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REGLAN

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Reglan Adverse Events Reported to the FDA Over Time

How are Reglan adverse event reports trending over time?

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

Most Common Reglan Adverse Events Reported to the FDA

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

Tardive Dyskinesia
27315 (17.08%)
Extrapyramidal Disorder
22810 (14.26%)
Dystonia
14250 (8.91%)
Nervous System Disorder
10712 (6.7%)
Dyskinesia
4593 (2.87%)
Movement Disorder
4493 (2.81%)
Economic Problem
4273 (2.67%)
Pain
3694 (2.31%)
Incorrect Drug Administration Durat...
3454 (2.16%)
Activities Of Daily Living Impaired
3183 (1.99%)
Tremor
2935 (1.83%)
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Akathisia
2834 (1.77%)
Anxiety
2777 (1.74%)
Multiple Injuries
2660 (1.66%)
Deformity
2507 (1.57%)
Quality Of Life Decreased
2078 (1.3%)
Family Stress
1953 (1.22%)
Emotional Distress
1733 (1.08%)
Fear
1640 (1.03%)
Anhedonia
1589 (.99%)
Unevaluable Event
1446 (.9%)
Emotional Disorder
1393 (.87%)
Restless Legs Syndrome
1176 (.74%)
Visual Impairment
1138 (.71%)
Mental Disorder
1134 (.71%)
Injury
949 (.59%)
Asthenia
946 (.59%)
Depression
784 (.49%)
Parkinsonism
670 (.42%)
Depression Suicidal
668 (.42%)
Drug Interaction
597 (.37%)
Suicidal Ideation
577 (.36%)
Condition Aggravated
516 (.32%)
Metabolic Disorder
500 (.31%)
Neuropathy Peripheral
499 (.31%)
Impaired Work Ability
498 (.31%)
Overdose
467 (.29%)
Chorea
380 (.24%)
Excessive Eye Blinking
357 (.22%)
Grimacing
329 (.21%)
Nausea
322 (.2%)
Vomiting
264 (.17%)
Death
201 (.13%)
Headache
194 (.12%)
Gait Disturbance
190 (.12%)
Essential Tremor
188 (.12%)
Dyspnoea
186 (.12%)
Insomnia
185 (.12%)
Dysphagia
180 (.11%)
Dizziness
179 (.11%)
Muscle Spasms
171 (.11%)
Fatigue
168 (.11%)
Fall
166 (.1%)
Convulsion
161 (.1%)
Hypertension
159 (.1%)
Muscle Twitching
152 (.1%)
Back Pain
146 (.09%)
Restlessness
145 (.09%)
Confusional State
138 (.09%)
Diarrhoea
138 (.09%)
Weight Decreased
138 (.09%)
Speech Disorder
130 (.08%)
Gastrooesophageal Reflux Disease
126 (.08%)
Dysarthria
120 (.08%)
Abdominal Pain
119 (.07%)
Agitation
115 (.07%)
Hypoaesthesia
111 (.07%)
Myoclonus
111 (.07%)
Disability
105 (.07%)
Constipation
104 (.07%)
Dehydration
104 (.07%)
Somnolence
104 (.07%)
Pain In Extremity
103 (.06%)
Arthralgia
100 (.06%)
Drug Exposure During Pregnancy
100 (.06%)
Abdominal Distension
98 (.06%)
Feeling Abnormal
97 (.06%)
Nervousness
97 (.06%)
Paraesthesia
97 (.06%)
Balance Disorder
96 (.06%)
Hyperhidrosis
96 (.06%)
Bruxism
95 (.06%)
Partner Stress
95 (.06%)
Stereotypy
95 (.06%)
Hypotension
92 (.06%)
Drug Ineffective
89 (.06%)
Cardiac Arrest
88 (.06%)
Loss Of Consciousness
86 (.05%)
Chest Pain
83 (.05%)
Malaise
81 (.05%)
Neuroleptic Malignant Syndrome
80 (.05%)
Completed Suicide
79 (.05%)
Blood Pressure Increased
77 (.05%)
Impaired Gastric Emptying
77 (.05%)
Urinary Tract Infection
75 (.05%)
Abdominal Pain Upper
74 (.05%)
Gastritis
73 (.05%)
Dyspepsia
71 (.04%)
Memory Impairment
71 (.04%)
Musculoskeletal Stiffness
70 (.04%)
Decreased Appetite
69 (.04%)

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

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

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

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

Product Used For Unknown Indication
10702
Dyspepsia
4829
Abdominal Distension
4815
Nausea
1970
Drug Use For Unknown Indication
1277
Gastrooesophageal Reflux Disease
1047
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Gastrointestinal Disorder
933
Vomiting
663
Impaired Gastric Emptying
600
Gastric Disorder
257
Prophylaxis Of Nausea And Vomiting
244
Prophylaxis
172
Diabetic Gastroparesis
168
Antiemetic Supportive Care
168
Premedication
78
Abdominal Pain
74
Migraine
62
Gastritis
56
Abdominal Discomfort
54
Gastrointestinal Motility Disorder
53
Constipation
47
Ill-defined Disorder
44
Abdominal Pain Upper
42
Hiccups
41
Irritable Bowel Syndrome
35
Hiatus Hernia
33
Hypertension
31
Hyperemesis Gravidarum
24
Ulcer
22
Crohns Disease
22
Reflux Oesophagitis
21
Foetal Exposure During Pregnancy
20
Gastric Ulcer
20
Diabetes Mellitus
20
Headache
20
Gastroenteritis
18
Chemotherapy
18
Reflux Gastritis
17
Malaise
15
Dysphagia
15
Oesophagitis
14
Drug Exposure During Pregnancy
14
Gastritis Prophylaxis
13
Procedural Nausea
13
Diarrhoea
12
Vomiting In Pregnancy
11
Drug Withdrawal Syndrome
11
Decreased Appetite
11
Fabrys Disease
11
Gastrointestinal Hypomotility
10
Pain
10

Drug Labels

LabelLabelerEffective
ReglanGeneral Injectables & Vaccines, Inc23-AUG-10
ReglanSTAT RX USA LLC31-AUG-10
ReglanBaxter Healthcare Corporation18-NOV-10
ReglanUCB, Inc.25-MAR-11
ReglanANIP Acquisition Company12-SEP-12

Reglan Case Reports

What Reglan 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 Reglan. 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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