Diclegis Side Effects Center

Last updated on RxList: 11/10/2022
Diclegis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Diclegis?

Diclegis (doxylamine succinate and pyridoxine hydrochloride) is an antiemetic (anti-nausea and vomiting) agent used to treat nausea and vomiting in pregnant women.

What Are Side Effects of Diclegis?

Diclegis may cause serious side effects including:

  • mood changes,
  • confusion,
  • irritability,
  • nervousness,
  • trouble urinating,
  • easy bruising or bleeding,
  • fast or irregular heartbeat,
  • rash,
  • itching,
  • swelling of the face, tongue or throat,
  • severe dizziness, and
  • trouble breathing

Get medical help right away, if you have any of the symptoms listed above.

Common side effects of Diclegis include:

  • sleepiness,
  • drowsiness,
  • dizziness,
  • stomach upset,
  • diarrhea,
  • constipation,
  • headache,
  • trouble sleeping (insomnia),
  • blurred vision,
  • shortness of breath,
  • palpitations,
  • fast heart rate, vertigo,
  • bloating,
  • fatigue,
  • irritability,
  • malaise,
  • numbness and tingling,
  • anxiety, nightmares,
  • difficulty urinating,
  • itching, or
  • rash

Diclegis should be used with caution, especially with respect to activities that require complete mental alertness.

Seek medical care or call 911 at once if you have the following serious side effects:

  • Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
  • Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in your chest; shortness of breath; and sudden dizziness, lightheadedness, or passing out;
  • Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors.

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Dosage for Diclegis?

Diclegis are available as delayed-release tablets containing 10 mg doxylamine succinate and 10 mg pyridoxine hydrochloride. Patients should take two tablets of Diclegis at bedtime. If nausea and vomiting is not controlled with two tablets, the dose may be increased to a maximum of four tablets daily.

What Drugs, Substances, or Supplements Interact with Diclegis?

Diclegis should not be used by women with sensitivities to any ingredient in Diclegis. Severe drowsiness can occur when using Diclegis with other sedative medications. Diclegis interacts with monoamine oxidase inhibitors (MAOIs), or alcohol and other CNS depressants (such as hypnotic sedatives and tranquilizers). Tell your doctor all medications and supplements you use.

Diclegis During Pregnancy and Breastfeeding

Diclegis is intended for use in pregnant women. Women should not breastfeed while using Diclegis.

Additional Information

Our Diclegis (doxylamine succinate and pyridoxine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


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Diclegis Consumer Information

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Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Common side effects may include:

  • drowsiness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.


The first sign of pregnancy is most often: See Answer
Diclegis Professional Information


The following adverse reactions are discussed elsewhere in the labeling:

  • Falls or other accidents resulting from the effect of the combined use of DICLEGIS with CNS depressants including alcohol [see WARNINGS AND PRECAUTIONS]

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]. Adverse reactions for DICLEGIS that occurred at an incidence ≥5 percent and exceeded the incidence for placebo are summarized in Table 1.

Table 1: Number (Percent) of Subjects with ≥ 5 Percent Adverse Reactions in a 15–Day Placebo-Controlled Study of DICLEGIS (Only Those Adverse Reactions Occurring at an Incidence ≥ 5 Percent and at a Higher Incidence with DICLEGIS than Placebo are Shown)

Diclegis (N = 133)Placebo (n = 128)
Somnolence19 (14.3%)15 (11.7%)

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 maculo-papular

Read the entire FDA prescribing information for Diclegis (Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-release Tablets)

© Diclegis Patient Information is supplied by Cerner Multum, Inc. and Diclegis Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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