Get emergency medical help if you have any of these signs of an allergic reaction to Dazit: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
fast, pounding, or uneven heartbeat;
fever, flu symptoms;
seizure (convulsions); or
jaundice (yellowing of the skin or eyes).
Less serious Dazit side effects may include:
dry mouth, sore throat, cough;
drowsiness, tired feeling;
nausea, diarrhea; or
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.
Side effects of Dazit in details
A side effect of any drug can be defined as the unwanted or undesired effect produced by the drug. The side effect can be major or in few medications minor that can be ignored. Side effects not only vary from drug to drug, but it also depends on the dose of the drug, the individual sensitivity of the person, brand or company which manufactures it. If side effects overweigh the actual effect of the medicine, it may be difficult to convince the patient to take the drug. Few patients get specific side effects to specific drugs; in that case, a doctor replaces the drug with another. If you feel any side effect and it troubles you, do not forget to share with your healthcare practitioner.
The following adverse reactions are discussed in greater detail in other sections of the label:
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
Adults and Adolescents
Allergic Rhinitis: In multiple-dose placebo-controlled trials, 2834 patients ages 12 years or older received Dazit tablets at doses of 2.5 mg to 20 mg daily, of whom 1655 patients received the recommended daily dose of 5 mg. In patients receiving 5 mg daily, the rate of adverse events was similar between Dazit and placebo-treated patients. The percent of patients who withdrew prematurely due to adverse events was 2.4% in the Dazit group and 2.6% in the placebo group. There were no serious adverse events in these trials in patients receiving Dazit. All adverse events that were reported by greater than or equal to 2% of patients who received the recommended daily dose of Dazit tablets (5 mg once daily), and that were more common with Dazit tablets than placebo, are listed in Table 1.
The frequency and magnitude of laboratory and electrocardiographic abnormalities were similar in Dazit and placebo-treated patients.
There were no differences in adverse events for subgroups of patients as defined by gender, age, or race.
Chronic Idiopathic Urticaria: In multiple-dose, placebo-controlled trials of chronic idiopathic urticaria, 211 patients ages 12 years or older received Dazit tablets and 205 received placebo. Adverse events that were reported by greater than or equal to 2% of patients who received Dazit tablets and that were more common with Dazit than placebo were (rates for Dazit and placebo, respectively): headache (14%, 13%), nausea (5%, 2%), fatigue (5%, 1%), dizziness (4%, 3%), pharyngitis (3%, 2%), dyspepsia (3%, 1%), and myalgia (3%, 1%).
Two hundred and forty-six pediatric subjects 6 months to 11 years of age received Dazit
Oral Solution for 15 days in three placebo-controlled clinical trials. Pediatric subjects aged 6 to 11 years received 2.5 mg once a day, subjects aged 1 to 5 years received 1.25 mg once a day, and subjects 6 to 11 months of age received 1.0 mg once a day.
In subjects 6 to 11 years of age, no individual adverse event was reported by 2 percent or more of the subjects.
In subjects 2 to 5 years of age, adverse events reported for Dazit and placebo in at least 2 percent of subjects receiving Dazit
Oral Solution and at a frequency greater than placebo were fever (5.5%, 5.4%), urinary tract infection (3.6%, 0%) and varicella (3.6%, 0%).
In subjects 12 months to 23 months of age, adverse events reported for the Dazit product and placebo in at least 2 percent of subjects receiving Dazit
Oral Solution and at a frequency greater than placebo were fever (16.9%, 12.9%), diarrhea (15.4%, 11.3%), upper respiratory tract infections (10.8%, 9.7%), coughing (10.8%, 6.5%), appetite increased (3.1%, 1.6%), emotional lability (3.1%, 0%), epistaxis (3.1%, 0%), parasitic infection (3.1%, 0%), pharyngitis (3.1%, 0%), rash maculopapular (3.1%, 0%).
In subjects 6 months to 11 months of age, adverse events reported for Dazit and placebo in at least 2 percent of subjects receiving Dazit
Oral Solution and at a frequency greater than placebo were upper respiratory tract infections (21.2%, 12.9%), diarrhea (19.7%, 8.1%), fever (12.1%, 1.6%), irritability (12.1%, 11.3%), coughing (10.6%, 9.7%), somnolence (9.1%, 8.1%), bronchitis (6.1%, 0%), otitis media (6.1%, 1.6%), vomiting (6.1%, 3.2%), anorexia (4.5%, 1.6%), pharyngitis (4.5%, 1.6%), insomnia (4.5%, 0%), rhinorrhea (4.5%, 3.2%), erythema (3.0%, 1.6%), and nausea (3.0%, 0%).
There were no clinically meaningful changes in any electrocardiographic parameter, including the QTc interval. Only one of the 246 pediatric subjects receiving Dazit
Oral Solution in the clinical trials discontinued treatment because of an adverse event.
Because adverse events are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following spontaneous adverse events have been reported during the marketing of Dazit: tachycardia, palpitations, rare cases of hypersensitivity reactions (such as rash, pruritus, urticaria, edema, dyspnea, and anaphylaxis), psychomotor hyperactivity, movement disorders (including dystonia, tics, and extrapyramidal symptoms), seizures, and elevated liver enzymes including bilirubin, and very rarely, hepatitis.
What is the most important information I should know about Dazit?
Dazit orally disintegrating tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Dazit orally disintegrating tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Do not change your dose or take Dazit orally disintegrating tablets more often than prescribed without checking with your doctor. Drowsiness may occur if you take more of Dazit orally disintegrating tablets than prescribed.
Some of these products contain phenylalanine. If you must have a diet that is low in phenylalanine, ask your pharmacist if it is in your product.
Dazit orally disintegrating tablets may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Dazit orally disintegrating tablets for a few days before the tests.
Dazit orally disintegrating tablets should be used with extreme caution in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of taking Dazit orally disintegrating tablets while you are pregnant. Dazit orally disintegrating tablets is found in breast milk. Do not breast-feed while taking Dazit orally disintegrating tablets.
Contraindication can be described as a special circumstance or a disease or a condition wherein you are not supposed to use the drug or undergo particular treatment as it can harm the patient; at times, it can be dangerous and life threatening as well. When a procedure should not be combined with other procedure or when a medicine cannot be taken with another medicine, it is called Relative contraindication. Contraindications should be taken seriously as they are based on the relative clinical experience of health care providers or from proven research findings.
You should not take this medication if you are allergic to Dazit or to loratadine (Claritin).
Before taking Dazit, tell your doctor if you are allergic to any drugs, or if you have liver or kidney disease.
Do not give this medication to a child younger than 2 years old without the advice of a doctor.
Dazit disintegrating tablets (Dazit RediTabs) may contain phenylalanine. Talk to your doctor before using this form of Dazit if you have phenylketonuria (PKU).
DailyMed. "DESLORATADINE: 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).
DTP/NCI. "Descarboethoxyoratidine: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
European Chemicals Agency - ECHA. "13-chloro-2-(piperidin-4-ylidene)-4-azatricyclo[188.8.131.52³,⁸]pentadeca-1(15),3,5,7,11,13-hexaene: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).
The results of a survey conducted on ndrugs.com for Dazit 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 Dazit. 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.
2 consumers reported side effects
Did you experience side effects while taking Dazit drug? According to the report by ndrugs.com, the below mentioned statistics discuss the number of people who experienced side effects after taking Dazit drug. Every drug produces at least minor unwanted effects, which we call side effects. The side effects can be bothersome, or they can be minor so patients do not know they are experiencing them. The side effects of the drug depend on the individual, severity of disease, symptom, and associated conditions in the patient. The most deciding factor is the drug dosage. The higher the dosage, the higher the therapeutic result, and the more side effects. Every patient need not have the same intensity of side effect. When the side effects are greater, immediately consult your health care provider.
No side effects
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