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Pamelor Adverse Events Reported to the FDA Over Time

How are Pamelor adverse event reports trending over time?

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

Most Common Pamelor Adverse Events Reported to the FDA

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

Completed Suicide
205 (4.25%)
Drug Ineffective
92 (1.91%)
Suicidal Ideation
89 (1.85%)
Drug Toxicity
76 (1.58%)
Convulsion
55 (1.14%)
Cardiac Arrest
51 (1.06%)
Constipation
48 (1%)
Insomnia
48 (1%)
Drug Interaction
47 (.98%)
Hypotension
47 (.98%)
Headache
45 (.93%)
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Somnolence
45 (.93%)
Cardio-respiratory Arrest
44 (.91%)
Overdose
44 (.91%)
Vomiting
44 (.91%)
Multiple Drug Overdose
43 (.89%)
Death
42 (.87%)
Dizziness
42 (.87%)
Weight Increased
42 (.87%)
Confusional State
39 (.81%)
Weight Decreased
37 (.77%)
Depression
35 (.73%)
Dyspnoea
35 (.73%)
Intentional Overdose
35 (.73%)
Loss Of Consciousness
35 (.73%)
Nausea
33 (.68%)
Respiratory Arrest
33 (.68%)
Tremor
33 (.68%)
Suicide Attempt
32 (.66%)
Dyspepsia
30 (.62%)
Agitation
29 (.6%)
Diarrhoea
29 (.6%)
Fall
29 (.6%)
Gastrointestinal Disorder
28 (.58%)
Syncope
27 (.56%)
Gastrooesophageal Reflux Disease
25 (.52%)
Pain
25 (.52%)
Paraesthesia
24 (.5%)
Dry Mouth
23 (.48%)
Heart Rate Increased
23 (.48%)
Intentional Drug Misuse
23 (.48%)
Malaise
23 (.48%)
Oedema
23 (.48%)
Oedema Peripheral
23 (.48%)
Ventricular Tachycardia
23 (.48%)
Coma
22 (.46%)
Duodenal Ulcer
22 (.46%)
Multiple Drug Overdose Intentional
22 (.46%)
Rectal Haemorrhage
22 (.46%)
Abdominal Distension
21 (.44%)
Fatigue
21 (.44%)
Gastritis
21 (.44%)
Blood Pressure Increased
19 (.39%)
Drug Abuse
19 (.39%)
Reflux Oesophagitis
19 (.39%)
Accidental Overdose
18 (.37%)
Anxiety
18 (.37%)
Arrhythmia
18 (.37%)
Faeces Hard
18 (.37%)
Haemorrhoids
18 (.37%)
Palpitations
18 (.37%)
Condition Aggravated
17 (.35%)
Poisoning
17 (.35%)
Pulmonary Embolism
17 (.35%)
Respiratory Depression
17 (.35%)
Feeling Abnormal
16 (.33%)
Long Qt Syndrome
16 (.33%)
Migraine
16 (.33%)
Nightmare
16 (.33%)
Tachycardia
16 (.33%)
Abdominal Pain
15 (.31%)
Aggression
15 (.31%)
Anger
15 (.31%)
Asthenia
15 (.31%)
Dyskinesia
15 (.31%)
Hyperprolactinaemia
15 (.31%)
Vision Blurred
15 (.31%)
Abnormal Behaviour
14 (.29%)
Amnesia
14 (.29%)
Back Pain
14 (.29%)
Brugada Syndrome
14 (.29%)
Chest Pain
14 (.29%)
Delirium
14 (.29%)
Disorientation
14 (.29%)
Hypertension
14 (.29%)
Mental Status Changes
14 (.29%)
Mydriasis
14 (.29%)
Pneumonia
14 (.29%)
Accidental Death
13 (.27%)
Electrocardiogram Qrs Complex Prolo...
13 (.27%)
Hallucination
13 (.27%)
Muscle Spasms
13 (.27%)
Neck Pain
13 (.27%)
Off Label Use
13 (.27%)
Pain In Extremity
13 (.27%)
Blood Pressure Decreased
12 (.25%)
Bradycardia
12 (.25%)
Drug Level Increased
12 (.25%)
Dysgeusia
12 (.25%)
Hyperhidrosis
12 (.25%)
Multiple Drug Overdose Accidental
12 (.25%)

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

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

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

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

Depression
445
Drug Use For Unknown Indication
318
Product Used For Unknown Indication
254
Pain
128
Migraine
90
Anxiety
65
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Sleep Disorder
64
Major Depression
57
Headache
51
Insomnia
37
Antidepressant Therapy
36
Neuralgia
36
Fibromyalgia
32
Neuropathy Peripheral
32
Limb Discomfort
22
Trigeminal Neuralgia
18
Irritable Bowel Syndrome
16
Ill-defined Disorder
15
Back Pain
14
Suicide Attempt
13
Pain In Extremity
12
Sleep Disorder Therapy
10
Prophylaxis
10
Bipolar Disorder
9
Muscle Spasms
9
Nerve Injury
8
Migraine Prophylaxis
8
Post Herpetic Neuralgia
7
Psychotic Disorder
6
Paraesthesia
6
Nervousness
6
Panic Disorder
6
Breakthrough Pain
5
Mood Swings
5
Pain Management
5
Rheumatoid Arthritis
5
Fatigue
5
Tension Headache
4
Stress
4
Completed Suicide
4
Arthralgia
4
Complex Regional Pain Syndrome
4
Hypoaesthesia
4
Mental Disorder
4
Burning Sensation
4
Pelvic Discomfort
3
Osteoarthritis
3
Somnolence
3
Hypertension
3
Temporomandibular Joint Syndrome
3
Pruritus
3

Drug Labels

LabelLabelerEffective
PamelorMallinckrodt, Inc.01-OCT-12

Pamelor Case Reports

What Pamelor 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 Pamelor. 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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