Zyrtec-D

What Is Zyrtec-D?

Zyrtec-D (cetirizine and pseudoephedrine) is a combination of an antihistamine and a decongestant used to treat cold or allergy symptoms such as nasal and sinus congestion, sneezing, itching, watery eyes, or runny nose. Zyrtec-D is available over-the-counter (OTC) and in generic form.

What Are Side Effects of Zyrtec-D?

Side effects of Zyrtec-D include:

• dry mouth,
• dizziness,
• drowsiness,
• tiredness,
• nausea,
• stomach pain,
• constipation,
• ringing in your ears,
• headache,
• trouble sleeping, or
• problems with concentration.

Dosage for Zyrtec-D

The dose of Zyrtec-D for adults and children 12 years and over is 1 tablet every 12 hours; not more than 2 tablets in 24 hours.

What Drugs, Substances, or Supplements Interact with Zyrtec-D?

Zyrtec-D may interact with other medicines that make you sleepy (other cold or allergy medicines, narcotic pain medicines, sleeping pills, muscle relaxers, and medicines for seizures, depression, or anxiety), digoxin, blood pressure medications, diet pills, stimulants, or ADHD medications. Tell your doctor all medications and supplements you use.

Zyrtec-D During Pregnancy and Breastfeeding

It is not known whether cetirizine and pseudoephedrine is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Cetirizine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Consult your doctor before breastfeeding.

Additional Information

Our Zyrtec-D (cetirizine and pseudoephedrine) Side Effects Drug Center provides a comprehensive vie w of available drug information on the potential side effects when taking this medication.

 

Zyrtec-D Consumer Information

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

Stop using cetirizine and pseudoephedrine and call your doctor at once if you have:

• fast, pounding, or uneven heartbeat;
• weakness, tremors (uncontrolled shaking)
• severe restless feeling, hyperactivity, extreme feeling of fear or confusion;
• problems with vision;
• little or no urinating; or
• high blood pressure (severe headache, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats).

Common side effects may include:

• dizziness, drowsiness, tired feeling;
• sleep problems (insomnia);
• dry mouth, nausea, stomach pain, constipation; or
• trouble concentrating.

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.

Read the entire detailed patient monograph for Zyrtec-D (Cetirizine, Pseudoephedrine)

 

Zyrtec-D Professional Information

SIDE EFFECTS

ZYRTEC-D (cetirizine, pseudoephedrine) Tablets

In two double-blind, placebo-controlled trials (n = 2094) in which 701 patients with seasonal allergic rhinitis were treated with ZYRTEC-D (cetirizine, pseudoephedrine) Tablets (cetirizine hydrochloride 5 mg and pseudoephedrine hydrochloride 120 mg) twice daily for two weeks, the percent of patients who withdrew prematurely due to adverse events was 2.0% in the ZYRTEC-D (cetirizine, pseudoephedrine) group, compared with 1.1% in the placebo group. All adverse events that were reported by greater than 1% of patients in the ZYRTEC-D (cetirizine, pseudoephedrine) group are listed in Table 1.

TABLE 1. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN SEASONAL ALLERGIC RHINITIS TRIALS OF ZYRTEC-D (cetirizine, pseudoephedrine) TABLETS AT RATES OF 1% OR GREATER (PERCENT INCIDENCE)

ADVERSE EXPERIENCE	ZYRTEC-D	PLACEBO
	(n = 701)	(n = 696)
Insomnia	4.0	0.6
Dry Mouth	3.6	0.4
Fatigue	2.4	0.9
Somnolence	1.9	0.1
Pharyngitis	1.7	1.1
Epistaxis	1.1	0.9
Accidental Injury	1.1	0.4
Dizziness	1.1	0.1
Sinusitis	1.0	0.6

ZYRTEC Tablets

Controlled and uncontrolled clinical trials of cetirizine conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving cetirizine at doses of 5 to 20 mg per day. The duration of treatment ranged from 1 week to 6 months, with a mean exposure of 30 days.

Most adverse reactions reported during therapy with cetirizine were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving cetirizine 5 mg or 10 mg was not significantly different from placebo (2.9% vs. 2.4%, respectively).

The most common adverse reaction in patients aged 12 years and older that occurred more frequently on cetirizine than placebo was somnolence. The incidence of somnolence associated with cetirizine was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for cetirizine were uncommon (1.0% on cetirizine vs. 0.6% on placebo). Fatigue and dry mouth also appeared to be treatment-related adverse reactions. There were no differences by age, race, gender or by body weight with regard to the incidence of adverse reactions.

Table 2 lists adverse experiences in patients aged 12 years and older that were reported for cetirizine 5 and 10 mg in controlled clinical trials in the United States and were more common with cetirizine than placebo.

TABLE 2. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN PLACEBO-CONTROLLED UNITED STATES CETIRIZINE TRIALS (MAXIMUM DOSE OF 10 MG) AT RATES OF 2% OR GREATER (PERCENT INCIDENCE)

ADVERSE EXPERIENCE	CETIRIZINE	PLACEBO
	(n=2034)	(n=1612)
Somnolence	13.7	6.3
Fatigue	5.9	2.6
Dry Mouth	5.0	2.3
Pharyngitis	2.0	1.9
Dizziness	2.0	1.2

In addition, headache and nausea occurred in more than 2% of the patients, but were more common in placebo patients.

The following events were observed infrequently (less than 2%), in 3982 adults and children 12 years and older or in 659 pediatric (6 to 11 years) patients who received cetirizine in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with cetirizine administration has not been established.

Autonomic Nervous System: anorexia, flushing, increased salivation, urinary retention.

Cardiovascular: cardiac failure, hypertension, palpitation, tachycardia.

Central and Peripheral Nervous Systems: abnormal coordination, ataxia, confusion, dysphonia, hyperesthesia, hyperkinesia, hypertonia, hypoesthesia, leg cramps, migraine, myelitis, paralysis, paresthesia, ptosis, syncope, tremor, twitching, vertigo, visual field defect.

Gastrointestinal: abnormal hepatic function, aggravated tooth caries, constipation, dyspepsia, eructation, flatulence, gastritis, hemorrhoids, increased appetite, melena, rectal hemorrhage, stomatitis including ulcerative stomatitis, tongue discoloration, tongue edema.

Genitourinary: cystitis, dysuria, hematuria, micturition frequency, polyuria, urinary incontinence, urinary tract infection.

Hearing and Vestibular: deafness, earache, ototoxicity, tinnitus.

Metabolic/Nutritional: dehydration, diabetes mellitus, thirst.

Musculoskeletal: arthralgia, arthritis, arthrosis, muscle weakness, myalgia.

Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.

Respiratory System: bronchitis, dyspnea, hyperventilation, increased sputum, pneumonia, respiratory disorder, rhinitis, sinusitis, upper respiratory tract infection.

Reproductive: dysmenorrhea, female breast pain, intermenstrual bleeding, leukorrhea, menorrhagia, vaginitis.

Reticuloendothelial: lymphadenopathy.

Skin: acne, alopecia, angioedema, bullous eruption, dermatitis, dry skin, eczema, erythematous rash, furunculosis, hyperkeratosis, hypertrichosis, increased sweating, maculopapular rash, photosensitivity reaction, photosensitivity toxic reaction, pruritus, purpura, rash, seborrhea, skin disorder, skin nodule, urticaria.

Special Senses: parosmia, taste loss, taste perversion.

Vision: blindness, conjunctivitis, eye pain, glaucoma, loss of accommodation, ocular hemorrhage, xerophthalmia.

Body as a Whole: accidental injury, asthenia, back pain, chest pain, enlarged abdomen, face edema, fever, generalized edema, hot flashes, increased weight, leg edema, malaise, nasal polyp, pain, pallor, periorbital edema, peripheral edema, rigors.

Occasional instances of transient, reversible hepatic transaminase elevations have occurred during cetirizine therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of cetirizine has been reported.

In foreign marketing experience or experience in the post market period, the following additional rare, but potentially severe adverse events have been reported: anaphylaxis, cholestasis, glomerulonephritis, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, thrombocytopenia, aggressive reaction and convulsions.

Pseudoephedrine Hydrochloride

Pseudoephedrine hydrochloride may cause mild CNS stimulation in hypersensitive patients.

Nervousness, excitability, restlessness, dizziness, weakness, or insomnia may occur. Headache, nausea, drowsiness, tachycardia, palpitation, pressor activity, and cardiac arrhythmias have been reported. Sympathomimetic drugs have also been associated with other untoward effects such as fear, anxiety, tenseness, tremor, hallucinations, seizures, pallor, respiratory difficulty, dysuria, and cardiovascular collapse.

Read the entire FDA prescribing information for Zyrtec-D (Cetirizine, Pseudoephedrine)