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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.

In Summary

Common side effects of Savella include: hypertensive crisis, constipation, dizziness, headache, hot flash, nausea, and insomnia. Other side effects include: hypertension, increased heart rate, migraine, palpitations, skin rash, vomiting, anxiety, increased pulse, increased serum alanine aminotransferase, increased serum aspartate aminotransferase, hyperhidrosis, and xerostomia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to milnacipran: oral tablet

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

  • Blurred vision
  • body aches or pain
  • chills
  • cough
  • difficulty with breathing
  • dizziness
  • ear congestion
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fear or nervousness
  • fever
  • headache
  • increased sweating
  • loss of voice
  • nasal congestion
  • pounding in the ears
  • runny nose
  • slow or fast heartbeat
  • sneezing
  • sore throat
  • unusual tiredness or weakness

Less Common

  • Back pain
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • chest pain or discomfort
  • chills
  • decrease in frequency of urination
  • decrease in urine volume
  • difficult or painful urination
  • difficulty in passing urine (dribbling)
  • frequent urination
  • groin pain
  • muscle aches
  • pain or burning with urination
  • shakiness in the legs, arms, hands, or feet
  • swollen, tender prostate
  • tightness in the chest

Rare

  • Bladder pain
  • bloating or swelling of the face, arms, hands, lower legs, or feet
  • bloody or cloudy urine
  • bruise
  • discouragement
  • fall
  • feeling sad or empty
  • frequent urge to urinate
  • full or bloated feeling
  • heartburn
  • increased or decreased weight
  • irritability
  • lack of appetite
  • loss of interest or pleasure
  • lower back or side pain
  • pressure in the stomach
  • rapid weight gain
  • swelling of the abdominal or stomach area
  • tingling of the hands or feet
  • tiredness
  • trouble concentrating
  • trouble sleeping
  • unusual weight gain or loss
  • vomiting

Incidence Not Known

  • Agitation
  • black, tarry stools
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • coma
  • confusion as to time, place, or person
  • convulsions
  • dark-colored urine
  • decreased urine output
  • diarrhea
  • difficulty with swallowing
  • general tiredness and weakness
  • high fever
  • holding false beliefs that cannot be changed by fact
  • increased sweating
  • increased thirst
  • itching
  • joint or muscle pain
  • light-colored stools
  • loss of balance control
  • loss of consciousness
  • mask-like face
  • muscle cramps or spasms
  • muscle pain or stiffness
  • overactive reflexes
  • pinpoint red spots on the skin
  • poor coordination
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • restlessness
  • seeing, hearing, or feeling things that are not there
  • seizures
  • severe muscle stiffness
  • shuffling walk
  • slowed movements
  • slurred speech
  • sores, ulcers, or white spots on the lips or in the mouth
  • stiffness of the arms and legs
  • sweating
  • swelling of the face, ankles, fingers, or lower legs
  • swollen glands
  • talking or acting with excitement you cannot control
  • tic-like (jerky) movements of the head, face, mouth, and neck
  • tiredness
  • trembling and shaking of the fingers and hands
  • twitching
  • unusual bleeding or bruising
  • unusual excitement, nervousness, or restlessness
  • unusually pale skin
  • upper right abdominal or stomach pain
  • weight gain
  • yellow eyes and skin

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

  • Feeling of warmth
  • headache, severe and throbbing
  • redness of the face, neck, arms, and occasionally, upper chest
  • sudden sweating

Less Common

  • Abdominal or stomach pain
  • change or problem with discharge of semen
  • decreased appetite
  • decreased interest in sexual intercourse
  • inability to have or keep an erection
  • loss in sexual ability, desire, drive, or performance
  • not able to ejaculate semen
  • rash
  • swelling of the testes

Rare

  • Acid or sour stomach
  • belching
  • bloated
  • change in taste
  • excess air or gas in the stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • irritability
  • loss of taste
  • night sweats
  • passing gas
  • sleepiness or unusual drowsiness
  • stomach discomfort or upset

Incidence Not Known

  • Swelling of the breasts or unusual milk production
  • unexpected or excess milk flow from the breasts

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. "Product Information. Savella (milnacipran)." Forest Pharmaceuticals, St. Louis, MO.

2. Cerner Multum, Inc. "Australian Product Information." O 0

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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