Docusate Other names: Docusate sodium

There are no adequate data from the use of the drug in pregnant women. The potential risk for humans is unknown.

Nonclinical studies are insufficient with respect to effects on pregnancy and fetal development. Docusate sodium should be used during pregnancy only if the benefits outweigh the risks.

There is no evidence to suggest that docusate sodium ear drops should not be used during pregnancy.

Non-clinical studies have shown excretion of docusate sodium and its metabolites into breast milk when administered systemically. Docusate sodium should be used with caution in nursing mothers.

There is no evidence to suggest that docusate sodium ear drops should not be used during lactation.

Fertility

There is insufficient data on the effect of docusate sodium on fertility.

None known.

Oral administration

The following CIOMS frequency rating is used, when applicable: Very common ≥10%; Common ≥1 and <10%; Uncommon ≥0.1 and <1%; Rare ≥0.01 and <0.1%; Very rare <0.01%; Not known (cannot be estimated from available data).

Gastrointestinal disorders

Rare: Diarrhoea, nausea, abdominal cramps

Skin and subcutaneous tissue disorders

Frequency unknown: Rash and pruritus

Auricular administration

Immune system disorders: Hypersensitivity/allergic reactions.

Skin disorders: Contact dermatitis and allergic skin reactions.

General disorders: Application site reactions rarely including transient stinging or irritation may occur. Injuries or inflammation in the auditory canal may result in painful symptoms.