SALICYLIC ACID: 2,201 Adverse Event Reports & Safety Profile
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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?
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
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 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 |
What Is SALICYLIC ACID Used For?
| Indication | Reports |
|---|---|
| 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?
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