Milnacipran is a serotonin and norepinephrine reuptake inhibitor indicated for the management of fibromyalgia, among other approved uses. It is available as tablets and kits for oral use. MedsAcross supplies Milnacipran for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
Milnacipran hydrochloride is indicated for the management of fibromyalgia. Milnacipran hydrochloride is not approved for use in pediatric patients. • Milnacipran hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia. • Milnacipran hydrochloride is not approved for use in pediatric patients.
Source: US FDA prescribing information
The exact mechanism of the central pain inhibitory action of milnacipran and its ability to improve the symptoms of fibromyalgia in humans are unknown. Preclinical studies have shown that milnacipran is a potent inhibitor of neuronal norepinephrine and serotonin reuptake, milnacipran inhibits norepinephrine uptake with approximately 3-fold higher potency in vitro than serotonin without directly affecting the uptake of dopamine or other neurotransmitters. Milnacipran has no significant affinity for serotonergic (5-HT1-7), α- and β-adrenergic, muscarinic (M1-5), histamine (H1-4), dopamine (D1-5), opiate, benzodiazepine, and γ-aminobutyric acid (GABA) receptors in vitro. Pharmacologic activity at these receptors is hypothesized to be associated with the various anticholinergic, sedative, and cardiovascular effects seen with other psychotropic drugs.
Source: US FDA prescribing information
Milnacipran hydrochloride is given orally with or without food. Taking milnacipran hydrochloride with food may improve the tolerability of the drug. • Administer Milnacipran hydrochloride in two divided doses per day. • Based on efficacy and tolerability, dosing may be titrated according to the following schedule: Day 1: 12.5 mg once Days 2-3: 25 mg/day (12.5 mg twice daily) Days 4-7: 50 mg/day (25 mg twice daily) After Day 7: 100 mg/day (50 mg twice daily) • Recommended dose is 100 mg/day. • May be increased to 200 mg/day based on individual patient response. • Adjust dose in patients with severe renal impairment.
Source: US FDA prescribing information
• Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with milnacipran hydrochloride or within 5 days of stopping treatment with milnacipran hydrochloride. Do not use milnacipran hydrochloride within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start milnacipran hydrochloride in a patient who is being treated with linezolid or intravenous methylene blue.
Source: US FDA prescribing information
Boxed warning (suicidality and antidepressant drugs): 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. • Suicidality: Monitor for worsening of depressive symptoms and suicide risk. • Serotonin Syndrome: Increased risk when co-administered with other serotonergic agents, but also when taken alone. If it occurs, discontinue milnacipran hydrochloride and any other serotonergic agents, and initiate supportive treatment. • Elevated Blood Pressure and Heart Rate: Milnacipran hydrochloride may increase blood pressure and heart rate. Measure blood pressure and heart rate prior to initiating treatment with milnacipran hydrochloride and monitor periodically throughout treatment. • Seizures: Cases have been reported with milnacipran hydrochloride therapy.
Source: US FDA prescribing information
The most frequently occurring adverse reactions (≥ 5% and greater than placebo) were nausea, headache, constipation, dizziness, insomnia, hot flush, hyperhidrosis, vomiting, palpitations, heart rate increased, dry mouth, and hypertension.
Source: US FDA prescribing information
Milnacipran undergoes minimal CYP450 related metabolism, with the majority of the dose excreted unchanged in urine (55%) and has a low binding to plasma proteins (13%). In vitro and in vivo studies showed that milnacipran hydrochloride is unlikely to be involved in clinically significant pharmacokinetic drug interactions. • Milnacipran hydrochloride is unlikely to be involved in clinically significant pharmacokinetic drug interactions. • Pharmacodynamic interactions of milnacipran hydrochloride with other drugs can occur.
Source: US FDA prescribing information
Storage Store at 25°C (77°F), excursions permitted between 15°C and 30°C (between 59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
9 presentations of Milnacipran, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Milnacipran 100 mg tabletOralGeneric name | — | US FDA | Available on request |
| Milnacipran 50 mg tabletOralGeneric name | — | US FDA | Available on request |
| Milnacipran 12.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Milnacipran 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Savella 50 mg tabletOral | Allergan | US FDA | Available on request |
| Savella kitOral | Allergan | US FDA | Available on request |
| Savella 100 mg tabletOral | Allergan | US FDA | Available on request |
| Savella 12.5 mg tabletOral | Allergan | US FDA | Available on request |
| Savella 25 mg tabletOral | Allergan | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 14 January 2009 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Milnacipran in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 9 presentations of Milnacipran and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Milnacipran, including Savella.
Yes. The US FDA first approved Milnacipran on 14 January 2009, according to Drugs@FDA.
No listed presentation of Milnacipran is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Milnacipran is classified under ATC code N06AX17 (Milnacipran).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.