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Duloxetine Side Effects

PatientsVille

Common Duloxetine Side Effects


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

Product Substitution Issue (53)
Nausea (48)
Headache (47)
Dizziness (45)
Completed Suicide (42)
Depression (40)
Anxiety (34)
Toxicity To Various Agents (34)
Insomnia (34)
Loss Of Consciousness (33)
Suicidal Ideation (32)
Death (28)
Cardiac Arrest (27)
Condition Aggravated (25)
Serotonin Syndrome (23)
Fall (22)
Vomiting (21)
Alanine Aminotransferase Increased (21)
Suicide Attempt (19)
Tremor (19)

➢ 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.

Duloxetine Side Effects Reported to FDA



Duloxetine Side Effect Report#9999603
Weight Increased, Fatigue, Disturbance In Attention, Depressed Level Of Consciousness
This is a report of a 40-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fibromyalgia, who was treated with Duloxetine (dosage: Mid January To Present?60 Mg ?daily?po?, start time: NS), combined with:
  • Gabapentin
  • Ibuprofen
  • Loratadine
  • Naproxen Sodium
  • Protonix
and developed a serious reaction and side effect(s): Weight Increased, Fatigue, Disturbance In Attention, Depressed Level Of Consciousness after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine treatment in female patients, resulting in Weight Increased side effect.
Duloxetine Side Effect Report#9999244
Coma, Poisoning
This report suggests a potential Duloxetine Hydrochloride Coma side effect(s) that can have serious consequences. A 37-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: NA and used Duloxetine Hydrochloride (dosage: NA) starting
Feb 03, 2014. After starting Duloxetine Hydrochloride the patient began experiencing various side effects, including: Coma, PoisoningAdditional drugs used concurrently: NA.The patient was hospitalized. Although Duloxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coma, may still occur.
Duloxetine Side Effect Report#9999070
Product Substitution Issue, Abdominal Pain Upper, Nausea, Syncope, Abdominal Pain Upper
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 31-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Mar 07, 2014 this consumer started treatment with Duloxetine (dosage: 2 Pills Morning, 1 Pill Evening). The following drugs were being taken at the same time: NA. When using Duloxetine, the patient experienced the following unwanted symptoms/side effects: Product Substitution Issue, Abdominal Pain Upper, Nausea, Syncope, Abdominal Pain UpperAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Substitution Issue, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9998964
Nausea, Vomiting, Crying, Paraesthesia Oral, Product Substitution Issue
This Nausea side effect was reported by a health professional from US. A 40-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Duloxetine (drug dosage: NA), which was initiated on
Jan 09, 2014. Concurrently used drugs: NA..After starting to take Duloxetine the consumer reported adverse symptoms, such as: Nausea, Vomiting, Crying, Paraesthesia Oral, Product Substitution IssueThese side effects may potentially be related to Duloxetine.
Duloxetine Side Effect Report#9996242
Migraine
This is a report of a 51-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: restless legs syndrome, who was treated with Duloxetine Delayed-release (dosage: NA, start time:
Mar 03, 2014), combined with: NA. and developed a serious reaction and side effect(s): Migraine after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine Delayed-release treatment in male patients, resulting in Migraine side effect.
Duloxetine Side Effect Report#9996024
Diarrhoea, Product Substitution Issue
This report suggests a potential Duloxetine Diarrhoea 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: pain and used Duloxetine (dosage: By Mouth) starting
Feb 13, 2014. After starting Duloxetine the patient began experiencing various side effects, including: Diarrhoea, Product Substitution IssueAdditional drugs used concurrently:
  • Femara
  • Montelukast
  • Clarinex
  • Patanase Nasal Spray
  • Advair
  • Albuterol
  • Vitamin E
Although Duloxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Diarrhoea, may still occur.
Duloxetine Side Effect Report#9995966
Headache, Product Substitution Issue
This Headache problem was reported by a consumer or non-health professional from US. A 47-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: arthralgia. On NS this consumer started treatment with Duloxetine (dosage: 1/day Once Daily Taken By Mouth). The following drugs were being taken at the same time: NA. When using Duloxetine, the patient experienced the following unwanted symptoms/side effects: Headache, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Headache, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9994777
Sensory Loss, Activities Of Daily Living Impaired
This Sensory Loss side effect was reported by a consumer or non-health professional from US. A 70-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Duloxetine (drug dosage: NA), which was initiated on
Dec 29, 2013. Concurrently used drugs:
  • Provigil Modafinil
  • Zestril Lisinopril
  • Levothryoxine
  • Prevacid (lansoprazole)
  • Ferrous Sulflate
  • Plavix Clopidogrel
  • Cymbalta
  • Vitamin D3
.After starting to take Duloxetine the consumer reported adverse symptoms, such as: Sensory Loss, Activities Of Daily Living ImpairedThese side effects may potentially be related to Duloxetine.
Duloxetine Side Effect Report#9990834
Bone Pain, Condition Aggravated
This is a report of a female patient (weight: NA) from US, suffering from the following health symptoms/conditions: osteoarthritis, who was treated with Duloxetine Delayed-release (dosage: NA, start time:
Jan 03, 2014), combined with: NA. and developed a serious reaction and side effect(s): Bone Pain, Condition Aggravated after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine Delayed-release treatment in female patients, resulting in Bone Pain side effect.
Duloxetine Side Effect Report#9981523
Depressed Mood, Anxiety, Insomnia, Suicidal Ideation
This report suggests a potential Duloxetine Depressed Mood 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: depression and used Duloxetine (dosage: NA) starting 201401. After starting Duloxetine the patient began experiencing various side effects, including: Depressed Mood, Anxiety, Insomnia, Suicidal IdeationAdditional drugs used concurrently: NA. Although Duloxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Depressed Mood, may still occur.
Duloxetine Side Effect Report#9981471
Diarrhoea, Product Substitution Issue
This Diarrhoea problem was reported by a physician from US. A 37-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: depression. On
Feb 01, 2014 this consumer started treatment with Duloxetine (dosage: NA). The following drugs were being taken at the same time: NA. When using Duloxetine, the patient experienced the following unwanted symptoms/side effects: Diarrhoea, Product Substitution IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Diarrhoea, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9960835
Disturbance In Attention, Feeling Abnormal, Affect Lability, Product Substitution Issue
This Disturbance In Attention side effect was reported by a physician from US. A 61-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression.The patient was prescribed Duloxetine (drug dosage: NA), which was initiated on
Jan 01, 2013. Concurrently used drugs: NA..After starting to take Duloxetine the consumer reported adverse symptoms, such as: Disturbance In Attention, Feeling Abnormal, Affect Lability, Product Substitution IssueThese side effects may potentially be related to Duloxetine.
Duloxetine Side Effect Report#9959193
Product Substitution Issue, Tremor, Anxiety, Insomnia, Hypervigilance, Chest Discomfort
This is a report of a 57-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: pain management, who was treated with Duloxetine Hcl (dosage: 2 Caps Once Daily Taken By Mouth, start time:
Feb 08, 2014), combined with: NA. and developed a serious reaction and side effect(s): Product Substitution Issue, Tremor, Anxiety, Insomnia, Hypervigilance, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine Hcl treatment in female patients, resulting in Product Substitution Issue side effect.
Duloxetine Side Effect Report#9958806
Hypersensitivity, Product Substitution Issue
This report suggests a potential Duloxetine Hypersensitivity side effect(s) that can have serious consequences. A 62-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Duloxetine (dosage: NA) starting
Feb 09, 2014. After starting Duloxetine the patient began experiencing various side effects, including: Hypersensitivity, Product Substitution IssueAdditional drugs used concurrently: NA. Although Duloxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Hypersensitivity, may still occur.
Duloxetine Side Effect Report#9931836
Product Substitution Issue, Depression, Arthralgia, Product Formulation Issue
This Product Substitution Issue problem was reported by a consumer or non-health professional from US. A 56-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Jan 01, 2014 this consumer started treatment with Duloxetine 60 Mg Teva (dosage: NA). The following drugs were being taken at the same time: NA. When using Duloxetine 60 Mg Teva, the patient experienced the following unwanted symptoms/side effects: Product Substitution Issue, Depression, Arthralgia, Product Formulation IssueAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Product Substitution Issue, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9928281
Depression, Feeling Abnormal, Anxiety, Headache
This Depression side effect was reported by a consumer or non-health professional from US. A 52-year-old female patient (weight:NA) experienced the following symptoms/conditions: depression,headache.The patient was prescribed Duloxetine (drug dosage: 1 Per Day Once Daily Taken By Mouth), which was initiated on
Dec 30, 2013. Concurrently used drugs: NA..After starting to take Duloxetine the consumer reported adverse symptoms, such as: Depression, Feeling Abnormal, Anxiety, HeadacheThese side effects may potentially be related to Duloxetine.
Duloxetine Side Effect Report#9925562
Pain, Product Substitution Issue
This is a report of a 49-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: fibromyalgia, who was treated with Duloxetine (dosage: NA, start time:
Jan 10, 2014), combined with: NA. and developed a serious reaction and side effect(s): Pain, Product Substitution Issue after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine treatment in female patients, resulting in Pain side effect.
Duloxetine Side Effect Report#9925000
Anxiety, Product Substitution Issue
This report suggests a potential Duloxetine Anxiety side effect(s) that can have serious consequences. A 35-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Duloxetine (dosage: NA) starting
Feb 07, 2014. After starting Duloxetine the patient began experiencing various side effects, including: Anxiety, Product Substitution IssueAdditional drugs used concurrently: NA. Although Duloxetine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Anxiety, may still occur.
Duloxetine Side Effect Report#9921859
Headache
This Headache problem was reported by a consumer or non-health professional from US. A female patient (weight: NA) was diagnosed with the following symptoms/conditions: migraine prophylaxis. On 2008 this consumer started treatment with Duloxetine Delayed-release (dosage: NA). The following drugs were being taken at the same time:
  • Allegra
  • Baby Aspirin
  • Plaquenil
  • Cymbalta
When using Duloxetine Delayed-release, the patient experienced the following unwanted symptoms/side effects: HeadacheAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Headache, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9921315
Headache, Tendon Pain, Arthralgia, Sleep Disorder, Sinus Tachycardia, Palpitations, Hypertension, Vertigo, Tremor
This Headache side effect was reported by a consumer or non-health professional from US. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Duloxetine (drug dosage: NA), which was initiated on
Jan 12, 2014. Concurrently used drugs: NA..After starting to take Duloxetine the consumer reported adverse symptoms, such as: Headache, Tendon Pain, Arthralgia, Sleep Disorder, Sinus Tachycardia, Palpitations, Hypertension, Vertigo, TremorThese side effects may potentially be related to Duloxetine. The patient was hospitalized.
Duloxetine Side Effect Report#9917528
Psychomotor Hyperactivity, Dizziness, Feeling Abnormal, Abnormal Behaviour
This is a report of a male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Duloxetine (dosage: 40 Milligram Daily;, start time: NS), combined with:
  • Quetiapine Fumarate
and developed a serious reaction and side effect(s): Psychomotor Hyperactivity, Dizziness, Feeling Abnormal, Abnormal Behaviour after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine treatment in male patients, resulting in Psychomotor Hyperactivity side effect. The patient was hospitalized.
Duloxetine Side Effect Report#9916881
Tremor, Fall, Urinary Tract Infection, C-reactive Protein Increased, Diarrhoea, Blood Cholesterol Increased, Gamma-glutamyltransferase Increased
This report suggests a potential Duloxetine Hydrochloride Tremor side effect(s) that can have serious consequences. A 71-year-old female patient (weight: NA) from AT was diagnosed with the following symptoms/conditions: NA and used Duloxetine Hydrochloride (dosage: NA) starting NS. After starting Duloxetine Hydrochloride the patient began experiencing various side effects, including: Tremor, Fall, Urinary Tract Infection, C-reactive Protein Increased, Diarrhoea, Blood Cholesterol Increased, Gamma-glutamyltransferase IncreasedAdditional drugs used concurrently:
  • Lyrica
  • Mirtabene
  • Zoldem
  • Xanor
  • Mutaflor
The patient was hospitalized. Although Duloxetine Hydrochloride demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Tremor, may still occur.
Duloxetine Side Effect Report#9916819
Cardio-respiratory Arrest
This Death problem was reported by a physician from US. A 45-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Duloxetine Hydrochloride (dosage: NA). The following drugs were being taken at the same time:
  • Ephedrine
  • Venlafaxine
  • Hydrocodone
When using Duloxetine Hydrochloride, the patient experienced the following unwanted symptoms/side effects: Cardio-respiratory ArrestAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Death, may become evident only after a product is in use by the general population.
Duloxetine Side Effect Report#9916807
Completed Suicide, Cardio-respiratory Arrest, Atrial Flutter, Haematemesis, Nystagmus, Livedo Reticularis, Tremor, Muscle Rigidity, Hyperhidrosis
This Completed Suicide side effect was reported by a physician from US. A 55-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Duloxetine Hydrochloride (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Alprazolam (50 Mg, Single)
  • Salicylate Sodium
  • Escitalopram
  • Clonazepam
  • Aripiprazole
.After starting to take Duloxetine Hydrochloride the consumer reported adverse symptoms, such as: Completed Suicide, Cardio-respiratory Arrest, Atrial Flutter, Haematemesis, Nystagmus, Livedo Reticularis, Tremor, Muscle Rigidity, HyperhidrosisThese side effects may potentially be related to Duloxetine Hydrochloride. The patient was hospitalized.
Duloxetine Side Effect Report#9916805
This is a report of a 41-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Duloxetine Hydrochloride (dosage: NA, start time: NS), combined with:
  • Methadone
  • Acetaminophen W/hydrocodone
and developed a serious reaction and side effect(s): after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Duloxetine Hydrochloride treatment in female patients, resulting in Death side effect.


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The appearance of Duloxetine 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 Duloxetine Side Effects for Women?

Women Side EffectsReports
Product Substitution Issue 42
Nausea 39
Depression 36
Headache 34
Dizziness 31
Anxiety 28
Loss Of Consciousness 27
Completed Suicide 25
Condition Aggravated 22
Insomnia 21

What are common Duloxetine Side Effects for Men?

Men Side EffectsReports
Completed Suicide 17
Toxicity To Various Agents 17
Death 15
Dizziness 14
Cardiac Arrest 13
Insomnia 12
Suicidal Ideation 12
Urinary Retention 12
Headache 11
Serotonin Syndrome 10

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.

    Duloxetine 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.

    Discuss Duloxetine Side Effects

    Did You Have a Duloxetine Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Duloxetine for You?

    Exceeded Expectations
    Effective
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    Duloxetine Safety Alerts, Active Ingredients, Usage Information

    NDC0093-7542
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameDuloxetine
    NameDuloxetine
    Dosage FormCAPSULE, DELAYED RELEASE
    RouteORAL
    On market since20131211
    LabelerTeva Pharmaceuticals USA Inc
    Active Ingredient(s)DULOXETINE HYDROCHLORIDE
    Strength(s)20
    Unit(s)mg/1
    Pharma ClassNorepinephrine Uptake Inhibitors [MoA],Serotonin and Norepinephrine Reuptake Inhibitor [EPC],Seroton

    More About Duloxetine

    Side Effects reported to FDA: 860

    Duloxetine safety alerts: 2005

    Reported deaths: 153

    Reported hospitalizations: 298

    Cymbalta (duloxetine) Public Health Advisory: Suicidality in Adults Being Treated with Antidepressant Medications

    Audience: Neuropsychiatric healthcare professionals and consumers

    [UPDATE 07/08/2005] FDA notified healthcare professionals about the availability of updated Healthcare Professional and Patient Information Sheets for antidepressant medications that were the subject of a June 30, 2005 Public Health Advisory issued about the risk of suicidality (suicidal thinking or behavior) in adults being treated with antidepressant medications.

    [Posted 07/01/2005] In response to recent scientific publications that report the possibility of increased risk of suicidal behavior in adults treated with antidepressants, the FDA has issued a Public Health Advisory to update patients and healthcare providers with the latest information on this subject. Even before the publication of these recent reports, FDA had already begun the process of reviewing available data to determine whether there is an increased risk of suicidal behavior in adults taking antidepressants. The Agency has asked manufacturers to provide information from their trials using an approach similar to that used in the evaluation of the risk of suicidal behavior in the pediatric population taking antidepressants. This effort will involve hundreds of clinical trials and may take more than a year to complete.

    [July 08, 2005 - Healthcare Professional and Patient Information Sheets - FDA]
    [June 30, 2005 - Public Health Advisory - FDA]
    [June 30, 2005 - Drug Information Page - FDA]

    Latest Duloxetine clinical trials