Indicated for:

• Major Depressive Disorder in adults

• Generalized Anxiety Disorder in adults and pediatric patients 7 years of age and older

• Diabetic Peripheral Neuropathy in adults)

• Chronic Musculoskeletal Pain in adults

• Fibromyalgia in adults and pediatric patients 13 years of age and older

Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber.

Do not use MAOIs intended to treat psychiatric disorders with CYMBALTA or within 5 days of stopping treatment with CYMBALTA. Do not use CYMBALTA within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start CYMBALTA in a patient who is being treated with linezolid or intravenous methylene blue.

The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including CYMBALTA, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, amphetamines, and St. John’s Wort) and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).

Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that CYMBALTA is not approved for use in treating bipolar depression.

Activation of mania or hypomania has been reported in a small proportion of patients with mood disorders who were treated with other marketed drugs effective in the treatment of major depressive disorder. As with these other agents, CYMBALTA should be used cautiously in patients with a history of mania.

Avoid use of CYMBALTA in patients with chronic liver disease or cirrhosis and avoid use in patients with severe renal impairment, GFR <30 mL/min.

There have been reports of hepatic failure, sometimes fatal, in patients treated with CYMBALTA.

Severe skin reactions, including erythema multiforme and Stevens-Johnson Syndrome (SJS), can occur with CYMBALTA.

Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment.

As observed in DPNP trials, CYMBALTA treatment worsens glycemic control in some patients with diabetes.

Decreased appetite and weight loss have been observed in association with the use of SSRIs and SNRIs.

CYMBALTA should be prescribed with care in patients with a history of a seizure disorder.

The pupillary dilation that occurs following use of many antidepressant drugs including CYMBALTA may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.

Orthostatic hypotension, falls and syncope have been reported with therapeutic doses of CYMBALTA. Syncope and orthostatic hypotension tend to occur within the first week of therapy but can occur at any time during CYMBALTA treatment, particularly after dose increases.

Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including CYMBALTA. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH).

CYMBALTA is in a class of drugs known to affect urethral resistance. If symptoms of urinary hesitation develop during treatment with CYMBALTA, consideration should be given to the possibility that they might be drug-related.

Caution is advised in using CYMBALTA in patients with conditions that may slow gastric emptying (e.g., some diabetics).

Use of SNRIs, including CYMBALTA, may cause symptoms of sexual dysfunction. In male patients, SNRI use may result in ejaculatory delay or failure, decreased libido, and erectile dysfunction. In female patients, SNRI use may result in decreased libido and delayed or absent orgasm.

Use of CYMBALTA concomitantly with heavy alcohol intake may be associated with severe liver injury. For this reason, CYMBALTA should not be prescribed for patients with substantial alcohol use.

Should not administer CYMBALTA with inhibitors of CYP1A2 or Thioridazine.

CYMBALTA should not be prescribed for patients with substantial alcohol use.

Concomitant use of CYMBALTA with potent inhibitors of CYP2D6 would be expected to, and does, result in higher concentrations (on average of 60%) of CYMBALTA.

Co-administration of CYMBALTA with drugs that are extensively metabolized by CYP2D6 and that have a narrow therapeutic index, including certain antidepressants (tricyclic antidepressants [TCAs], such as nortriptyline, amitriptyline, and imipramine), phenothiazines and Type 1C antiarrhythmics (e.g., propafenone, flecainide), should be approached with caution.

SSRIs and SNRIs, including CYMBALTA, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk.

There are no adequate and well-controlled studies of CYMBALTA administration in pregnant women. Animal studies: adverse effects on embryo/fetal and postnatal development.

Neonates exposed during pregnancy to serotonin norepinephrine reuptake inhibitors (SNRIs) or selective serotonin reuptake inhibitors (SSRIs) have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding which can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability, and constant crying. features are consistent with either a direct toxic effect of the SNRIs or SSRIs, or possibly, a drug discontinuation syndrome.

CYMBALTA is present in human milk.

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• Use in patients under the age of 18 for major depressive disorder, diabetic peripheral neuropathic pain, chronic musculoskeletal pain and fibromyalgia. GoToSource

• Bipolar depression. GoToSource

• Obsessive compulsive disorder. GoToSource

• Stress urinary incontinence. GoToSource

• Bulimia. GoToSource

• Attention-deficit/hyperactivity disorder. GoToSource

• Migraines. GoToSource

• Panic attacks, social phobia and insomnia. GoToSource

• Menopausal symptoms. GoToSource

• Treatment of seasonal affective disorder. GoToSource

• Depression in patients with multiple sclerosis. GoToSource

• Post-stroke depression. GoToSource

• Osteoarthritis. GoToSource

• Depressive and psychotic disorders in patients with HIV infection. GoToSource

• Non-major chronic depression. GoToSource

• Post-traumatic stress disorder. GoToSource

• Use with clozapine for schizophrenia. GoToSource

Increased risk of bleeding. GoToSource

Bilateral acute angle-closure glaucoma. GoToSource

Suicidal ideation and behavior. GoToSource

Serotonin syndrome (life-threatening drug interaction). GoToSource

Gynecomastia (enlarged male breast tissue). GoToSource

Increased blood pressure. GoToSource

Tachycardia. GoToSource

Erectile dysfunction and bleeding gums. GoToSource

Anxiety, aggressiveness and panic attacks. GoToSource

Restless legs syndrome. GoToSource

Takotsubo cardiomyopathy (weakening of the left ventricle). GoToSource 

Birth defects. GoToSource 

Discontinuation symptoms including insomnia, nausea, imbalance, sensory disturbances, and hyperarousal. GoToSource

Falls. GoToSource

Orthostatic hypotension (fall in blood pressure after standing). GoToSource

Liver failure. GoToSource

Seizures. GoToSource

Lymphocytic colitis. GoToSource

Activation of mania or hypomania. GoToSource

Hyponatremia (low blood sodium level). GoToSource

Urinary hesitancy and retention. GoToSource

Severe skin reactions, including erythema multiforme and stevens-johnson syndrome. GoToSource

Parkinsonism. GoToSource

Lawsuits filed for birth defects, suicide and liver damage.