed demographics →

Is METHYLCELLULOSE Getting Safer? Reports by Year

YearReportsDeathsHosp.
2008 1 1 0
2013 1 0 0
2014 1 0 1
2015 3 0 0
2016 4 0 0
2017 2 0 1
2018 5 0 0
2019 4 0 0
2020 3 1 1
2021 1 1 1
2022 3 0 0
2023 2 0 0
2024 1 0 0
2025 1 0 0

View full timeline →

What Is METHYLCELLULOSE Used For?

IndicationReports
Product used for unknown indication 42
Constipation 13
Supplementation therapy 10
Gastrointestinal disorder 5

Official FDA Label for METHYLCELLULOSE

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses helps restore and maintain regularity and relieves constipation (irregularity) in the treatment of constipation associated with other bowel disorders when recommended by a doctor Warnings Choking : Taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have abdominal pain, nausea or vomiting sensitivity to any of the ingredients a sudden change in bowel habits that persists over a period of 2 weeks When using this product do not exceed recommended maximum daily dose unless directed by a doctor do not use laxative products for a period longer than one week unless directed by a doctor Stop use and ask a doctor if rectal bleeding occurs you fail to have a bowel movement after use Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions MIX THIS PRODUCT (CHILD OR ADULT DOSE) WITH AT LEAST 8 OUNCES (A FULL GLASS) OF WATER OR OTHER FLUID. TAKING THIS PRODUCT WITHOUT ENOUGH LIQUID MAY CAUSE CHOKING. SEE CHOKING WARNING use product at the first sign of constipation or irregularity put one dose in a full glass of cold water stir briskly and drink promptly drinking another glass of water is helpful CITRUCEL Orange Age Dose adults and children 12 years of age and over start with 1 heaping tablespoon . Increase as needed, 1 heaping tablespoon at a time, up to 3 times per day. children 6 - 11 years of age start with 2.5 level teaspoons . Increase as needed, 2.5 level teaspoons at a time, up to 3 times per day. children under 6 years of age consult a doctor CITRUCEL Sugar Free Age Dose adults and children 12 years of age and over start with 1 rounded tablespoon . Increase as needed, 1 rounded tablespoon at a time, up to 3 times per day. children 6 - 11 years of age start with 2 level teaspoons . Increase as needed, 2 level teaspoons at a time, up to 3 times per day. children under 6 years of age consult a doctor

FDA Boxed Warning

BLACK BOX WARNING

TAMPER EVIDENT PACKAGE Do not use if printed seal under cap is torn or missing.

Warnings

Warnings CHOKING: taking this product without adequate fluid may cause it to swell and block your throat or esophagus and may cause choking. Do not take this product if you have difficulty in swallowing. If you experience chest pain, vomiting, or difficulty in swallowing or breathing after taking this product, seek immediate medical attention. Ask a doctor before use if you have

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits that persists over a period of 2 weeks
  • sensitivity to any of the ingredients Stop use and ask a doctor if
  • you have rectal bleeding
  • you fail to have a bowl movement after use.
  • These could be signs of a serious condition. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away at 1-800-222-1222. When using this product
  • do not exceed recommended maximum daily dose unless directed by a doctor
  • do not use laxative products for a period longer than one week unless directed by a doctor

Active Ingredient

Active ingredient (in each heaping tablespoon)

Citrucel

Orange Methylcellulose (a non-allergenic fiber) 2 g

Active ingredient (in each rounded tablespoon)

Citrucel

Sugar Free Methylcellulose (a non-allergenic fiber) 2 g

Inactive Ingredients

Inactive ingredients (Citrucel Orange) citric acid, dibasic calcium phosphate, FD&C yellow #6 lake, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin, soy lecithin, sucrose, titanium dioxide, tricalcium phosphate

Inactive ingredients (Citrucel Sugar Free) aspartame, dibasic calcium phosphate, FD&C yellow #6 lake, malic acid, maltodextrin, orange flavors (natural and artificial), potassium citrate, riboflavin