Diclegis Adverse Reactions

Summary of the safety profile: Adverse reaction information is derived from clinical trials and worldwide postmarketing experience.
There has been a vast clinical experience regarding the use of this medicinal product combination (doxylamine hydrogen succinate and pyridoxine hydrochloride). In a double-blind, randomised, placebo-controlled trial of 15 days duration, 261 women with nausea and vomiting of pregnancy were included of which 128 were treated with placebo and 133 with doxylamine hydrogen succinate/pyridoxine hydrochloride. The mean gestational age at enrolment was 9.3 weeks; gestation range was from 7 to 14 weeks. The incidence of treatment-emergent adverse events was similar for both treatment and placebo groups. The most frequently reported adverse reaction (≥5% and exceeding the rate in placebo) was somnolence.
Tabulated list of adverse reactions: The following listing of adverse reactions is based on clinical trial experience and/or post-marketing use, with this medicine and other similar medicine containing the same active ingredients.
Undesirable effects are displayed by MedDRA System Organ Classes and use the following conventions for frequency: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to < 1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
The frequency of adverse reactions reported during post-marketing use cannot be determined as they are derived from spontaneous reports. Consequently, the frequency of these adverse reactions is qualified as "not known". (See Table 6.)

Click on icon to see table/diagram/image

Description of selected adverse reactions: Severe drowsiness may occur if this medicinal product is taken along with CNS depressants including alcohol (see Precautions and Interactions).
Anticholinergic effects of this medicinal product may be prolonged and intensified by monoamine oxidase inhibitors (MAOIs) (see Contraindications and Interactions).
Possible adverse anticholinergic effects associated with the use of antihistamines as a class in general include: dryness of mouth, nose and throat; dysuria; urinary retention; vertigo, visual disturbances, blurred vision, diplopia, tinnitus; acute labyrinthitis; insomnia; tremors, nervousness; irritability; and facial dyskinesia. Tightness of chest, thickening of bronchial secretions, wheezing, nasal stuffiness, sweating, chills, early menses, toxic psychosis, headache, faintness and paresthesia have occurred.
Rarely, agranulocytosis, haemolytic anaemia, leukopenia, thrombocytopenia, and pancytopenia have been reported in a few patients receiving some antihistamines. Increased appetite and/or weight gain also occurred in patients receiving antihistamines.
Reporting of suspected adverse reactions: Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. For suspected adverse drug reaction, report to the FDA: www.fda.gov.ph.
Seek medical attention immediately at the first sign of any adverse drug reaction.