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DESLORATADINE

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Desloratadine Adverse Events Reported to the FDA Over Time

How are Desloratadine adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Desloratadine, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Desloratadine is flagged as the suspect drug causing the adverse event.

Most Common Desloratadine Adverse Events Reported to the FDA

What are the most common Desloratadine adverse events reported to the FDA?

Nausea
57 (1.37%)
Dyspnoea
54 (1.3%)
Condition Aggravated
47 (1.13%)
Vomiting
44 (1.06%)
Tachycardia
43 (1.03%)
Fatigue
38 (.91%)
Headache
38 (.91%)
Cytolytic Hepatitis
37 (.89%)
Dizziness
37 (.89%)
Loss Of Consciousness
37 (.89%)
Pruritus
35 (.84%)
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Hallucination
34 (.82%)
Pyrexia
34 (.82%)
Somnolence
34 (.82%)
Fall
32 (.77%)
Urticaria
31 (.75%)
Drug Ineffective
30 (.72%)
Hypersensitivity
29 (.7%)
Insomnia
29 (.7%)
Toxic Skin Eruption
29 (.7%)
Malaise
27 (.65%)
Agitation
26 (.63%)
Feeling Abnormal
26 (.63%)
Angioedema
25 (.6%)
Abdominal Pain
24 (.58%)
Cholestasis
23 (.55%)
Palpitations
23 (.55%)
Blood Pressure Increased
22 (.53%)
Psychomotor Hyperactivity
22 (.53%)
Epilepsy
21 (.5%)
Hypotension
21 (.5%)
Arrhythmia
20 (.48%)
Aspartate Aminotransferase Increase...
20 (.48%)
Asthenia
20 (.48%)
Diarrhoea
20 (.48%)
Drug Exposure During Pregnancy
20 (.48%)
Rash
20 (.48%)
Alanine Aminotransferase Increased
19 (.46%)
Anaemia
19 (.46%)
Confusional State
19 (.46%)
Dry Mouth
19 (.46%)
Erythema
19 (.46%)
Hallucination, Visual
19 (.46%)
Myalgia
19 (.46%)
Anxiety
18 (.43%)
Aggression
17 (.41%)
Electrocardiogram Qt Prolonged
17 (.41%)
Asthma
16 (.38%)
Depression
16 (.38%)
Drug Hypersensitivity
16 (.38%)
Drug Rash With Eosinophilia And Sys...
16 (.38%)
General Physical Health Deteriorati...
16 (.38%)
Hyperhidrosis
16 (.38%)
Pharyngeal Oedema
16 (.38%)
Swelling Face
16 (.38%)
Thrombocytopenia
16 (.38%)
Balance Disorder
15 (.36%)
Deep Vein Thrombosis
15 (.36%)
Hepatitis
15 (.36%)
Oedema Peripheral
15 (.36%)
Stevens-johnson Syndrome
15 (.36%)
Syncope
15 (.36%)
Abdominal Pain Upper
14 (.34%)
Convulsion
14 (.34%)
Drug Interaction
14 (.34%)
Hypertension
14 (.34%)
Inflammation
14 (.34%)
Neutropenia
14 (.34%)
Rash Erythematous
14 (.34%)
Suicide Attempt
14 (.34%)
Tinnitus
14 (.34%)
Chest Pain
13 (.31%)
Face Oedema
13 (.31%)
Hepatitis Cholestatic
13 (.31%)
Maternal Drugs Affecting Foetus
13 (.31%)
Vertigo
13 (.31%)
Dyskinesia
12 (.29%)
Hypoaesthesia
12 (.29%)
Speech Disorder
12 (.29%)
Cough
11 (.26%)
Delusion
11 (.26%)
Gait Disturbance
11 (.26%)
International Normalised Ratio Incr...
11 (.26%)
Pain In Extremity
11 (.26%)
Rhinitis
11 (.26%)
Staphylococcal Sepsis
11 (.26%)
Arthralgia
10 (.24%)
Cardiac Arrest
10 (.24%)
Epistaxis
10 (.24%)
Leukopenia
10 (.24%)
Lichenoid Keratosis
10 (.24%)
Mydriasis
10 (.24%)
Pain
10 (.24%)
Paraesthesia
10 (.24%)
Product Quality Issue
10 (.24%)
Prurigo
10 (.24%)
Purpura
10 (.24%)
Renal Failure
10 (.24%)
Bradycardia
9 (.22%)
Bronchospasm
9 (.22%)
Cyanosis
9 (.22%)

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This graph shows the top adverse events submitted to the FDA for Desloratadine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Desloratadine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Desloratadine

What are the most common Desloratadine adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Desloratadine, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Desloratadine is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Desloratadine According to Those Reporting Adverse Events

Why are people taking Desloratadine, according to those reporting adverse events to the FDA?

Product Used For Unknown Indication
173
Drug Use For Unknown Indication
173
Hypersensitivity
170
Rhinitis Allergic
147
Urticaria
79
Seasonal Allergy
72
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Asthma
58
Pruritus
55
Rhinitis
48
Premedication
43
Rash
30
Nasopharyngitis
19
Cough
17
Sinusitis
17
Rhinitis Seasonal
17
Multiple Allergies
15
Dermatitis Allergic
14
Nasal Congestion
13
Prophylaxis
10
Antiallergic Therapy
9
Urticaria Chronic
9
Eczema
9
Suicide Attempt
7
Angina Pectoris
7
Ill-defined Disorder
7
Allergic Cough
7
Chronic Sinusitis
6
Ear Congestion
5
Nasal Polyps
5
Influenza
5
Allergy Prophylaxis
5
Solar Urticaria
5
Pruritus Generalised
5
Photosensitivity Reaction
4
Unevaluable Event
4
Rhinitis Perennial
4
Pharyngitis
4
Sleep Apnoea Syndrome
4
House Dust Allergy
4
Dermatitis
3
Conjunctivitis
3
Pregnancy
3
Allergic Respiratory Disease
3
Allergic Sinusitis
3
Throat Irritation
3
Rash Pruritic
3
Erythema
3
Prurigo
3
Dermatitis Atopic
3
Tympanic Membrane Disorder
3
Urticaria Thermal
3

Drug Labels

LabelLabelerEffective
Clarinex-d 12 HourSchering Plough Corporation30-DEC-09
Clarinex-d 12 HourPhysicians Total Care, Inc.30-DEC-09
Clarinex-d 24 HourSchering Plough Corporation30-DEC-09
Clarinex-d 24 HourMerck Sharp & Dohme Corp.30-DEC-09
Clarinex-d 24 HourPhysiciains Total Care, Inc.30-DEC-09
ClarinexRebel Distributors Corp23-SEP-10
DesloratadineDr. Reddy's Laboratories Limited25-APR-11
ClarinexSchering Corporation26-OCT-11
Clarinex ReditabsSchering Corporation26-OCT-11
DesloratadineMylan Pharmaceuticals Inc.02-FEB-12
DesloratadineVirtus Pharmaceuticals25-JUN-12
Desloratadine AvKARE, Inc.05-JUL-12
DesloratadineSun Pharmaceutical Industries Limited 08-AUG-12
DesloratadineNorthstar Rx LLC25-SEP-12
DesloratadineBelcher Pharmaceuticals,LLC31-DEC-12
DesloratadineMylan Pharmaceuticals Inc.02-APR-13

Desloratadine Case Reports

What Desloratadine safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Desloratadine. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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