What the label lists and what reports show
Doxylamine and pyridoxine side effects
Doxylamine and pyridoxine's FDA label: “The most common adverse reaction with DICLEGIS (≥5 percent and exceeding the rate in placebo) is somnolence.” FAERS holds 522 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is premature delivery (47 reports).
- Generic listed
Check it at the source: the doxylamine and pyridoxine FDA label on DailyMed (effective December 3, 2025, Duchesnay USA, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of DICLEGIS?DICLEGIS may cause serious side effects, including drowsiness. Drowsiness is a common side effect when taking DICLEGIS, but can also be severe: Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take DICLEGIS. Severe drowsiness can happen or become worse causing falls or accidents. DICLEGIS may cause false positive urine drug screening test for methadone, opiates and PCP. These are not all the possible side effects of DICLEGIS. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, Duchesnay USA, Inc., effective December 3, 2025 (SPL set 8bde08f6-e8bd-4e90-baa7-82e01876a86a), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reaction with DICLEGIS (≥5 percent and exceeding the rate in placebo) is somnolence.
From the label: adverse reactions, continuedThe following adverse reactions are discussed elsewhere in the labeling: Somnolence [see Warnings and Precautions ( 5.1 ) ] Falls or other accidents resulting from the effect of the combined use of DICLEGIS with CNS depressants including alcohol [see Warnings and Precautions ( 5.1 ) ] The most common adverse reaction with DICLEGIS (≥5 percent and exceeding the rate in placebo) is somnolence. ( 6 ) 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 DICLEGIS were compared to placebo 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 [ see Clinical Studies (14) ]. Adverse reactions for DICLEGIS that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.
Source: FDA drug label, Duchesnay USA, Inc., effective December 3, 2025 (SPL set 8bde08f6-e8bd-4e90-baa7-82e01876a86a), via openFDA; the full label on DailyMed
What do FAERS reports show?
522 reports list doxylamine and pyridoxine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 11 are coded as a death and 104 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Doxylamine and pyridoxine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions