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PRISTIQ

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Pristiq Adverse Events Reported to the FDA Over Time

How are Pristiq adverse event reports trending over time?

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

Most Common Pristiq Adverse Events Reported to the FDA

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

Nausea
1547 (3.84%)
Dizziness
1221 (3.03%)
Drug Ineffective
1213 (3.01%)
Headache
1169 (2.9%)
Insomnia
1067 (2.65%)
Anxiety
1020 (2.53%)
Drug Withdrawal Syndrome
1009 (2.51%)
Fatigue
833 (2.07%)
Feeling Abnormal
805 (2%)
Condition Aggravated
733 (1.82%)
Depression
672 (1.67%)
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Medication Residue
658 (1.63%)
Hyperhidrosis
529 (1.31%)
Diarrhoea
505 (1.25%)
Somnolence
483 (1.2%)
Suicidal Ideation
458 (1.14%)
Malaise
438 (1.09%)
Tremor
428 (1.06%)
Crying
377 (.94%)
Irritability
370 (.92%)
Weight Increased
366 (.91%)
Decreased Appetite
365 (.91%)
Paraesthesia
362 (.9%)
Blood Pressure Increased
361 (.9%)
Constipation
337 (.84%)
Vomiting
328 (.81%)
Agitation
320 (.79%)
Hypertension
307 (.76%)
Drug Effect Decreased
289 (.72%)
Asthenia
271 (.67%)
Vision Blurred
259 (.64%)
Dry Mouth
257 (.64%)
Anger
251 (.62%)
Nervousness
242 (.6%)
Weight Decreased
236 (.59%)
Withdrawal Syndrome
227 (.56%)
Unevaluable Event
221 (.55%)
Palpitations
211 (.52%)
Confusional State
209 (.52%)
Abnormal Dreams
205 (.51%)
Pain
196 (.49%)
Panic Attack
193 (.48%)
Dyspnoea
188 (.47%)
Heart Rate Increased
188 (.47%)
Tinnitus
183 (.45%)
Rash
177 (.44%)
Aggression
176 (.44%)
Convulsion
175 (.43%)
Pruritus
170 (.42%)
Disturbance In Attention
157 (.39%)
Restlessness
154 (.38%)
Memory Impairment
152 (.38%)
Wrong Technique In Drug Usage Proce...
152 (.38%)
Intentional Drug Misuse
150 (.37%)
Suicide Attempt
150 (.37%)
Migraine
148 (.37%)
Drug Interaction
147 (.37%)
Blood Cholesterol Increased
146 (.36%)
Nightmare
146 (.36%)
Alopecia
145 (.36%)
Thinking Abnormal
144 (.36%)
Emotional Disorder
140 (.35%)
Abdominal Pain Upper
135 (.34%)
Feeling Jittery
134 (.33%)
Depressed Mood
132 (.33%)
Fall
130 (.32%)
Loss Of Consciousness
129 (.32%)
Oedema Peripheral
127 (.32%)
Arthralgia
125 (.31%)
Abdominal Discomfort
122 (.3%)
Contusion
121 (.3%)
Chest Pain
120 (.3%)
Hot Flush
118 (.29%)
Abnormal Behaviour
117 (.29%)
Amnesia
114 (.28%)
Mydriasis
114 (.28%)
Hypoaesthesia
112 (.28%)
Completed Suicide
110 (.27%)
Vertigo
109 (.27%)
Muscle Spasms
107 (.27%)
Balance Disorder
106 (.26%)
Middle Insomnia
103 (.26%)
Myalgia
102 (.25%)
Activities Of Daily Living Impaired
98 (.24%)
Urticaria
98 (.24%)
Lethargy
94 (.23%)
Gait Disturbance
91 (.23%)
Impaired Work Ability
91 (.23%)
Serotonin Syndrome
91 (.23%)
Mania
88 (.22%)
Pain In Extremity
88 (.22%)
Impaired Driving Ability
87 (.22%)
Stress
87 (.22%)
Visual Impairment
86 (.21%)
Libido Decreased
83 (.21%)
Drug Screen False Positive
82 (.2%)
Disorientation
81 (.2%)
Dyskinesia
80 (.2%)
Feeling Hot
79 (.2%)
Hallucination
78 (.19%)
Hypersensitivity
78 (.19%)

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

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

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

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

Depression
5785
Anxiety
1093
Major Depression
740
Product Used For Unknown Indication
138
Bipolar Disorder
114
Fibromyalgia
79
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Obsessive-compulsive Disorder
63
Panic Attack
60
Pain
55
Bipolar I Disorder
50
Stress
49
Drug Use For Unknown Indication
47
Hot Flush
47
Menopausal Symptoms
47
Post-traumatic Stress Disorder
45
Panic Disorder
37
Generalised Anxiety Disorder
35
Depressed Mood
28
Insomnia
22
Fatigue
21
Mood Swings
18
Postpartum Depression
18
Nervousness
18
Antidepressant Therapy
16
Migraine
16
Menopause
15
Crying
14
Asthenia
13
Affective Disorder
12
Irritable Bowel Syndrome
12
Anxiety Disorder
12
Mental Disorder
12
Sleep Disorder
11
Attention Deficit/hyperactivity Dis...
11
Anger
10
Premenstrual Syndrome
10
Prophylaxis
9
Mood Altered
8
Poor Quality Sleep
8
Irritability
8
Neuralgia
8
Suicidal Ideation
7
Back Pain
7
Bipolar Ii Disorder
7
Dizziness
7
Neuropathy Peripheral
7
Headache
7
Night Sweats
6
Malaise
6
Disturbance In Attention
6
Social Phobia
5

Drug Labels

LabelLabelerEffective
Pristiq Extended-release Extended-releasePD-Rx Pharmaceuticals, Inc.12-MAY-10
Pristiqextended ReleaseLake Erie Medical DBA Quality Care Products LLC17-JAN-11
Pristiqextended-releaseLake Erie Medical & Surgical Supply DBA Quality Care Products LLC16-APR-12
Pristiqextended-releasePhysicians Total Care, Inc.26-OCT-12
Pristiq Extended-releaseWyeth Pharmaceuticals Company, a subsidiary of Pfizer Inc.21-FEB-13
Pristiqextended-releaseCardinal Health22-MAR-13

Pristiq Case Reports

What Pristiq 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 Pristiq. 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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