Applies to sinecatechins topical: topical application ointment.

Serious side effects

Along with its needed effects, sinecatechins topical may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking sinecatechins topical:

More common

• Blistering, peeling, or loosening of the skin
• breakdown of skin
• burning of skin
• cracking of skin
• flushing, redness of skin
• hardening or thickening of skin
• irritation of skin
• itching skin
• pain or discomfort in skin
• swelling of skin
• unusually warm skin

Less common

• Bleeding of skin
• blood in urine
• break in the skin, especially associated with blue-black discoloration, swelling, or drainage of fluid
• burning or itching around anus
• changes in skin coloring
• discharge from skin
• dryness of skin
• increased frequency of urination
• increased sensitivity to pain
• increased sensitivity to touch
• pain or burning during urination
• peeling of one area of skin
• pelvic pain
• problems with foreskin of penis
• rash with flat lesions or small raised lesions on the skin
• scarring of skin
• skin rash, encrusted, scaly and oozing
• skin rash on the face
• swollen, painful, or tender lymph glands in neck, armpit, or groin
• tingling in the hands and feet

For Healthcare Professionals

Applies to sinecatechins topical: topical ointment.

General

The most frequently reported side effects were local skin and application site reactions, including erythema, pruritus, burning, pain/discomfort, erosion/ulceration, edema, induration, and vesicular rash.

During clinical trials, 5% of patients experienced local adverse events that led to dose reduction, dose interruption, or discontinuation of this drug. These events included application site reactions (local pain, erythema, vesicles, skin erosion/ulceration), phimosis, inguinal lymphadenitis, urethral meatal stenosis, dysuria, genital herpes simplex, vulvitis, hypersensitivity, pruritus, pyodermitis, skin ulcer, erosions in the urethral meatus, and superinfection of warts and ulcers.^[Ref]

Local

Very common (10% or more): Burning (67%), pain/discomfort (56%), erosion/ulceration (49%), induration (35%)

Common (1% to 10%): Discharge, bleeding, localized reaction, scar, irritation

Uncommon (0.1% to 1%): Localized inflammation

Frequency not reported: Vesicles, necrosis, papules, discoloration, eczema, pigmentation changes, dryness^[Ref]

Dermatologic

Very common (10% or more): Erythema (70%), pruritus (69%), vesicular rash (20%)

Common (1% to 10%): Desquamation, rash

Frequency not reported: Pyodermitis, cutaneous facial rash^[Ref]

Other

Very common (10% or more): Edema (45%)

Frequency not reported: Genital herpes simplex, superinfection of warts and ulcers, perianal infection^[Ref]

Hematologic

Common (1% to 10%): Regional/inguinal lymphadenitis

Frequency not reported: Staphylococcemia^[Ref]

Genitourinary

Common (1% to 10%): Phimosis

Frequency not reported: Dysuria, vulvitis, cervical dysplasia, pelvic pain^[Ref]

Hypersensitivity

Common (1% to 10%): Type IV hypersensitivity

Frequency not reported: Hypersensitivity^[Ref]

Nervous system

Frequency not reported: Hyperesthesia^[Ref]

Renal

Frequency not reported: Urethral meatal stenosis, erosions in urethral meatus, urethritis^[Ref]