TOBACCO LEAF: 324 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available
First Report: 1973 · Latest Report: 20240713
What Are the Most Common TOBACCO LEAF Side Effects?
All TOBACCO LEAF Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 231 | 71.3% | 5 | 178 |
| Drug dependence | 104 | 32.1% | 0 | 75 |
| Intentional product misuse | 68 | 21.0% | 5 | 55 |
| Withdrawal syndrome | 57 | 17.6% | 1 | 46 |
| Alcohol abuse | 55 | 17.0% | 5 | 40 |
| Tachycardia | 39 | 12.0% | 2 | 29 |
| Toxicity to various agents | 37 | 11.4% | 3 | 28 |
| Intentional product use issue | 31 | 9.6% | 1 | 24 |
| Miosis | 22 | 6.8% | 0 | 19 |
| Substance abuse | 19 | 5.9% | 0 | 9 |
| Agitation | 18 | 5.6% | 0 | 16 |
| Coma | 16 | 4.9% | 0 | 16 |
| Vomiting | 16 | 4.9% | 0 | 12 |
| Foetal exposure during pregnancy | 15 | 4.6% | 0 | 9 |
| Anxiety | 14 | 4.3% | 0 | 11 |
| Off label use | 14 | 4.3% | 1 | 9 |
| Rhabdomyolysis | 14 | 4.3% | 0 | 14 |
| Suicidal ideation | 14 | 4.3% | 0 | 13 |
| Hyperhidrosis | 12 | 3.7% | 0 | 11 |
| Memory impairment | 11 | 3.4% | 0 | 6 |
Who Reports TOBACCO LEAF Side Effects? Age & Gender Data
Gender: 27.3% female, 72.7% male. Average age: 37.4 years. Most reports from: FR. View detailed demographics →
Is TOBACCO LEAF Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 7 | 0 | 5 |
| 2002 | 7 | 0 | 6 |
| 2004 | 1 | 0 | 1 |
| 2005 | 5 | 0 | 5 |
| 2006 | 3 | 0 | 3 |
| 2007 | 6 | 0 | 5 |
| 2008 | 3 | 0 | 3 |
| 2009 | 1 | 0 | 1 |
| 2010 | 1 | 1 | 0 |
| 2011 | 5 | 0 | 4 |
| 2012 | 7 | 2 | 2 |
| 2013 | 5 | 0 | 4 |
| 2014 | 1 | 1 | 0 |
| 2015 | 8 | 0 | 6 |
| 2016 | 4 | 0 | 4 |
| 2017 | 13 | 5 | 3 |
| 2018 | 25 | 1 | 15 |
| 2019 | 25 | 0 | 18 |
| 2020 | 18 | 1 | 17 |
| 2021 | 38 | 0 | 32 |
| 2022 | 8 | 0 | 7 |
| 2023 | 11 | 0 | 9 |
| 2024 | 9 | 1 | 8 |
What Is TOBACCO LEAF Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 165 |
| Tobacco user | 91 |
TOBACCO LEAF vs Alternatives: Which Is Safer?
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for TOBACCO LEAF
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Motion Sickness With Cold Sweat And Improved By Fresh Air *
Dosage & Administration
Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.
Warnings
Warnings Use only if cap seal is unbroken. If pregnant or breastfeeding, ask a healthcare professional before use. Keep this and all medication out of the reach of children.
Active Ingredient
INGREDIENTS ACTIVE Tobacco 6/12/30x INACTIVE 20% alcohol in purified water.
Inactive Ingredients
INACTIVE 20% alcohol in purified water.