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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.

SALICYLIC ACID: 2,201 Adverse Event Reports & Safety Profile

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2,201
Total FAERS Reports
777 (35.3%)
Deaths Reported
365
Hospitalizations
2,201
As Primary/Secondary Suspect
103
Life-Threatening
83
Disabilities
Retail Business Services, LLC
Manufacturer

Route: TOPICAL · Manufacturer: Retail Business Services, LLC · HUMAN OTC DRUG · FDA Label: Available

First Report: 1945 · Latest Report: 20250818

What Are the Most Common SALICYLIC ACID Side Effects?

#1 Most Reported
Completed suicide
319 reports (14.5%)
#2 Most Reported
Drug ineffective
317 reports (14.4%)
#3 Most Reported
Toxicity to various agents
258 reports (11.7%)

All SALICYLIC ACID Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Completed suicide 319 14.5% 318 88
Drug ineffective 317 14.4% 37 36
Toxicity to various agents 258 11.7% 237 99
Pruritus 197 9.0% 86 49
Urticaria 192 8.7% 114 46
Hypersensitivity 189 8.6% 84 43
Dyspnoea 161 7.3% 54 40
Rash 142 6.5% 69 28
Pain 134 6.1% 83 23
Condition aggravated 133 6.0% 77 41
Erythema 127 5.8% 0 13
Type 2 diabetes mellitus 120 5.5% 120 46
Vomiting 117 5.3% 112 38
Weight increased 115 5.2% 115 41
Hypoaesthesia 114 5.2% 103 43
Swelling face 114 5.2% 0 19
Wheezing 114 5.2% 91 29
Hypertension 112 5.1% 105 44
Pain in extremity 112 5.1% 85 27
Osteoarthritis 107 4.9% 107 44

Who Reports SALICYLIC ACID Side Effects? Age & Gender Data

Gender: 71.3% female, 28.7% male. Average age: 43.6 years. Most reports from: US. View detailed demographics →

Is SALICYLIC ACID Getting Safer? Reports by Year

YearReportsDeathsHosp.
2004 1 0 1
2006 1 0 1
2008 4 2 2
2009 2 1 0
2010 2 0 1
2012 5 3 0
2013 9 6 0
2014 138 16 12
2015 159 12 24
2016 76 6 10
2017 76 3 11
2018 104 9 11
2019 48 9 5
2020 40 7 4
2021 45 23 1
2022 18 6 1
2023 23 9 0
2024 16 1 7
2025 15 0 2

View full timeline →

What Is SALICYLIC ACID Used For?

IndicationReports
Product used for unknown indication 979
Acne 238
Hyperkeratosis 151
Skin papilloma 120
Suicide attempt 55
Removal of inert matter from skin or subcutaneous tissue 33
Psoriasis 28
Therapeutic skin care topical 20
Uveitis 20
Rheumatoid arthritis 19

SALICYLIC ACID vs Alternatives: Which Is Safer?

SALICYLIC ACID vs SALMETEROL SALICYLIC ACID vs SAMSCA SALICYLIC ACID vs SANDOSTATIN LAR SALICYLIC ACID vs SANDOZ FENTANYL SYSTEM SALICYLIC ACID vs SAPROPTERIN SALICYLIC ACID vs SAQUINAVIR SALICYLIC ACID vs SARECYCLINE SALICYLIC ACID vs SARGRAMOSTIM SALICYLIC ACID vs SARILUMAB SALICYLIC ACID vs SATRALIZUMAB

Official FDA Label for SALICYLIC ACID

Official prescribing information from the FDA-approved drug label.

Drug Description

PROD. NO. 10624 Psoriasis Medicated Scalp and Body Wash helps fight the itching, redness, irritation and scaling associated with Psoriasis, dandruff and seborrheic dermatitis. The active ingredient, Salicylic Acid, is combined with a soothing, moisturizing base that includes the following natural ingredients: Allantoin, Aloe Vera Gel, Carrot Oil, Echinacea Extract and Jojoba Oil.

At Home

Health, years of research have gone into creating truly effective personal care products based on traditional, natural ingredients. You can rely on Home Health to deliver the natural health products your family deserves. Free of preservatives, parabens, mineral oil, petroleum, animal materials, artificial colors and artificial fragrance. Store in a cool, dry place. Contents may separate when left standing. Shake vigorously. GUARANTEED LABORATORY TESTED QUALITY 3 18858 10624 0 Carefully Manufactured for Home Health, Co. Ronkonkoma, NY 11779 U.S.A www.HomeHealthUS.com C2009 Home Health B10624 08C

FDA Approved Uses (Indications)

Drug Facts Active Ingredients Active Ingredients Purpose Salicylic Acid 2.0% Acne Medication Uses For the management of acne. Penetrates pores to control acne blemishes. Helps prevent new acne blemishes from forming.

Warnings

For external use only. When using this product skin irritation and dryness is more likely to occur if you use another topical acne mediation at the same time. If irritation occurs, only use one topical acne medication at a time. Stop use and ask a doctor if irritation occurs or gets worse. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions Sensitivity

Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below. Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other Information

Protect this product from excessive heat and direct sun.

Inactive Ingredients

Water, Cocamidopropyl Dimethylamine, Glycerin, Sclerotium Gum, Dimethicone, Silica, Cetyl Glyceryl Ether, Retinol, Cetyl Alcohol, Cetyl Tranexamate Mesylate, Carthamus Tinctorius (Safflower)

Seed

Oil, Olea Europaea (Olive)

Fruit

Oil, Rosa Canina Fruit Extract, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Lecithin, Propanediol, Potassium Azeloyl Diglycinate, BHT, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sodium Bisulfite, Sodium Metabisulfite, Sodium Sulfite, Sodium Sulfate, Polysorbate 20, Acrylamide/Sodium Acryloyldimethyltaurate Copolymer, Butylene Glycol, Isohexadecane, Bakuchiol, Aminomethyl Propanol, Caprylhydroxamic Acid, Disodium EDTA, Polysorbate 80, Phenoxyethanol, Ethylhexylglycerin.

Dosage & Administration

Directions Dots : For products applied to and left on the skin : Cleanse thoroughly before applying this product Cover the entire affected area with one dot Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times a daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or even every other day Sensitivity Test for a New User : Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above. Serum: For products applied to and left on the skin: Clean the skin thoroughly before applying this product Cover the entire affected area with a thin layer one to three times daily Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor If bothersome dryness or peeling occurs, reduce application to once a day or every other day Sensitivity Test for a New User : Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated above. Moisturizer : AM/PM: After cleansing and applying serum or treatment steps, massage a dime-sized amount onto face, neck and decollete. Follw with SPF in the AM.

Sensitivity

Test for New Users : Apply product to a small area once a day for 3 days to test if you are sensitive to this product. Cleanser : AM/PM: Twist the cap to the right and squeeze. Apply a dime size amount on damp skin, gently massage in circular motions onto face and neck avoiding the eye area. May also be used on chest and back. Rinse skin thoroughly with warm water and pat dry. Twist cap again to close. Follow with serum, moisturizer or SPF (AM).

Sensitivity

Test for New Users : Apply product to a small area once a day for 3 days to test if you are sensitive to this product.

Contraindications

CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product. Patients with diabetes or impaired blood circulation should not use this product. This product also should not be used on moles, birthmarks, and unusual warts with hair growing from them, or warts on the face.

Known Adverse Reactions

ADVERSE REACTION *This product is not manufactured or distributed by Johnson & Johnson Consumer Products Company, distributor of Clean & Clear ® Sensitive Skin Deep Cleaning Astringent. Visit us here for more information: http://topbrands.com DISTRIBUTED BY TOPCO ASSOCIATES LLC 150 NORTHEST POINT BOULEVARD ELK GROVE VILLAGE, IL 60007 1-888-423-0139 TOPCO VIJA0119 topcare@ topco.com QUALITY GUARANTEED

Warnings

Warnings: For external use only. When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Sun

Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings: For external use only. When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Sunburn

Alert: This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterward. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Warnings: For external use only. When using this product Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at the same time. If irritation occurs, only use one topical medication at a time. Avoid contact with eyes. If contact occurs, flush thoroughly with water Sun Alert: Because this product may make your skin more sensitive to the sun, be certain you have adequate sunscreen protection while using this product and for a week after you discontinue use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Precautions

PRECAUTIONS: Salicylic Acid, 27.5% Wart Remover is for external use only. Do not permit Salicylic Acid, 27.5% Wart Remover to contact eyes or mucous membranes. If contact with eyes or mucous membranes occurs, immediately flush with water for 15 minutes.

Salicylic

Acid, 27.5% Wart Remover should not be allowed to contact normal skin surrounding wart. Treatment should be discontinued if excessive irritation occurs.

Salicylic

Acid, 27.5% Wart Remover is flammable and should be kept away from fire or flame. Keep bottle tightly capped when not in use. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Drug Interactions

DRUG INTERACTIONS The following interactions are from a published review and include reports concerning both oral and topical salicylate administration. The relationship of these interactions to the use of Salycim™ Cream is not known. I. Due to the competition of salicylate with other drugs for binding to serum albumin the following drug interactions may occur: DRUG DESCRIPTION OF INTERACTION Sulfonylureas Hypoglycemia potentiated.

Methotrexate

Decreases tubular reabsorption; clinical toxicity from methotrexate can result.

Oral Anticoagulants

Increased bleeding. II. Drugs changing salicylate levels by altering renal tubular reabsorption: DRUG DESCRIPTION OF INTERACTION Corticosteroids Decreases plasma salicylate level; tapering doses of steroids may promote salicylism.

Acidifying Agents

Increases plasma salicylate levels.

Alkanizing Agents

Decreased plasma salicylate levels. III. Drugs with complicated interactions with salicylates: DRUG DESCRIPTION OF INTERACTION Heparin Salicylate decreases platelet adhesiveness and interferes with hemostasis in heparin-treated patients.

Pyrazinamide

Inhibits pyrazinamide-induced hyperuricemia.

Uricosuric Agents

Effect of probenemide, sulfinpyrazone and phenylbutazone inhibited. The following alterations of laboratory tests have been reported during salicylate therapy: LABORATORY TESTS EFFECT OF SALICYLATES Thyroid Function Decreased PBI; increased t 3 uptake.

Urinary Sugar

False negative with glucose oxidase; false positive with Clinitest with high-dose salicylate therapy (2-5g q.d.). 5-Hydroxyindole acetic acid False negative with fluorometric test. Acetone ketone bodies False positive FeCI 3 in Gerhardt reaction; red color persists with boiling. 17-OH corticosteroids False reduced values with >4.8g q.d. salicylate. Vanilmandelic acid False reduced values.

Uric Acid

May increase or decrease depending on dose.

Prothrombin

Decreased levels; slightly increased prothrombin time.

Active Ingredient

SALICYLICUM ACIDUM 200CK HPUS Less than 10 -12 mg salicylic acid per pellet Active ingredient**: See product name on front panel (contains 0.443 mg of the active ingredient per pellet).

Inactive Ingredients

Inactive ingredients Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow)

Bark

Extract, Rosa Canina (Rosehip)

Seed

Extract, Citrus Paradisi (Grapefruit)

Peel

Extract, Symphytum Officinale (Comfrey)

Leaf

Extract, Lavandula Angustifolia (Lavender)

Flower

Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint)

Leaf

Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glyceri], Decyl Glucoside, Sodium Cocoyl Glutamate, Citrus Grandis (Grapefruit)

Peel

Oil, Metha Spicata (Spearmint)

Leaf

Oil, Caprylyl Glycol, Tocopherol (Vitamin E), Panthenol (Provitamin B5), Thymus Vulgans (Thyme) Extract, Cinnamomum Zeylanicum (Cinnamon)

Bark

Extract, Ole Europaea (Olive)

Leaf

Extract, Rosmarinus Officinalis (Rosemary)

Leaf

Extract, Cocamidopropyl Dimethylamine, Mentha Piperita (Peppermint)

Leaf

Extract, Lavandula Angustifolia (Lavender)

Flower

Extract, Hydrastis Canadensis (Goldenseal)

Root

Extract, Citrus Limon (Lemon)

Peel

Extract, Ethylhexylglycerin, Caffeine (from Green Tea), Sodium PCA, Arbutin, Biocomplex2 [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10), Vegetable Glycerin. *Certified organic ingredient

Inactive ingredients Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow)

Bark

Extract, Rosa Canina (Rosehip)

Seed

Extract, Citrus Paradisi (Grapefruit)

Peel

Extract, Symphytum Officinale (Comfrey)

Leaf

Extract, Lavandula Angustifolia (Lavender)

Flower

Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint)

Leaf

Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], Kaolin Clay, Red Kaolin Clay, Vegetable Glycerin, Glycine Soja Soybean) Oil, Benzyl Alcohol, Helianthus Annuus (Sunflower Seed) Oil, Sorbic Acid, Polyacrylate 13, Citrus Grandis (Grapefruit)

Peel

Oil, Metha Spicata (Spearmint)

Leaf

Oil, Polysobutene, Cocamidopropyl Dimethylamine, Sulfur, Ocimum Basillicum (Basil) Oil, Lavandula Angustifolia (Lavender)

Flower

Extract, Tocopheryl Acetate (Vitamin E), Xanthan Gum, Montmorillonite Caly, Sodium PCA, Polysorbate 20, Eucalyptus Globulus (Eucalyptus) Oil, Retinyl Palmitate (Vitamin A), Usnea Barbata (Lichen) Extract, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10) *Certified organic ingredient

Inactive ingredients Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow)

Bark

Extract, Rosa Canina (Rosehip)

Seed

Extract, Citrus Paradisi (Grapefruit)

Peel

Extract, Symphytum Officinale (Comfrey)

Leaf

Extract, Lavandula Angustifolia (Lavender)

Flower

Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint)

Leaf

Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol, Citrus Grandis (Grapefruit)

Peel

Oil, Mentha Spicata (Spearmint)

Leaf

Oil, Sodium Acrylate, Nyphaea Caerulea (Blue Lotus)

Flower

Extract, Nelumbo Nucifera (Sacred Lotus)

Flower

Extract, Origanum Vulgare (Oregano)

Leaf

Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium (Cinnamon)

Bark

Extract, Olea Europaea (Olive)

Leaf

Extract, Rosmarinus Officinalis (Rosemary)

Leaf

Extract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint)

Leaf

Extract, Lavandula Angustifolia (Lavender)

Flower

Extract, Hydrastis Canadensis (Goldenseal)

Root

Extract, Citrus Limon (Lemon)

Peel

Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5), Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate, Arbutin, Cocamidopropyl Dimethylamine, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10) *Certified organic ingredient