Savella Side Effects

Generic name: milnacipran

Note: This document contains side effect information about milnacipran. Some of the dosage forms listed on this page may not apply to the brand name Savella.

Some side effects of Savella may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

Applies to milnacipran: oral tablet

Get emergency medical help if you have any of these signs of an allergic reaction while taking milnacipran (the active ingredient contained in Savella) skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Report any new or worsening symptoms to your doctor, such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:

• pounding heartbeats or fluttering in your chest;

• painful or difficult urination;

• easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;

• severe weakness, seizure (convulsions);

• chills or goose bumps, memory problems, trouble concentrating,

• agitation, hallucinations, fast heart rate, overactive reflexes, nausea, vomiting, diarrhea, loss of coordination, fainting;

• very stiff (rigid) muscles, high fever, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• high blood pressure (severe headache, blurred vision, buzzing in your ears, chest pain, shortness of breath, uneven heartbeats); or

• stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects of milnacipran may include:

• headache;

• dizziness, drowsiness, tired feeling;

• swelling in your hands or feet;

• constipation, upset stomach, bloating;

• dry mouth;

• sleep problems (insomnia);

• hot flashes, sweating;

• weight changes; or

• decreased sex drive, impotence, or difficulty having an orgasm.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to milnacipran: oral tablet

Gastrointestinal

Very common (10% or more): Nausea (35%), constipation (16%),
Common (1% to 10%): Vomiting (6%), dry mouth (5%), abdominal pain (3%)
Uncommon (0.1% to 1%): Decreased appetite (1%)
Frequency not reported: Anorexia, diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, abdominal distension

Nervous system

Very common (10% or more): Headache (19%), dizziness (11%)
Common (1% to 10%): Migraine (6%), paresthesia (2%), tremor (2%), tension headache (2%), hypoesthesia (1%)
Frequency not reported: Night sweats, somnolence, dysgeusia, fatigue, convulsions (including grand mal), loss of consciousness, neuroleptic malignant syndrome, Parkinsonism, serotonin syndrome

Psychiatric

Very common (10% or more): Insomnia (12%)
Common (1% to 10%): anxiety (5%)
Frequency not reported: Aggression, depression, stress, anger, delirium, hallucinations, homicidal ideation, irritability

Cardiovascular

Common (1% to 10%): Palpitations (8%), hypertension (7%), increased heart rate (5%), increased blood pressure (3%), tachycardia (3%), chest pain (3%), chest discomfort (2%)
Postmarketing reports: Supraventricular tachycardia, hypertensive crisis

Dermatologic

Common (1% to 10%): Hyperhidrosis (8%), rash (3%), pruritus (3%)
Frequency not reported: Night sweats, erythema multiforme, Stevens Johnson syndrome

Respiratory

Common (1% to 10%): Upper respiratory tract infection (7%), upper respiratory tract infection (6%), dyspnea (2%)

Ocular

Common (1% to 10%): Blurred vision (1%)
Frequency not reported: Accommodation disorder

Genitourinary

Common (1% to 10%): Reported in at least 2% of males: Dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, decreased libido, prostatitis, scrotal pain, testicular pain, testicular swelling, urinary hesitation, urinary retention, urethral pain, decreased urine flow, cystitis, galactorrhea
Frequency not reported: Urinary tract infection

Other

Frequency not reported: Contusion, fall, physical dependence

Milnacipran produces physical dependence, including withdrawal symptoms following drug discontinuation, similar to other SNRIs and SSRIs. These withdrawal symptoms can be severe.

Metabolic

Very common (10% or more): Hot flush (11%)
Common (1% to 10%): Flushing (2%), chills (1%)
Frequency not reported: Weight decreased or increased, hypercholesterolemia, hyponatremia, pyrexia, peripheral edema

Renal

Frequency not reported: Urinary tract infection, cystitis, acute renal failure

Hematologic

Frequency not reported: Leukopenia, neutropenia, thrombocytopenia

Endocrine

Frequency not reported: Hyperprolactinemia, galactorrhea

Hepatic

Frequency not reported: Hepatitis

Musculoskeletal

Frequency not reported: Rhabdomyolysis

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