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Antidepressant medications, such as Duloxetine (Cymbalta), are effective for treating depression and various mental or mood disorders. While these medications can prevent suicidal thoughts and provide significant benefits, they also carry potential risks. Below is important safety and warning information to consider:

• Risk of Suicidal Thoughts and Behavior: Especially in individuals 24 years or younger and those with a history of depression or mental health conditions, Duloxetine may increase the risk of worsening depression or suicidal thoughts. Monitor for any new or worsening symptoms, especially when initiating treatment or modifying dosage. Immediate consultation with a healthcare professional (HCP) is advised if such changes occur.

• Liver Damage: Rare but serious liver issues have been reported. Symptoms like stomach pain, nausea, vomiting, leg swelling, and jaundice require urgent medical attention. Individuals with a history of liver problems or those consuming alcohol are at higher risk.

• Blood Pressure Changes and Fall Risk: Regular blood pressure monitoring is essential as Duloxetine can cause fluctuations. The risk is heightened in older adults, those with balance issues, or individuals taking more than 60 mg daily or other blood pressure-lowering drugs.

• Serotonin Syndrome: This potentially life-threatening condition occurs with excessive serotonin in the brain, especially when combined with other serotonergic drugs. Seek immediate medical help if symptoms like a fast heart rate, sweating, muscle stiffness, high fever, or confusion arise.

• Increased Bleeding Risk: Duloxetine may elevate bleeding risk, particularly if combined with aspirin, NSAIDs, or blood thinners. Be alert for unexplained bruising, black stools, pink/red urine, or unusual nose/gum bleeding, and inform your HCP promptly.

• Severe Skin Reactions: Rare severe skin reactions can occur. Urgent medical attention is necessary if painful blisters, peeling rash, or sores develop.

• Withdrawal Symptoms: Abrupt discontinuation can trigger withdrawal effects such as nausea, anxiety, confusion, trouble sleeping, and dizziness. Consult your HCP for a gradual tapering plan.

• Mania: In individuals with a personal or family history of bipolar disorder, Duloxetine may provoke manic episodes. Report any unusual behavioral changes to your HCP immediately.

• Low Sodium Levels: This condition may develop, particularly in older adults or those with SIADH, taking diuretics, or experiencing dehydration. Symptoms like headaches, confusion, or balance issues warrant contacting your HCP.

• Sexual Problems: Some adults may experience sexual dysfunction, including erectile issues and decreased libido. Discuss any distressing sexual side effects with your HCP.

Contraindications: Duloxetine should not be used if you are currently taking or have recently taken a monoamine oxidase inhibitor (MAOI) within the last 14 days, or if undergoing treatment with linezolid (Zyvox) or methylene blue. Always consult your healthcare provider before starting this medication if these conditions apply to you.

Common side effects:

• nausea
• dry mouth
• constipation
• loss of appetite
• tiredness
• drowsiness
• dizziness
• increased sweating
• headaches
• trouble sleeping
• diarrhea
• stomach pain

Less common but important to monitor:

• blurry vision
• abnormal heartbeat
• tremors
• vomiting
• low sex drive
• yawning
• changes in weight

Serious side effects:

• suicidal thoughts or behaviors
• significant liver damage
• symptoms of serotonin syndrome
• severe bleeding or bruising
• low sodium levels
• severe skin reactions
• seizures
• confusion
• hallucinations
• unexplained fever
• severe dizziness
• fast heartbeat
• very serious allergic reaction
• rash
• itching/swelling (especially of the face, tongue, or throat)
• trouble breathing
• skin blisters
• mouth sores

Interactions with high risk of serious adverse effects and should be avoided:

• MAO Inhibitors (isocarboxazid, Linezolid, methylene blue, moclobemide, phenelzine, procarbazine, Rasagiline, safinamide, Selegiline, Tranylcypromine)
• Thioridazine
• Viloxazine

Interactions with moderate risk that may require dose adjustment, closer monitoring, or timing changes:

• Clopidogrel
• NSAIDs (Ibuprofen, Naproxen)
• Blood thinners (Dabigatran, Warfarin)
• Aspirin
• Serotonin-increasing drugs (certain antidepressants, St. John's wort, Tryptophan)
• Cimetidine
• Certain quinolone antibiotics (Ciprofloxacin, enoxacin)
• Antiarrhythmic drugs (Propafenone, Flecainide, quinidine)
• Antipsychotics (including thioridazine)
• Tricyclic antidepressants (Desipramine, imipramine)

Interactions with low risk that usually do not require a change in therapy:

• Alcohol
• Cannabis
• Antihistamines (Cetirizine, diphenhydramine)
• Drugs for sleep or anxiety (Alprazolam, Diazepam, Zolpidem)
• Muscle relaxants
• Opioid pain relievers (codeine)