BLACK COHOSH: 64 Adverse Event Reports & Safety Profile
Thyroid Balance & Feminine Wellness
Thyrafemme Balance — 14 gentle ingredients for energy, mood & hormonal harmony.
Route: ORAL · Manufacturer: Professional Complementary Health Formulas · HUMAN OTC DRUG · FDA Label: Available
First Report: 20010219 · Latest Report: 20250601
What Are the Most Common BLACK COHOSH Side Effects?
All BLACK COHOSH Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Completed suicide | 11 | 17.2% | 11 | 8 |
| Asthenia | 10 | 15.6% | 0 | 3 |
| Nausea | 10 | 15.6% | 0 | 3 |
| Decreased appetite | 9 | 14.1% | 0 | 4 |
| Drug ineffective | 7 | 10.9% | 0 | 3 |
| Hepatic enzyme increased | 6 | 9.4% | 0 | 2 |
| Jaundice | 6 | 9.4% | 0 | 2 |
| Toxicity to various agents | 6 | 9.4% | 6 | 6 |
| Weight decreased | 6 | 9.4% | 0 | 2 |
| Blood prolactin increased | 5 | 7.8% | 0 | 5 |
| Delusion | 5 | 7.8% | 0 | 5 |
| Drug hypersensitivity | 5 | 7.8% | 0 | 0 |
| Hormone level abnormal | 5 | 7.8% | 0 | 5 |
| Hot flush | 5 | 7.8% | 1 | 0 |
| Liver injury | 5 | 7.8% | 0 | 5 |
| Malaise | 5 | 7.8% | 0 | 0 |
Who Reports BLACK COHOSH Side Effects? Age & Gender Data
Gender: 84.5% female, 15.5% male. Average age: 51.4 years. Most reports from: US. View detailed demographics →
Is BLACK COHOSH Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2001 | 1 | 0 | 1 |
| 2010 | 1 | 1 | 0 |
| 2013 | 2 | 0 | 0 |
| 2014 | 3 | 0 | 1 |
| 2016 | 3 | 0 | 3 |
| 2017 | 4 | 0 | 4 |
| 2018 | 4 | 0 | 4 |
| 2019 | 6 | 0 | 0 |
| 2020 | 2 | 0 | 2 |
| 2021 | 9 | 5 | 2 |
| 2025 | 4 | 0 | 2 |
What Is BLACK COHOSH Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 29 |
| Menopausal symptoms | 8 |
| Menopause | 7 |
Official FDA Label for BLACK COHOSH
Official prescribing information from the FDA-approved drug label.
FDA Approved Uses (Indications)
HOMEOPATHIC INDICATIONS: For temporary relief of symptoms related to hormonal dysfunction including fluid retention, hot flashes, painful menses, irregular and painful menstruation, and mood swings.** ** These statements are based upon homeopathic principles. They have not been reviewed by the Food and Drug Administration.
Dosage & Administration
Dosage & Administration Directions: Sublingual homeopathic medication. Place tablets under tongue at least 15 minutes before or 30 minutes after eating, brushing teeth, or drinking anything except water. Adults and children 12 years and over: Take 3 tablets every hour until symptoms subside, then take 3 tablets every 2 hours until relieved.
Children
6 to 12 years of age: Take 1 1/2 tablets every hour until symptoms subside, then take 1 1/2 tablets every 2 hours until relieved. Children under 6 years of age: Consult a doctor.
Contraindications
Care & contra-indications: This is a homoeopathic remedy, no contra-indications are established.
Warnings
WARNINGS Persistent symptoms may be a sign of a serious condition. If symptoms persist or are accompanied by a fever, persistent headache, dizziness, or loss of hearing, consult a doctor. Keep out of the reach of children. In case of overdose, get medical help or contact a poison control center right away. If pregnant or breastfeeding, ask a healthcare professional before use. Keep out of the reach of children. If pregnant or breastfeeding, ask a healthcare professional before use.
Drug Interactions
Safe - no side effects - no drug interactions - works naturally with your body
Active Ingredient
ACTIVE INGREDIENTS: Chamomilla 3X, Cimicifuga Racemosa 3X, Helonias Dioica 3X, Mentha Piperita 3X, Senna (Cassia Angustifolia) 3X, Valeriana Officinalis 3X, Viola Odorata 3X, Agnus Castus 4X, Ledum Palustre 4X, Lilium Tigrinum 4X, Staphysagria 4X, Crocus Sativus 6X, Hydrastis Canadensis 6X, Cinchona Officinalis 8X, Convallaria Majalis 8X, Cyclamen Europaeum 8X, Cinnamomum 12X, Murex Purpurea 12X, Naja Tripudians 15X.
Inactive Ingredients
WATER BUTYLENE GLYCOL COCONUT OIL JOJOBA OIL SHEA BUTTER CETOSTEARYL ALCOHOL TOCOPHEROL ALOE VERA LEAF JUICE REYNOUTRIA JAPONICA ROOT PUERARIA MIRIFICA ROOT POMEGRANATE TEA LEAF ASIAN GINSENG ORANGE OIL, COLD PRESSED CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) ARGININE 1,2-HEXANEDIOL