Savella Side Effects
Generic name: milnacipran
Medically reviewed by Drugs.com. Last updated on Oct 13, 2024.
Note: This document provides detailed information about Savella Side Effects associated with milnacipran. Some dosage forms listed on this page may not apply specifically to the brand name Savella.
Applies to milnacipran: oral tablet.
Important warnings
This medicine can cause some serious health issues
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.
Precautions
It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help reduce any side effects. Blood and urine tests may be needed to check for any unwanted effects.
Milnacipran may cause some teenagers and young adults to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Some people may have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. If you or your caregiver notice any of these unwanted effects, tell your doctor right away. Let the doctor know if you or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.
Do not take this medicine during 14 days after stopping a monoamine oxidase inhibitor (MAOI) (eg, isocarboxazid [Marplan®], linezolid [Zyvox®], methylene blue injection, phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®]). Do not take an MAO inhibitor for at least 5 days after stopping milnacipran (the active ingredient contained in Savella) Talk to your doctor about this if you have questions.
Make sure your doctor knows if you are also using aspirin, NSAIDs (eg, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Motrin®), or a blood thinner (eg, warfarin, Coumadin®). Milnacipran may increase your risk of bleeding problems when taken together with these medicines.
This medicine may cause a serious condition called serotonin syndrome when taken with certain medicines such as St. John's wort, buspirone, fentanyl, lithium, tryptophan, amphetamines, other medicines to treat depression, or some pain or migraine medicines (eg, rizatriptan [Maxalt®], sumatriptan [Imitrex®], tramadol [Ultram®], or zolmitriptan [Zomig®]. Check with your doctor first before taking any other medicines. Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there.
You will also need to have your blood pressure and pulse measured before starting and while you are using this medicine. If you notice any change to your recommended blood pressure or pulse rate, call your doctor right away. If you have questions about this, talk to your doctor.
Check with your doctor right away if you have clay-colored stools, dark urine, decreased appetite, fever, headache, itching, loss of appetite, nausea and vomiting, skin rash, stomach pain or tenderness, swelling of the feet or lower legs, unusual tiredness or weakness, or yellow eyes or skin. These may be symptoms of a serious liver problem.
Avoid drinking alcohol while you are using this medicine.
This medicine may cause some people to become less alert than they are normally. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Check with your doctor right away if you have confusion, headache, memory problems, trouble concentrating, weakness, or feel unsteady when standing.
Do not stop using this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely to decrease the chance of side effects, including actions that are out of control, agitation, anxiety, confusion, continuing ringing or buzzing or other unexplained noise in the ears, dizziness, headache, hearing loss, irritability, nervousness, seizures, talking, feeling, and acting with excitement, trouble sleeping, or unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness.
Check with your doctor right away if you have decreased interest in sexual intercourse, delayed or inability to have and orgasm in women, inability to have or keep an erection in men, or loss in sexual ability, desire, drive, or performance. These could be symptoms of sexual dysfunction.
Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (eg, St. John's wort) or vitamin supplements.
Serious side effects of Savella
Along with its needed effects, milnacipran 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 side effects
- 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 side effects
- back pain
- burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
- chest pain, discomfort, or tightness
- 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
Rare side effects
- 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 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
- dark-colored urine
- delayed or inability to have an orgasm
- decreased interest in sexual intercourse
- decreased urine output
- diarrhea
- difficulty with swallowing
- general tiredness and weakness
- high fever
- holding false beliefs that cannot be changed by fact
- inability to have or keep an erection
- increased sweating
- increased thirst
- itching
- joint or muscle pain
- light-colored stools
- loss in sexual ability, desire, drive, or performance
- 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
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 side effects
- feeling of warmth
- headache, severe and throbbing
- redness of the face, neck, arms, and occasionally, upper chest
- sudden sweating
Less common side effects
- decreased appetite
- rash
- stomach pain
- swelling of the testes
Rare side effects
- 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 adverse events
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]
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References
1. Cerner Multum, Inc. "Australian Product Information."
2. (2009) "Product Information. Savella (milnacipran)." Forest Pharmaceuticals
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Further information
Savella side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.