CAPSICUM: 38 Adverse Event Reports & Safety Profile
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Drug Class: Allergens [CS] · Route: TOPICAL · Manufacturer: Valu Merchandisers Company · HUMAN OTC DRUG · FDA Label: Available
First Report: 2014 · Latest Report: 20250402
What Are the Most Common CAPSICUM Side Effects?
All CAPSICUM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Immune thrombocytopenia | 22 | 57.9% | 0 | 0 |
| Weight increased | 22 | 57.9% | 0 | 0 |
| Therapy non-responder | 21 | 55.3% | 0 | 0 |
| Withdrawal syndrome | 7 | 18.4% | 0 | 0 |
Who Reports CAPSICUM Side Effects? Age & Gender Data
Gender: 87.2% female, 12.8% male. Average age: 27.9 years. Most reports from: CA. View detailed demographics →
Is CAPSICUM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 1 | 0 | 0 |
| 2016 | 1 | 0 | 0 |
| 2018 | 1 | 0 | 0 |
| 2019 | 1 | 0 | 1 |
| 2020 | 1 | 0 | 0 |
| 2021 | 1 | 0 | 0 |
| 2024 | 2 | 0 | 0 |
| 2025 | 3 | 0 | 0 |
What Is CAPSICUM Used For?
| Indication | Reports |
|---|---|
| Complex regional pain syndrome | 21 |
| Product used for unknown indication | 5 |
Other Drugs in Same Class: Allergens [CS]
Official FDA Label for CAPSICUM
Official prescribing information from the FDA-approved drug label.
Drug Description
Extra Strength Balm Warming pain relief ointment 0.9 fl oz (25 g)
FDA Approved Uses (Indications)
Uses Temporarily relieves occasional irritation or sores in the mouth, discomfort, bad breath, soreness, and white-coated tongue.* *CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED. This product is not intended to diagnose, treat, cure, or prevent any disease.
Dosage & Administration
Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, oitments and creams. Carefully remove backing starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary.
Maximum
3 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.
Warnings
Warnings For external use only Do not use on wounds or damaged skin with pain rubs, medicated lotions, creams or ointments with a heating pad. When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly discontinue use at least 1 hour before a bath or shower do not use immediately after a bath or shower do not microwave dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch. Stop use and ask a doctor if skin reactions such as redness, itching, rash, excessive irritation, burning sensation, swelling or blistering occur condition worsens symptoms persist more than 7 days symptoms clear and reoccur within a few days. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, contact a poison control center (1-800-222-1222) right away.
Active Ingredient
Active Ingredients: BoraxD100+100C (Sodium Borate), CapsicumD100+100C(Bell Pepper), CondurangoD6+60C(Marsdenia Condurango), Hydrastis MuD3+30C(Hydrastinum-Muriaticum), Kali PermanganatumD3+30C (Kalium Permanganatum), Merc SoliD100+100C(Mercurius Solubilis), Nitric AcidD100+100C, Sulphuric AcidD100+100C
Inactive Ingredients
Inactive Ingredients Beeswax, butyrospermum parkii (shea) butter, calendula officinalis flower extract, capryloyl glycerin, cinnamomum zeylanicum (cinnamon) leaf oil, cocos nucifera (coconut) oil, diheptyl succinate, elettaria cardamomum (cardamom) seed oil, eugenia caryophyllus (clove) bud oil, glycine soja (soybean) oil, olea europaea (olive) fruit oil, prunus amygdalus dulcis (sweet almond) oil, rosmarinus officinalis (rosemary) extract, rosmarinus officinalis (rosemary) leaf oil, rubus idaeus (raspberry) seed oil, sebacic acid copolymer, simmondsia chinensis (jojoba) seed oil, squalane, theobroma cacao (cocoa) seed butter, tocopherol, zingiber officinale (ginger) root oil