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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.

PSYLLIUM HUSK: 470 Adverse Event Reports & Safety Profile

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470
Total FAERS Reports
124 (26.4%)
Deaths Reported
106
Hospitalizations
470
As Primary/Secondary Suspect
63
Life-Threatening
58
Disabilities
QUALITY CHOICE (CHAIN DRUG ...
Manufacturer

Route: ORAL · Manufacturer: QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION) · HUMAN OTC DRUG · FDA Label: Available

First Report: 1993 · Latest Report: 20250617

What Are the Most Common PSYLLIUM HUSK Side Effects?

#1 Most Reported
Exposure during pregnancy
220 reports (46.8%)
#2 Most Reported
Off label use
212 reports (45.1%)
#3 Most Reported
Intentional product misuse
185 reports (39.4%)

All PSYLLIUM HUSK Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Exposure during pregnancy 220 46.8% 54 4
Off label use 212 45.1% 94 40
Intentional product misuse 185 39.4% 87 31
Headache 173 36.8% 61 7
Hypertension 173 36.8% 64 10
Hyperhidrosis 171 36.4% 59 6
Food allergy 168 35.7% 59 3
Immunodeficiency 167 35.5% 58 3
Joint swelling 167 35.5% 59 3
Hepatic enzyme increased 166 35.3% 57 3
Hypersensitivity 165 35.1% 53 3
Pain 161 34.3% 60 6
Product use issue 160 34.0% 57 5
Prescribed overdose 156 33.2% 59 3
Overdose 155 33.0% 57 4
Infusion related reaction 152 32.3% 56 3
Constipation 150 31.9% 96 41
Asthma 147 31.3% 59 4
Pyrexia 142 30.2% 60 4
Rash erythematous 142 30.2% 59 2

Who Reports PSYLLIUM HUSK Side Effects? Age & Gender Data

Gender: 74.3% female, 25.7% male. Average age: 60.6 years. Most reports from: CA. View detailed demographics →

Is PSYLLIUM HUSK Getting Safer? Reports by Year

YearReportsDeathsHosp.
2012 1 0 1
2013 1 0 1
2014 1 0 0
2015 10 0 7
2016 10 0 4
2017 4 0 2
2018 6 0 2
2019 12 0 7
2020 23 12 14
2021 5 1 1
2022 6 0 0
2023 7 4 0
2024 2 0 0
2025 3 0 0

View full timeline →

What Is PSYLLIUM HUSK Used For?

IndicationReports
Product used for unknown indication 326
Constipation 24
Vitamin supplementation 20
Bowel movement irregularity 7
Diarrhoea 7

PSYLLIUM HUSK vs Alternatives: Which Is Safer?

PSYLLIUM HUSK vs PULMICORT FLEXHALER PSYLLIUM HUSK vs PYRAZINAMIDE PSYLLIUM HUSK vs PYRIDOSTIGMINE PSYLLIUM HUSK vs PYRIDOXINE PSYLLIUM HUSK vs PYRIDOXINE\THIAMINE PSYLLIUM HUSK vs PYRIMETHAMINE PSYLLIUM HUSK vs PYROTINIB PSYLLIUM HUSK vs QSYMIA PSYLLIUM HUSK vs QUETIAPINE PSYLLIUM HUSK vs QUINACRINE

Official FDA Label for PSYLLIUM HUSK

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

adults take intake does of 3.5g twice a day morning and evening on an empty stomach, however, taking the minimum amount of the first time and watching the shape and condition of the stomach gradually increases or decreases

Dosage & Administration

Directions: Put one dose into an empty glass. 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. Stir briskly and drink promptly. If mixture thickens, add more liquid and stir. Adults & children 12 years & older: 1 rounded TABLESPOON in 8 oz of liquid at the first sign of irregularity. Can be taken up to 3 times daily. Generally produces effect in 12–72 hours.

Children

6 – 11 yrs: ½ adult dose in 8 oz of liquid, up to 3 times daily Children under 6 yrs: Consult a doctor Bulk forming fibers like psyllium husk may affect how well other medicines work. If you are taking a prescription medicine by mouth, take this product at least 2 hours before or 2 hours after the prescribed medicine. As your body adjusts to increased fiber intake, you may experience changes in bowel habits or minor bloating.

New Users

Start with 1 serving per day; gradually increased to desired daily intake. You may initially experience changes in bowel habits or minor bloating, as your body adjusts to increased fiber intake.

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.

Allergy

Alert: This product may cause allergic reactions in people, sensitive to inhaled or ingested psyllium. Do not use if allergic to any ingredient in this product Ask a doctor before use if you have abdominal pain, nausea or vomiting noticed a sudden change in bowel habits that persists over a period of 2 weeks a sodium restricted diet Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. When using this product take this product 2 hours before or after other drugs Stop use and ask a doctor if

  • constipation lasts more than 7 days
  • rectal bleeding occurs
  • you fail to have a bowel movement after use of a laxative. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient

Supplement Facts Serving Size 1 rounded teaspoon ( 7g) Servings per Container About 85 Amount Per Serving %DV* Calories 25 Total Carbohydrate 7 g 3% Dietary Fiber 3g 11% Soluble Fiber 2g † Total Sugars 4g † Includes Added Sugars 4g 8% Iron 0.4mg 2% Sodium 5mg <1% Potassium 30 mg 1% *Percent Daily Values (%DV) are based on a 2000 calorie diet, † Daily Value (DV) not established

Inactive Ingredients

Inactive ingredients: acesulfame potassium, aspartame, citric acid, FD&C Blue 1, FD&C Red 40, maltodextrin, natural and artificial flavors, silica. Questions or comments? 1-866-467-2748