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Paxil Side Effects

Common Paxil Side Effects


The most commonly reported Paxil side effects (click to view or check a box to report):

Atrial Septal Defect (1274)
Anxiety (1196)
Dizziness (973)
Cardiac Murmur (812)
Depression (755)
Nausea (682)
Insomnia (645)
Headache (597)
Agitation (588)
Completed Suicide (547)
Aggression (505)
Suicidal Ideation (458)
Fatigue (412)
Ventricular Septal Defect (392)
Patent Ductus Arteriosus (389)
Feeling Abnormal (383)
Anger (362)
Suicide Attempt (357)
Irritability (354)
Cardiomegaly (344)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

Paxil Side Effects Reported to FDA

The following Paxil reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.


The appearance of Paxil on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.
Asthenia, Chills, Pyrexia
This is a report of a 40-year-old female patient (weight: NA) from COUNTRY NOT SPECIFIED, suffering from the following symptoms/conditions: anxiety,crohn^s disease, who was treated with Paxil (dosage: Daily, start time: Jan 02, 2013), combined with:
  • Humira
  • Lialda (Daily)
and developed a serious reaction and side effect(s). The consumer presented with:
  • Asthenia
  • Chills
  • Pyrexia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paxil treatment in female patients, resulting in asthenia side effect.

Dizziness, Confusional State, Lethargy, Malaise, Product Substitution Issue, Product Quality Issue
This report suggests a potential Paxil Dizziness, Confusional State, Lethargy, Malaise, Product Substitution Issue, Product Quality Issue side effect(s) that can have serious consequences. A 37-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Paxil (dosage: NA) starting NS. Soon after starting Paxil the patient began experiencing various side effects, including:
  • Dizziness
  • Confusional State
  • Lethargy
  • Malaise
  • Product Substitution Issue
  • Product Quality Issue
Drugs used concurrently: NA. Although Paxil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as dizziness, may still occur.

Convulsion, Loss Of Consciousness, Disorientation, Somnolence, Urinary Incontinence, Blood Electrolytes Abnormal
This Convulsion, Loss Of Consciousness, Disorientation, Somnolence, Urinary Incontinence, Blood Electrolytes Abnormal problem was reported by a health professional from CR. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety disorder. On Sep 15, 2013 this consumer started treatment with Paxil (dosage: 20mg Per Day). The following drugs were being taken at the same time: NA. When commencing Paxil, the patient experienced the following unwanted symptoms/side effects:
  • Convulsion
  • Loss Of Consciousness
  • Disorientation
  • Somnolence
  • Urinary Incontinence
  • Blood Electrolytes Abnormal
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as convulsion, may become evident only after a product is in use by the general population.

Thrombocytopenia
This is a report of a 51-year-old male patient (weight: NA) from JP. The patient developed the following symptoms/conditions: depression and was treated with Paxil (dosage: 20 Mg, Unk) starting NS. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Thrombocytopenia
This opens a possibility that Paxil treatment could cause the above reactions, including thrombocytopenia, and some male subjects may be more susceptible.


Sedation, Bradyphrenia, Somnolence, Blood Pressure Decreased, Decreased Appetite, Listless, Hypoaesthesia
A 83-year-old female patient (weight: NA) from JP with the following symptoms/conditions: depression started Paxil treatment (dosage: 12.5mg Per Day) on Apr 10, 2013. Soon after starting Paxil treatment, the subject experienced various side effects, including:
  • Sedation
  • Bradyphrenia
  • Somnolence
  • Blood Pressure Decreased
  • Decreased Appetite
  • Listless
  • Hypoaesthesia
Concurrently used drugs:
  • Dogmatyl
  • Bufferin (81mg Per Day)
  • Coniel (4mg Per Day)
  • Isosorbide Mononitrate (40mg Twice Per Day)
  • Furosemide (20mg Per Day)
  • Wypax (.5mg Per Day)
  • Edirol (.75mg Per Day)
  • Sigmart (15mg Three Times Per Day)
The patient was hospitalized. This finding indicates that some female patients could be more vulnerable to Paxil.

Cardiac Failure Chronic, Cardiac Arrest, Somnolence, Blunted Affect, Pleural Effusion, Cardiomegaly, Chest Discomfort, Hypoaesthesia, Decreased Activity
A 88-year-old male patient from JP (weight: NA) experienced symptoms, such as: depressive symptom,anxiety disorder,hypertension and was treated with Paxil(dosage: 12.5mg Per Day). The treatment was initiated on Sep 25, 2013. After that a consumer reported the following side effect(s):
  • Cardiac Failure Chronic
  • Cardiac Arrest
  • Somnolence
  • Blunted Affect
  • Pleural Effusion
  • Cardiomegaly
  • Chest Discomfort
  • Hypoaesthesia
  • Decreased Activity
Concurrently used drugs, which potentially could have contributed to side effect(s) or affected Paxil efficacy:
  • Depas (.5mg Per Day)
  • Micardis (40mg Per Day)
  • Micardis (40mg Per Day)
  • Diart (30mg Per Day)
  • Diart (60mg Per Day)
  • Edirol (.75mcg Per Day)
  • Miya Bm (60mg Three Times Per Day)
  • Slow-k (600mg Per Day)
The patient was hospitalized.

Rhabdomyolysis, Grand Mal Convulsion, Fall, Dizziness, Ill-defined Disorder, Loss Of Consciousness, Myalgia, Blood Creatine Phosphokinase Increased, Pyrexia
In this report, Paxil was administered for the following condition: depression,sleep disorder,anxiety.A 27-year-old male consumer from JP (weight: NA) started Paxil treatment (dosage: 20mg Per Day) on Feb 24, 2010.Sometime after starting the treatment, the patient complained of the following side effect(s):
  • Rhabdomyolysis
  • Grand Mal Convulsion
  • Fall
  • Dizziness
  • Ill-defined Disorder
  • Loss Of Consciousness
  • Myalgia
  • Blood Creatine Phosphokinase Increased
  • Pyrexia
A possible interaction with other drugs could have contributed to this reaction:
  • Seroquel (25mg Per Day)
  • Depas (225mg Per Day)
  • Desyrel (50mg Per Day)
The patient was hospitalized.Establishing a causal relationship between a specific drug and consumer's side effects is complex, but it is possible that in this report Paxil treatment could be related to the listed above side effect(s).

Suicide Attempt, Diabetes Mellitus, Screaming, Obesity, Hypertension, Euphoric Mood, Confusional State, Diarrhoea, Increased Appetite
This is a report of the following Paxil side effect(s):
  • Suicide Attempt
  • Diabetes Mellitus
  • Screaming
  • Obesity
  • Hypertension
  • Euphoric Mood
  • Confusional State
  • Diarrhoea
  • Increased Appetite
A 26-year-old male patient from JP (weight: NA) presented with the following condition: autism spectrum disorder and received a treatment with Paxil (dosage: NA) starting: Dec 27, 2013.The following concurrently used drugs could have generated interactions:
  • Lamictal (25mg Alternate Days)
  • Flunitrazepam
  • Vegetamin
  • Akineton
  • Neuleptil
  • Tegretol
  • Risperidone
This report suggests that a Paxil treatment could be associated with the listed above side effect(s).

Rectal Haemorrhage, Malaise, Dizziness, Photopsia
This Paxil report was submitted by a 63-year-old male consumer from US (weight: NA). The patient was diagnosed with: depression and Paxil was administered (dosage: NA) starting: Oct 22, 2013. The consumer developed a set of symptoms:
  • Rectal Haemorrhage
  • Malaise
  • Dizziness
  • Photopsia
Other drugs used simultaneously:
  • Viibryd
  • Losartan
  • Omeprazole
  • Hydrochlorothiazide
  • Baby Aspirin
  • Multivitamin
Those unexpected symptoms could be linked to a Paxil treatment, however establishing a potential drug-safety problem requires a more detailed clinical analysis.

Muscle Twitching, Tic, Headache
This is a report of a possible correlation between Paxil use and the following symptoms/side effect(s):
  • Muscle Twitching
  • Tic
  • Headache
which could contribute to an assessment of Paxil risk profile.A 28-year-old female consumer from US (weight: NA) was suffering from anxiety,depression and was treated with Paxil (dosage: NA) starting Dec 07, 2013.Other concurrent medications: NA.

Victim Of Homicide
A 51-year-old female patient from US (weight: NA) presented with the following symptoms: depression and after a treatment with Paxil (dosage: 37.5mg Per Day) experienced the following side effect(s):
  • Victim Of Homicide
The treatment was started on NS. Paxil was used in combination with the following drugs:
  • Xanax
This report could alert potential Paxil consumers.

Tremor, Muscular Weakness, Product Quality Issue
In this report, a 57-year-old female patient from US (weight: NA) was affected by a possible Paxil Cr side effect.The patient was diagnosed with depression. After a treatment with Paxil Cr (dosage: 1 Tablet Once A Day, Once Daily, Taken By Mouth, start date: Mar 04, 2004), the patient experienced the following side effect(s):
  • Tremor
  • Muscular Weakness
  • Product Quality Issue
The following simultaneously used drugs could have led to this reaction: NA.The findings here stress that side effects should be taken into consideration when evaluating a Paxil Cr treatment.

Anxiety, Insomnia, Decreased Appetite, Diarrhoea
This is a report of a 43-year-old female patient from JP (weight: NA), who used Paxil (dosage: 12.5mg Per Day) for a treatment of anxiety disorder,dysmenorrhoea. After starting a treatment on Oct 25, 2013, the patient experienced the following side effect(s):
  • Anxiety
  • Insomnia
  • Decreased Appetite
  • Diarrhoea
The following drugs could possibly have interacted with the Paxil treatment
  • Dinagest
  • Wypax
Taken together, these observations suggest that a Paxil treatment could be related to side effect(s), such as Anxiety, Insomnia, Decreased Appetite, Diarrhoea.

Hepatic Function Abnormal, Malaise, Jaundice, Decreased Appetite, Blood Bilirubin Increased, Aspartate Aminotransferase Increased, Alanine Aminotransferase Increased, Gamma-glutamyltransferase Increased
This hepatic function abnormal side effect was reported by a health professional from JP. A 36-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression. The patient was prescribed Paxil (dosage: 10mg Per Day), which was started on Mar 26, 2012. Concurrently used drugs: NA. When starting to take Paxil the consumer reported the following symptoms:
  • Hepatic Function Abnormal
  • Malaise
  • Jaundice
  • Decreased Appetite
  • Blood Bilirubin Increased
  • Aspartate Aminotransferase Increased
  • Alanine Aminotransferase Increased
  • Gamma-glutamyltransferase Increased
The patient was hospitalized. These side effects may potentially be related to Paxil.

Cardiac Failure, Dyspnoea, Brain Natriuretic Peptide Increased
This is a Paxil side effect report of a 37-year-old female patient (weight:NA) from JP, suffering from the following symptoms/conditions: NA, who was treated with Paxil (dosage:NA, start time: NS), combined with:
  • Anafranil
  • Solanax
  • Dogmatyl
, and developed a serious reaction and a cardiac failure side effect. The patient presented with:
  • Cardiac Failure
  • Dyspnoea
  • Brain Natriuretic Peptide Increased
which developed after the beginning of treatment. This side effect report can indicate a possible existence of increased vulnerability to Paxil treatment in female patients suffering from NA, resulting in cardiac failure.

Delirium, Parkinsonism, Dyskinesia, Disorientation, Restlessness, Depressed Mood, Hypophagia
This report suggests a potential Paxil delirium side effect(s) that can have serious consequences. A 68-year-old female patient from JP (weight:NA) was diagnosed with the following health condition(s): depression and used Paxil (dosage: 20mg Per Day) starting Oct 10, 2013. Soon after starting Paxil the patient began experiencing various side effects, including:
  • Delirium
  • Parkinsonism
  • Dyskinesia
  • Disorientation
  • Restlessness
  • Depressed Mood
  • Hypophagia
Drugs used concurrently:NA. The patient was hospitalized. Although Paxil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as delirium, may still occur.

Abdominal Discomfort, Urinary Tract Infection, Hypophagia
This abdominal discomfort problem was reported by a physician from JP. A 80-year-old patient (weight: NA) was diagnosed with the following medical condition(s): depression.On NS a consumer started treatment with Paxil (dosage: 12.5mg Per Day). The following drugs/medications were being taken at the same time: NA. When commencing Paxil, the patient experienced the following unwanted symptoms /side effects:
  • Abdominal Discomfort
  • Urinary Tract Infection
  • Hypophagia
The patient was hospitalized. Although all drugs are carefully tested before they are licensed for use, they carry potential side effect risks. Some side effects, such as abdominal discomfort, may become evident only after a product is in use by the general population.

Anxiety
This is a Paxil side effect report of a 38-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: anxiety,depression and was treated with Paxil (dosage: NA) starting NS. Concurrently used drugs:
  • Buspar
Soon after that, the consumer experienced the following of symptoms:
  • Anxiety
This opens a possibility that Paxil could cause anxiety and that some female patients may be more susceptible.

Hot Flush, Restlessness, Sleep Disorder
A 51-year-old female patient (weight: NA) from US with the following symptoms: depression,anxiety,hot flush started Paxil Cr treatment (dosage: NA) on NS. Soon after starting Paxil Cr treatment, the consumer experienced several side effects, including:
  • Hot Flush
  • Restlessness
  • Sleep Disorder
. Concurrently used drugs: NA. This finding indicates that some patients can be more vulnerable to developing Paxil Cr side effects, such as hot flush.

Completed Suicide
This completed suicide side effect was reported by a consumer or non-health professional from CR. A 46-year-old male patient (weight:NA) experienced the following symptoms/conditions: major depression.The patient was prescribed Paxil Cr (dosage: NA), which was started on NS. Concurrently used drugs: NA..When starting to take Paxil Cr the consumer reported symptoms, such as:
  • Completed Suicide
These side effects may potentially be related to Paxil Cr.

Myoclonus, Pyrexia
This is a report of a 66-year-old female patient (weight: NA) from JP, suffering from the following symptoms/conditions: depression, who was treated with Paxil (dosage: 25mg Per Day, start time: Oct 29, 2005), combined with: NA. and developed a serious reaction and side effect(s). The consumer presented with:
  • Myoclonus
  • Pyrexia
which developed after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paxil treatment in female patients, resulting in myoclonus side effect.

Syncope, Convulsion
This report suggests a potential Paxil Syncope, Convulsion side effect(s) that can have serious consequences. A 25-year-old male patient (weight: NA) from JM was diagnosed with the following symptoms/conditions: NA and used Paxil (dosage: 20mg Per Day) starting Sep 12, 2013. Soon after starting Paxil the patient began experiencing various side effects, including:
  • Syncope
  • Convulsion
Drugs used concurrently: NA.The patient was hospitalized and became disabled. Although Paxil demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as syncope, may still occur.

Hallucination, Cognitive Disorder, Thinking Abnormal, Accidental Overdose
This Hallucination, Cognitive Disorder, Thinking Abnormal, Accidental Overdose problem was reported by a pharmacist from JP. A 84-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On NS this consumer started treatment with Paxil (dosage: 25mg Per Day). The following drugs were being taken at the same time: NA. When commencing Paxil, the patient experienced the following unwanted symptoms/side effects:
  • Hallucination
  • Cognitive Disorder
  • Thinking Abnormal
  • Accidental Overdose
Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as hallucination, may become evident only after a product is in use by the general population.

Surgery
This is a report of a 62-year-old female patient (weight: NA) from US. The patient developed the following symptoms/conditions: NA and was treated with Paxil (dosage: NA) starting Feb 04, 2009. Concurrently used drugs: NA.Soon after that, the consumer experienced the following side effects:
  • Surgery
The patient was hospitalized. This opens a possibility that Paxil treatment could cause the above reactions, including surgery, and some female subjects may be more susceptible.

Brain Neoplasm Malignant, Surgery
A 54-year-old female patient (weight: NA) from US with the following symptoms/conditions: NA started Paxil Cr treatment (dosage: NA) on Dec 08, 2003. Soon after starting Paxil Cr treatment, the subject experienced various side effects, including:
  • Brain Neoplasm Malignant
  • Surgery
Concurrently used drugs: NA. This finding indicates that some female patients could be more vulnerable to Paxil Cr.

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Top 10 Paxil Side Effects for Women

Women Side EffectsReports
Anxiety 726
Dizziness 716
Atrial Septal Defect 599
Nausea 516
Depression 454
Headache 395
Insomnia 391
Cardiac Murmur 382
Agitation 322
Fatigue 293

Top 10 Paxil Side Effects for Men

Men Side EffectsReports
Atrial Septal Defect 673
Anxiety 462
Cardiac Murmur 429
Completed Suicide 372
Depression 297
Aggression 287
Agitation 264
Insomnia 252
Dizziness 250
Headache 200

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


    Discuss Paxil Side Effects

    Did You Have a Paxil Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Paxil for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Paxil Safety Alerts, Active Ingredients, Usage Information

    NDC16590-514
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NamePAXIL CR
    NamePAROXETINE HYDROCHLORIDE
    Dosage FormTABLET, FILM COATED, EXTENDED RELEASE
    RouteORAL
    On market since20020409
    LabelerSTAT RX USA LLC
    Active Ingredient(s)PAROXETINE HYDROCHLORIDE
    Strength(s)12.5
    Unit(s)mg/1
    Pharma ClassSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

    Paxil Dosage, Warnings, Usage.

    Side Effects reported to FDA: 10217

    Paxil safety alerts: 2006 2005 2004

    Reported deaths: 842

    Reported hospitalizations: 3542

    Paxil (paroxetine hydrochloride) Tablets and Oral Suspension

    Paxil (paroxetine hydrochloride) Tablets and Oral Suspension
    Paxil CR (paroxetine hydrochloride) Controlled-Release Tablets

    Audience: Neuropsychiatric and other healthcare professionals
    [Posted 05/12/2006] GlaxoSmithKline (GSK) and FDA notified healthcare professionals of changes to the Clinical Worsening and Suicide Risk subsection of the WARNINGS section in the prescribing Information for Paxil and Paxil CR. These labeling changes relate to adult patients, particularly those who are younger adults.

    A recent meta-analysis conducted of suicidal behavior and ideation in placebo-controlled clinical trials of paroxetine in adult patients with psychiatric disorders including Major Depressive Disorder (MDD), other depression and non-depression disorders. Results of this analysis showed a higher frequency of suicidal behavior in young adults treated with paroxetine compared with placebo. Further, in the analysis of adults with MDD (all ages), the frequency of suicidal behavior was higher in patients treated with paroxetine compared with placebo. This difference was statistically significant; however, as the absolute number and incidence of events are small, these data should be interpreted with caution. All of the reported events of suicidal behavior in the adult patients with MDD were non-fatal suicide attempts, and the majority of these attempts (8 of 11) were in younger adults aged 18-30. These MDD data suggest that the higher frequency observed in the younger adult population across psychiatric disorders may extend beyond the age of 24.

    It is important that all patients, especially young adults and those who are improving, receive careful monitoring during paroxetine therapy regardless of the condition being treated.

    [May 2006 - Dear Healthcare Professional letter - GlaxoSmithKline]

    Latest Paxil clinical trials