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Elavil Adverse Events Reported to the FDA Over Time

How are Elavil adverse event reports trending over time?

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

Most Common Elavil Adverse Events Reported to the FDA

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

Completed Suicide
739 (3.4%)
Cardiac Arrest
392 (1.8%)
Respiratory Arrest
326 (1.5%)
Drug Toxicity
325 (1.5%)
Drug Interaction
315 (1.45%)
Cardio-respiratory Arrest
252 (1.16%)
Somnolence
246 (1.13%)
Overdose
244 (1.12%)
Multiple Drug Overdose
228 (1.05%)
Confusional State
225 (1.04%)
Suicide Attempt
196 (.9%)
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Death
182 (.84%)
Agitation
178 (.82%)
Loss Of Consciousness
178 (.82%)
Drug Ineffective
175 (.81%)
Coma
174 (.8%)
Intentional Overdose
164 (.76%)
Multiple Drug Overdose Intentional
157 (.72%)
Serotonin Syndrome
156 (.72%)
Convulsion
155 (.71%)
Vomiting
149 (.69%)
Pain
148 (.68%)
Hypotension
147 (.68%)
Dizziness
135 (.62%)
Fall
128 (.59%)
Depression
127 (.58%)
Headache
122 (.56%)
Tachycardia
122 (.56%)
Hallucination
121 (.56%)
Tremor
120 (.55%)
Insomnia
117 (.54%)
Fatigue
116 (.53%)
Delirium
112 (.52%)
Suicidal Ideation
111 (.51%)
Anxiety
108 (.5%)
Depressed Level Of Consciousness
107 (.49%)
Pyrexia
107 (.49%)
Poisoning
106 (.49%)
Intentional Drug Misuse
103 (.47%)
Malaise
101 (.46%)
Asthenia
98 (.45%)
Dyspnoea
97 (.45%)
Feeling Abnormal
95 (.44%)
Diarrhoea
93 (.43%)
Nausea
92 (.42%)
Aggression
90 (.41%)
Arthralgia
89 (.41%)
Electrocardiogram Qt Prolonged
89 (.41%)
Weight Increased
89 (.41%)
Heart Rate Increased
86 (.4%)
Disorientation
79 (.36%)
Drug Abuse
78 (.36%)
Condition Aggravated
70 (.32%)
Grand Mal Convulsion
70 (.32%)
Pulmonary Oedema
70 (.32%)
Memory Impairment
69 (.32%)
Amnesia
67 (.31%)
Hyperhidrosis
67 (.31%)
Hypertension
67 (.31%)
Syncope
67 (.31%)
Drug Exposure During Pregnancy
66 (.3%)
Drug Withdrawal Syndrome
66 (.3%)
Electrocardiogram Qrs Complex Prolo...
66 (.3%)
Metabolic Acidosis
66 (.3%)
Renal Failure Acute
66 (.3%)
Dyskinesia
65 (.3%)
Pain In Extremity
65 (.3%)
Asthma
63 (.29%)
Multi-organ Failure
61 (.28%)
Urinary Retention
61 (.28%)
Hypoaesthesia
60 (.28%)
Mydriasis
60 (.28%)
Abnormal Behaviour
59 (.27%)
Unresponsive To Stimuli
59 (.27%)
Dry Mouth
58 (.27%)
Gait Disturbance
58 (.27%)
Acute Respiratory Distress Syndrome
57 (.26%)
Constipation
57 (.26%)
Speech Disorder
57 (.26%)
Oedema Peripheral
56 (.26%)
Paraesthesia
56 (.26%)
Disturbance In Attention
55 (.25%)
Mental Status Changes
55 (.25%)
Myalgia
55 (.25%)
Pneumonia
55 (.25%)
Medication Error
54 (.25%)
Irritability
53 (.24%)
Restlessness
53 (.24%)
Alanine Aminotransferase Increased
52 (.24%)
Blood Pressure Increased
51 (.23%)
Dysarthria
51 (.23%)
Rhabdomyolysis
51 (.23%)
Blood Sodium Decreased
50 (.23%)
Hypoglycaemia
49 (.23%)
Respiratory Depression
49 (.23%)
Shock
49 (.23%)
Weight Decreased
49 (.23%)
Anaemia
48 (.22%)
Balance Disorder
48 (.22%)
Ventricular Tachycardia
48 (.22%)
Rheumatoid Arthritis
46 (.21%)

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

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

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

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

Depression
1676
Drug Use For Unknown Indication
1607
Product Used For Unknown Indication
1540
Pain
720
Insomnia
576
Sleep Disorder
523
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Migraine
305
Fibromyalgia
236
Neuralgia
232
Anxiety
214
Headache
165
Neuropathy Peripheral
122
Sleep Disorder Therapy
117
Ill-defined Disorder
99
Antidepressant Therapy
82
Rheumatoid Arthritis
63
Irritable Bowel Syndrome
59
Muscle Spasms
58
Back Pain
56
Migraine Prophylaxis
56
Suicide Attempt
54
Neuropathy
44
Post Herpetic Neuralgia
39
Analgesic Therapy
38
Muscle Relaxant Therapy
34
Bipolar Disorder
33
Pain In Extremity
32
Cystitis Interstitial
31
Bipolar I Disorder
28
Diabetic Neuropathy
27
Prophylaxis
27
Mental Disorder
26
Major Depression
23
Intentional Overdose
22
Sedation
22
Sedative Therapy
21
Mood Altered
21
Overdose
21
Arthralgia
20
Polyneuropathy
19
Myalgia
19
Affective Disorder
18
Stress
18
Restless Legs Syndrome
18
Pain Management
16
Abdominal Pain
16
Herpes Zoster
16
Nervousness
16
Salivary Hypersecretion
16
Neuropathic Pain
15
Arthritis
14

Elavil Case Reports

What Elavil 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 Elavil. 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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