Duloxetine side effects

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of DRIZALMA SPRINKLE?

DRIZALMA SPRINKLE may cause serious side effects, including: •See, “What is the most important information I should know about DRIZALMA SPRINKLE?” • Liver problems. DRIZALMA SPRINKLE may cause severe liver problems that may cause death. Tell your healthcare provider right away if you develop any of the following symptoms of severe liver problems:• Decreased in blood pressure (orthostatic hypotension). You may feel lightheaded or faint when you rise too quickly from a sitting or lying position, especially when you start or restart treatment or when the dose is changed.• Falls and fainting. DRIZALMA SPRINKLE may cause you to feel sleepy or dizzy, may cause a decrease in your blood pressure when you rise to quickly from a sitting or lying position, and can slow your thinking and motor skills which may lead to falls that have caused fractures or other serious injuries.• Serotonin syndrome. […]

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): (6.1) Adults: nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients: nausea, diarrhea, decreased weight To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical Industries, Inc.

Table 3: Adverse Reactions: Incidence of 2% or More and Greater than Placebo in MDD and GAD Placebo-Controlled Trials in Adults a,b

This table is printed in the Duloxetine label published by Almatica Pharma LLC of March 2, 2026; the label quoted above does not print one.

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following adverse reactions are discussed in more detail in other sections of the labeling: Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Boxed Warning and Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Orthostatic Hypotension, Falls and Syncope [see Warnings and Precautions (5.3)] Serotonin Syndrome [see Warnings and Precautions (5.4)] Increased Risk of Bleeding [see Warnings and Precautions (5.5)] Severe Skin Reactions [see Warnings and Precautions (5.6)] Discontinuation Syndrome [see Warnings and Precautions (5.7)] Activation of Mania/Hypomania [see Warnings and Precautions (5.8)] Angle-Closure Glaucoma [see Warnings and Precautions (5.9)] Seizures [see Warnings and Precautions (5.10)] Increases in Blood Pressure [see Warnings and Precautions (5.11)] Clinically Important Drug Interactions [see Warnings and Precautions (5.12)] Hyponatremia [see Warnings and Precautions (5.13)] Urinary Hesitation and Retention [see Warnings and Precautions (5.15)] Sexual Dysfunction [see Warnings and Precautions (5.16)] Most common adverse reactions (≥5% and at least twice the incidence of placebo-treated patients): (6.1) Adults: nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis Pediatric Patients: nausea, diarrhea, decreased weight To report SUSPECTED ADVERSE REACTIONS, contact Sun Pharmaceutical …

What do FAERS reports show?

69,298 reports list duloxetine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,118 are coded as a death and 22,135 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

• 3,021
• 3,872
• 5,224
• 6,099
• 6,546
• 6,176
• 6,775
• 6,668
• 6,900
• 7,660
• 3,924

• 2016
• 2017
• 2018
• 2019
• 2020
• 2021
• 2022
• 2023
• 2024
• 2025
• 2026

The 25 most reported reactions

• Drug Ineffective (a use or a product term, not a reaction)5,438
• Nausea (named in the label)5,140
• Fatigue (named in the label)5,059
• Off Label Use (a use or a product term, not a reaction)4,390
• Pain (a use or a product term, not a reaction)3,916
• Headache (named in the label)3,913
• Diarrhoea (named in the label)3,508
• Dizziness (named in the label)3,223
• Fall2,948
• Vomiting (named in the label)2,625
• Arthralgia2,499
• Dyspnoea2,470
• Toxicity To Various Agents2,360
• Depression (a use or a product term, not a reaction)2,252
• Completed Suicide (an outcome recorded in the report)2,204
• Drug Interaction (a use or a product term, not a reaction)2,181
• Anxiety (a use or a product term, not a reaction)2,077
• Asthenia (named in the label)2,046
• Somnolence (named in the label)2,012
• Malaise (named in the label)1,895
• Condition Aggravated (a use or a product term, not a reaction)1,804
• Pain In Extremity1,800
• Insomnia (named in the label)1,793
• Death (an outcome recorded in the report)1,787
• Hyperhidrosis (named in the label)1,778

What next?

Duloxetine: the full record

label, generics, price, shortages, recalls

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