Chlorhexidine Other names: Decanoylacetaldehyde Sodium Sulfide

No harmful effects in human pregnancy have been reported. Nevertheless, like all medicines, care should be exercised during pregnancy.

Teratogenic Effects Pregnancy Category B

Reproduction studies have been performed in rats and rabbits at chlorhexidine gluconate doses up to 300 mg/kg/day and 40 mg/kg/day, respectively, and have not revealed evidence of harm to fetus. However, adequate and well-controlled studies in pregnant women have not been done. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

No harmful effects have been reported. Nevertheless, like all medicines, care should be exercised during lactation.

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when chlorhexidine gluconate oral rinse is administered to nursing women.

In parturition and lactation studies with rats, no evidence of impaired parturition or of toxic effects to suckling pups was observed when chlorhexidine gluconate was administered to dams at doses that were over 100 times greater than that which would results from a person’s ingesting 30 mL (2 doses) of chlorhexidine gluconate per day.

None known.

Skin disorders

Frequency not known: Allergic skin reactions such as dermatitis, pruritus, erythema, eczema, rash, urticaria, skin irritation, and blisters.

Nervous system disorders

Common: Aguesia/dysguesia, Glossodynia, Oral paraesthesia/hypoaesthesia

Gastrointestinal Disorders

Very Common: Tongue coated

Common: Dry mouth

Isolated reports: Discoloration of the teeth and tongue, Irritation of the mouth, Desquamation/swelling of oral mucosa, Parotid gland swelling

Immune system disorders

Frequency not known: Hypersensitivity including anaphylactic shock and anaphylaxis.

The most common side effects associated with chlorhexidine gluconate oral rinse are: 1) an increase in staining of the teeth and other oral surfaces; 2) an increase in calculus formation; and 3) an alteration in taste perception.

Oral irritation and local allergy-type symptoms have been spontaneously reported as side effects associated with use of chlorhexidine gluconate rinse. The following oral mucosal side effects were reported during placebo-controlled adult clinical trails: aphthous ulcer, grossly obvious gingivitis, trauma, ulceration, erythema, desquamation, coated tongue, keratinization, geographic tongue, mucocele, and short frenum. Each occurred at a frequency of less than 1.0%. Among post marketing reports, the most frequently reported oral mucosal symptoms associated with chlorhexidine gluconate oral rinse are stomatitis, gingivits, glossitis, ulcer, dry mouth, hypesthesia, glossal edema, and paresthesia. Minor irritation and superficial desquamation of the oral mucosa have been noted in patients using chlorhexidine gluconate oral rinse. There have been cases of parotid gland swelling and inflammation of the salivary glands (sialadenitis) reported in patients using chlorhexidine gluconate oral rinse.