Note: This document contains side effect information about doxylamine / pyridoxine. Some dosage forms listed on this page may not apply to the brand name Diclegis.

Summary

Common side effects of Diclegis include: drowsiness. Continue reading for a comprehensive list of adverse effects.

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

Serious side effects of Diclegis

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:

Incidence not known

• Blurred or loss of vision
• burning feeling while urinating
• chest discomfort or tightness
• decrease in the frequency of urination
• decrease in urine volume
• difficult or labored breathing
• difficult or painful urination
• disturbed color perception
• double vision
• fast, irregular, pounding, or racing heartbeat or pulse
• fever
• halos around lights
• headache, severe and throbbing
• hives, itching, skin rash
• hoarseness
• irritation
• joint pain, stiffness, or swelling
• night blindness
• overbright appearance of lights
• redness of the skin
• stomach distension or pain
• swelling of the eyelids, face, lips, hands, or feet
• trouble breathing or swallowing
• tunnel vision

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

Other side effects of Diclegis

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:

More common

• Unusual drowsiness

Incidence not known

• Anxiety
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• confusion about identity, place, and time
• constipation
• diarrhea
• dizziness or lightheadedness
• feeling of constant movement of self or surroundings
• general feeling of discomfort or illness
• headache
• increased sweating
• irritability
• nightmares
• sensation of spinning
• trouble sleeping
• unusual tiredness or weakness

For Healthcare Professionals

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

General

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

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

Common (1% to 10%): Fatigue

Postmarketing reports: Acute labyrinthitis, malaise, tinnitus^[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

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

Postmarketing reports: Hyperhidrosis, maculopapular rash, pruritus, rash, sweating^[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

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

Postmarketing reports: Dysuria, urinary retention^[Ref]

Metabolic

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

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

Ocular

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

Postmarketing reports: Visual disturbances^[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]