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DRAMAMINE

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Dramamine Adverse Events Reported to the FDA Over Time

How are Dramamine adverse event reports trending over time?

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

Most Common Dramamine Adverse Events Reported to the FDA

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

Drug Ineffective
99 (5.82%)
Dizziness
73 (4.29%)
Overdose
51 (3%)
Hallucination
50 (2.94%)
Completed Suicide
38 (2.23%)
Somnolence
35 (2.06%)
Nausea
28 (1.65%)
Feeling Abnormal
27 (1.59%)
Intentional Overdose
25 (1.47%)
Vomiting
24 (1.41%)
Malaise
22 (1.29%)
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Headache
21 (1.23%)
Incorrect Dose Administered
21 (1.23%)
Convulsion
19 (1.12%)
Drug Exposure During Pregnancy
19 (1.12%)
Intentional Drug Misuse
19 (1.12%)
Fall
18 (1.06%)
Abnormal Behaviour
16 (.94%)
Drug Toxicity
16 (.94%)
Hallucination, Visual
16 (.94%)
Dysarthria
15 (.88%)
Hyperhidrosis
15 (.88%)
Hypersensitivity
15 (.88%)
Loss Of Consciousness
15 (.88%)
Vertigo
14 (.82%)
Fatigue
13 (.76%)
Asthenia
12 (.71%)
Respiratory Arrest
12 (.71%)
Cardiac Arrest
11 (.65%)
Dyspnoea
11 (.65%)
Psychotic Disorder
11 (.65%)
Cardio-respiratory Arrest
10 (.59%)
Depression
10 (.59%)
Hypertension
10 (.59%)
Muscle Twitching
10 (.59%)
Nervousness
10 (.59%)
Syncope
10 (.59%)
Tremor
10 (.59%)
Vision Blurred
10 (.59%)
Alcohol Use
9 (.53%)
Drug Hypersensitivity
9 (.53%)
Drug Interaction
9 (.53%)
Euphoric Mood
9 (.53%)
Heart Rate Increased
9 (.53%)
Hypotension
9 (.53%)
Medication Error
9 (.53%)
Amnesia
8 (.47%)
Condition Aggravated
8 (.47%)
Death
8 (.47%)
Depressed Level Of Consciousness
8 (.47%)
Gait Disturbance
8 (.47%)
Insomnia
8 (.47%)
Multiple Drug Overdose Intentional
8 (.47%)
Speech Disorder
8 (.47%)
Diplopia
7 (.41%)
Drug Effect Decreased
7 (.41%)
Abdominal Discomfort
6 (.35%)
Abdominal Pain
6 (.35%)
Contusion
6 (.35%)
Diarrhoea
6 (.35%)
Disorientation
6 (.35%)
Hot Flush
6 (.35%)
Mydriasis
6 (.35%)
Accidental Exposure
5 (.29%)
Aggression
5 (.29%)
Blood Pressure Increased
5 (.29%)
Dry Mouth
5 (.29%)
Erectile Dysfunction
5 (.29%)
Eye Rolling
5 (.29%)
Intentional Self-injury
5 (.29%)
Memory Impairment
5 (.29%)
Movement Disorder
5 (.29%)
Pain
5 (.29%)
Pain In Extremity
5 (.29%)
Palpitations
5 (.29%)
Pyrexia
5 (.29%)
Road Traffic Accident
5 (.29%)
Weight Decreased
5 (.29%)
Abdominal Pain Upper
4 (.24%)
Anaemia
4 (.24%)
Anxiety
4 (.24%)
Balance Disorder
4 (.24%)
Bladder Neoplasm
4 (.24%)
Blood Creatinine Increased
4 (.24%)
Blood Glucose Decreased
4 (.24%)
Blood Testosterone Decreased
4 (.24%)
Central Nervous System Lesion
4 (.24%)
Clavicle Fracture
4 (.24%)
Confusional State
4 (.24%)
Cystic Lymphangioma
4 (.24%)
Delirium
4 (.24%)
Drug Abuse
4 (.24%)
Drug Abuser
4 (.24%)
Heart Rate Decreased
4 (.24%)
Inappropriate Schedule Of Drug Admi...
4 (.24%)
Incoherent
4 (.24%)
Irritability
4 (.24%)
Lethargy
4 (.24%)
Mental Status Changes
4 (.24%)
Oedema Peripheral
4 (.24%)
Orthostatic Hypotension
4 (.24%)

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

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

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

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

Dizziness
373
Vertigo
263
Drug Use For Unknown Indication
153
Product Used For Unknown Indication
123
Nausea
91
Motion Sickness
72
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Euphoric Mood
43
Menieres Disease
20
Balance Disorder
13
Intentional Overdose
8
Vomiting
8
Inner Ear Disorder
8
Akathisia
8
Intentional Misuse
8
Accidental Exposure
6
Overdose
6
Hypersensitivity
6
Tinnitus
6
Headache
6
Drug Exposure During Pregnancy
5
Migraine
5
Prophylaxis
5
Muscle Relaxant Therapy
4
Antiallergic Therapy
4
Sleep Disorder
4
Premedication
4
Sinusitis
4
Vertigo Positional
4
Accidental Overdose
4
Antiemetic Supportive Care
3
Pain
3
Suicide Attempt
3
Labyrinthitis
3
Drug Therapy
3
Multiple Sclerosis
3
Pneumonia
2
Diabetes Mellitus
2
Insomnia
2
Hypertension
2
Ear Disorder
2
Acoustic Neuroma
2
Autoimmune Disorder
2
Supplementation Therapy
2
Dependence
2
Malaise
2
Hallucination
2
Brain Injury
2
Cerebrovascular Accident
2
Drug Abuse
2
Drug Abuser
1
Traumatic Brain Injury
1

Drug Labels

LabelLabelerEffective
Dramamine Less DrowsyMedtech Products Inc.29-AUG-11
Dramamine OrangeMedtech Products Inc.13-APR-12
Dramamine For KidsMedtech Products Inc.13-APR-12
Dramamine Original FormulaMedtech Products Inc.13-APR-12
Dramamine Chewable FormulaMcNeil Consumer Healthcare Div McNeil-PPC, Inc30-APR-12
Dramamine Original FormulaMcNeil Consumer Healthcare Div McNeil-PPC, Inc30-APR-12
Dramamine Less Drowsy FormulaMcNeil Consumer Healthcare Div McNeil-PPC, Inc30-APR-12
DramamineLil' Drug Store Products, Inc.28-DEC-12

Dramamine Case Reports

What Dramamine 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 Dramamine. 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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