duloxetine

Name: duloxetine — FDA Drug Safety & Adverse Event Data
Creator: PlainMeds
License: https://creativecommons.org/publicdomain/zero/1.0/

Reviewed byPlainmeds Editorial, Drug Information Editorial Team · June 5, 2026

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Brand names: Cymbalta

Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) Rx

Duloxetine is a medicine that can help treat depression and anxiety. It can also help with certain types of pain.

Drug Pricing (NADAC)

Brand Price

$8.01/unit

Generic Price

$0.10/unit

Generic Savings

99%

Generic Available

Yes (16 manufacturers)

Pricing data from NADAC (CMS), effective December 18, 2024. Compare all drug costs →

View Alternatives → Compare with Another Drug → Full Side Effects Report →

What it does

Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older).

Common side effects

Nausea, Dry mouth, Sleepiness

Key warnings

Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults.

How It Works

Duloxetine is a type of drug called an SNRI. It works by increasing the levels of serotonin and norepinephrine in your brain. These chemicals can help improve mood and reduce pain.

How to Take It

Take duloxetine capsules once a day, with or without food. Swallow the capsules whole. Do not crush, chew, or open them. If you miss a dose, take it as soon as you remember unless it is almost time for your next dose.

Pregnancy & Breastfeeding

Using duloxetine in the last month of pregnancy may cause problems in the newborn. Talk to your doctor about the risks and benefits of taking duloxetine during pregnancy. Women who stop taking antidepressants during pregnancy are more likely to experience a relapse of depression.

Missed Dose

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and continue with your regular schedule. Do not take two doses at the same time.

Storage

Store duloxetine capsules at room temperature (between 59°F and 86°F).

Side Effects (from patient reports)

Based on 37,574 FDA adverse event reports.

The medicine is not working

5,075

Tiredness

4,788

Feeling sick to your stomach

4,783

Using the medicine for something it's not approved for

4,039

Aches or soreness

3,698

Head pain

3,653

Loose stools

3,262

Feeling lightheaded

3,034

Accidental fall

2,785

Throwing up

2,457

FDA Adverse Event Report Analysis

Detailed analysis of 65,067 reports from the FDA Adverse Event Reporting System (FAERS). Reports span 2004–2025.

Total Reports

65,067

Death-Related Reports

6,708

Hospitalization Reports

20,822

Top Indication

Product Used For Unknown Indication

Gender Distribution

Female 41,657 (70%)

Male 17,542 (30%)

Age Distribution

0–17 860

18–44 9,060

45–64 19,541

65–74 9,251

75+ 6,702

Most Reported Adverse Reactions (FAERS)

#	Reaction	Reports
1	DRUG INEFFECTIVE	5,074
2	FATIGUE	4,787
3	NAUSEA	4,782
4	OFF LABEL USE	4,039
5	PAIN	3,697
6	HEADACHE	3,654
7	DIARRHOEA	3,262
8	DIZZINESS	3,034
9	FALL	2,784
10	VOMITING	2,456
11	ARTHRALGIA	2,387
12	DYSPNOEA	2,300
13	TOXICITY TO VARIOUS AGENTS	2,212
14	DEPRESSION	2,156
15	COMPLETED SUICIDE	2,079

Reactions in Death Reports

COMPLETED SUICIDE 2,077

DEATH 1,663

TOXICITY TO VARIOUS AGENTS 1,449

CARDIO-RESPIRATORY ARREST 338

CARDIAC ARREST 333

OVERDOSE 305

DRUG INTERACTION 296

OFF LABEL USE 288

DRUG ABUSE 240

RESPIRATORY ARREST 230

Reactions in Hospitalization Reports

FALL 1,482

NAUSEA 1,416

FATIGUE 1,226

OFF LABEL USE 1,173

PAIN 1,148

DIARRHOEA 1,098

PNEUMONIA 1,085

DYSPNOEA 1,063

VOMITING 1,059

DRUG INTERACTION 1,004

Source: FDA FAERS (Adverse Event Reporting System) FDA FAERS (Adverse Event Reporting System) Reports are voluntary and do not establish causation

Serious Warnings

Antidepressants may increase the risk of suicidal thoughts and behaviors in children, teenagers, and young adults. Watch closely for worsening depression or suicidal thoughts. Tell your doctor right away if you notice any changes in mood or behavior.

Known Drug Interactions

moderate aspirin

7.4 Drugs that Interfere with Hemostasis (e.g., NSAIDs, Aspirin, and Warfarin) Serotonin release by platelets plays an important role in hemostasis. Epidemiological studies of the case-control and cohort design that have demonstrated an association between use of psychotropic drugs that interfere with serotonin reuptake and the occurrence of upper gastrointestinal bleeding have also shown that concurrent use of an NSAID or aspirin may potentiate this risk of bleeding.

Mechanism: Both of these medicines can make it harder for your blood to clot, which raises your risk of having a serious stomach bleed.

What to do: Use caution when taking these together and tell your doctor immediately if you notice unusual bruising or bleeding.

minor fluoxetine

Similar effects would be expected with other potent CYP2D6 inhibitors (e.g., fluoxetine, quinidine) [see Warnings and Precautions (5.12) ].

Mechanism: Fluoxetine blocks the liver's ability to break down duloxetine, which can lead to a buildup of duloxetine in your system.

What to do: Your doctor may need to adjust your duloxetine dose or monitor you more closely for side effects.

minor famotidine

However, co- administration of Duloxetine delayed-release capsules with aluminum- and magnesium-containing antacids (51 mEq) or Duloxetine delayed-release capsules with famotidine, had no significant effect on the rate or extent of duloxetine absorption after administration of a 40 mg oral dose.

Mechanism: Taking these two drugs together does not change how much of the medicine gets into your body.

What to do: You can take these medications together without any special changes to your routine.

minor buspirone

7.14 Other Serotonergic Drugs The concomitant use of serotonergic drugs (including other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, buspirone, amphetamines, tryptophan, and St.

Mechanism: Both of these medicines increase a brain chemical called serotonin, which can cause a dangerous reaction if levels get too high.

What to do: Your doctor should watch you closely for symptoms like confusion, sweating, or a fast heart rate.

minor paroxetine

7.2 Inhibitors of CYP2D6 Concomitant use of duloxetine (40 mg once daily) with paroxetine (20 mg once daily) increased the concentration of duloxetine AUC by about 60%, and greater degrees of inhibition are expected with higher doses of paroxetine.

Mechanism: Paroxetine blocks the protein your body uses to break down duloxetine, which can cause duloxetine levels to rise.

What to do: Your doctor may need to lower your dose of duloxetine to avoid side effects.

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Common Questions

Can I open the capsule and sprinkle it on food?

No, swallow the capsule whole. Do not crush, chew, or open the capsule.

What should I do if I feel worse after starting duloxetine?

Tell your doctor right away if you feel your depression is worsening or you have thoughts of suicide.

Can I drink alcohol while taking duloxetine?

Avoid drinking a lot of alcohol while taking duloxetine, as it can harm your liver.

Will duloxetine cause me to gain weight?

Duloxetine can cause weight loss or decreased appetite in some people.

Can I stop taking duloxetine suddenly?

No, talk to your doctor before stopping duloxetine. Stopping suddenly can cause withdrawal symptoms.

Does duloxetine interact with other medications?

Yes, duloxetine can interact with other medications. Tell your doctor about all the medicines you take.

How long does it take for duloxetine to start working?

It may take several weeks for duloxetine to start working. Be patient and continue taking it as prescribed.

Can duloxetine cause sexual side effects?

Yes, duloxetine can cause sexual side effects in some people.

What is the maximum dose of duloxetine?

The maximum dose depends on the condition being treated, but it is generally 120 mg per day.

Can children take duloxetine?

Yes, duloxetine can be used to treat generalized anxiety disorder in children 7 years and older and fibromyalgia in children 13 years and older.

What are the common side effects of duloxetine?

The most commonly reported side effects of duloxetine include Nausea, Dry mouth, Sleepiness, Constipation, Decreased appetite. Based on 37,574 FDA adverse event reports. Always consult your healthcare provider about potential side effects.

Does duloxetine interact with other medications?

Yes, duloxetine has 18 known drug interactions. Notable interactions include aspirin, fluoxetine, famotidine. Always inform your doctor about all medications you are taking.

What drug class is duloxetine?

duloxetine belongs to the Serotonin-Norepinephrine Reuptake Inhibitor (SNRI) drug class. It requires a prescription (Rx). Duloxetine can treat major depressive disorder and generalized anxiety disorder in adults and children (7 years and older).

Is there a generic version of duloxetine?

Yes, generic duloxetine is available from 16 manufacturers. The generic costs $0.10 per unit compared to $8.01 for the brand version, saving approximately 99%. Pricing is based on NADAC (National Average Drug Acquisition Cost) data from CMS.

Is duloxetine safe during pregnancy?

Using duloxetine in the last month of pregnancy may cause problems in the newborn. Talk to your doctor about the risks and benefits of taking duloxetine during pregnancy. Always consult your healthcare provider before using any medication during pregnancy or breastfeeding.

Has duloxetine been recalled?

There are 15 recalls associated with duloxetine products. CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. Check the recalls section below for full details and affected products.