Note: This document contains side effect information about chlorhexidine topical. Some dosage forms listed on this page may not apply to the brand name Biopatch.

Applies to chlorhexidine topical: oral liquid, oral solution. Other dosage forms:

• topical application liquid, topical application solution

Serious side effects of Biopatch

Along with its needed effects, chlorhexidine topical (the active ingredient contained in Biopatch) 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 chlorhexidine topical:

Rare

• Signs of allergic reaction (nasal congestion; shortness of breath or troubled breathing; skin rash, hives, or itching; or swelling of face

Other side effects of Biopatch

Some side effects of chlorhexidine topical may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Change in taste
• increase in tartar (calculus) on teeth
• staining of teeth, mouth, tooth fillings, and dentures or other mouth appliances

Less common or rare

• Mouth irritation
• swollen glands on side of face or neck
• tongue tip irritation

For Healthcare Professionals

Applies to chlorhexidine topical: compounding liquid, mucous membrane insert, mucous membrane liquid, topical dressing, topical liquid, topical pad, topical soap, topical solution, topical sponge.

General

The most commonly reported side effects include toothache, tongue coating, skin irritation and hypersensitivity reactions.^[Ref]

Gastrointestinal

Very common (10% or more): Toothache (up to 50.7%)

Common (1% to 10%): Dry mouth, glossodynia, oral paresthesia, dyspepsia, ulcerative stomatitis, gum hyperplasia

Frequency not reported: Mouth irritation, coated tongue, desquamation/superficial desquamation/oral mucosa swelling, parotid gland swelling, burning sensation of the tongue, increased dental calculus formation, aphthous ulcer, gingivitis/grossly obvious gingivitis, geographic tongue, tooth disorder, dental/gingival/mouth pain, broken/cracked/fractured teeth, mobile teeth, lost bridges/crowns/fillings, discoloration of the teeth, gums, and dorsum of the tongue

Postmarketing reports: Stomatitis, glossitis, ulcer, glossal edema, sialadenitis/inflammation of the salivary glands^[Ref]

Toothache occurred most often in patients receiving the periodontal chip, and included dental/gingival/mouth pain, tenderness, aching, throbbing, soreness, discomfort, or sensitivity.

Tooth disorder occurred most often in patients receiving the periodontal chip, and included broken/cracked/fractured teeth, mobile teeth, and lost bridges/crowns/fillings.^[Ref]

Respiratory

Bronchospasm occurred with hypersensitivity reactions.

Upper respiratory tract infection and sinusitis have occurred most commonly in patients receiving the periodontal chip.^[Ref]

Very common (10% or more): Upper respiratory tract infection (up to 28.4%), sinusitis (up to 13.8%)

Common (1% to 10%): Bronchitis, pharyngitis

Frequency not reported: Bronchospasm, rhinitis, coughing, dyspnea^[Ref]

Nervous system

Common (1% to 10%): Ageusia/dysgeusia, hypoesthesia

Frequency not reported: Transient dysgeusia, headache, loss of consciousness

Postmarketing reports: Hypesthesia, paresthesia^[Ref]

Musculoskeletal

Common (1% to 10%): Arthrosis, tendinitis

Frequency not reported: Back pain, myalgia, arthralgia^[Ref]

Local

Frequency not reported: Ulceration, desquamation, keratinization, mucocele, short frenum, pain, tenderness, aching, throbbing, soreness, discomfort, sensitivity

Postmarketing reports: Minor irritation^[Ref]

Dermatologic

Rash, erythema, and urticaria occurred with hypersensitivity reactions.

Dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters occurred with allergic skin reactions.^[Ref]

Frequency not reported: Rash, erythema/generalized erythema, urticaria, dermatitis, pruritus, eczema, skin irritation, blisters, cold sweat, irritative or allergic skin reactions^[Ref]

Other

Frequency not reported: Chemical burns in neonates, trauma, abscess, influenza-like symptoms, deafness, sensitive tissue irritation^[Ref]

Cardiovascular

Cardiac arrest, circulatory collapse, hypotension, and tachycardia occurred as hypersensitivity reactions.^[Ref]

Frequency not reported: Cardiac arrest, circulatory collapse, hypotension, tachycardia, hypertension^[Ref]

Hypersensitivity

Frequency not reported: Anaphylactic shock, anaphylactoid reactions/fatal anaphylactic reactions

Postmarketing reports: Hypersensitivity and anaphylaxis^[Ref]

Ocular

Frequency not reported: Irreversible corneal damage, irritation to the conjunctiva^[Ref]

Exposure of the eye to chlorhexidine cleanser, generally during preparation for facial surgery, has resulted in eye pain, edema of the epithelium, keratitis, inflammation of the conjunctiva, corneal epithelial cell loss, chronic corneal ulcers, and opacification. Corneal transplantation to correct permanent damage has been required in some patients.

Allergic conjunctivitis is rarely associated with the use of contact lens solutions which contain low concentrations of chlorhexidine as a preservative.^[Ref]

Genitourinary

Hematuria occurred after bladder irrigation.^[Ref]

Frequency not reported: Dysmenorrhea, hematuria^[Ref]

Immunologic

Frequency not reported: Allergy^[Ref]