What the label lists and what reports show
Milnacipran side effects
Milnacipran's FDA label: “Most Common Adverse Reactions in Placebo Controlled Trials In the placebo-controlled fibromyalgia patient trials, the most frequently occurring adverse reaction in clinical trials was nausea.” FAERS holds 5,981 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is nausea (696 reports).
- Generic listed
- Boxed warning
Check it at the source: the milnacipran FDA label on DailyMed (effective September 10, 2025, Allergan, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of SAVELLA ?SAVELLA may cause side effects, some serious, including: See “ What is the most important information I should know about SAVELLA ? ” The most common side effects of SAVELLA include: • nausea • vomiting • headache • irregular heartbeat (palpitations) • constipation • heart rate increased • dizziness • dry mouth • trouble sleeping • high blood pressure (hypertension) • hot flush • increased sweating Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of SAVELLA. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Source: FDA drug label, 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 label list?
From the label: adverse reactionsMost Common Adverse Reactions in Placebo Controlled Trials In the placebo-controlled fibromyalgia patient trials, the most frequently occurring adverse reaction in clinical trials was nausea.
Table 4: Treatment-Emergent Adverse Reaction Incidence in Placebo Controlled Trials in Fibromyalgia Patients (Events Occurring in at Least 2% of All SAVELLA-Treated Patients and Occurring More Frequently in Either…
| System Organ Class– Preferred Term | SAVELLA 100 mg/day (n = 623) % | SAVELLA 200 mg/day (n = 934) % | All SAVELLA (n = 1557) % | Placebo (n = 652) % |
|---|---|---|---|---|
| Palpitations | 8 | 7 | 7 | 2 |
| Tachycardia | 3 | 2 | 2 | 1 |
| Vision blurred | 1 | 2 | 2 | 1 |
| Nausea | 35 | 39 | 37 | 20 |
| Constipation | 16 | 15 | 16 | 4 |
| Vomiting | 6 | 7 | 7 | 2 |
| Dry mouth | 5 | 5 | 5 | 2 |
| Abdominal pain | 3 | 3 | 3 | 2 |
| Chest pain | 3 | 2 | 2 | 2 |
| Chills | 1 | 2 | 2 | 0 |
| Chest discomfort | 2 | 1 | 1 | 1 |
| Upper respiratory tract infection | 7 | 6 | 6 | 6 |
| Heart rate increased | 5 | 6 | 6 | 1 |
| Blood pressure increased | 3 | 3 | 3 | 1 |
| Decreased appetite | 1 | 2 | 2 | 0 |
| Headache | 19 | 17 | 18 | 14 |
| Dizziness | 11 | 10 | 10 | 6 |
| Migraine | 6 | 4 | 5 | 3 |
| Paresthesia | 2 | 3 | 2 | 2 |
| Tremor | 2 | 2 | 2 | 1 |
| Hypoesthesia | 1 | 2 | 1 | 1 |
| Tension headache | 2 | 1 | 1 | 1 |
| Insomnia | 12 | 12 | 12 | 10 |
| Anxiety | 5 | 3 | 4 | 4 |
| Dyspnea | 2 | 2 | 2 | 1 |
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, continuedThe 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 ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact AbbVie at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial s Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Patient Exposure SAVELLA was evaluated in three double-blind placebo-controlled trials involving 2209 fibromyalgia patients (1557 patients treated with SAVELLA and 652 patients treated with placebo) for a treatment period up to 29 weeks. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. A reaction was considered treatment emergent if it occurred for the first time or worsened while receiving therapy following baseline evaluation. …
Source: FDA drug label, 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?
5,981 reports list milnacipran among the medicines taken, 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. Of the 23 reactions below, 15 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
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Milnacipran: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions