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Zofran Adverse Events Reported to the FDA Over Time

How are Zofran adverse event reports trending over time?

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

Most Common Zofran Adverse Events Reported to the FDA

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

Drug Exposure During Pregnancy
282 (4.07%)
Nausea
212 (3.06%)
Vomiting
203 (2.93%)
Drug Ineffective
201 (2.9%)
Death
117 (1.69%)
Dehydration
86 (1.24%)
Malaise
80 (1.15%)
Headache
78 (1.13%)
Abdominal Pain
76 (1.1%)
Constipation
68 (.98%)
Dyspnoea
64 (.92%)
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Pyrexia
60 (.87%)
Diarrhoea
55 (.79%)
Dizziness
53 (.76%)
Pruritus
52 (.75%)
Convulsion
45 (.65%)
Erythema
45 (.65%)
Asthenia
43 (.62%)
Drug Interaction
42 (.61%)
Hypotension
40 (.58%)
Weight Decreased
39 (.56%)
Dyskinesia
37 (.53%)
Anxiety
33 (.48%)
Fatigue
33 (.48%)
Hypersensitivity
33 (.48%)
Pneumonia
33 (.48%)
Rash
31 (.45%)
Dystonia
30 (.43%)
Somnolence
30 (.43%)
Chest Pain
28 (.4%)
Disease Progression
27 (.39%)
Extrapyramidal Disorder
27 (.39%)
Hypoaesthesia
26 (.38%)
Loss Of Consciousness
26 (.38%)
Urticaria
26 (.38%)
Anaemia
25 (.36%)
Pain
25 (.36%)
Tremor
25 (.36%)
Chills
24 (.35%)
Dysgeusia
24 (.35%)
Febrile Neutropenia
24 (.35%)
Hyperhidrosis
23 (.33%)
Medication Error
23 (.33%)
Cognitive Disorder
22 (.32%)
Live Birth
22 (.32%)
Neutropenia
22 (.32%)
Off Label Use
21 (.3%)
Vertigo
21 (.3%)
Agitation
20 (.29%)
Atrial Fibrillation
20 (.29%)
Migraine
20 (.29%)
Renal Failure Acute
20 (.29%)
Vision Blurred
20 (.29%)
Bradycardia
19 (.27%)
Cardiac Arrest
19 (.27%)
Leukopenia
19 (.27%)
White Blood Cell Count Decreased
19 (.27%)
Blood Bilirubin Increased
18 (.26%)
Burning Sensation
18 (.26%)
Depressed Level Of Consciousness
18 (.26%)
Paraesthesia
18 (.26%)
Rash Erythematous
18 (.26%)
Tachycardia
18 (.26%)
Abdominal Distension
17 (.25%)
Abdominal Pain Upper
17 (.25%)
Coma
17 (.25%)
Condition Aggravated
17 (.25%)
Drug Administration Error
17 (.25%)
Drug Toxicity
17 (.25%)
Hepatic Enzyme Increased
17 (.25%)
Muscle Spasms
17 (.25%)
Syncope
17 (.25%)
Abnormal Behaviour
16 (.23%)
Depression
16 (.23%)
Dysphagia
16 (.23%)
Feeling Abnormal
16 (.23%)
General Physical Health Deteriorati...
16 (.23%)
Neoplasm Malignant
16 (.23%)
Rash Papular
16 (.23%)
Sepsis
16 (.23%)
Shock
16 (.23%)
Ventricular Tachycardia
16 (.23%)
Adverse Event
15 (.22%)
Alanine Aminotransferase Increased
15 (.22%)
Haemoglobin Decreased
15 (.22%)
Insomnia
15 (.22%)
Malignant Neoplasm Progression
15 (.22%)
Neonatal Respiratory Distress Syndr...
15 (.22%)
Premature Baby
15 (.22%)
Abortion Spontaneous
14 (.2%)
Blindness Transient
14 (.2%)
Cholestasis
14 (.2%)
Confusional State
14 (.2%)
Deafness Unilateral
14 (.2%)
Hypoglycaemia Neonatal
14 (.2%)
Hypoxia
14 (.2%)
Intra-uterine Death
14 (.2%)
Rash Pruritic
14 (.2%)
Therapeutic Response Unexpected
14 (.2%)
Aspartate Aminotransferase Increase...
13 (.19%)
Blood Pressure Decreased
13 (.19%)

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

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

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

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

Nausea
2283
Drug Use For Unknown Indication
845
Product Used For Unknown Indication
665
Vomiting
612
Prophylaxis Of Nausea And Vomiting
494
Premedication
491
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Prophylaxis
171
Antiemetic Supportive Care
122
Hyperemesis Gravidarum
60
Ill-defined Disorder
35
Chemotherapy
22
Gastrooesophageal Reflux Disease
19
Pain
17
Migraine
16
Vomiting In Pregnancy
15
Procedural Nausea
14
Breast Cancer
11
Prophylactic Chemotherapy
11
Gastrointestinal Disorder
10
Drug Withdrawal Syndrome
10
Crohns Disease
9
Post Procedural Nausea
9
Cyclic Vomiting Syndrome
9
Foetal Exposure During Pregnancy
9
Gastroenteritis
7
Unevaluable Event
6
Acute Lymphocytic Leukaemia
6
Abdominal Pain
6
Drug Exposure During Pregnancy
6
Impaired Gastric Emptying
6
Diarrhoea
5
Abdominal Discomfort
5
Influenza Like Illness
5
Oesophageal Neoplasm
4
Headache
4
Cholecystectomy
4
Neoplasm Malignant
4
Schizophrenia
4
Thermal Burn
4
Pregnancy
4
Gastric Disorder
4
Dizziness
4
Chronic Lymphocytic Leukaemia
4
Brain Neoplasm
3
Colonoscopy
3
Allergy Prophylaxis
3
Procedural Vomiting
3
Diffuse Large B-cell Lymphoma
3
Vomiting Projectile
3
Colon Cancer
3
Cranial Nerve Disorder
3

Drug Labels

LabelLabelerEffective
ZofranCardinal Health04-AUG-11
ZofranodtGlaxoSmithKline LLC14-SEP-11
ZofranGlaxoSmithKline LLC14-SEP-11
ZofranREMEDYREPACK INC. 19-DEC-11
ZofranGlaxoSmithKline LLC14-NOV-12

Zofran Case Reports

What Zofran 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 Zofran. 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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