VALERIAN: 163 Adverse Event Reports & Safety Profile
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Route: ORAL · Manufacturer: Boiron · HUMAN OTC DRUG · FDA Label: Available
First Report: 19970630 · Latest Report: 20240618
What Are the Most Common VALERIAN Side Effects?
All VALERIAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Drug abuse | 41 | 25.2% | 0 | 35 |
| Suicide attempt | 32 | 19.6% | 0 | 22 |
| Intentional overdose | 25 | 15.3% | 0 | 18 |
| Sopor | 25 | 15.3% | 0 | 24 |
| Fatigue | 23 | 14.1% | 0 | 17 |
| Toxicity to various agents | 18 | 11.0% | 0 | 8 |
| Intentional self-injury | 17 | 10.4% | 0 | 16 |
| Restlessness | 17 | 10.4% | 0 | 15 |
| Nausea | 16 | 9.8% | 0 | 14 |
| Somnolence | 16 | 9.8% | 0 | 5 |
| Confusional state | 14 | 8.6% | 0 | 8 |
| Pruritus | 12 | 7.4% | 1 | 9 |
| Pyrexia | 11 | 6.8% | 2 | 10 |
| Sleep disorder | 11 | 6.8% | 0 | 4 |
| Alanine aminotransferase increased | 10 | 6.1% | 0 | 9 |
| Aspartate aminotransferase increased | 10 | 6.1% | 0 | 9 |
| Drug-induced liver injury | 10 | 6.1% | 0 | 0 |
| Epilepsy | 10 | 6.1% | 0 | 9 |
| Erythema | 10 | 6.1% | 1 | 8 |
| Stevens-johnson syndrome | 10 | 6.1% | 0 | 10 |
Who Reports VALERIAN Side Effects? Age & Gender Data
Gender: 60.1% female, 39.9% male. Average age: 45.0 years. Most reports from: DE. View detailed demographics →
Is VALERIAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 9 | 0 | 9 |
| 2004 | 1 | 1 | 0 |
| 2010 | 2 | 0 | 2 |
| 2012 | 1 | 0 | 1 |
| 2013 | 3 | 0 | 3 |
| 2014 | 30 | 0 | 29 |
| 2015 | 19 | 0 | 12 |
| 2016 | 5 | 0 | 3 |
| 2017 | 2 | 0 | 0 |
| 2018 | 3 | 0 | 2 |
| 2019 | 6 | 0 | 5 |
| 2020 | 11 | 0 | 5 |
| 2021 | 3 | 0 | 3 |
| 2023 | 6 | 0 | 5 |
| 2024 | 2 | 0 | 1 |
What Is VALERIAN Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 86 |
| Insomnia | 11 |
| Intentional self-injury | 9 |
| Suicide attempt | 9 |
| Restlessness | 6 |
VALERIAN vs Alternatives: Which Is Safer?
Official FDA Label for VALERIAN
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
Relieves sleeplessness with hypersensitivity to stress * Uses: See symptoms on front panel.
Dosage & Administration
DIRECTIONS Adults: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides. Children: Dissolve 3 to 5 under the tongue three times a day or as directed by Lic. Practitioner. Take at greater intervals as condition subsides.
Warnings
Warnings: NOT FOR INJECTION Do not use if allergic to any ingredient. Consult a physician if symptoms worsen. If pregnant or nursing, consult a physician before use. Claims based on traditional homepathic practice, not accepted medical evidence. Not FDA evaluated.
Active Ingredient
VALERIANA OFFICINALIS 200CK HPUS Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).
Inactive Ingredients
Inactive Ingredients: Water, Salt Prepared using rhythmical processes.