Duloxetine Side Effects

Not all side effects for duloxetine may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to duloxetine: oral capsule, oral capsule delayed release

In addition to its needed effects, some unwanted effects may be caused by duloxetine. In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking duloxetine:

Incidence not known
  • Abdominal or stomach pain
  • area rash
  • blindness
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • change in consciousness
  • chills
  • clay-colored stools
  • cold sweats
  • confusion
  • convulsions
  • dark urine
  • decreased urine output
  • decreased vision
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • eye pain
  • fainting
  • fast or irregular heartbeat
  • general tiredness or weakness
  • hives or welts, itching, or skin rash
  • hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of consciousness
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the face, ankles, or hands
  • tearing
  • tightness in the chest
  • unpleasant breath odor
  • upper right stomach pain
  • vomiting of blood
  • yellow eyes and skin

If any of the following symptoms of overdose occur while taking duloxetine, get emergency help immediately:

Symptoms of overdose
  • Agitation
  • diarrhea
  • fever
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • overactive reflexes
  • poor coordination
  • restlessness
  • shivering
  • sleepiness or unusual drowsiness
  • sudden loss of consciousness
  • sweating
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching
  • unusual tiredness or weakness
  • vomiting

Some of the side effects that can occur with duloxetine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Body aches or pain
  • cough
  • difficulty having a bowel movement (stool)
  • dry mouth
  • ear congestion
  • frequent urination
  • headache
  • lack or loss of strength
  • loss of appetite
  • loss of voice
  • muscle aches
  • nausea
  • sleepiness or unusual drowsiness
  • sneezing
  • sore throat
  • stuffy or runny nose
  • sweating increased
  • trouble sleeping
  • weight loss
Less common
  • Abnormal orgasm
  • acid or sour stomach
  • belching
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • change in taste
  • change or problem with discharge of semen
  • decreased interest in sexual intercourse
  • difficulty with moving
  • feeling of warmth or redness of the face, neck, arms, and occasionally, upper chest
  • heartburn
  • inability to have or keep an erection
  • indigestion
  • joint pain
  • longer than usual time to ejaculation of semen
  • loose stools
  • loss in sexual ability, desire, drive, or performance
  • loss of taste
  • muscle aching or cramping
  • muscle pains or stiffness
  • shakiness in the legs, arms, hands, or feet
  • stomach discomfort or upset
  • sudden sweating
  • swollen joints
  • trembling or shaking of the hands or feet

For Healthcare Professionals

Applies to duloxetine: oral delayed release capsule

General

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.[Ref]

Gastrointestinal

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.[Ref]

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[Ref]

Nervous system

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[Ref]

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.[Ref]

Psychiatric

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.[Ref]

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[Ref]

Metabolic

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[Ref]

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.[Ref]

Other

Falls were reported more commonly in patients 65 years of age or older.[Ref]

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[Ref]

Cardiovascular

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.[Ref]

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[Ref]

Dermatologic

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).[Ref]

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[Ref]

Endocrine

Uncommon (0.1% to 1%): Hypothyroidism, syndrome of inappropriate secretion of antidiuretic hormone (SIADH)
Postmarketing reports: Hyperprolactinemia[Ref]

Genitourinary

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.[Ref]

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[Ref]

Hematologic

Concomitant use of aspirin, NSAIDs, warfarin, and other anticoagulants may increase the risk of bleeding events associated with duloxetine.[Ref]

Postmarketing reports: Life-threatening hemorrhage, blood dyscrasias[Ref]

Hepatic

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.[Ref]

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[Ref]

Hypersensitivity

Postmarketing reports: Anaphylactic reaction, hypersensitivity[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Musculoskeletal

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[Ref]

Ocular

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.[Ref]

Common (1% to 10%): Blurred vision
Uncommon (0.1% to 1%): Diplopia, dry eye, mydriasis, visual impairment
Rare (less than 0.1%): Glaucoma[Ref]

Renal

Postmarketing reports: Renal impairment[Ref]

Respiratory

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[Ref]

References

1. "Product Information. Cymbalta (duloxetine)." Lilly, Eli and Company, Indianapolis, IN.

2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

3. Cerner Multum, Inc. "Australian Product Information." O 0

4. Dirks AC, van Hyfte DM "Recurrent hyponatremia after substitution of citalopram with duloxetine." J Clin Psychopharmacol 27 (2007): 313

5. Safdieh JE, Rudominer R "A case of hyponatremia induced by duloxetine." J Clin Psychopharmacol 26 (2006): 675-676

6. Kruger S, Lindstaedt M "Duloxetine and hyponatremia: a report of 5 cases." J Clin Psychopharmacol 27 (2007): 101-104

7. Maramattom BV "Duloxetine-induced syndrome of inappropriate antidiuretic hormone secretion and seizures." Neurology 66 (2006): 773-4

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