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FEXOFENADINE

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Fexofenadine Adverse Events Reported to the FDA Over Time

How are Fexofenadine adverse event reports trending over time?

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

Most Common Fexofenadine Adverse Events Reported to the FDA

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

Drug Ineffective
136 (1.92%)
Dizziness
114 (1.61%)
Malaise
106 (1.49%)
Completed Suicide
88 (1.24%)
Loss Of Consciousness
88 (1.24%)
Dyspnoea
82 (1.16%)
Hepatic Function Abnormal
82 (1.16%)
Nausea
80 (1.13%)
Vomiting
79 (1.11%)
Jaundice
73 (1.03%)
Headache
72 (1.01%)
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Urticaria
71 (1%)
Alanine Aminotransferase Increased
69 (.97%)
Aspartate Aminotransferase Increase...
65 (.92%)
Rash
65 (.92%)
Liver Disorder
57 (.8%)
Pruritus
57 (.8%)
Palpitations
55 (.77%)
Convulsion
54 (.76%)
Medication Residue
54 (.76%)
Insomnia
53 (.75%)
Hypersensitivity
50 (.7%)
Condition Aggravated
47 (.66%)
Abdominal Pain
44 (.62%)
Hypoaesthesia
44 (.62%)
Fatigue
43 (.61%)
Hallucination
42 (.59%)
Platelet Count Decreased
41 (.58%)
Pyrexia
41 (.58%)
Drug Interaction
40 (.56%)
Fall
39 (.55%)
Syncope
39 (.55%)
Tachycardia
38 (.54%)
Feeling Abnormal
37 (.52%)
Hypertension
37 (.52%)
Asthenia
36 (.51%)
Chest Discomfort
36 (.51%)
Diarrhoea
36 (.51%)
Abdominal Pain Upper
35 (.49%)
Electrocardiogram Qt Prolonged
35 (.49%)
Atrial Fibrillation
33 (.46%)
Heart Rate Increased
33 (.46%)
Swelling Face
33 (.46%)
Chest Pain
32 (.45%)
Therapeutic Response Unexpected Wit...
32 (.45%)
Pneumonia
31 (.44%)
Somnolence
31 (.44%)
Blood Pressure Increased
29 (.41%)
Hypotension
28 (.39%)
Overdose
28 (.39%)
Weight Decreased
28 (.39%)
Abdominal Discomfort
27 (.38%)
Anxiety
27 (.38%)
Back Pain
27 (.38%)
Off Label Use
27 (.38%)
Paraesthesia
27 (.38%)
Anaemia
25 (.35%)
Blood Bilirubin Increased
25 (.35%)
Drug Toxicity
25 (.35%)
Nervousness
25 (.35%)
Myocardial Infarction
24 (.34%)
Cerebrovascular Accident
23 (.32%)
Cough
23 (.32%)
Dry Mouth
23 (.32%)
Gamma-glutamyltransferase Increased
23 (.32%)
Hepatitis Fulminant
23 (.32%)
Product Quality Issue
23 (.32%)
Product Substitution Issue
23 (.32%)
Urinary Incontinence
23 (.32%)
Blood Alkaline Phosphatase Increase...
22 (.31%)
Drug Exposure During Pregnancy
22 (.31%)
White Blood Cell Count Decreased
22 (.31%)
Angioedema
21 (.3%)
Asthma
21 (.3%)
Depression
21 (.3%)
Pain
21 (.3%)
Agitation
20 (.28%)
Decreased Appetite
20 (.28%)
Disorientation
20 (.28%)
Drug Hypersensitivity
19 (.27%)
Erythema
19 (.27%)
Gait Disturbance
19 (.27%)
Oedema Peripheral
19 (.27%)
Vertigo
19 (.27%)
Abdominal Distension
18 (.25%)
Abnormal Behaviour
18 (.25%)
Blindness
18 (.25%)
Dysgeusia
18 (.25%)
Medication Error
18 (.25%)
Nasopharyngitis
18 (.25%)
Urinary Retention
18 (.25%)
Cardiac Arrest
17 (.24%)
Cystitis Interstitial
17 (.24%)
Sinusitis
17 (.24%)
Weight Increased
17 (.24%)
Blood Creatine Phosphokinase Increa...
16 (.23%)
Confusional State
16 (.23%)
Dyspepsia
16 (.23%)
Dysphagia
16 (.23%)
Flushing
16 (.23%)
Hepatitis
16 (.23%)

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

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

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

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

Hypersensitivity
1671
Drug Use For Unknown Indication
861
Product Used For Unknown Indication
704
Seasonal Allergy
680
Multiple Allergies
661
Rhinitis Allergic
352
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Urticaria
181
Pruritus
148
Asthma
119
Sinus Disorder
87
Rash
80
Sinusitis
78
Prophylaxis
75
Rhinitis
66
Premedication
64
Eczema
49
Allergic Sinusitis
34
Nasal Congestion
32
Sinus Congestion
32
Antiallergic Therapy
30
Urticaria Chronic
24
Chronic Sinusitis
21
Dermatitis
21
Dermatitis Atopic
20
Dermatitis Allergic
19
Rhinitis Seasonal
17
Ill-defined Disorder
16
Diarrhoea
14
Nasopharyngitis
14
Conjunctivitis Allergic
12
Postnasal Drip
11
Upper Respiratory Tract Infection
11
Pruritus Generalised
11
Cough
10
Drug Eruption
10
Palmar-plantar Erythrodysaesthesia ...
10
Chronic Obstructive Pulmonary Disea...
9
Psoriasis
8
Angioedema
8
Acute Sinusitis
8
Headache
8
Suicide Attempt
8
Skin Disorder
7
Lacrimation Increased
7
Upper Respiratory Tract Inflammatio...
7
Dyspnoea
7
Pharyngitis
7
Menieres Disease
6
House Dust Allergy
5
Dermatitis Contact
5
Drug Hypersensitivity
5

Drug Labels

LabelLabelerEffective
Fexofenadine HydrochlorideBryant Ranch Prepack12-APR-06
AllegraSanofi-Synthelabo Limited15-DEC-08
Fexofenadine HydrochlorideMajor Pharmaceuticals11-SEP-09
Allegra D-12 HourPhysicians Total Care, Inc.08-DEC-09
Allegra D-12 Hoursanofi-aventis U.S. LLC08-DEC-09
Fexofenadine HydrochlorideAmerican Health Packaging08-DEC-09
Allegra--d 24 Hoursanofi-aventis U.S. LLC11-DEC-09
Fexofenadine HydrochloridePhysicians Total Care, Inc.22-JAN-10
Fexofenadine Hydrochloride And Pseudoephedrine HydrochloridePhysicians Total Care, Inc.22-JAN-10
Fexofenadine HydrochloridePD-Rx Pharmaceuticals, Inc.20-APR-10
Fexofenadine HydrochlorideMylan Pharmaceuticals Inc.20-APR-10
Fexofenadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs21-MAY-10
Fexofenadine HydrochlorideLake Erie Medical DBA Quality Care Products LLC07-JUN-10
Fexofenadine Hcl And Pseudoephedrine Hcl Dr.Reddy's Laboratories Limited16-JUN-10
Fexofenadine HydrochlorideUDL Laboratories, Inc.27-AUG-10
Fexofenadine HydrochlorideTEVA Pharmaceutical Industries Ltd.17-SEP-10
Fexofenadine HydrochlorideRebel Distributors Corp27-JAN-11
Fexofenadine Hydrochloride And Pseudoephedrine HydrochlorideBarr Laboratories Inc.15-FEB-11
Fexofenadine Hydrochloride And Pseudoephedrine HydrochlorideRebel Distributors Corp13-APR-11
Fexofenadine HydrochlorideDr. Reddy's Laboratories Limited25-APR-11
Fexofenadine HydrochloridePhysicians Total Care, Inc.25-APR-11
Fexofenadine Hcl And Pseudoephedrine HciDr.Reddy's Laboratories Limited25-MAY-11
Fexofenadine HydrochlorideMylan Pharmaceuticals Inc.05-JUN-11
Fexofenadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs14-JUN-11
Fexofenadine HydrochlorideUDL Laboratories Inc.15-JUL-11
Fexofenadine HydrochloridePerrigo New York Inc11-AUG-11
Fexofenadine HydrochlorideREMEDYREPACK INC. 22-AUG-11
Fexofenadine HydrochlorideREMEDYREPACK INC. 22-AUG-11
Fexofenadine HydrochloridePerrigo New York Inc08-NOV-11
Fexofenadine HydrochlorideSafeway09-NOV-11
Fexofenadine HydrochlorideWestern Family Foods Inc09-NOV-11
Sunmark Fexofenadine HydrochlorideMcKesson09-NOV-11
Fexofenadine HydrochlorideMajor Pharmaceuticals21-NOV-11
Members Mark FexofenadineSam's West Inc21-DEC-11
Fexofenadine HydrochlorideRebel Distributors Corp17-JAN-12
Fexofenadine HydrochlorideDispensing Solutions, Inc.03-FEB-12
Fexofenadine HydrochlorideDispensing Solutions, Inc.03-FEB-12
Sunmark Fexofenadine HydrochlorideMcKesson06-FEB-12
Fexofenadine HydrochlorideSun Pharmaceutical Industries Limited 07-FEB-12
Fexofenadine HydrochlorideSun Pharmaceutical Industries Limited 14-FEB-12
FexofenadineHyVee Inc24-FEB-12
Topcare Fexofenadine HydrochlorideTopco Associates LLC28-FEB-12
Fexofenadine HydrochlorideRebel Distributors Corp29-FEB-12
FexofenadineWockhardt USA LLC.05-MAR-12
Allegrasanofi-aventis U.S. LLC21-MAR-12
Health Mart Fexofenadine HydrochlorideMcKesson17-APR-12
Health Mart Fexofenadine HydrochlorideMcKesson18-APR-12
Fexofenadine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs26-APR-12
Fexofenodine HydrochlorideNCS HealthCare of KY, Inc dba Vangard Labs26-APR-12
FexofenadineWockhardt USA LLC.08-MAY-12
FexofenadineWockhardt Limited08-MAY-12
Fexofenadine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLC23-MAY-12
Fexofenadine HydrochlorideAphena Pharma Solutions - Tennessee, Inc.16-JUL-12
Fexofenadine HydrochlorideLake Erie Medical & Surgical Supply DBA Quality Care Products LLC08-AUG-12
Fexofenadine HydrochlorideMajor Pharmaceuticals09-AUG-12
Fexofenadine HclChain Drug Marketing Association29-AUG-12
Fexofenadine HclShopko Stores Operating Co., LLC.30-AUG-12
Fexofenadine HclChain Drug Consortium, LLC (Premier Value)17-SEP-12
Allegra--d 24 HourPhysicians Total Care, Inc.25-SEP-12
Topcare Fexofenadine HydrochlorideTopco Associates LLC09-OCT-12
Fexofenadine HclValu Merchandisers Company (Best Choice)15-NOV-12
Fexofenadine Hydrochloride St Marys Medical Park Pharmacy10-JAN-13
Fexofenadine HydrochlorideBryant Ranch Prepack18-JAN-13
Fexofenadine HclPreferred Plus (Kinray)21-MAR-13

Fexofenadine Case Reports

What Fexofenadine 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 Fexofenadine. 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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