CALCIUM POLYCARBOPHIL: 112 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Wal-Mart Stores, Inc. · HUMAN OTC DRUG · FDA Label: Available
First Report: 1997 · Latest Report: 20241001
What Are the Most Common CALCIUM POLYCARBOPHIL Side Effects?
All CALCIUM POLYCARBOPHIL Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Diarrhoea | 21 | 18.8% | 2 | 5 |
| Drug ineffective | 13 | 11.6% | 3 | 7 |
| Constipation | 10 | 8.9% | 2 | 5 |
| Off label use | 10 | 8.9% | 4 | 6 |
| Nausea | 8 | 7.1% | 2 | 3 |
| Product use issue | 8 | 7.1% | 0 | 1 |
| Choking | 7 | 6.3% | 0 | 1 |
| Condition aggravated | 7 | 6.3% | 3 | 4 |
| Toxic skin eruption | 7 | 6.3% | 0 | 7 |
| Dermatitis exfoliative generalised | 6 | 5.4% | 0 | 6 |
| Flatulence | 6 | 5.4% | 0 | 1 |
| Intentional product misuse | 6 | 5.4% | 3 | 3 |
| Underdose | 6 | 5.4% | 0 | 2 |
| Abdominal distension | 5 | 4.5% | 2 | 3 |
| Abdominal pain | 5 | 4.5% | 2 | 4 |
| Dysphagia | 5 | 4.5% | 0 | 3 |
| Hypertension | 5 | 4.5% | 3 | 4 |
| Intentional product use issue | 5 | 4.5% | 0 | 0 |
Who Reports CALCIUM POLYCARBOPHIL Side Effects? Age & Gender Data
Gender: 59.2% female, 40.8% male. Average age: 66.2 years. Most reports from: US. View detailed demographics →
Is CALCIUM POLYCARBOPHIL Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2007 | 1 | 0 | 0 |
| 2010 | 1 | 0 | 0 |
| 2011 | 1 | 0 | 1 |
| 2012 | 3 | 0 | 2 |
| 2013 | 1 | 0 | 1 |
| 2014 | 4 | 0 | 2 |
| 2015 | 11 | 1 | 3 |
| 2016 | 11 | 1 | 5 |
| 2017 | 10 | 0 | 8 |
| 2018 | 5 | 1 | 2 |
| 2019 | 4 | 1 | 1 |
| 2020 | 4 | 2 | 1 |
| 2021 | 1 | 0 | 0 |
| 2022 | 1 | 0 | 0 |
| 2023 | 3 | 0 | 1 |
| 2024 | 4 | 0 | 0 |
What Is CALCIUM POLYCARBOPHIL Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 21 |
| Diarrhoea | 20 |
| Constipation | 15 |
| Irritable bowel syndrome | 7 |
CALCIUM POLYCARBOPHIL vs Alternatives: Which Is Safer?
Official FDA Label for CALCIUM POLYCARBOPHIL
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses relieves: constipation helps restore and maintain regularity promotes normal function of the bowel this product generally produces bowel movement in 12 to 72 hours
Dosage & Administration
Directions take each dose of this product 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. This laxative works naturally so continued use for one to three days is normally required to provide full benefit. Dosage may vary according to diet, exercise, previous laxative use or severity of constipation. adults and children 12 years of age and older Starting dose: 2 caplets once a day Maximum dose: 2 caplets four times a day or as directed by a doctor children under 12 years of age consult a doctor
Warnings
Warnings 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. Choking: Ask a doctor before use if you have abdominal pain, nausea, or vomiting difficulty in swallowing a sudden change in bowel habits that persists over a period of 2 weeks Ask a doctor or pharmacist before use if you are taking any other drug. Take this product 2 or more hours before or after other drugs. All laxatives may affect how other drugs work. When using this product do not use for more than 7 days unless directed by a doctor do not take more than 8 tablets in a 24 hour period unless directed b y a doctor Stop use and ask a doctor if you experience chest pain, abdominal pain, nausea, vomiting, difficulty in breathing or swallowing you fail to have a bowel movement after use or have rectal bleeding. 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 (1-800-222-1222) right away.
Active Ingredient
Active ingredient (in each tablet) Calcium polycarbophil 625 mg (Equivalent to 500 mg polycarbophil)
Purpose
Bulk-forming laxative
Inactive Ingredients
Inactive ingredients calcium carbonate, caramel, crospovidone, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium lauryl sulfate Questions? Call 1-800-910-6874