| Fact Table | |
|---|---|
| Formula | C18H19NOS·HCl (duloxetine hydrochloride); C18H19NOS (duloxetine base) |
| License | FDA approved (NDA 021427; initial U.S. approval 2004) |
| Bioavailability | Absolute bioavailability not stated in U.S. label; orally well absorbed; food delays Tmax and decreases AUC by about 10%; smoking reduces AUC by about one-third |
| Legal status | Prescription only (Rx-only) |
| Chemical Name | (+)-(S)-N-methyl-?-(1-naphthyloxy)-2-thiophenepropylamine hydrochloride |
| Elimination half-life | About 12 hours; range 8–17 hours |
| Dosage (Strength) | Delayed-release capsules: 20 mg, 30 mg, and 60 mg duloxetine; generally once daily without regard to meals; adult target dose commonly 60 mg/day, with maximum up to 120 mg/day for some indications |
| Pregnancy | Use during pregnancy only if potential benefit justifies potential fetal risk; late third-trimester SSRI/SNRI exposure may cause neonatal complications |
| Brands | Cymbalta, Drizalma Sprinkle, Irenka; generics available |
| Protein binding | >90% bound to human plasma proteins, mainly albumin and a1-acid glycoprotein |
| PubChem CID | 60835 (duloxetine); 11966283 (duloxetine hydrochloride) |
| MedlinePlus | a604030 |
| ChEBI | 36795 ((S)-duloxetine); 31526 ((S)-duloxetine hydrochloride) |
| ATC code | N06AX21 |
| DrugBank | DB00476; DBSALT000378 (duloxetine hydrochloride) |
| KEGG | D07880 (duloxetine); D01179 (duloxetine hydrochloride) |
| Routes of administration | By mouth (oral delayed-release capsules) |
Cymbalta (duloxetine) is an oral capsule used to treat depression, generalized anxiety disorder, diabetic nerve pain, fibromyalgia, and chronic musculoskeletal pain. It works by increasing serotonin and norepinephrine levels in the brain, which may help improve mood, ease anxiety, and manage pain. It is available in several strengths and comes as a delayed-release capsule.
Take Cymbalta exactly as prescribed by your doctor or healthcare provider. Swallow the capsule whole; do not crush, chew, or open it. Cymbalta may be taken with or without food.
For major depressive disorder, the typical starting dose is 40 to 60 mg per day, taken once daily or divided into two doses. For generalized anxiety disorder, the recommended dose is 60 mg once daily, though your doctor may start you at a lower dose. For diabetic nerve pain, the dose is 60 mg once daily. For fibromyalgia and chronic musculoskeletal pain, the usual starting dose is 30 mg once daily for one week, then increased to 60 mg once daily. Do not stop taking Cymbalta suddenly without your doctor's guidance.
The active ingredient in Cymbalta is duloxetine hydrochloride. Inactive ingredients may include FD and C Blue No. 2, gelatin, hypromellose, hydroxypropyl methylcellulose acetate succinate, sodium lauryl sulfate, sucrose, sugar spheres, talc, titanium dioxide, and triethyl citrate. The 20 mg and 60 mg capsules also contain iron oxide yellow.
Before using this medication, you may want to consult a healthcare provider about the following:
Cymbalta carries a boxed warning about an increased risk of suicidal thoughts and behavior in children, adolescents, and young adults under 25 years of age. Patients and caregivers should monitor closely for changes in mood or behavior, especially during the first few months of treatment or when the dose is changed.
Cymbalta may cause liver damage. Tell your doctor if you have a history of liver disease or heavy alcohol use.
This medication may cause dizziness, lightheadedness, or fainting when standing up, also known as orthostatic hypotension, especially when first starting treatment. It is important to get up slowly from sitting or lying down.
Serotonin syndrome, a potentially life-threatening condition, can occur when Cymbalta is used with other serotonergic drugs. Seek immediate medical attention if you develop agitation, hallucinations, rapid heartbeat, fever, muscle stiffness, or loss of coordination.
Cymbalta may increase the risk of bleeding, especially when taken with blood thinners, aspirin, or NSAIDs.
Do not stop taking Cymbalta abruptly. Gradually reducing the dose under medical supervision is recommended to avoid discontinuation symptoms such as dizziness, nausea, headache, and irritability.
Avoid taking or using this medication if any of the following apply:
Common side effects of Cymbalta include:
Serious side effects are rare but can include suicidal thoughts or behavior, liver problems, serotonin syndrome, severe skin reactions, and unusual bleeding or bruising.
Symptoms of liver problems may include dark urine, yellowing of the skin or eyes, or unexplained abdominal pain.
Seek medical attention immediately if you experience any of these.
What is Cymbalta?
Cymbalta is a brand-name prescription medicine that contains duloxetine hydrochloride. It is a serotonin and norepinephrine reuptake inhibitor, or SNRI, and is supplied as delayed-release capsules taken by mouth.
What is Cymbalta used for?
Cymbalta is approved to treat major depressive disorder in adults, generalized anxiety disorder in adults and children 7 years and older, diabetic peripheral neuropathic pain in adults, fibromyalgia in adults and children 13 years and older, and chronic musculoskeletal pain in adults.
How does Cymbalta work?
Duloxetine works by increasing the activity of serotonin and norepinephrine, two chemical messengers involved in mood regulation and pain signaling. This helps explain why Cymbalta can be used for both mood and certain chronic pain conditions.
How is Cymbalta usually taken?
Cymbalta is usually taken once daily, with or without food. The capsule should be swallowed whole and should not be crushed, chewed, opened, sprinkled on food, or mixed with liquids because this can affect the delayed-release coating.
How long does Cymbalta take to work?
Some symptoms may begin to improve earlier, but depression, anxiety, and pain-related benefits often take several weeks of consistent use. Dose adjustments may be made based on the condition being treated, response, and tolerability.
What are common side effects of Cymbalta?
Common side effects include nausea, dry mouth, constipation, sleepiness, increased sweating, decreased appetite, fatigue, insomnia, dizziness, diarrhea, headache, and sexual side effects. Some side effects may lessen as the body adjusts.
What serious warnings are associated with Cymbalta?
Cymbalta carries a boxed warning for increased risk of suicidal thoughts and behaviors in children, adolescents, and young adults taking antidepressants. Other serious risks include serotonin syndrome, liver injury, increased bleeding risk, severe skin reactions, low blood pressure with fainting or falls, seizures, mania or hypomania, angle-closure glaucoma, low sodium levels, urinary retention, and increased blood pressure.
Who should not take Cymbalta?
Cymbalta should not be used with monoamine oxidase inhibitors, including certain psychiatric MAOIs, linezolid, or intravenous methylene blue, because of the risk of serotonin syndrome. It should also be avoided by anyone with a known serious allergy to duloxetine or any capsule ingredient.
Can Cymbalta be stopped suddenly?
Cymbalta should generally not be stopped abruptly unless medically necessary. Stopping suddenly may cause discontinuation symptoms such as dizziness, nausea, headache, fatigue, irritability, sleep disturbance, diarrhea, anxiety, sweating, tingling sensations, or vertigo.
What should be discussed before taking Cymbalta?
Before taking Cymbalta, it is important to discuss liver disease, heavy alcohol use, kidney disease, high blood pressure, glaucoma, seizure history, bipolar disorder, bleeding risk, pregnancy, breastfeeding, and all other medicines or supplements, especially serotonergic drugs, blood thinners, NSAIDs, aspirin, and strong CYP1A2 or CYP2D6 inhibitors.
A generic drug is a copy of the brand-name drug with the same dosage, safety, strength, quality, consumption method, performance, and intended use. Before generics become available on the market, the generic company must prove it has the same active ingredients as the brand-name drug and works in the same way and in the same amount of time in the body.
The only differences between generics and their brand-name counterparts is that generics are less expensive and may look slightly different (e.g., different shape or color), as trademark laws prevent a generic from looking exactly like the brand-name drug.
Generics are less expensive because generic manufacturers don't have to invest large sums of money to develop a drug. When the brand-name patent expires, generic companies can manufacture a copy of the brand-name and sell it at a substantial discount.