Prescription medicine
Milnacipran Brand names: Savella
Milnacipran (Savella) is a prescription medicine with an FDA approval on record since 2009. FDA's NDC Directory lists it from 4 generic labelers, and pharmacies paid $2.82 per milnacipran HCl 100 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the milnacipran FDA label on DailyMed (effective September 10, 2025, Allergan, Inc.); the NDA 22256 record on Drugs@FDA; every milnacipran label on DailyMed.
Highlights of the record
FDA label of September 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
SUICIDALITY AND ANTIDEPRESSANT DRUGS.
SAVELLA 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 SAVELLA 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. SAVELLA is not approved for use in the treatment of major depressive disorder. […]
Used for
From the label: indications and usageSAVELLA is indicated for the management of fibromyalgia.
Forms and strengths
- 12.5 mg
- 25 mg
- 50 mg
- 100 mg
Film-coated tablet; tablet; kit.
On the market
- Earliest approval on file
- January 14, 2009 Savella, Abbvie; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 5 first January 27, 2016; 5 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 7 of which 4 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- September 19, 2029 Savella tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $2.82 per tablet Milnacipran HCl 100 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 5,981 through July 30, 2026
What is milnacipran used for?
From the label: indications and usageSAVELLA is indicated for the management of fibromyalgia. SAVELLA is not approved for use in pediatric patients [see Use in Specific Populations ( 8.4 )]. SAVELLA ® is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for the management of fibromyalgia ( 1 ). SAVELLA is not approved for use in pediatric patients ( 1 ).
Conditions named in the indications of milnacipran's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Serotonin and Norepinephrine Reuptake Inhibitor.
Source: FDA drug label (Savella), NDA022256 (Abbvie), as published by Allergan, Inc., effective September 10, 2025 (SPL set 16a4a314-f97e-4e91-95e9-576a3773d284), via openFDA; the full label on DailyMed
What does the patient leaflet for milnacipran say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about SAVELLA ?SAVELLA and antidepressant medicines may cause serious side effects, including: 1. Suicidal thoughts or actions: SAVELLA and antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment or when the dose is changed. Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions. Watch for these changes and call your healthcare provider right away if you notice: New or sudden changes, in mood, behavior, thoughts, or feelings, especially if severe. Pay particular attention to such changes when SAVELLA is started or when the dose is changed. Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms. Call your healthcare provider right away or go to the nearest hospital emergency room if you have any of the following symptoms, especially if they are new, worse, or worry you: • attempts to commit suicide • feeling agitated, restless, angry or irritable • acting on dangerous impulses • trouble sleeping (insomnia) • acting aggressive, being angry, or violent • an increase in activity or talking more than what is normal for you • thoughts about suicide or dying • other unusual changes in behavior or mood • new or worse depression • new or worse anxiety or panic attacks Call your healthcare provider right away or go to the nearest hospital emergency room if you have any symptoms of the serious side effects listed below: 2. Serotonin Syndrome. […]
From the patient leaflet: What should I avoid while taking SAVELLA ?Do not drive or operate machinery until you know how SAVELLA affects you. SAVELLA may make you less alert and affect your reaction time.
From the patient leaflet: How should I store SAVELLA ?Store at room temperature between 68°F to 77°F (20°C to 25°C). Keep SAVELLA and all medicines out of the reach of children.
Source: FDA drug label (Savella), NDA022256 (Abbvie), as published by Allergan, Inc., effective September 10, 2025 (SPL set 16a4a314-f97e-4e91-95e9-576a3773d284), via openFDA; the full label on DailyMed
Is there a generic for milnacipran (Savella)?
The FDA approved the first generic milnacipran on January 27, 2016. 5 generic applications are approved; 5 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale. Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
FDA's NDC Directory lists milnacipran from 4 labelers under a generic (ANDA) application and from 2 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists 1 patent for Savella tablets, the last expiring on September 19, 2029. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2009 earliest approval on file
- 2016 first generic approved
- 2029 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for milnacipran (Savella)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $2.82 per Milnacipran HCl 100 mg tablet. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Milnacipran HCl 12.5 mg tablet (generic)
- Savella titration pack (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Milnacipran HCl 100 mg tablet | Generic | $2.82 per tablet | $84.57 | n/a |
| Milnacipran HCl 12.5 mg tablet | Generic | $0.782 per tablet | $23.47 | n/a |
| Milnacipran HCl 25 mg tablet | Generic | $2.53 per tablet | $75.78 | n/a |
| Milnacipran HCl 50 mg tablet | Generic | $2.80 per tablet | $84.05 | n/a |
| Savella 100 mg tablet | Brand | $8.15 per tablet | $244.52 | -0.2% |
| Savella 12.5 mg tablet | Brand | $8.16 per tablet | $244.92 | +0.1% |
| Savella 25 mg tablet | Brand | $8.16 per tablet | $244.68 | -0.1% |
| Savella 50 mg tablet | Brand | $8.16 per tablet | $244.76 | no change |
| Savella titration pack | Brand | $8.14 per unit | n/a | -0.1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the milnacipran label say about other medicines?
The milnacipran label names 14 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name milnacipran. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Aspirin | drug interactions | Drugs that Interfere with Hemostasis Concomitant use of SAVELLA with an antiplatelet or anticoagulant drug (e.g., NSAIDs, aspirin, and warfarin) may potentiate the risk of bleeding. |
| Buspirone | drug interactions | Serotonin syndrome can occur with use of SAVELLA and other serotonergic drugs (other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort), or with drugs that impair metabolism of serotonin (i.e., monoamine oxidase inhibitors). |
| Clomipramine | drug interactions | Clomipramine: In a drug-drug interaction study, an increase in euphoria and postural hypotension was observed in patients who switched from clomipramine to SAVELLA. |
| Clonidine | drug interactions | Because SAVELLA inhibits norepinephrine reuptake, co-administration with clonidine may inhibit clonidine’s anti-hypertensive effect. |
| Digoxin | drug interactions | Interactions with Select Cardiovascular Agents Digoxin: Use of SAVELLA concomitantly with digoxin may be associated with potentiation of adverse hemodynamic effects. |
| Epinephrine | drug interactions | Therefore, concomitant use of SAVELLA with epinephrine and norepinephrine may be associated with paroxysmal hypertension and possible arrhythmia [see Warnings and Precautions ( 5.3 , 5.4 )]. |
| Fentanyl | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. … |
| Linezolid | contraindications | Starting SAVELLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.2 )]. |
| Lithium | drug interactions | Serotonin syndrome can occur with use of SAVELLA and other serotonergic drugs (other SNRIs, SSRIs, triptans, tricyclic antidepressants, opioids, lithium, tryptophan, buspirone, amphetamines, and St. John’s Wort), or with drugs that impair metabolism of serotonin (i.e., monoamine oxidase inhibitors). |
| Meperidine | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. … |
| Methadone | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. … |
| Methylene blue | contraindications | Starting SAVELLA in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome [see Dosage and Administration ( 2.6 ), Warnings and Precautions ( 5.2 )]. |
| Tramadol | warnings and precautions | The risk is increased with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, tramadol, meperidine, methadone, lithium, tryptophan, buspirone, amphetamines, and St. … |
| Warfarin | drug interactions | Drugs that Interfere with Hemostasis Concomitant use of SAVELLA with an antiplatelet or anticoagulant drug (e.g., NSAIDs, aspirin, and warfarin) may potentiate the risk of bleeding. |
Other labels that name milnacipran
Source: FDA drug label (Savella), NDA022256 (Abbvie), as published by Allergan, Inc., effective September 10, 2025 (SPL set 16a4a314-f97e-4e91-95e9-576a3773d284), via openFDA; the full label on DailyMed
What do FAERS reports show for milnacipran?
The FDA Adverse Event Reporting System holds 5,981 reports that list milnacipran among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 152 are coded as a death and 931 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as milnacipran?
4 other medicines are given the same way (oral) and in the same FDA class as milnacipran or labeled mainly for the same use (nerve pain and fibromyalgia), the same class first. Nerve pain and fibromyalgia lists all 6 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Duloxetine | Nerve pain and fibromyalgia | 45 labelers | $0.102 per capsule 30 mg capsule | No current entry |
| Gabapentin | Nerve pain and fibromyalgia | 87 labelers | $0.0218 per capsule 100 mg capsule | No current entry |
| Pregabalin | Nerve pain and fibromyalgia | 53 labelers | $0.0571 per capsule 100 mg capsule | No current entry |
| Gabapentin enacarbil | Nerve pain and fibromyalgia | none listed | $17.93 per tablet 300 mg tablet | No current entry |
Every medicine labeled for the same conditions as milnacipran
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
How does milnacipran compare with medicines for the same use?
1 side-by-side page set milnacipran beside a medicine whose label shares a use: approvals, generics, pharmacy cost, warnings and supply.
What next?
- Alternatives to milnacipran
- 4 medicines for the same use
- Other SNRIs
- the pharmacologic class, with prices and generics
- Milnacipran side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other