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Savella Side Effects

Generic name: milnacipran

Medically reviewed by Drugs.com. Last updated on Mar 26, 2023.

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

Applies to milnacipran: oral tablet.

Warning

Oral route (Tablet)

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 with placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies with 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 with placebo in adults beyond age 24 years; there was a reduction in risk with antidepressants compared with placebo in adults aged 65 or 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 MDD. Milnacipran hydrochloride is not approved for use in pediatric patients.

Serious side effects of Savella

Along with its needed effects, milnacipran (the active ingredient contained in Savella) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking milnacipran:

More common

Less common

Rare

Incidence not known

Other side effects of Savella

Some side effects of milnacipran may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

Less common

Rare

Incidence not known

For Healthcare Professionals

Applies to milnacipran: oral tablet.

General

The most commonly reported side effects were nausea, constipation, headache, dizziness, insomnia, and hot flush.[Ref]

Gastrointestinal

Very common (10% or more): Nausea (up to 39%), constipation (up to 16%)

Common (1% to 10%): Vomiting, dry mouth, abdominal pain/upper abdominal pain, diarrhea, dyspepsia, gastroesophageal reflux disease, flatulence, abdominal distension

Uncommon (0.1% to 1%): Gastritis, stomatitis, hemorrhoids

Postmarketing reports: Acute pancreatitis[Ref]

Nervous system

Very common (10% or more): Headache (up to 19%), dizziness (up to 11%)

Common (1% to 10%): Migraine, paresthesia, tremor, tension headache, hypoesthesia, dysesthesia, somnolence, dysgeusia, convulsions (including grand mal), loss of consciousness, Parkinsonism, memory impairment

Uncommon (0.1% to 1%): Syncope, vertigo

Rare (0.01% to 0.1%): Balance disorder, cerebrovascular accident

Frequency not reported: Serotonin syndrome[Ref]

Dermatologic

Very common (10% or more): Hyperhidrosis (up to 14%)

Common (1% to 10%): Rash, pruritus, night sweats

Uncommon (0.1% to 1%): Urticaria

Rare (0.01% to 0.1%): Photosensitivity reaction

Postmarketing reports: Erythema multiforme, Stevens Johnson syndrome, ecchymosis/cutaneous or mucosal bleeding[Ref]

Cardiovascular

Very common (10% or more): Hot flush (up to 12%)

Common (1% to 10%): Palpitations, hypertension, increased heart rate, increased blood pressure, tachycardia, chest pain, chest discomfort, flushing

Uncommon (0.1% to 1%): Arrhythmia, extrasystoles, hypotension, orthostatic hypotension, Raynaud's phenomena

Rare (0.01% to 0.1%): Acute coronary syndrome, angina pectoris

Frequency not reported: Contusion, peripheral edema

Postmarketing reports: Supraventricular tachycardia, hypertensive crisis[Ref]

Psychiatric

Very common (10% or more): Insomnia (up to 12%)

Common (1% to 10%): Anxiety, depression, stress, irritability, agitation

Uncommon (0.1% to 1%): Suicidal ideation, panic attack, confusion, hallucination, nightmares, decreased libido

Frequency not reported: Physical dependence

Postmarketing reports: Aggression, anger, delirium, homicidal ideation, elimination of psychomotor inhibition with suicidal risk, mood switch with episodes of mania, reactivation of delusions in patients with psychosis[Ref]

Genitourinary

Common (1% to 10%): Dysuria, ejaculation disorder, erectile dysfunction, ejaculation failure, prostatitis, scrotal pain, testicular pain, testicular swelling, urinary hesitation, urinary retention, urethral pain, decreased urine flow, cystitis, urinary tract infection

Uncommon (0.1% to 1%): Pollakiuria, metrorrhagia

Rare (0.01% to 0.1%): Amenorrhea[Ref]

Other

Common (1% to 10%): Chills, pyrexia, fatigue, fall, pain

Uncommon (0.1% to 1%): Tinnitus, feeling of body temperature change[Ref]

Musculoskeletal

Common (1% to 10%): Back pain, fibromyalgia, muscle spasms, arthralgia, pain in extremity

Postmarketing reports: Rhabdomyolysis[Ref]

Respiratory

Common (1% to 10%): Upper respiratory tract infection, dyspnea, sinusitis, nasopharyngitis

Uncommon (0.1% to 1%): Dyspnea

Rare (0.01% to 0.1%): Epistaxis[Ref]

Metabolic

Common (1% to 10%): Decreased or increased weight, hypercholesterolemia, decreased appetite

Postmarketing reports: Hyponatremia, anorexia[Ref]

Ocular

Common (1% to 10%): Blurred vision

Uncommon (0.1% to 1%): Dry eye, mydriasis, reduced visual acuity

Postmarketing reports: Accommodation disorder[Ref]

Immunologic

Common (1% to 10%): Influenza[Ref]

Hepatic

Uncommon (0.1% to 1%): Increased hepatic enzymes

Rare (0.01% to 0.1%): Hepatitis

Postmarketing reports: Cytolytic hepatitis[Ref]

Hypersensitivity

Uncommon (0.1% to 1%): Hypersensitivity[Ref]

Renal

Frequency not reported: Cystitis

Postmarketing reports: Acute renal failure[Ref]

Hematologic

Postmarketing reports: Leukopenia, neutropenia, thrombocytopenia[Ref]

Endocrine

Postmarketing reports: Hyperprolactinemia, galactorrhea[Ref]

References

1. Cerner Multum, Inc. Australian Product Information.

2. Product Information. Savella (milnacipran). Forest Pharmaceuticals. 2009.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

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