What are the possible side effects of Tzine-X?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Dizziness.
- Feeling nervous and excitable.
- Not able to sleep.
- Feeling sleepy.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.
See also:
Cetirizine (Tzine-X)/Pseudoephedrine (Tzine-X) side effects (in more detail)
Side effects of Tzine-X in details
Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) Tablets
In two double-blind, placebo-controlled trials (n = 2094) in which 701 patients with seasonal allergic rhinitis were treated with Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) Tablets (Cetirizine (Tzine-X) hydrochloride 5 mg and Pseudoephedrine (Tzine-X) hydrochloride 120 mg) twice daily for two weeks, the percent of patients who withdrew prematurely due to adverse events was 2.0% in the Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) group, compared with 1.1% in the placebo group. All adverse events that were reported by greater than 1% of patients in the Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) group are listed in Table 1.
TABLE 1. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN SEASONAL ALLERGIC RHINITIS TRIALS OF Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) TABLETS AT RATES OF 1% OR GREATER (PERCENT INCIDENCE)
| ADVERSE EXPERIENCE | Tzine-X | 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 (Tzine-X) conducted in the United States and Canada included more than 6000 patients aged 12 years and older, with more than 3900 receiving Cetirizine (Tzine-X) 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 (Tzine-X) were mild or moderate. In placebo-controlled trials, the incidence of discontinuations due to adverse reactions in patients receiving Cetirizine (Tzine-X) 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 (Tzine-X) than placebo was somnolence. The incidence of somnolence associated with Cetirizine (Tzine-X) was dose related, 6% in placebo, 11% at 5 mg and 14% at 10 mg. Discontinuations due to somnolence for Cetirizine (Tzine-X) were uncommon (1.0% on Cetirizine (Tzine-X) 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 (Tzine-X) 5 and 10 mg in controlled clinical trials in the United States and were more common with Cetirizine (Tzine-X) than placebo.
TABLE 2. ADVERSE EXPERIENCES REPORTED IN PATIENTS AGED 12 YEARS AND OLDER IN PLACEBO-CONTROLLED UNITED STATES Cetirizine (Tzine-X) TRIALS (MAXIMUM DOSE OF 10 MG) AT RATES OF 2% OR GREATER (PERCENT INCIDENCE)
| ADVERSE EXPERIENCE | Cetirizine (Tzine-X) | 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 (Tzine-X) in U.S. trials, including an open study of six months duration. A causal relationship of these infrequent events with Cetirizine (Tzine-X) 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 (Tzine-X) therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Cetirizine (Tzine-X) 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 (Tzine-X) Hydrochloride
Pseudoephedrine (Tzine-X) 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.
What is the most important information I should know about Tzine-X?
- Tzine-X may cause dizziness or drowsiness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Tzine-X. Using Tzine-X alone, with certain other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks.
- Avoid drinking alcohol or taking other medicines that cause drowsiness (eg, sedatives, tranquilizers) while taking Tzine-X. Tzine-X will add to the effects of alcohol and other depressants. Ask your pharmacist if you have questions about which medicines are depressants.
- If you have trouble sleeping, ask your doctor or pharmacist about the best time to take Tzine-X.
- Tzine-X may interfere with allergy test results. Check with your doctor for more information.
- Diabetes patients - Tzine-X may affect your blood sugar level. Your doctor may need to change the amount of diabetes medicine you are taking.
- Use Tzine-X with caution in the ELDERLY because they may be more sensitive to its effects, especially drowsiness.
- Tzine-X is not recommended for use in children younger than 12 years of age. Safety and effectiveness in the age group have not been confirmed.
- PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Tzine-X during pregnancy. Tzine-X is excreted in breast milk. Do not breast-feed while taking Tzine-X.
Tzine-X contraindications
Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) Tablets are contraindicated in patients with a known hypersensitivity to any of its ingredients or to hydroxyzine.
Due to its Pseudoephedrine (Tzine-X) component, Tzine-X (Cetirizine (Tzine-X), Pseudoephedrine (Tzine-X)) Tablets are contraindicated in patients with narrow-angle glaucoma or urinary retention, and in patients receiving monoamine oxidase (MAO) inhibitor therapy or within fourteen (14) days of stopping such treatment. It is also contraindicated in patients with severe hypertension, or severe coronary artery disease, and in those who have shown hypersensitivity or idiosyncrasy to its components, to adrenergic agents, or to other drugs of similar chemical structures. Manifestations of patient idiosyncrasy to adrenergic agents include insomnia, dizziness, weakness, tremor, or arrhythmias.
References
- DailyMed. "PSEUDOEPHEDRINE SULFATE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "DEXTROMETHORPHAN HYDROBROMIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
Reviews
The results of a survey conducted on ndrugs.com for Tzine-X are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Tzine-X. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.User reports
Consumer reported side effects
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Information checked by Dr. Sachin Kumar, MD Pharmacology
