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CLARITIN

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Claritin Adverse Events Reported to the FDA Over Time

How are Claritin adverse event reports trending over time?

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

Most Common Claritin Adverse Events Reported to the FDA

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

Drug Ineffective
261 (2.23%)
Dizziness
186 (1.59%)
Dyspnoea
160 (1.37%)
Loss Of Consciousness
146 (1.25%)
Overdose
146 (1.25%)
Insomnia
142 (1.21%)
Completed Suicide
141 (1.2%)
Drug Toxicity
141 (1.2%)
Convulsion
133 (1.14%)
Nausea
128 (1.09%)
Vomiting
126 (1.08%)
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Somnolence
124 (1.06%)
Headache
120 (1.03%)
Feeling Abnormal
106 (.91%)
Hypersensitivity
96 (.82%)
Palpitations
96 (.82%)
Death
89 (.76%)
Hallucination
84 (.72%)
No Therapeutic Response
84 (.72%)
Heart Rate Increased
83 (.71%)
Malaise
81 (.69%)
Rash
80 (.68%)
Blood Pressure Increased
74 (.63%)
Tremor
74 (.63%)
Condition Aggravated
73 (.62%)
Chest Pain
72 (.62%)
Fatigue
72 (.62%)
Pyrexia
72 (.62%)
Anxiety
69 (.59%)
Drug Hypersensitivity
69 (.59%)
Asthenia
67 (.57%)
Tachycardia
65 (.56%)
Pruritus
64 (.55%)
Dry Mouth
59 (.5%)
Drug Interaction
57 (.49%)
Cardiac Arrest
56 (.48%)
Crying
53 (.45%)
Diarrhoea
51 (.44%)
Hypertension
49 (.42%)
Aspartate Aminotransferase Increase...
48 (.41%)
Alanine Aminotransferase Increased
47 (.4%)
Fall
47 (.4%)
Cardio-respiratory Arrest
46 (.39%)
Urticaria
46 (.39%)
Accidental Overdose
45 (.38%)
Hypoaesthesia
45 (.38%)
Hyperhidrosis
44 (.38%)
Medication Error
44 (.38%)
Lip Swelling
43 (.37%)
Asthma
42 (.36%)
Dysuria
42 (.36%)
Nervousness
41 (.35%)
Swollen Tongue
41 (.35%)
Arrhythmia
40 (.34%)
Confusional State
40 (.34%)
Depression
40 (.34%)
Liver Disorder
40 (.34%)
Pneumonia
40 (.34%)
Multiple Drug Overdose
39 (.33%)
Abdominal Pain Upper
38 (.32%)
Drug Effect Decreased
38 (.32%)
Dysgeusia
38 (.32%)
Oedema Peripheral
38 (.32%)
Paraesthesia
38 (.32%)
Respiratory Arrest
38 (.32%)
Swelling Face
38 (.32%)
Abnormal Behaviour
37 (.32%)
Sudden Infant Death Syndrome
37 (.32%)
Cough
36 (.31%)
Drug Exposure During Pregnancy
36 (.31%)
Muscle Spasms
36 (.31%)
Pain
36 (.31%)
Chills
35 (.3%)
Erythema
35 (.3%)
Pain In Extremity
35 (.3%)
Syncope
35 (.3%)
Tinnitus
35 (.3%)
Intentional Overdose
34 (.29%)
Psychomotor Hyperactivity
34 (.29%)
Urinary Retention
34 (.29%)
Accidental Drug Intake By Child
33 (.28%)
Hepatic Function Abnormal
33 (.28%)
Pharyngeal Oedema
33 (.28%)
Throat Tightness
33 (.28%)
Vision Blurred
33 (.28%)
Decreased Appetite
32 (.27%)
Hallucination, Visual
31 (.26%)
Irritability
31 (.26%)
Intentional Drug Misuse
30 (.26%)
Agitation
29 (.25%)
Gamma-glutamyltransferase Increased
29 (.25%)
Aggression
28 (.24%)
Anorexia
28 (.24%)
Chest Discomfort
28 (.24%)
Grand Mal Convulsion
28 (.24%)
Incorrect Dose Administered
28 (.24%)
Platelet Count Decreased
28 (.24%)
Blood Alkaline Phosphatase Increase...
27 (.23%)
Cerebrovascular Accident
27 (.23%)
Dehydration
27 (.23%)
Hypotension
27 (.23%)

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This graph shows the top adverse events submitted to the FDA for Claritin, 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 Claritin 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 Claritin

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

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This graph shows the top categories of adverse events submitted to the FDA for Claritin, 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 Claritin 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 Claritin According to Those Reporting Adverse Events

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

Hypersensitivity
1171
Product Used For Unknown Indication
743
Drug Use For Unknown Indication
714
Seasonal Allergy
578
Multiple Allergies
451
Rhinitis Allergic
307
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Nasopharyngitis
192
Rhinorrhoea
188
Nasal Congestion
180
Premedication
160
Sinus Disorder
157
Sneezing
138
Pruritus
135
Cough
118
Rhinitis
106
Sinusitis
86
Sinus Congestion
82
Lacrimation Increased
78
Asthma
77
Medical Observation
74
Prophylaxis
73
Urticaria
63
Eye Pruritus
60
Rash
48
Sinus Headache
43
Influenza
39
Ill-defined Disorder
34
Throat Irritation
33
Suicide Attempt
33
Upper Respiratory Tract Infection
33
Headache
27
Eczema
26
Postnasal Drip
23
Allergic Sinusitis
21
Dermatitis Atopic
21
Bronchitis
19
Accidental Exposure
17
Nasal Decongestion Therapy
15
Antiallergic Therapy
14
Rhinitis Seasonal
14
Oropharyngeal Pain
14
Respiratory Tract Congestion
13
Pain
12
Chronic Sinusitis
12
Intentional Overdose
11
Off Label Use
11
Allergy To Animal
9
Pyrexia
9
Ear Infection
9
Eczema Nummular
8
Upper-airway Cough Syndrome
8

Drug Labels

LabelLabelerEffective
Claritin ReditabsMSD Consumer Care, Inc.24-APR-12
Claritin ReditabsMSD Consumer Care, Inc.24-APR-12
Claritin Liqui-gelsMSD Consumer Care, Inc.14-JUL-12
ClaritinMSD Consumer Care, Inc.17-JUL-12
ClaritinMSD Consumer Care, Inc.17-JUL-12
Claritin-d 12 HourMSD Consumer Care, Inc.04-SEP-12
Claritin-d 24 HourMSD Consumer Care, Inc.04-SEP-12
ClaritinMSD Consumer Care, Inc.04-SEP-12
ClaritinMSD Consumer Care, Inc.14-MAR-13

Claritin Case Reports

What Claritin 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 Claritin. 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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