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Zyrtec (Cetirizine Hydrochloride) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

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.

Table 1. Adverse Experiences Reported in Patients Aged 12 Years and Older in Placebo-Controlled United States ZYRTEC Trials (Maximum Dose of 10 mg) at Rates of 2% or Greater (Percent Incidence)
Adverse
Experience
ZYRTEC
(N=2034)
Placebo
(N=1612)
Somnolence13.76.3
Fatigue  5.92.6
Dry Mouth  5.02.3
Pharyngitis  2.01.9
Dizziness  2.01.2

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.

Table 2. Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States ZYRTEC Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg ZYRTEC Group, and More Frequently Than in the Placebo Group
ZYRTEC
Adverse ExperiencesPlacebo
(N=309)
5 mg
(N=161)
10 mg
(N=215)
Headache12.3%11.0%14.0%
Pharyngitis  2.9%  6.2%  2.8%
Abdominal pain  1.9%  4.4%  5.6%
Coughing  3.9%  4.4%  2.8%
Somnolence  1.3%  1.9%  4.2%
Diarrhea  1.3%  3.1%  1.9%
Epistaxis  2.9%  3.7%  1.9%
Bronchospasm  1.9%  3.1%  1.9%
Nausea  1.9%  1.9%  2.8%
Vomiting  1.0%  2.5%   2.3%

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.



REPORTS OF SUSPECTED ZYRTEC SIDE EFFECTS / ADVERSE REACTIONS

Below is a sample of reports where side effects / adverse reactions may be related to Zyrtec. The information is not vetted and should not be considered as verified clinical evidence.

Possible Zyrtec side effects / adverse reactions in 18 year old female

Reported by a health professional (non-physician/pharmacist) from Poland on 2011-10-05

Patient: 18 year old female

Reactions: Metabolic Acidosis, Intentional Overdose, Hypotension, Coma, Hypokalaemia, Convulsion, Heart Rate Decreased, Respiratory Failure, Ventricular Tachycardia, Completed Suicide, Ventricular Fibrillation, Cardiac Arrest

Adverse event resulted in: death, hospitalization

Suspect drug(s):
Zyrtec

Zyrtec
    Dosage: 270 mg, 7 tabs
    Indication: Rhinitis Allergic
    Start date: 2003-05-01
    End date: 2003-05-01

Cetirizine HCL
    Dosage: daily dose qty: 200 mg
    Indication: Rhinitis Allergic
    End date: 2003-05-01



Possible Zyrtec side effects / adverse reactions in 86 year old male

Reported by a consumer/non-health professional from United States on 2011-10-10

Patient: 86 year old male

Reactions: Anxiety, Dependence, Insomnia

Suspect drug(s):
Zyrtec
    Dosage: reduced to 1/2 a tablet per day
    Administration route: Oral

Zyrtec
    Administration route: Oral
    Indication: Pruritus

Zyrtec
    Administration route: Oral

Zyrtec
    Dosage: reduced to 1/2 a tablet per day
    Administration route: Oral

Other drugs received by patient: Warfarin Sodium; Hypertension Medications



Possible Zyrtec side effects / adverse reactions in 55 year old female

Reported by a consumer/non-health professional from United States on 2011-10-12

Patient: 55 year old female

Reactions: Memory Impairment, Cardiac Disorder

Suspect drug(s):
Valsartan
    Dosage: 160 mg , 1 d, oral
    Administration route: Oral
    Indication: Hypertension
    Start date: 2002-01-01

Bupropion HCL
    Dosage: 300 mg, 1 d, oral
    Administration route: Oral
    Indication: Depression

Ventolin
    Dosage: 90 mcg, 2 hr
    Indication: Asthma

Gabapentin
    Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
    Administration route: Oral
    Indication: Fibromyalgia
    Start date: 2004-01-01

Gabapentin
    Dosage: 6 dosage forms (2 dosage forms, 3 in 1 d), oral
    Administration route: Oral
    Indication: Diabetic Neuropathy
    Start date: 2004-01-01

Vicodin
    Dosage: 4 hr, oral
    Administration route: Oral
    Indication: Arthralgia
    Start date: 2006-01-01

Metformin Hydrodchloride/sitagliptin (Metformin and Sitagliptin)
    Dosage: 1 d, oral
    Administration route: Oral
    Indication: Diabetes Mellitus

Klonopin
    Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
    Administration route: Oral
    Indication: Anxiety

Klonopin
    Dosage: 1 mg (0.5 mg, 2 in 1 d),oral
    Administration route: Oral
    Indication: Panic Attack

Prilosec
    Dosage: 40 mg (20 mg, 2 in d, oral
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Epipen
    Dosage: transdermal
    Indication: Hypersensitivity

Imiprex (Imipraminoxide Hydrochloride)
    Dosage: 100 mg, as required, oral
    Administration route: Oral
    Indication: Migraine

Nitroglycerin
    Dosage: 0.4 mg, as required, other
    Indication: Chest Pain

Flovent
    Dosage: 220 mcg (110 mcg, 2 in 1 d)
    Indication: Asthma

Simvastatin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zyrtec
    Dosage: 10 mg (10 mg, 1 in 1 d),oral
    Administration route: Oral
    Indication: Hypersensitivity
    Start date: 2009-01-01

Lozol
    Dosage: 1.25 mg, 1 d, oral
    Administration route: Oral
    Indication: Fluid Retention
    Start date: 2002-01-01

Carafate
    Dosage: 2 gm (1 gm, 2 in 1 d),oral
    Administration route: Oral
    Indication: Gastrooesophageal Reflux Disease

Flonase
    Dosage: 500 mcg, 1 d), nasal
    Indication: Hypersensitivity

Multivitamin
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Zanaflex
    Dosage: 4 mg (2 mg, 2 in 1 d), oral
    Administration route: Oral
    Indication: Muscle Spasms
    Start date: 2009-01-01

Lortab
    Dosage: oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication

Metofrmin (Metformin)
    Dosage: 500 mg, 1 in d, oral
    Administration route: Oral
    Indication: Diabetes Mellitus

Aggrenox
    Dosage: 2 in 1 d, oral
    Administration route: Oral
    Indication: Product Used FOR Unknown Indication
    Start date: 2009-12-01



See index of all Zyrtec side effect reports >>

Drug label data at the top of this Page last updated: 2006-10-06

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