SENNOSIDES: 2,288 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Bryant Ranch Prepack · HUMAN OTC DRUG · FDA Label: Available
First Report: 1985 · Latest Report: 20250825
What Are the Most Common SENNOSIDES Side Effects?
All SENNOSIDES Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Asthma | 706 | 30.9% | 168 | 241 |
| Fatigue | 636 | 27.8% | 129 | 131 |
| Pain | 584 | 25.5% | 125 | 134 |
| Hyperhidrosis | 575 | 25.1% | 111 | 5 |
| Headache | 560 | 24.5% | 128 | 118 |
| Constipation | 549 | 24.0% | 120 | 162 |
| Upper respiratory tract infection | 529 | 23.1% | 116 | 129 |
| Fluid retention | 511 | 22.3% | 112 | 6 |
| Pyrexia | 457 | 20.0% | 153 | 172 |
| Drug hypersensitivity | 433 | 18.9% | 113 | 101 |
| Off label use | 430 | 18.8% | 123 | 75 |
| Hypersensitivity | 426 | 18.6% | 107 | 9 |
| Immunodeficiency | 426 | 18.6% | 113 | 5 |
| Hepatic enzyme increased | 425 | 18.6% | 111 | 6 |
| Food allergy | 417 | 18.2% | 109 | 4 |
| Drug ineffective | 414 | 18.1% | 115 | 166 |
| Rash | 411 | 18.0% | 107 | 35 |
| Rheumatoid arthritis | 411 | 18.0% | 111 | 12 |
| Rash erythematous | 401 | 17.5% | 105 | 2 |
| Overdose | 376 | 16.4% | 120 | 46 |
Who Reports SENNOSIDES Side Effects? Age & Gender Data
Gender: 77.0% female, 23.0% male. Average age: 60.7 years. Most reports from: CA. View detailed demographics →
Is SENNOSIDES Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2003 | 1 | 0 | 0 |
| 2005 | 2 | 0 | 0 |
| 2006 | 1 | 0 | 1 |
| 2007 | 2 | 0 | 1 |
| 2008 | 1 | 0 | 1 |
| 2009 | 1 | 0 | 0 |
| 2011 | 3 | 3 | 3 |
| 2012 | 7 | 1 | 5 |
| 2013 | 6 | 0 | 2 |
| 2014 | 29 | 10 | 14 |
| 2015 | 34 | 3 | 17 |
| 2016 | 22 | 2 | 6 |
| 2017 | 24 | 6 | 5 |
| 2018 | 34 | 6 | 15 |
| 2019 | 23 | 2 | 6 |
| 2020 | 25 | 6 | 11 |
| 2021 | 13 | 5 | 5 |
| 2022 | 13 | 1 | 3 |
| 2023 | 33 | 22 | 8 |
| 2024 | 18 | 0 | 8 |
| 2025 | 12 | 0 | 0 |
What Is SENNOSIDES Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 1,665 |
| Constipation | 224 |
| Abdominal pain | 149 |
| Pain | 34 |
| Off label use | 13 |
| Ewing's sarcoma | 7 |
SENNOSIDES vs Alternatives: Which Is Safer?
Official FDA Label for SENNOSIDES
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
INDICATIONS & USAGE Uses: Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours
Dosage & Administration
DOSAGE AND ADMINISTRATION shake well before use Do not exceed recommended dose Age Starting Dose Maximum dosage Adults and children 12 years and older 2-3 teaspoonfuls once a day preferably at bedtime; increase as needed or as recommended by a doctor 3 teaspoons in the morning and 3 teaspoons at bedtime Under 12 years of age ask a doctor ask a doctor Other information store at room temperature 20° to 25°C (68° to 77°F). a brown, natural flavored syrup supplied in the following oral dosage form: NDC 0121-4967-05: 5 mL unit dose cup, in a tray of ten cups. NDC 0121-4967-40: Case contains 40 unit dose cups of 5 mL (0121-4967-05) packaged in 4 trays of 10 unit dose cups each.
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 Do not use laxative products longer than 1 week unless directed by a doctor Ask a doctor before use if you have
- stomach pain
- nausea
- vomiting
- noticed a sudden change in bowel habits that continues for a period of 2 weeks. Stop use and ask a doctor if
- you have rectal bleeding
- you fail to have bowel movement after use of a laxative. These may indicale 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
Senna Syrup (8.8 mg/5 mL) Active ingredient per 5 mL(1 Unit Dose)
Sennosides
8.8 mg
Inactive Ingredients
Inactive ingredients (0067-0003) acacia, alginic acid, carnauba wax, colloidal silicon dioxide, dibasic calcium phosphate, iron oxides, magnesium stearate, microcrystalline cellulose, potassium hydroxide, pregelatinized starch, propylene glycol, shellac, sodium benzoate, sodium lauryl sulfate, stearic acid, sucrose, talc, titanium dioxide
Inactive Ingredients (0067-8141) acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate, iron oxide black, iron oxide red, iron oxide yellow, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide