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Relpax Adverse Events Reported to the FDA Over Time

How are Relpax adverse event reports trending over time?

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

Most Common Relpax Adverse Events Reported to the FDA

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

Migraine
182 (4.03%)
Headache
178 (3.94%)
Drug Ineffective
172 (3.81%)
Nausea
76 (1.68%)
Vomiting
68 (1.51%)
Dizziness
60 (1.33%)
Feeling Abnormal
58 (1.29%)
Dyspnoea
53 (1.17%)
Chest Discomfort
47 (1.04%)
Chest Pain
47 (1.04%)
Drug Interaction
41 (.91%)
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Fatigue
38 (.84%)
Loss Of Consciousness
38 (.84%)
Drug Dependence
37 (.82%)
Pain
37 (.82%)
Hypoaesthesia
36 (.8%)
Throat Tightness
34 (.75%)
Depression
33 (.73%)
Malaise
33 (.73%)
Asthenia
32 (.71%)
Pain In Extremity
31 (.69%)
Somnolence
31 (.69%)
Drug Exposure During Pregnancy
30 (.66%)
Myocardial Infarction
30 (.66%)
Cerebrovascular Accident
27 (.6%)
Confusional State
27 (.6%)
Convulsion
26 (.58%)
Anxiety
25 (.55%)
Condition Aggravated
25 (.55%)
Neck Pain
25 (.55%)
Paraesthesia
25 (.55%)
Urticaria
24 (.53%)
Weight Increased
24 (.53%)
Fall
23 (.51%)
Hypersensitivity
22 (.49%)
Intentional Drug Misuse
22 (.49%)
Palpitations
22 (.49%)
Back Pain
21 (.47%)
Blindness Transient
21 (.47%)
Hypertension
21 (.47%)
Hyperacusis
20 (.44%)
Speech Disorder
20 (.44%)
Arthralgia
19 (.42%)
Muscle Tightness
19 (.42%)
Rash
19 (.42%)
Syncope
19 (.42%)
Amnesia
18 (.4%)
Swelling Face
18 (.4%)
Deafness Transitory
17 (.38%)
Disorientation
17 (.38%)
Insomnia
17 (.38%)
Musculoskeletal Stiffness
17 (.38%)
Vision Blurred
17 (.38%)
Drug Abuse
16 (.35%)
Tachycardia
16 (.35%)
Abortion Spontaneous
15 (.33%)
Cardiac Arrest
15 (.33%)
Diarrhoea
15 (.33%)
Drug Abuser
15 (.33%)
Myalgia
15 (.33%)
Abdominal Pain Upper
14 (.31%)
Heart Rate Increased
14 (.31%)
Overdose
14 (.31%)
Photophobia
14 (.31%)
Angioedema
13 (.29%)
Blood Pressure Increased
13 (.29%)
Erythema
13 (.29%)
Agitation
12 (.27%)
Drug Effect Decreased
12 (.27%)
Muscle Spasms
12 (.27%)
Nasopharyngitis
12 (.27%)
Pharyngeal Oedema
12 (.27%)
Pulmonary Embolism
12 (.27%)
Stress
12 (.27%)
Abdominal Discomfort
11 (.24%)
Abdominal Pain
11 (.24%)
Asthma
11 (.24%)
Depressed Level Of Consciousness
11 (.24%)
Dystonia
11 (.24%)
Hyperhidrosis
11 (.24%)
Nervousness
11 (.24%)
Pain In Jaw
11 (.24%)
Serotonin Syndrome
11 (.24%)
Abnormal Behaviour
10 (.22%)
Balance Disorder
10 (.22%)
Disturbance In Attention
10 (.22%)
Memory Impairment
10 (.22%)
Pruritus
10 (.22%)
Surgery
10 (.22%)
Anaphylactic Reaction
9 (.2%)
Angiopathy
9 (.2%)
Colitis Ischaemic
9 (.2%)
Coma
9 (.2%)
Drug Withdrawal Syndrome
9 (.2%)
Dysphagia
9 (.2%)
Feeling Hot
9 (.2%)
Hypotension
9 (.2%)
Mental Disorder
9 (.2%)
Multiple Sclerosis
9 (.2%)
Oropharyngeal Pain
9 (.2%)
Pallor
9 (.2%)

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

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

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

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

Migraine
1234
Ill-defined Disorder
150
Headache
141
Product Used For Unknown Indication
32
Migraine Without Aura
22
Drug Use For Unknown Indication
16
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Migraine With Aura
9
Cluster Headache
7
Multiple Sclerosis
3
Migraine Prophylaxis
3
Cranial Neuropathy
2
Premenstrual Syndrome
2
Aura
2
Tinnitus
2
Stress
2
Pain
2
Influenza Like Illness
2
Prophylaxis
1
Hypersensitivity
1
Visual Impairment
1
Drug Exposure During Pregnancy
1
Premedication
1
Tension Headache
1
Restless Legs Syndrome
1
Intentional Drug Misuse
1
Off Label Use
1
Back Pain
1
Nausea
1
Horners Syndrome
1
Benign Intracranial Hypertension
1

Drug Labels

LabelLabelerEffective
RelpaxU.S. Pharmaceuticals19-JAN-10
RelpaxRebel Distributors Corp27-DEC-10
RelpaxPhysicians Total Care, Inc.01-JUN-12
RelpaxSTAT Rx USA LLC13-AUG-12
RelpaxRoerig25-FEB-13

Relpax Case Reports

What Relpax 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 Relpax. 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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