SENNOSIDES A AND B: 484 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: ATLANTIC BIOLOGICALS CORP. · HUMAN OTC DRUG · FDA Label: Available
First Report: 1993 · Latest Report: 20250101
What Are the Most Common SENNOSIDES A AND B Side Effects?
All SENNOSIDES A AND B Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Asthma | 103 | 21.3% | 27 | 42 |
| Dyspnoea | 96 | 19.8% | 30 | 69 |
| Somnolence | 88 | 18.2% | 0 | 85 |
| Pyrexia | 86 | 17.8% | 37 | 50 |
| Gastrooesophageal reflux disease | 85 | 17.6% | 1 | 80 |
| Pneumonia aspiration | 84 | 17.4% | 0 | 80 |
| Coma | 79 | 16.3% | 0 | 75 |
| Off label use | 78 | 16.1% | 23 | 33 |
| Constipation | 75 | 15.5% | 18 | 25 |
| Headache | 70 | 14.5% | 18 | 21 |
| Rash | 70 | 14.5% | 39 | 28 |
| Pain | 67 | 13.8% | 18 | 16 |
| Wheezing | 63 | 13.0% | 9 | 41 |
| Fatigue | 60 | 12.4% | 18 | 13 |
| Haemoptysis | 60 | 12.4% | 28 | 37 |
| Hyperhidrosis | 57 | 11.8% | 18 | 4 |
| Overdose | 56 | 11.6% | 20 | 15 |
| Upper respiratory tract infection | 56 | 11.6% | 17 | 18 |
| Therapeutic product effect incomplete | 53 | 11.0% | 9 | 32 |
| Exposure during pregnancy | 52 | 10.7% | 18 | 1 |
Who Reports SENNOSIDES A AND B Side Effects? Age & Gender Data
Gender: 70.3% female, 29.7% male. Average age: 64.2 years. Most reports from: CA. View detailed demographics →
Is SENNOSIDES A AND B Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 2 | 1 | 0 |
| 2007 | 1 | 1 | 0 |
| 2009 | 1 | 1 | 0 |
| 2010 | 6 | 0 | 4 |
| 2011 | 2 | 1 | 2 |
| 2012 | 3 | 0 | 2 |
| 2013 | 5 | 2 | 2 |
| 2014 | 19 | 3 | 13 |
| 2015 | 14 | 1 | 12 |
| 2016 | 11 | 2 | 5 |
| 2017 | 23 | 6 | 11 |
| 2018 | 30 | 19 | 25 |
| 2019 | 5 | 1 | 3 |
| 2020 | 12 | 2 | 6 |
| 2021 | 2 | 0 | 1 |
| 2022 | 10 | 3 | 5 |
| 2023 | 9 | 3 | 5 |
| 2024 | 6 | 0 | 3 |
| 2025 | 1 | 0 | 1 |
What Is SENNOSIDES A AND B Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 319 |
| Constipation | 79 |
| Pain | 8 |
| Abdominal pain | 6 |
SENNOSIDES A AND B vs Alternatives: Which Is Safer?
Official FDA Label for SENNOSIDES A AND B
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Uses
- relieve occasional constipation (irregularity)
- this product generally produces a bowel movement in 6 to 12 hours
Dosage & Administration
Directions: Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and over - starting dosage: 2 tablets once a day maximum dosage: 4 tablets twice a day Children 6 to under 12 years - starting dosage: 1 tablet once a day maximum dosage: 2 tablets twice a day Children 6 to under 12 years - starting dosage: 1/2 tablet once a day maximum dosage: 1 tablet twice a day Children under 2 years - Ask a doctor
Warnings
Warnings Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor. Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks. Ask a doctor or pharmacist before use if you are are taking a prescription drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs. When using this product, do not use for a period longer than 1 week. Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occurs 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 at (1-800-222-1222).
Active Ingredient
Active Ingredient Active ingredient (in each teaspoonful)
Purpose Sennosides
8.8 mg …………………………................Laxative
Inactive Ingredients
Inactive ingredients acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide, iron oxide black, iron oxide yellow, kaolin, magnesium stearate, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, shellac, stearic acid, sugar, talc, titanium dioxide.