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EXCEDRIN

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Excedrin Adverse Events Reported to the FDA Over Time

How are Excedrin adverse event reports trending over time?

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

Most Common Excedrin Adverse Events Reported to the FDA

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

Completed Suicide
1499 (4.6%)
Drug Toxicity
689 (2.11%)
Drug Ineffective
655 (2.01%)
Overdose
541 (1.66%)
Cardiac Arrest
500 (1.53%)
Death
500 (1.53%)
Cardio-respiratory Arrest
452 (1.39%)
Respiratory Arrest
428 (1.31%)
Vomiting
384 (1.18%)
Drug Dependence
382 (1.17%)
Nausea
360 (1.1%)
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Dizziness
356 (1.09%)
Intentional Drug Misuse
329 (1.01%)
Headache
311 (.95%)
Dyspnoea
294 (.9%)
Incorrect Drug Administration Durat...
275 (.84%)
Underdose
250 (.77%)
Loss Of Consciousness
242 (.74%)
Off Label Use
237 (.73%)
Somnolence
231 (.71%)
Intentional Overdose
228 (.7%)
Convulsion
226 (.69%)
Insomnia
224 (.69%)
Medication Error
212 (.65%)
Feeling Abnormal
210 (.64%)
Malaise
207 (.64%)
Abdominal Pain Upper
197 (.6%)
Heart Rate Increased
197 (.6%)
Multiple Drug Overdose
184 (.56%)
Hypertension
181 (.56%)
Hypotension
177 (.54%)
Incorrect Dose Administered
168 (.52%)
Fatigue
163 (.5%)
Tachycardia
162 (.5%)
Drug Abuse
161 (.49%)
Pain
159 (.49%)
Blood Pressure Increased
157 (.48%)
Poisoning
154 (.47%)
Tremor
150 (.46%)
Multiple Drug Overdose Intentional
149 (.46%)
Hypersensitivity
146 (.45%)
Diarrhoea
141 (.43%)
Chest Pain
138 (.42%)
Suicide Attempt
137 (.42%)
Asthenia
115 (.35%)
Rash
114 (.35%)
Coma
113 (.35%)
Drug Abuser
113 (.35%)
Drug Interaction
110 (.34%)
Pruritus
109 (.33%)
Unresponsive To Stimuli
108 (.33%)
Fall
105 (.32%)
Palpitations
105 (.32%)
Urticaria
105 (.32%)
Anxiety
104 (.32%)
Confusional State
104 (.32%)
Drug Administration Error
102 (.31%)
Pulmonary Oedema
102 (.31%)
Agitation
101 (.31%)
Hyperhidrosis
101 (.31%)
Accidental Overdose
99 (.3%)
Pyrexia
96 (.29%)
Hypoaesthesia
93 (.29%)
Drug Screen Positive
90 (.28%)
Swelling Face
90 (.28%)
Hallucination
89 (.27%)
Cerebrovascular Accident
86 (.26%)
Depression
86 (.26%)
Abdominal Discomfort
80 (.25%)
Aspartate Aminotransferase Increase...
80 (.25%)
Myocardial Infarction
78 (.24%)
Alanine Aminotransferase Increased
77 (.24%)
Condition Aggravated
77 (.24%)
Oedema Peripheral
75 (.23%)
Dysphagia
74 (.23%)
Pain In Extremity
74 (.23%)
Blood Glucose Increased
72 (.22%)
Dehydration
72 (.22%)
Delirium
72 (.22%)
Drug Exposure During Pregnancy
72 (.22%)
Pneumonia
72 (.22%)
Therapeutic Response Unexpected
72 (.22%)
Blood Pressure Decreased
71 (.22%)
Dyspepsia
71 (.22%)
Muscle Spasms
71 (.22%)
Nervousness
71 (.22%)
Rhabdomyolysis
70 (.21%)
Vision Blurred
70 (.21%)
Toxic Anterior Segment Syndrome
69 (.21%)
Accidental Drug Intake By Child
68 (.21%)
Back Pain
68 (.21%)
Erythema
68 (.21%)
Mydriasis
67 (.21%)
Migraine
66 (.2%)
Drug Hypersensitivity
65 (.2%)
Syncope
63 (.19%)
Abdominal Pain
62 (.19%)
Gait Disturbance
62 (.19%)
Road Traffic Accident
61 (.19%)
Amnesia
60 (.18%)
Hepatic Failure
60 (.18%)

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

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

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

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

Headache
1577
Drug Use For Unknown Indication
1348
Product Used For Unknown Indication
1160
Migraine
1065
Premedication
924
Suicide Attempt
459
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Pain
318
Nasopharyngitis
250
Hypersensitivity
247
Insomnia
219
Prophylaxis
208
Nasal Congestion
179
Back Pain
130
Pruritus
120
Arthritis
107
Sinus Headache
90
Cough
88
Ill-defined Disorder
84
Preoperative Care
82
Sleep Disorder
77
Arthralgia
67
Intentional Overdose
65
Sinus Disorder
63
Hypotension
62
Seasonal Allergy
55
Multiple Allergies
54
Mydriasis
54
Sinus Congestion
54
Influenza
53
Accidental Exposure
52
Sinusitis
52
Completed Suicide
49
Rash
49
Upper Respiratory Tract Infection
43
Cataract Operation
42
Rhinitis
41
Toothache
38
Tension Headache
33
Sleep Disorder Therapy
31
Urticaria
26
Rhinorrhoea
25
Rhinitis Allergic
24
Hyperemesis Gravidarum
23
Nausea
22
Ophthalmological Examination
21
Allergy Prophylaxis
19
Neck Pain
19
Pyrexia
18
Nasal Decongestion Therapy
17
Chemotherapy
17
Analgesic Therapy
16

Drug Labels

LabelLabelerEffective
Excedrinmenstrual CompleteNovartis Consumer Health, Inc.28-OCT-09
Excedrin Extra StrengthLil' Drug Store Products, Inc.02-JAN-13

Excedrin Case Reports

What Excedrin 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 Excedrin. 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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