Milnacipran
Milnacipran Glenmark, Milnacipran Rivopharm · ATC code N06AX17
Also known as: Milnasipran · Brand names: Milnacipran Glenmark, Milnacipran Rivopharm, Milnacipran Holsten, Milnacipran Micro Labs, Milnaneurax, Savella
- Key facts
- Active substance
- Milnacipran
- Drug class
- Antidepressant
- ATC code
- N06AX17
- Authorisation
- authorised nationally; no central EU authorisation
- Information as of
- 2026-10-29
Boxed warning
Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI), similar to some drugs used for the treatment of depression and other psychiatric disorders. Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of such drugs in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on milnacipran hydrochloride should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Milnacipran hydrochloride is not approved for use in the treatment of major depressive disorder. Milnacipran hydrochloride is not approved for use in pediatric patients [see Indications and Usage (1), Warnings and Precautions (5.1), Use in Specific Populations (8.4)].
Key facts
Milnacipran is a selective serotonin and norepinephrine reuptake inhibitor (SNRI). Per the US prescribing information, it is used for the management of fibromyalgia and is not approved there for depression.
What it is used for
- Management of fibromyalgia in adults
- Not approved for major depressive disorder and not approved for pediatric patients
Dosing
- Recommended dose 100 mg/day (50 mg twice daily), with or without food; taking it with food may improve tolerability
- Titration: Day 1: 12.5 mg once; Days 2-3: 25 mg/day; Days 4-7: 50 mg/day; after Day 7: 100 mg/day
- Based on response, may increase to 200 mg/day (100 mg twice daily); higher doses not studied
- Severe renal impairment (creatinine clearance 5-29 mL/min): reduce maintenance dose by 50% to 50 mg/day; not recommended in end-stage renal disease
- Taper after extended use rather than stopping abruptly
- MAOIs: at least 14 days before starting, at least 5 days after stopping milnacipran
Contraindications
- Use of MAOIs for psychiatric disorders with milnacipran or within 5 days of stopping it; starting milnacipran within 14 days of stopping an MAOI
- Starting in a patient treated with linezolid or intravenous methylene blue
Important warnings
- Boxed warning: antidepressants increase the risk of suicidal thinking and behavior in children, adolescents and young adults; monitor patients closely
- Serotonin syndrome, potentially life-threatening
- Elevated blood pressure and heart rate; monitor before and during treatment
- Hepatotoxicity, hyponatremia and increased risk of bleeding
- Withdrawal symptoms on abrupt discontinuation; caution with seizures, mania and dysuria
Side effects
- Most frequent: nausea, headache, constipation, dizziness, insomnia, hot flush
- Common and at least twice placebo: constipation, hot flush, hyperhidrosis, vomiting, palpitations, increased heart rate, dry mouth, hypertension
Interactions
- MAOIs, linezolid, methylene blue: serotonin syndrome
- Other serotonergic drugs: increased risk of serotonin syndrome
- Aspirin, NSAIDs, warfarin and other anticoagulants: increased bleeding risk
- Minimal CYP450 metabolism; pharmacokinetic interactions unlikely
Pregnancy and breastfeeding
- SNRI exposure, particularly in the month before delivery, is associated with an increased risk of postpartum hemorrhage
Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.
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For patients
Patient information (US)
This product has no separate US patient information.
Authorisation and brand names by country
Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.
Austria
- Milnacipran GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Milnacipran RivopharmHolsten Pharma Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
Germany
- Milnacipran GlenmarkGlenmark Arzneimittel Gmbh · 1 register entry
- Milnacipran HolstenHolsten Pharma Gmbh · 1 register entry
- Milnacipran Micro LabsMicro Labs Gmbh · 1 register entry
- MilnaneuraxNeuraxpharm Arzneimittel Gmbh · 1 register entry
Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29
USA
- SavellaAllergan, Inc. · 2 register entries
Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29
Brand names in 2 more European countries
- France
- Milnacipran Arrow, Milnacipran Eg, Milnacipran Venipharm
- Luxembourg
- Milnacipran Micro Labs
EMA – Article 57 product data (EU/EEA), 2026-10-29
Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.
Other substances in the same group
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Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.
Sources
- U.S. Food and Drug Administration. Milnacipran Hydrochloride (Glenmark Pharmaceuticals Inc., USA) – Prescribing Information, 2026-03-19. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=b66b1850-0d2a-41d6-b0ad-c676166394c7
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
- U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/
- Wikidata (CC0): ATC N06AX.
Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error
Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.