Duloxetine (Cymbalta®)

IMPORTANT SAFETY INFORMATION

Do not take Duloxetine if you:

  • are allergic to Duloxetine, or any of the ingredients in Duloxetine
  • take any medicines called monoamine oxidase inhibitor (MAOI), or if you have stopped taking an MAOI in the last 14 days
  • have a medical history of a liver disease
  • are drinking alcohol
  • are using or abusing recreation drugs or prescription medications

Duloxetine can cause serious side effects. Rarely reported side effects include:

  • liver failure, sometimes fatal
  • orthostatic hypotension,a drop in blood pressure when standing or getting up from sleep
  • increased risk of bleeding
  • increased heart rate
  • irregular menstrual cycle
  • frequency of urination or difficulty urinating
  • angle closure glaucoma (symptoms of angle closure glaucoma may include eye pain, changes in vision, swelling or redness in or around eye)
  • serotonin syndrome (symptoms may include shivering, diarrhea, confusion, severe muscle tightness, fever, seizures, and death)
  • hypertensive crisis
  • Stevens-Johnson Syndrome (rash)
  • pancreatitis

Before you take Duloxetine, tell your healthcare provider if you:

  • have thoughts of suicide or harming yourself
  • have a history of psychiatric or medical problems, including bipolar disorder
  • have taken any medication in the past for your condition, whether effective or not
  • have suffered adverse or side effects from previous medication therapies
  • are receiving any non-medication treatment, such as talk therapy
  • drink alcohol or use/abuse recreational or prescription drugs
  • are pregnant, plan to become pregnant, or are breastfeeding

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, herbal supplements, and recreational drugs.

Duloxetine may affect the way other medicines work, and other medicines may affect the way Duloxetine works, causing side effects. Especially tell your healthcare provider if you take any of the following:

  • any other serotonergic medications, migraine medications (triptans), pain medications (tramadol), antibiotic linezolid, amphetamines
  • anticoagulant therapy
  • cimetidine (Tagamet®)
  • ciprofloxacin (Cipro®)

During treatment with this medication, the side effects of this medication may go away as your body adjusts to the medication. The most common side effects of Duloxetine: headache, nausea, diarrhea, dry mouth, constipation, increased sweating, feeling nervous, restless, fatigued, sleepy or having trouble sleeping (insomnia). Sexual side effects (such as problems with orgasm or ejaculatory delay) or increased blood pressure. These often do not improve over time.

Duloxetine is a prescription medicine used to treat major depressive disorder (MDD), generalized anxiety disorder (GAD), diabetic peripheral neuropathic pain (DPNP), fibromyalgia, and chronic musculoskeletal pain.

Swallow the capsule whole. Do not break, crush or chew it. If you miss a dose of duloxetine take it as soon as you remember, unless it is closer to the time of your next dose. Discuss this with your healthcare provider. Do not double your next dose or take more than what is prescribed.

Do not abruptly stop taking Duloxetine even when you feel better. Abruptly stopping can cause withdrawal symptoms including: vomiting, irritability, dizziness, headaches, sensation of tingling skin, or nightmares.

Sleep, energy, or appetite may show some improvement within the first 1-2 weeks. Improvement in these physical symptoms can be an important early signal that the medication is working. Depressed mood and lack of interest in activities may need up to 6-8 weeks to fully improve.

Patients, their families, and caregivers should be alert to the emergence of anxiety, restlessness, irritability, aggressiveness and insomnia. If these symptoms emerge, they should be reported to the patient’s prescriber or healthcare professional. All patients being treated with antidepressants for any indication should watch for and notify their healthcare provider for worsening symptoms, suicidality and unusual changes in behavior, especially during the first few months of treatment.

If you no longer need your medication, the best way to dispose of most types of old, unused, unwanted, or expired medicines (both prescription and over the counter) is to drop off the medicine at a drug take back site, location, or program immediately. You can use the DEA DIVERSION CONTROL DIVISION LOOKUP to find your nearest drug disposal site.

If no drug take back sites, locations, or programs are available in your area, and there are no specific disposal instructions (such as flushing) in the medication guide or package insert, you can follow these simple steps to dispose of most medicines in your trash at home:

  • Mix medicines (liquid or pills; do not crush tablets or capsules) with an unappealing substance such as dirt, cat litter, or used coffee grounds;
  • Place the mixture in a container such as a sealed plastic bag;
  • Throw away the container in your trash at home; and
  • Delete all personal information on the prescription label of empty medicine bottles or medicine packaging, then trash or recycle the empty bottle or packaging.
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