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Paroxetine Side Effects

PatientsVille

Common Paroxetine Side Effects


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

Anxiety (577)
Dizziness (539)
Agitation (451)
Depression (394)
Aggression (352)
Confusional State (339)
Headache (275)
Fatigue (272)
Hyperhidrosis (267)
Disturbance In Attention (260)
Nausea (249)
Suicidal Ideation (242)
Diarrhoea (240)
Insomnia (222)
Depressed Mood (177)
Anger (174)
Completed Suicide (168)
Crying (151)
Tremor (141)
Feeling Abnormal (132)

➢ 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.

Paroxetine Side Effects Reported to FDA



Paroxetine Side Effect Report#9999501
Angioedema
This is a report of a 64-year-old female patient (weight: NA) from JM, suffering from the following health symptoms/conditions: depression,anxiety, who was treated with Paroxetine Hydrochloride (dosage: NA, start time: 201402), combined with: NA. and developed a serious reaction and side effect(s): Angioedema after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine Hydrochloride treatment in female patients, resulting in Angioedema side effect.
Paroxetine Side Effect Report#9999259
Pulmonary Artery Stenosis Congenital, Feeding Disorder Neonatal
This report suggests a potential Paroxetine Hydrochloride Pulmonary Artery Stenosis Congenital side effect(s) that can have serious consequences. A male patient (weight: NA) from DE was diagnosed with the following symptoms/conditions: depression and used Paroxetine Hydrochloride (dosage: NA) starting
Aug 18, 2012. After starting Paroxetine Hydrochloride the patient began experiencing various side effects, including: Pulmonary Artery Stenosis Congenital, Feeding Disorder NeonatalAdditional drugs used concurrently:
  • Thyroxine Sodium
  • Esomeprazole
  • Vitamin B12+folic Acid
  • Iodine
  • Seasonal Trival Influ Dresd
Although Paroxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Artery Stenosis Congenital, may still occur.
Paroxetine Side Effect Report#9999134
Suicide Attempt, Withdrawal Syndrome, Anxiety, Weight Decreased, Vomiting, Aphagia, Malaise, Disease Recurrence
This Suicide Attempt problem was reported by a consumer or non-health professional from GB. A 26-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety. On 1999 this consumer started treatment with Paroxetine Hydrochloride (dosage: NA). The following drugs were being taken at the same time: NA. When using Paroxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Suicide Attempt, Withdrawal Syndrome, Anxiety, Weight Decreased, Vomiting, Aphagia, Malaise, Disease RecurrenceThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Suicide Attempt, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9999065
Product Substitution Issue, Vertigo, Impaired Work Ability, Inner Ear Disorder, Chest Pain, Muscular Weakness
This Product Substitution Issue side effect was reported by a consumer or non-health professional from US. A 48-year-old male patient (weight:NA) experienced the following symptoms/conditions: anxiety.The patient was prescribed Paroxetine Hcl, 20 Mg, Zydus (drug dosage: Taken By Mouth), which was initiated on NS. Concurrently used drugs: NA..After starting to take Paroxetine Hcl, 20 Mg, Zydus the consumer reported adverse symptoms, such as: Product Substitution Issue, Vertigo, Impaired Work Ability, Inner Ear Disorder, Chest Pain, Muscular WeaknessThese side effects may potentially be related to Paroxetine Hcl, 20 Mg, Zydus. The patient was hospitalized and became disabled.
Paroxetine Side Effect Report#9993331
Overdose, Headache, Nausea
This is a report of a 22-year-old female patient (weight: NA) from PT, suffering from the following health symptoms/conditions: depression, who was treated with Paroxetine (dosage: 15 Tablets, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Overdose, Headache, Nausea after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine treatment in female patients, resulting in Overdose side effect.
Paroxetine Side Effect Report#9970152
Foetal Exposure During Pregnancy
This report suggests a potential Paroxetine Hydrochloride Foetal Exposure During Pregnancy side effect(s) that can have serious consequences. A 30-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Paroxetine Hydrochloride (dosage: Oral , Alternative Days) starting NS. After starting Paroxetine Hydrochloride the patient began experiencing various side effects, including: Foetal Exposure During PregnancyAdditional drugs used concurrently: NA. Although Paroxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Foetal Exposure During Pregnancy, may still occur.
Paroxetine Side Effect Report#9958884
Aplastic Anaemia
This Aplastic Anaemia problem was reported by a physician from JP. A 75-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression,hypertension. On
Jun 04, 2013 this consumer started treatment with Paroxetine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Candesartan Cilexetil + Hydrochlorothiazide
  • Pregabalin
  • Ethyl Icosapentate
  • Amlodipine Besylate
When using Paroxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Aplastic AnaemiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Aplastic Anaemia, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9958861
Confusional State, Hallucination, Visual, Pneumonia Aspiration, Somnolence
This Confusional State side effect was reported by a consumer or non-health professional from US. A 83-year-old male patient (weight:NA) experienced the following symptoms/conditions: depression,alcohol withdrawal syndrome,hypertension.The patient was prescribed Paroxetine Hydrochloride (drug dosage: NA), which was initiated on
Dec 17, 2013. Concurrently used drugs:
  • Diazepam
  • Lercanidipine Hydrochloride
.After starting to take Paroxetine Hydrochloride the consumer reported adverse symptoms, such as: Confusional State, Hallucination, Visual, Pneumonia Aspiration, SomnolenceThese side effects may potentially be related to Paroxetine Hydrochloride.
Paroxetine Side Effect Report#9958852
Ventricular Septal Defect, Heart Disease Congenital, Atrial Septal Defect
This is a report of a male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: NA, who was treated with Paroxetine Hydrochloride (dosage: 40 Mg Per Day, start time: NS), combined with:
  • Amitriptyline
  • Diazepam
  • Dihydrocodeine
  • Tramadol Hydrochloride
  • Fluoxetine
and developed a serious reaction and side effect(s): Ventricular Septal Defect, Heart Disease Congenital, Atrial Septal Defect after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine Hydrochloride treatment in male patients, resulting in Ventricular Septal Defect side effect.
Paroxetine Side Effect Report#9958590
Anxiety, Headache
This report suggests a potential Paroxetine Hcl Anxiety side effect(s) that can have serious consequences. A 67-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: anxiety and used Paroxetine Hcl (dosage: NA) starting NS. After starting Paroxetine Hcl the patient began experiencing various side effects, including: Anxiety, HeadacheAdditional drugs used concurrently: NA. Although Paroxetine Hcl demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Paroxetine Side Effect Report#9958588
Anxiety, Insomnia
This Anxiety problem was reported by a consumer or non-health professional from US. A 67-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: anxiety. On
May 19, 2011 this consumer started treatment with Paroxetine (dosage: NA). The following drugs were being taken at the same time:
  • Clonazepam
  • Hydrocodone
  • Lithium Carbonate
  • Paroxetine Hydrochloride
When using Paroxetine, the patient experienced the following unwanted symptoms/side effects: Anxiety, InsomniaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Anxiety, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9932405
Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal Defect
This Heart Disease Congenital side effect was reported by a consumer or non-health professional from GB. A male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Paroxetine (drug dosage: 40 Mg, 1 In 1 D), which was initiated on NS. Concurrently used drugs:
  • Amitriptyline
  • Diazepam
  • Dihydrocodeine
  • Fluoxetine
  • Tramadol
.After starting to take Paroxetine the consumer reported adverse symptoms, such as: Heart Disease Congenital, Ventricular Septal Defect, Atrial Septal DefectThese side effects may potentially be related to Paroxetine.
Paroxetine Side Effect Report#9928770
Myocardial Infarction
This is a report of a 48-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: depression, who was treated with Paroxetine Hcl Tablets (dosage: NA, start time:
Jan 08, 2009), combined with: NA. and developed a serious reaction and side effect(s): Myocardial Infarction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine Hcl Tablets treatment in male patients, resulting in Myocardial Infarction side effect.
Paroxetine Side Effect Report#9928194
Exposure Via Ingestion
This report suggests a potential Paroxetine Exposure Via Ingestion side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Paroxetine (dosage: NA) starting NS. After starting Paroxetine the patient began experiencing various side effects, including: Exposure Via IngestionAdditional drugs used concurrently:
  • Zolpidem
  • Trazodone
Although Paroxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Exposure Via Ingestion, may still occur.
Paroxetine Side Effect Report#9928108
Rhabdomyolysis, Gastritis
This Rhabdomyolysis problem was reported by a consumer or non-health professional from JP. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Paroxetine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Vegetamin A
  • Quetiapine
  • Alprazolam
  • Diazepam
  • Chlorpromazine Hcl
  • Clotiazepam
  • Amoxapine
  • Fluvoxamine Maleate
When using Paroxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Rhabdomyolysis, GastritisAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Rhabdomyolysis, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9927875
Toxicity To Various Agents, Asthenia, Tremor, Dysarthria, Abasia, Somnolence, Paraparesis, Areflexia, Asterixis
This Toxicity To Various Agents side effect was reported by a consumer or non-health professional from PT. A 53-year-old male patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Paroxetine Hydrochloride (drug dosage: NA), which was initiated on
Oct 14, 2002. Concurrently used drugs: NA..After starting to take Paroxetine Hydrochloride the consumer reported adverse symptoms, such as: Toxicity To Various Agents, Asthenia, Tremor, Dysarthria, Abasia, Somnolence, Paraparesis, Areflexia, AsterixisThese side effects may potentially be related to Paroxetine Hydrochloride. The patient was hospitalized.
Paroxetine Side Effect Report#9927863
Fall, Depressed Mood, Psychomotor Retardation, Asthenia, Mobility Decreased, Forearm Fracture, Fracture Displacement, Wound, Pyrexia
This is a report of a 91-year-old female patient (weight: NA) from FR, suffering from the following health symptoms/conditions: NA, who was treated with Paroxetine Hydrochloride (dosage: NA, start time:
Dec 03, 2013), combined with:
  • Alprazolam
  • Venlafaxine Hydrochloride
  • Oxazepam
  • Pipamperone
  • Valproic Acid
  • Frusemide
  • Valpromide
  • Nebivolol Hcl
and developed a serious reaction and side effect(s): Fall, Depressed Mood, Psychomotor Retardation, Asthenia, Mobility Decreased, Forearm Fracture, Fracture Displacement, Wound, Pyrexia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine Hydrochloride treatment in female patients, resulting in Fall side effect. The patient was hospitalized.
Paroxetine Side Effect Report#9927860
Melaena, Anaemia
This report suggests a potential Paroxetine Hydrochloride Melaena side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: anxiety,coagulopathy and used Paroxetine Hydrochloride (dosage: NA) starting
Oct 01, 2013. After starting Paroxetine Hydrochloride the patient began experiencing various side effects, including: Melaena, AnaemiaAdditional drugs used concurrently:
  • Warfarin Sodium (warfarin Sodium)
  • Fondaparinux Sodium
  • Zolpidem
  • Perindopril
  • Alprazolam
  • Rivaroxaban
The patient was hospitalized. Although Paroxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Melaena, may still occur.
Paroxetine Side Effect Report#9927859
Myoclonus, Pain, Gait Disturbance, Dyskinesia
This Myoclonus problem was reported by a consumer or non-health professional from FR. A 49-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 201208 this consumer started treatment with Paroxetine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Carbamazepine
  • Celiprolol Hydrochloride
  • Bromazepam
  • Zolpidem
  • Indapamide
  • Lysine Aspirin
  • Atorvastatin Calcium
When using Paroxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Myoclonus, Pain, Gait Disturbance, DyskinesiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Myoclonus, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9927858
Lacrimation Increased, Restlessness, Violence-related Symptom, Suicidal Ideation, Impulsive Behaviour
This Lacrimation Increased side effect was reported by a health professional from JP. A 24-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Paroxetine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Paroxetine Hydrochloride the consumer reported adverse symptoms, such as: Lacrimation Increased, Restlessness, Violence-related Symptom, Suicidal Ideation, Impulsive BehaviourThese side effects may potentially be related to Paroxetine Hydrochloride.
Paroxetine Side Effect Report#9914290
Face Oedema, Allergic Oedema, Urticaria
This is a report of a 59-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Paroxetine Hydrochloride (dosage: NA, start time:
Jun 13, 2013), combined with:
  • Olmesartan Medoxomil (olmesartan Medoxomil)
and developed a serious reaction and side effect(s): Face Oedema, Allergic Oedema, Urticaria after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine Hydrochloride treatment in male patients, resulting in Face Oedema side effect.
Paroxetine Side Effect Report#9914243
Abasia, Spinal Cord Oedema, Hypoaesthesia, Paraesthesia
This report suggests a potential Paroxetine Hcl Tablets Abasia side effect(s) that can have serious consequences. A 74-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: parkinson^s disease and used Paroxetine Hcl Tablets (dosage: NA) starting NS. After starting Paroxetine Hcl Tablets the patient began experiencing various side effects, including: Abasia, Spinal Cord Oedema, Hypoaesthesia, ParaesthesiaAdditional drugs used concurrently:
  • Selegiline
Although Paroxetine Hcl Tablets demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Abasia, may still occur.
Paroxetine Side Effect Report#9914099
Toxicity To Various Agents
This Toxicity To Various Agents problem was reported by a pharmacist from US. A 50-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Paroxetine (paroxetine) (dosage: NA). The following drugs were being taken at the same time:
  • Morphine
  • Dextromethorphan (dextromethorphan)
  • Doxylamine (doxylamine)
  • Diphenhydramine (diphenhydramine)
When using Paroxetine (paroxetine), the patient experienced the following unwanted symptoms/side effects: Toxicity To Various AgentsAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Toxicity To Various Agents, may become evident only after a product is in use by the general population.
Paroxetine Side Effect Report#9913925
Respiratory Arrest, Cardiac Arrest, Toxicity To Various Agents
This Respiratory Arrest side effect was reported by a pharmacist from US. A 42-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Paroxetine (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Clonazepam
  • Amitriptyline
.After starting to take Paroxetine the consumer reported adverse symptoms, such as: Respiratory Arrest, Cardiac Arrest, Toxicity To Various AgentsThese side effects may potentially be related to Paroxetine.
Paroxetine Side Effect Report#9913921
Completed Suicide, Toxicity To Various Agents
This is a report of a 60-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Paroxetine (paroxetine) (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Completed Suicide, Toxicity To Various Agents after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Paroxetine (paroxetine) treatment in male patients, resulting in Completed Suicide side effect.


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The appearance of Paroxetine 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.

What are common Paroxetine Side Effects for Women?

Women Side EffectsReports
Anxiety 429
Dizziness 409
Agitation 329
Depression 270
Confusional State 248
Fatigue 205
Headache 204
Disturbance In Attention 190
Aggression 188
Nausea 178

What are common Paroxetine Side Effects for Men?

Men Side EffectsReports
Aggression 164
Anxiety 148
Dizziness 129
Depression 123
Agitation 119
Suicidal Ideation 98
Hyperhidrosis 92
Completed Suicide 90
Confusional State 90
Diarrhoea 79

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health 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

    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.

    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.

    Paroxetine 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.

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    How Effective is Paroxetine for You?

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    Paroxetine Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7114
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameParoxetine
    NameParoxetine Hydrochloride
    Dosage FormTABLET, FILM COATED
    RouteORAL
    On market since20051107
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)PAROXETINE HYDROCHLORIDE ANHYDROUS
    Strength(s)10
    Unit(s)mg/1
    Pharma ClassSerotonin Reuptake Inhibitor [EPC],Serotonin Uptake Inhibitors [MoA]

    Paroxetine Dosage, Warnings, Usage.

    Side Effects reported to FDA: 3784

    Paroxetine safety alerts: 2006 2005 2004

    Reported deaths: 211

    Reported hospitalizations: 732

    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 Paroxetine clinical trials