Zyrtec Side Effects

Generic Name: cetirizine

Please note - some side effects for Zyrtec 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 - for the Consumer

Zyrtec

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:

Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of eyes or skin.

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 Chewable Tablets

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 Chewable Tablets:

Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of eyes or skin.

Zyrtec Syrup

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 Syrup:

Drowsiness; dry mouth; stomach pain (in children); tiredness; trouble sleeping (in children).

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; unusual hoarseness); dark urine; fainting; fast or irregular heartbeat; mental or mood changes; persistent fatigue; seizures; severe dizziness; unusual bruising or bleeding; yellowing of eyes or skin.

Zyrtec Side Effects - for the Professional

Zyrtec

Controlled and uncontrolled clinical trials conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving Zyrtec 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 Zyrtec were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving Zyrtec 5 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 Zyrtec than placebo was somnolence. The incidence of somnolence associated with Zyrtec was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for Zyrtec were uncommon (1.0% on Zyrtec 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 1 lists adverse experiences in patients aged 12 years and older which were reported for Zyrtec 5 and 10 mg in controlled clinical trials in the United States and that were more common with Zyrtec than placebo.

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

Pediatric studies were also conducted with Zyrtec. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Zyrtec at doses of 1.25 to 10 mg per day were included in controlled and uncontrolled clinical trials conducted in the United States. The duration of treatment ranged from 2 to 12 weeks. Placebo-controlled trials up to 4 weeks duration included 168 pediatric patients aged 2 to 5 years who received cetirizine, the majority of whom received single daily doses of 5 mg. A placebo-controlled trial 18 months in duration included 399 patients aged 12 to 24 months treated with cetirizine (0.25 mg/kg bid), and another placebo-controlled trial of 7 days duration included 42 patients aged 6 to 11 months who were treated with cetirizine (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Zyrtec were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in pediatric patients receiving up to 10 mg of Zyrtec was uncommon (0.4% on Zyrtec vs. 1.0% on placebo).

Table 2 lists adverse experiences which were reported for Zyrtec 5 and 10 mg in pediatric patients aged 6 to 11 years in placebo-controlled clinical trials in the United States and were more common with Zyrtec than placebo. Of these, abdominal pain was considered treatment-related and somnolence appeared to be dose-related, 1.3% in placebo, 1.9% at 5 mg and 4.2% at 10 mg. The adverse experiences reported in pediatric patients aged 2 to 5 years in placebo-controlled trials were qualitatively similar in nature and generally similar in frequency to those reported in trials with children aged 6 to 11 years.

In the placebo-controlled trials of pediatric patients 6 to 24 months of age, the incidences of adverse experiences were similar in the cetirizine and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received cetirizine and patients who received placebo. In a study of 1 week duration in children 6–11 months of age, patients who received cetirizine exhibited greater irritability/fussiness than patients on placebo. In a study of 18 months duration in patients 12 months and older, insomnia occurred more frequently in patients who received cetirizine compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of cetirizine as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

The following events were observed infrequently (less than 2%), in either 3982 adults and children 12 years and older or in 659 pediatric patients aged 6 to 11 years who received Zyrtec in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Zyrtec 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 Zyrtec has been reported.

Post-Marketing Experience

In the post-marketing period, the following additional rare, but potentially severe adverse events have been reported: aggressive reaction, anaphylaxis, cholestasis, convulsions, glomerulonephritis, hallucinations, hemolytic anemia, hepatitis, orofacial dyskinesia, severe hypotension, stillbirth, suicidal ideation, suicide and thrombocytopenia.

Side Effects by Body System

Nervous system

Nervous system side effects 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.

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

Gastrointestinal

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

Hepatic

Hepatic side effects have included rare liver function test abnormalities which resolved spontaneously following discontinuation of cetirizine therapy. At least one case of recurrent acute hepatitis has also been associated with cetirizine use.

Respiratory

Respiratory side effects have included relatively rare reports of wheezing, coughing, bronchitis, sinusitis, and asthma.

Dermatologic

Dermatologic side effects have included reports of maculopapular and urticarial eruptions. Fixed drug eruptions have also been associated with cetirizine.

General

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

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.