Zyrtec-D 12 Hour Side Effects

Please note - some side effects for Zyrtec-D 12 Hour may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).

Side Effects of Zyrtec-D 12 Hour - for the Consumer

Zyrtec-D 12 Hour

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Zyrtec-D 12 Hour:

Dizziness; drowsiness; dry mouth; fatigue; headache; nausea; nervousness; sore throat; trouble sleeping.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); dark urine; difficulty urinating; mental or mood changes; persistent tiredness; seizures; sleeplessness; uncontrolled shaking or tremor; unusually fast/irregular heart rhythm; weakness; yellowing of the eyes or skin.

Zyrtec-D 12 Hour Side Effects - for the Professional

Zyrtec-D 12 Hour

Zyrtec-D 12 Hour Extended Release Tablets

In two double-blind, placebo-controlled trials (n=2094) in which 701 patients with seasonal allergic rhinitis were treated with Zyrtec-D 12 Hour Extended Release 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 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 group are listed in Table 1.

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.

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.

Side Effects by Body System

Dermatologic

Dermatologic side effects have included maculopapular and urticarial eruptions.

Gastrointestinal

Gastrointestinal side effects of cetirizine have included dry mouth (5.7%) and nausea or vomiting (2.2%). Pharyngitis, dyspepsia, and increased appetite have occasionally been reported.

Gastrointestinal adverse effects of pseudoephedrine have included anorexia and gastric irritation (5%). Dry mouth, nose, or throat have occurred in up to 15% of patients.

Hepatic

Hepatic side effects have included rare liver function test abnormalities which resolved spontaneously following discontinuation of cetirizine therapy.

Nervous system

Cetirizine appears to be more sedating than terfenadine, astemizole, and loratadine.

Nervous system side effects of cetirizine administration have included headache (16%), fatigue (5.6%), and somnolence (5% to 20%). Somnolence tends to be dose-related and generally occurs more frequently with doses higher than 10 mg per day. Other nervous system side effects include dizziness (1.8%), insomnia (1.5%), and nervousness (1.1%). Post marketing reports have included aggression reaction and convulsions.

Nervous system side effects of pseudoephedrine have included insomnia in up to 30% of patients. Tremor, anxiety, nervousness, and headache have also been reported.

Respiratory

Respiratory side effects have included wheezing, coughing, bronchitis, sinusitis, and asthma.

Hypersensitivity

Hypersensitivity reactions have included fixed drug eruptions with pseudoephedrine use.

Cardiovascular

Cardiovascular side effects have included tachycardia. Some patients have developed hypertension and/or arrhythmias.

General

General side effects have included epistaxis (1.1%) and accidental injury (1.1%).

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