Important Safety Information

Indication

Diclegis® is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.

Limitations of Use

Diclegis® has not been studied in women with hyperemesis gravidarum.

Important Safety Information

Diclegis® is contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation. Diclegis® is also contraindicated in combination with monoamine oxidase inhibitors (MAOIs) as MAOIs intensify and prolong the adverse CNS effects of Diclegis®. Use of MAOIs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.

Diclegis® may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis® until cleared to do so by their healthcare provider.

Use of Diclegis® is not recommended if a woman is concurrently using CNS depressants, such as alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates, and sleep aids. The combination of Diclegis® and CNS depressants could result in severe drowsiness leading to falls or other accidents.

Diclegis® has anticholinergic properties and should be used with caution in women who have: (1) asthma, (2) increased intraocular pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction.

Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis® in children under 18 years of age have not been established.

Diclegis® is a delayed-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. If you suspect an overdose or seek additional overdose information, you can contact a poison control center at 1-800-222-1222.

The FDA granted Diclegis® Pregnancy Category A status, which means that the results of controlled studies have not shown increased risk to an unborn baby during pregnancy.

Women should not breast-feed while using Diclegis® because the antihistamine component (doxylamine succinate) in Diclegis® can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Diclegis® resulting in worsening of their apnea or respiratory conditions.

To report suspected adverse reactions, contact Duchesnay Inc. at 1-855-722-7734 or This email address is being protected from spambots. You need JavaScript enabled to view it. or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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