Zyrex Side effects

• Side effects of Zyrex in details
• Zyrex contraindications
• Zyrex reviews

What are the possible side effects of Zyrex?

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

Incidence not known

• Drowsiness
• relaxed and calm
• sleepiness or unusual drowsiness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Rare

• Acid or sour stomach
• belching
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• change or loss of taste
• feeling hot
• headache
• heartburn
• increased sweating
• indigestion
• stomach discomfort, upset, or pain

Incidence not known

• Bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also:

Zyrex side effects (in more detail)

Side effects of Zyrex in details

Pediatric studies were conducted with Zyrex. More than 1300 pediatric patients aged 6 to 11 years with more than 900 treated with Zyrex 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 Zyrex, 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 Zyrex (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 Zyrex (0.25 mg/kg bid).

The majority of adverse reactions reported in pediatric patients aged 2 to 11 years with Zyrex 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 Zyrex was uncommon (0.4% on Zyrex vs. 1.0% on placebo).

Table 1 lists adverse experiences which were reported for Zyrex 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 Zyrex 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 Zyrex and placebo treatment groups in each study. Somnolence occurred with essentially the same frequency in patients who received Zyrex and patients who received placebo. In a study of 1 week duration in children 6 to 11 months of age, patients who received Zyrex 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 Zyrex compared to patients who received placebo (9.0% v. 5.3%). In those patients who received 5 mg or more per day of Zyrex as compared to patients who received placebo, fatigue (3.6% v. 1.3%) and malaise (3.6% v. 1.8%) occurred more frequently.

Table 1.

Adverse Experiences Reported in Pediatric Patients Aged 6 to 11 Years in Placebo-Controlled United States Zyrex Trials (5 or 10 mg Dose) Which Occurred at a Frequency of ≥2% in Either the 5-mg or the 10-mg Zyrex Group, and More Frequently Than in the Placebo Group

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 Zyrex in U.S. trials, including an open adult study of six months duration. A causal relationship of these infrequent events with Zyrex 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 Zyrex therapy. Hepatitis with significant transaminase elevation and elevated bilirubin in association with the use of Zyrex has been reported.

Post-Marketing Experience

In the post-marketing experience 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.

What is the most important information I should know about Zyrex?

• Zyrex solution may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Zyrex solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Do not drink alcohol while you are using Zyrex solution.
• Check with your doctor before you use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Zyrex solution; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Zyrex solution may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Zyrex solution. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Zyrex solution may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Zyrex solution for a few days before the tests.
• Use Zyrex solution with caution in the ELDERLY; they may be more sensitive to its effects.
• Caution is advised when using Zyrex solution in CHILDREN; they may be more sensitive to its effects, especially stomach pain and trouble sleeping.
• PREGNANCY and BREAST-FEEDING: It is not known if Zyrex solution can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Zyrex solution while you are pregnant. Zyrex solution is found in breast milk. Do not breast-feed while taking Zyrex solution.

Zyrex contraindications

Tablet: Zyrex should not be used except under special circumstances for patients with hepatic and renal function impairment.

The risk-benefit should be considered when medical problems eg, bladder neck obstruction, prostatic hypertrophy, urinary retention and glaucoma exists.

Syrup: Hypersensitivity to Zyrex dihydrochloride, hydroxyzine, any piperazine derivatives or to any of the excipients of Zyrex. Patients with severe renal impairment CrCl <10 mL/min. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Zyrex.

References

1. DailyMed. "TERBUTALINE 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).
2. DailyMed. "GUAIFENESIN; HYDROCODONE BITARTRATE: 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).
3. 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

User reports

Consumer reviews

Information checked by Dr. Sachin Kumar, MD Pharmacology