"May 2, 2010 -- Manufacturing defects have led to the recall of 43 child and infant liquid formulations of Tylenol, Motrin, Zyrtec, and Benadryl by McNeil, a division of Johnson & Johnson.
No injuries or deaths have yet been reporte"...
Zyrtec Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Zyrtec (cetirizine hydrochloride) is an antihistamine that treats symptoms, such as itching, runny nose, watery eyes, and sneezing from hay fever (allergic rhinitis) and other allergies, such as allergies to molds and dust mites. It is available in generic form. Common side effects of Zyrtec include: drowsiness, fatigue, dizziness, dry mouth, sore throat, cough, nausea, constipation, or headache. In children, stomach pain and vomiting may occur.
Zyrtec is available as regular tablets and chewable tablets (5 mg and 10 mg) and syrup (1 mg/mL). It is available as an over-the-counter (OTC) drug, so no prescription is needed. Some patients reported the occurrence of sleepiness, or somnolence, when taking Zyrtec, so do not drive a car or operate potentially dangerous machinery. Combining Zyrtec with alcohol or other central nervous system (CNS) depressants should be avoided because additional reductions in alertness may occur. Zyrtec should be used during pregnancy only if clearly needed, and it is not recommended for nursing mothers.
Our Zyrtec (cetirizine hydrochloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
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.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Zyrtec in Detail - Patient Information: Side Effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have a serious side effect such as:
- fast, pounding, or uneven heartbeat;
- weakness, tremors (uncontrolled shaking), or sleep problems (insomnia);
- severe restless feeling, hyperactivity;
- problems with vision; or
- urinating less than usual or not at all.
Less serious side effects may include:
- dizziness, drowsiness;
- tired feeling;
- dry mouth;
- sore throat, cough;
- nausea, constipation; or
Read the entire detailed patient monograph for Zyrtec (Cetirizine)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Zyrtec Overview - Patient Information: Side Effects
If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: difficulty urinating, weakness.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Zyrtec (Cetirizine)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Zyrtec FDA Prescribing Information: Side Effects
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 (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 ZYRTEC (cetirizine) were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving ZYRTEC (cetirizine) 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 (cetirizine) than placebo was somnolence. The incidence of somnolence associated with ZYRTEC (cetirizine) was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for ZYRTEC (cetirizine) were uncommon (1.0% on ZYRTEC (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 1 lists adverse experiences in patients aged 12 years and older which were reported for ZYRTEC (cetirizine) 5 and 10 mg in controlled clinical trials in the United States and that were more common with ZYRTEC (cetirizine) than placebo.
Adverse Experiences Reported in Patients Aged 12 Years and Older in
Placebo-Controlled United States ZYRTEC (cetirizine) Trials (Maximum Dose of 10 mg)
at Rates of 2% or Greater (Percent Incidence)
|Adverse Experience|| ZYRTEC
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 (cetirizine) . More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with ZYRTEC (cetirizine) 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 (cetirizine) 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 (cetirizine) was uncommon (0.4% on ZYRTEC (cetirizine) vs. 1.0% on placebo).
Table 2 lists adverse experiences which were reported for ZYRTEC (cetirizine) 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 (cetirizine) 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.
Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States ZYRTEC (cetirizine) Trials (5 or 10 mg Dose) Which Occurred at a Frequency of =2% in Either the 5-mg or the 10-mg ZYRTEC (cetirizine) Group, and More Frequently< Than in the Placebo Group
|Adverse Experiences|| Placebo
| 5 mg
| 10 mg
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 (cetirizine) in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with ZYRTEC (cetirizine) administration has not been established.
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.
Psychiatric: abnormal thinking, agitation, amnesia, anxiety, decreased libido, depersonalization, depression, emotional lability, euphoria, impaired concentration, insomnia, nervousness, paroniria, sleep disorder.
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.
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 (cetirizine) has been reported.
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.
Drug Abuse And Dependence
There is no information to indicate that abuse or dependency occurs with ZYRTEC (cetirizine) .
Read the entire FDA prescribing information for Zyrtec (Cetirizine)
Additional Zyrtec Information
Zyrtec - User Reviews
Zyrtec User Reviews
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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