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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

CAPSICUM OLEORESIN: 21 Adverse Event Reports & Safety Profile

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21
Total FAERS Reports
0
Deaths Reported
1
Hospitalizations
21
As Primary/Secondary Suspect
2
Disabilities
PureTek Corporation
Manufacturer

Route: TOPICAL · Manufacturer: PureTek Corporation · HUMAN OTC DRUG · FDA Label: Available

First Report: 20140703 · Latest Report: 20211120

What Are the Most Common CAPSICUM OLEORESIN Side Effects?

#1 Most Reported
Weight increased
9 reports (42.9%)
#2 Most Reported
Therapy non-responder
9 reports (42.9%)
#3 Most Reported
Immune thrombocytopenia
9 reports (42.9%)

All CAPSICUM OLEORESIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Immune thrombocytopenia 9 42.9% 0 0
Therapy non-responder 9 42.9% 0 0
Weight increased 9 42.9% 0 0
Withdrawal syndrome 5 23.8% 0 0

Who Reports CAPSICUM OLEORESIN Side Effects? Age & Gender Data

Gender: 100.0% female, 0.0% male. Average age: 31.8 years. Most reports from: CA. View detailed demographics →

Is CAPSICUM OLEORESIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2014 2 0 0
2015 1 0 0
2021 2 0 0

View full timeline →

What Is CAPSICUM OLEORESIN Used For?

IndicationReports
Complex regional pain syndrome 5

Official FDA Label for CAPSICUM OLEORESIN

Official prescribing information from the FDA-approved drug label.

FDA Approved Uses (Indications)

Uses For the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

Dosage & Administration

Directions:

  • Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock.
  • Before using on children under 18 years of age consult a physician.
  • Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction.
  • Gently massage into the skin until fully absorbed.
  • Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Warnings

Warnings For external use only This is not a face cream. Do not apply to the face. Do not use at the same time with other topical analgesics Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped, or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna, or vigorous exercise. Warm water, perspiration, or open pores can intensify the impact of this product and burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burn. When using this product Do not get into the eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort, or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling, or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast- feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Active Ingredient

Active ingredient Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose Topical

Analgesic

Inactive Ingredients

Inactive ingredients Aloe Barbadensis (Aloe Vera)

Leaf

Juice, Aqua (Purified Water), Arnica Montana (Arnica)

Flower

Extract, Bisabolol, C12-15 Alkyl Benzoate, C13-14 Isoparaffin, Calcium Pantothenate (Vitamin B5), Calendula Officinalis Flower Extract, Carthamus Tinctorius (Safflower) Oleosomes, Cetearyl Alcohol, Chamomilla Recutita (Matricaria)

Flower

Extract, Dimethicone, DL-Alpha-Tocopheryl Acetate (Vitamin E), Ginkgo Biloba (Ginkgo)

Leaf

Extract, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Maltodextrin, Myristyl Myristate, Niacinamide (Vitamin B3), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Hyaluronate, Sodium Starch Octenylsuccinate, Zingiber Officinale (Ginger)

Root

Extract.