Doxylamineside effects

The following adverse reactions are discussed elsewhere in the labeling:

Somnolence

Falls or other accidents resulting from the effect of the combined use of BONJESTA with CNS depressants including alcohol The most common adverse reaction (≥5 percent and exceeding the rate in placebo) with combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets is somnolence. To report SUSPECTED ADVERSE REACTIONS, contact Duchesnay Inc. at 1-855-722-7734 or medicalinfo@duchesnayusa.com or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1 Clinical

Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety and efficacy of combination 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride tablets compared to placebo was studied in a double-blind, randomized, multi-center trial in 261 women with nausea and vomiting of pregnancy. The mean gestational age at enrollment was 9.3 weeks, range 7 to 14 weeks gestation. Adverse reactions that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.

Table 1: Number (Percent) of Women with ≥ 5 Percent Adverse Reactions in a 15-Day Placebo-Controlled Trial of Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence than Placebo are Shown) Adverse Reaction Combination 10 mg Doxylamine Succinate and 10 mg Pyridoxine Hydrochloride Tablets (N = 133) Placebo (n = 128) Somnolence 19 (14.3%) 15 (11.7%)

6.2 Postmarketing

Experience The following adverse events, listed alphabetically, have been identified during post-approval use of the combination of 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Cardiac disorders: dyspnea, palpitation, tachycardia Ear and labyrinth disorders: vertigo Eye disorders: vision blurred, visual disturbances Gastrointestinal disorders: abdominal distension, abdominal pain, constipation, diarrhea General disorders and administration site conditions: chest discomfort, fatigue, irritability, malaise Immune system disorders: hypersensitivity Nervous system disorders: dizziness, headache, migraines, paresthesia, psychomotor hyperactivity Psychiatric disorders: anxiety, disorientation, insomnia, nightmares Renal and urinary disorders: dysuria, urinary retention Skin and subcutaneous tissue disorders: hyperhidrosis, pruritus, rash, rash maculopapular