Doxylamine / Pyridoxine Side Effects

Medically reviewed by Drugs.com. Last updated on Feb 20, 2024.

Applies to doxylamine / pyridoxine: oral tablet delayed release, oral tablet extended release.

Precautions

It is important that your doctor check your progress while using this medicine to make sure this medicine is working properly and to check for unwanted effects.

If your symptoms do not improve or if they become worse, check with your doctor.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI) such as isocarboxazid [Marplan®], phenelzine [Nardil®], selegiline [Eldepryl®], tranylcypromine [Parnate®]). Using these medicines together may cause serious unwanted effects.

This medicine may make you drowsy or sleepy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds, sedatives, tranquilizers, or sleeping medicine, prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are using this medicine.

Signs of an overdose include: dizziness or lightheadedness, dry mouth, enlarged pupils, fast, pounding, irregular heartbeat or pulse, feeling of constant movement of self or surroundings, mental confusion, palpitations, restlessness, sensation of spinning, or sleepiness. Call your doctor right away if you notice these symptoms.

This medicine may cause dry mouth. A dry mouth may also damage your teeth and gums. To help prevent this condition, carefully brush your teeth at least 2 times a day and have regular visits with your dentist.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Other side effects

Some side effects of doxylamine / pyridoxine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Serious side effects

Along with its needed effects, doxylamine/pyridoxine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking doxylamine / pyridoxine:

Get emergency help immediately if any of the following symptoms of overdose occur while taking doxylamine / pyridoxine:

Symptoms of overdose

• dizziness or lightheadedness
• dry mouth
• enlarged pupils
• fast, pounding, or irregular heartbeat or pulse
• feeling of constant movement of self or surroundings
• mental confusion
• palpitations
• restlessness
• sensation of spinning
• sleepiness

For healthcare professionals

Applies to doxylamine / pyridoxine: oral delayed release tablet, oral tablet extended release.

General adverse events

The most commonly reported side effects were somnolence, dizziness, dry mouth, and fatigue.^[Ref]

Nervous system

• Very common (10% or more): Somnolence (up to 14.3%)
• Common (1% to 10%): Dizziness
• Postmarketing reports: Anticholinergic effects, blurred vision, diplopia, facial dyskinesia, faintness, headache, migraines, paresthesia, psychomotor hyperactivity, severe somnolence, tremors, vertigo^[Ref]

Severe somnolence occurred when this drug was coadministered with central nervous system depressants (e.g., alcohol).

Anticholinergic effects may be worsened and prolonged with the concomitant use of MAO inhibitors.

Blurred vision, facial dyskinesia, faintness, headache, paresthesia, tremors, and/or vertigo may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Gastrointestinal

• Common (1% to 10%): Dry mouth
• Postmarketing reports: Abdominal distention, abdominal pain, constipation, diarrhea, dry throat^[Ref]

Dry mouth and dry throat occurred as a result of anticholinergic effects associated with antihistamines.^[Ref]

Other

• Common (1% to 10%): Fatigue
• Postmarketing reports: Acute labyrinthitis, malaise, tinnitus^[Ref]

Acute labyrinthitis and tinnitus may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Psychiatric

• Postmarketing reports: Anxiety, disorientation, insomnia, irritability, nervousness, nightmares, toxic psychoses^[Ref]

Insomnia, irritability, nervousness, and/or toxic psychoses may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Dermatologic

• Postmarketing reports: Hyperhidrosis, maculopapular rash, pruritus, rash, sweating^[Ref]

Sweating may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Respiratory

• Postmarketing reports: Dry nose, dyspnea, nasal stuffiness, thickening of bronchial secretions, wheezing^[Ref]

Dry nose, nasal stuffiness, and thickening of bronchial secretions, and/or wheezing may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Hematologic

• Postmarketing reports: Agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, thrombocytopenia^[Ref]

Agranulocytosis, hemolytic anemia, leukopenia, pancytopenia, and/or thrombocytopenia was rarely reported in patients taking antihistamines.^[Ref]

Cardiovascular

• Postmarketing reports: Chest discomfort, chest tightness, palpitation, tachycardia^[Ref]

Chest tightness may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Genitourinary

• Postmarketing reports: Dysuria, urinary retention^[Ref]

Dysuria and urinary retention may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Metabolic

• Postmarketing reports: Increased appetite, weight gain^[Ref]

Increased appetite and/or weight gain occurred in patients taking antihistamines.^[Ref]

Ocular

• Postmarketing reports: Visual disturbances^[Ref]

Visual disturbances may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Hypersensitivity

• Postmarketing reports: Hypersensitivity^[Ref]

Musculoskeletal

• Postmarketing reports: Chills^[Ref]

Chills may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

Endocrine

• Postmarketing reports: Early menses^[Ref]

Early menses may occur as a result of anticholinergic effects associated with antihistamines.^[Ref]

See also:

Further information

Doxylamine/pyridoxine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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