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ANAFRANIL

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Anafranil Adverse Events Reported to the FDA Over Time

How are Anafranil adverse event reports trending over time?

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

Most Common Anafranil Adverse Events Reported to the FDA

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

Overdose
141 (2.34%)
Agitation
124 (2.06%)
White Blood Cell Count Increased
100 (1.66%)
Neutrophil Count Increased
92 (1.52%)
Drug Exposure During Pregnancy
71 (1.18%)
Drug Interaction
68 (1.13%)
Mechanical Ventilation
67 (1.11%)
Suicide Attempt
66 (1.09%)
Somnolence
61 (1.01%)
Drug Toxicity
55 (.91%)
Confusional State
54 (.89%)
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Serotonin Syndrome
54 (.89%)
Neuroleptic Malignant Syndrome
52 (.86%)
Pyrexia
47 (.78%)
Tremor
46 (.76%)
Fall
44 (.73%)
Depression
43 (.71%)
Hyponatraemia
41 (.68%)
Multiple Drug Overdose
41 (.68%)
Completed Suicide
40 (.66%)
Drug Ineffective
39 (.65%)
Convulsion
38 (.63%)
Dizziness
38 (.63%)
Vomiting
38 (.63%)
Anxiety
37 (.61%)
Hyperhidrosis
36 (.6%)
Rhabdomyolysis
36 (.6%)
Nausea
35 (.58%)
Insomnia
34 (.56%)
Loss Of Consciousness
34 (.56%)
Suicidal Ideation
33 (.55%)
Constipation
32 (.53%)
Grand Mal Convulsion
30 (.5%)
Multiple Drug Overdose Intentional
30 (.5%)
Fatigue
29 (.48%)
Renal Failure Acute
29 (.48%)
Tachycardia
29 (.48%)
Malaise
28 (.46%)
Coma
27 (.45%)
Dehydration
27 (.45%)
Hypotension
27 (.45%)
Premature Baby
25 (.41%)
Intentional Overdose
24 (.4%)
Orthostatic Hypotension
24 (.4%)
Blood Creatine Phosphokinase Increa...
23 (.38%)
Headache
23 (.38%)
Dyspnoea
22 (.36%)
Hypertension
22 (.36%)
Myoclonus
22 (.36%)
Weight Decreased
22 (.36%)
Drug Withdrawal Syndrome Neonatal
21 (.35%)
Pneumonia
21 (.35%)
Blood Alkaline Phosphatase Increase...
20 (.33%)
Caesarean Section
20 (.33%)
Depressed Level Of Consciousness
20 (.33%)
Sinus Tachycardia
20 (.33%)
Abnormal Behaviour
19 (.31%)
Condition Aggravated
19 (.31%)
Cytolytic Hepatitis
19 (.31%)
Disorientation
19 (.31%)
Weight Increased
19 (.31%)
Aggression
18 (.3%)
Mania
18 (.3%)
Mydriasis
18 (.3%)
Restlessness
18 (.3%)
Alanine Aminotransferase Increased
17 (.28%)
Gamma-glutamyltransferase Increased
17 (.28%)
Metabolic Acidosis
17 (.28%)
Ventricular Tachycardia
17 (.28%)
Asthenia
16 (.27%)
Cholestasis
16 (.27%)
Delirium
16 (.27%)
Sleep Disorder
16 (.27%)
Aspartate Aminotransferase Increase...
15 (.25%)
Blood Creatinine Increased
15 (.25%)
C-reactive Protein Increased
15 (.25%)
Diarrhoea
15 (.25%)
Drug Withdrawal Syndrome
15 (.25%)
Hypotonia
15 (.25%)
Irritability
15 (.25%)
Palpitations
15 (.25%)
Transaminases Increased
15 (.25%)
Death
14 (.23%)
Depressed Mood
14 (.23%)
Dyskinesia
14 (.23%)
Inappropriate Antidiuretic Hormone ...
14 (.23%)
Psychotic Disorder
14 (.23%)
Cardio-respiratory Arrest
13 (.22%)
Electrocardiogram Qrs Complex Prolo...
13 (.22%)
Hypokalaemia
13 (.22%)
Maternal Drugs Affecting Foetus
13 (.22%)
Multi-organ Failure
13 (.22%)
Muscle Rigidity
13 (.22%)
Pre-eclampsia
13 (.22%)
Pruritus
13 (.22%)
Pulmonary Embolism
13 (.22%)
Renal Failure
13 (.22%)
Abdominal Pain
12 (.2%)
Altered State Of Consciousness
12 (.2%)
Anorexia
12 (.2%)
Congestive Cardiomyopathy
12 (.2%)

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

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

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

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

Depression
622
Drug Use For Unknown Indication
167
Anxiety
120
Obsessive-compulsive Disorder
108
Product Used For Unknown Indication
79
Major Depression
54
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Bipolar Disorder
25
Suicide Attempt
19
Panic Disorder
19
Schizophrenia
16
Psychotic Disorder
16
Ill-defined Disorder
14
Pain
14
Depressive Symptom
11
Dysthymic Disorder
11
Insomnia
10
Bipolar I Disorder
9
Neuralgia
9
Cataplexy
8
Antidepressant Therapy
8
Panic Attack
8
Postpartum Depression
7
Narcolepsy
7
Anxiety Disorder
6
Drug Exposure During Pregnancy
6
Neurosis
5
Self Injurious Behaviour
5
Dementia
4
Overdose
4
Restless Legs Syndrome
4
Mental Disorder
4
Completed Suicide
4
Obsessive Thoughts
4
Aggression
3
Affective Disorder
3
Schizoaffective Disorder
3
Enuresis
3
Alcoholism
3
Bipolar Ii Disorder
3
Mental Retardation
3
Social Phobia
3
Nervous System Disorder
3
Nerve Injury
3
Sleep Disorder
3
Amnesia
3
Fibromyalgia
3
Dissociative Disorder
3
Sexual Dysfunction
2
Persecutory Delusion
2
Decreased Appetite
2
Multiple Myeloma
2

Drug Labels

LabelLabelerEffective
AnafranilMallinckrodt, Inc.23-OCT-12

Anafranil Case Reports

What Anafranil 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 Anafranil. 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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