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Duloxetine is a selective serotonin and norepinephrine reuptake inhibitor antidepressant (SSNRI). Duloxetine affects chemicals in the brain that may be unbalanced in people with depression.
Duloxetine is used to treat major depressive disorder in adults. It is also used to treat general anxiety disorder in adults and children who are at least 7 years old.
Duloxetine is also used in adults to treat fibromyalgia (a chronic pain disorder), or chronic muscle or joint pain (such as low back pain and osteoarthritis pain).
Duloxetine is also used to treat pain caused by nerve damage in adults with diabetes (diabetic neuropathy).
Do not take duloxetine within 5 days before or 14 days after you have used an MAO inhibitor, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine. A dangerous drug interaction could occur.
Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.
Do not stop using duloxetine without first talking to your doctor.
You should not use duloxetine if you are allergic to it.
Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with duloxetine and cause a serious condition called serotonin syndrome.
Duloxetine is not approved for use by anyone younger than 7 years old.
Tell your doctor if you have ever had:
liver or kidney disease;
slow digestion;
a seizure;
bleeding problems;
narrow-angle glaucoma;
bipolar disorder (manic depression); or
drug addiction or suicidal thoughts.
Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.
Taking duloxetine during pregnancy may cause breathing problems, feeding problems, seizures, or other complications in the newborn baby. However, you may have a relapse of depression if you stop taking this medicine. Tell your doctor right away if you become pregnant. Do not start or stop taking this medicine without your doctor's advice.
If you are pregnant, your name may be listed on a pregnancy registry to track the effects of duloxetine on the baby.
It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.
Take duloxetine exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.
Taking duloxetine in higher doses or more often than prescribed will not make it more effective, and may increase side effects.
Swallow the capsule whole and do not crush, chew, break, or open it.
You may take duloxetine with or without food.
It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.
Your blood pressure will need to be checked often.
Do not stop using this medicine suddenly, or you could have unpleasant symptoms (such as dizziness, nausea, diarrhea, irritability, or anxiety). Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat.
Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
Overdose symptoms may include severe drowsiness, seizures, fast heartbeats, fainting, or coma.
Avoid driving or hazardous activity until you know how duloxetine will affect you. Your reactions could be impaired. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or fainting can cause falls, accidents, or severe injuries.
Avoid drinking alcohol. It may increase your risk of liver damage.
Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with duloxetine may cause you to bruise or bleed easily.
Get emergency medical help if you have signs of an allergic reaction to duloxetine (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
pounding heartbeats or fluttering in your chest;
a light-headed feeling, like you might pass out;
easy bruising, unusual bleeding;
vision changes;
painful or difficult urination;
impotence, sexual problems;
liver problems - right-sided upper stomach pain, itching, dark urine, jaundice (yellowing of the skin or eyes);
low levels of sodium in the body - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or
a manic episode - racing thoughts, increased energy, reckless behavior, feeling extremely happy or irritable, talking more than usual, severe problems with sleep.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Common duloxetine side effects may include:
drowsiness;
nausea, constipation, loss of appetite;
dry mouth; or
increased sweating.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.
Many drugs can affect duloxetine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use duloxetine only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Duloxetine Hydrochloride (www.drugs.com/duloxetine.html).
Commonly reported side effects of duloxetine include: asthenia, constipation, diarrhea, dizziness, drowsiness, fatigue, hypersomnia, insomnia, nausea, sedated state, headache, and xerostomia. Other side effects include: agitation, erectile dysfunction, nervousness, psychomotor agitation, tension, vomiting, abdominal pain, anorexia, decreased appetite, decreased libido, hyperhidrosis, loss of libido, and restlessness. See below for a comprehensive list of adverse effects.
Applies to duloxetine: oral capsule delayed release
Oral route (Capsule, Delayed Release)
Antidepressants can increase the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder. Short-term studies did not show an increase in the risk of suicidality with antidepressants in adults beyond age 24, and there was a reduction in risk with antidepressants in adults aged 65 or older. Closely monitor patients of all ages for clinical worsening and emergence of suicidal thoughts and behaviors. Advise families and caregivers to closely observe the patient and communicate with the prescriber.
Along with its needed effects, duloxetine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking duloxetine:
Incidence not known
Get emergency help immediately if any of the following symptoms of overdose occur while taking duloxetine:
Symptoms of overdose
Some side effects of duloxetine may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Applies to duloxetine: oral delayed release capsule
The most commonly reported side effects reported in placebo-controlled clinical trials included nausea, dry mouth, somnolence, constipation, decreased appetite, hyperhidrosis, agitation, fatigue, insomnia, dizziness
The most commonly reported side effects reported in placebo-controlled clinical trials as a reason for treatment discontinuation and considered to be drug-related included nausea, dizziness, somnolence, headache, and fatigue.
Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between the use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding.
Very common (10% or more): Constipation, diarrhea, dry mouth, nausea
Common (1% to 10%): Abdominal pain, dyspepsia, flatulence, vomiting
Uncommon (0.1% to 1%): Dysphagia, eructation, gastritis, gastroenteritis, gastrointestinal hemorrhage, halitosis, hematochezia, stomatitis
Rare (less than 0.1%): Gastric ulcer
Postmarketing reports: Gastrointestinal bleeding, pancreatitis, colitis (microscopic or unspecified)
Very common (10% or more): Dizziness, headache, somnolence
Common (1% to 10%): Dysgeusia, lethargy, paraesthesia/hypoesthesia, tremor
Uncommon (0.1% to 1%): Convulsions, disturbance in attention, dyskinesia, extrapyramidal symptoms, myoclonus, psychomotor restlessness, restless legs syndrome, trismus, syncope
Rare (less than 0.1%): Akathisia, dysarthria, gait disturbance
Postmarketing reports: Intracerebral bleeding, seizures upon treatment discontinuation, serotonin syndrome, extrapyramidal disorder
Potentially life-threatening serotonin syndrome has been reported with SSRIs and SNRIs, including duloxetine as monotherapy, but particularly with concomitant use of other serotonergic drugs and drugs that impair the metabolism of serotonin.
Antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. An increased risk of suicidal thinking and behavior in children, adolescents, and young adults (aged 18 to 24 years) with major depressive disorder (MDD) and other psychiatric disorders has been reported with short-term use of antidepressant drugs.
Adult and pediatric patients receiving antidepressants for MDD, as well as for psychiatric and nonpsychiatric indications, have reported symptoms that may be precursors to emerging suicidality, including anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia, hypomania, and mania. Causality has not been established.
Aggression and anger have been reported particularly early in treatment or after treatment discontinuation.
Very common (10% or more): Insomnia
Common (1% to 10%): Abnormal dreams, agitation, anxiety, sleep disorder
Uncommon (0.1% to 1%): Apathy, bruxism, disorientation/confusional state, irritability, mood swings, nervousness, poor quality sleep, suicide attempt
Rare (less than 0.1%): Aggression and anger, completed suicide, hallucinations, mania, suicidal behavior and ideation
Common (1% to 10%): Decreased appetite, weight increase/decrease
Uncommon (0.1% to 1%): Dehydration, hyperlipidemia, hyponatremia, increased blood cholesterol, increased blood creatine phosphokinase
Rare (less than 0.1%): Dyslipidemia, increased blood potassium
Frequency not reported: Abnormal potassium levels, increased bicarbonate
Postmarketing reports: Hyperglycemia
Although infrequent, several cases of duloxetine induced hyponatremia have been reported. In one case report, duloxetine induced hyponatremia was confirmed after inadvertent rechallenge. It has been suggested that there is a dose-related effect in the development of hyponatremia with duloxetine. Numerous cases of hyponatremia have been reported following treatment with an SSRI. Risk factors include advanced age, female gender, concomitant use of diuretics, low body weight, and lower baseline serum sodium levels.
Hyponatremia tends to develop within the first few weeks of treatment (range 3 to 120 days) and typically resolves within 2 weeks (range 48 hours to 6 weeks) after therapy has been discontinued with some patients requiring treatment (e.g., water restriction, dietary sodium). The proposed mechanism for the development of hyponatremia involves the syndrome of inappropriate secretion of antidiuretic hormone (SIADH) via release of antidiuretic hormone.
Falls were reported more commonly in patients 65 years of age or older.
Very common (10% or more): Fatigue
Common (1% to 10%): Asthenia, chills/rigors, pyrexia, vertigo
Uncommon (0.1% to 1%): Ear pain, falls, feeling abnormal, feeling hot and/or cold, malaise, thirst, tinnitus
Orthostatic hypotension and syncope tend to occur within the first week of therapy; however, they may occur at any time during treatment, particularly after dose increases. The risk of blood pressure decreases may be greater when duloxetine is given concomitantly with drugs that may induce orthostatic hypotension, such as antihypertensives, with potent CYP450 1A2 inhibitors, or with duloxetine doses above 60 mg per day.
Common (1% to 10%): Flushing, hot flush, hypertension, increased blood pressure, palpitations
Uncommon (0.1% to 1%): Chest pain, myocardial infarction, orthostatic hypotension, peripheral coldness, tachycardia
Rare (less than 0.1%): Hypertensive crisis, supraventricular arrhythmia (mainly atrial fibrillation)
Postmarketing reports: Hematomas, ventricular arrhythmias
The reporting rate of Stevens-Johnson syndrome associated with duloxetine exceeds the general population background incidence rate (1 to 2 cases per million person years).
Common (1% to 10%): Pruritus, hyperhidrosis
Uncommon (0.1% to 1%): Cold sweat, contact dermatitis, erythema, increased tendency to bruise, night sweats, photosensitivity reaction, urticaria
Rare (less than 0.1%): Angioneurotic edema, ecchymosis, Stevens-Johnson syndrome
Postmarketing reports: Erythema multiforme, petechiae, cutaneous vasculitis (sometimes with systemic involvement)
Uncommon (0.1% to 1%): Hypothyroidism, syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Postmarketing reports: Hyperprolactinemia
The Arizona sexual experience scale, used to identify sexual side effects, was used prospectively in 4 major depressive disorder placebo-controlled trials showed that male patients treated with duloxetine experienced significantly more sexual dysfunction than patients treated with placebo.
Common (1% to 10%): Abnormal orgasm/anorgasmia, decreased libido, delayed ejaculation, ejaculation disorder, erectile dysfunction, urinary frequency
Uncommon (0.1% to 1%): Abnormal urine odor, dysuria, gynecological hemorrhage, menopausal symptoms, micturition urgency, nocturia, pollakiuria, polyuria, sexual dysfunction, testicular pain, urinary hesitation
Rare (less than 0.1%): Decreased urine flow, galactorrhea, menstrual disorder, urinary retention
Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may increase the risk of bleeding events associated with duloxetine.
Postmarketing reports: Life-threatening hemorrhage, blood dyscrasias
Cases of liver failure, including fatalities, have been reported. The majority of cases were reported in patients with past or current risk factors for liver injury, including alcohol abuse, hepatitis, or exposure to drugs with known adverse effects on the liver.
Uncommon (0.1% to 1%): Acute liver injury, elevated liver enzymes (ALT, AST, GGT, alkaline phosphatase), hepatitis, increased blood bilirubin
Rare (less than 0.1%): Hepatic failure, jaundice
Postmarketing reports: Anaphylactic reaction, hypersensitivity
Common (1% to 10%): Influenza
Common (1% to 10%): Back pain, muscle spasms, musculoskeletal pain (including myalgia, neck pain)
Uncommon (0.1% to 1%): Muscle tightness (including musculoskeletal stiffness), muscle twitching
Postmarketing reports: Rhabdomyolysis
Pupillary dilation that occurs following the use of many antidepressant drugs may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, mydriasis, visual impairment
Rare (less than 0.1%): Glaucoma
Postmarketing reports: Renal impairment
Common (1% to 10%): Cough, nasopharyngitis, oropharyngeal pain, pharyngolaryngeal pain, upper respiratory tract infection, yawning
Uncommon (0.1% to 1%): Laryngitis, throat tightness
Rare (less than 0.1%): Epistaxis
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Duloxetine Hydrochloride (www.drugs.com/duloxetine.html).
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