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Savella may cause congestion. This drug may also cause the following symptoms that are related to congestion: Medical Source InformationYellow highlights indicate symptoms related to congestion. Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.
Call your doctor at once if you have any new or worsening symptoms 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:
fast or pounding heartbeats;
painful or difficult urination;
easy bruising or bleeding, nosebleeds, bloody or tarry stools, coughing up blood;
confusion, hallucinations, severe weakness, seizure ( convulsions);
high fever, sweating, chills or goose bumps, memory problems, trouble concentrating, loss of coordination, overactive reflexes, vomiting, diarrhea;
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 may include:
constipation;
dry mouth, nausea, stomach pain, heartburn, bloating;
dizziness, drowsiness, headache, tired feeling;
stuffy nose, sneezing, or other cold symptoms;
sleep problems (insomnia);
swelling in your hands or feet;
hot flashes, sweating, itching, mild skin rash;
numbness or tingling;
blurred vision; 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. You may report side effects to FDA at 1-800-FDA-1088. You may report side effects to FDA at 1-800-FDA-1088.
Milnacipran 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 to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of 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 to placebo in adults beyond age of 24. There was a reduction in risk with antidepressants compared to placebo in adults aged 65 and 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 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.
The development of a potentially life-threatening serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions have been reported with SNRIs and SSRIs alone, including milnacipran, but particularly with concomitant use of serotonergic drugs (including triptans) with drugs which impair metabolism of serotonin (including MAOIs), or with antipsychotics or other dopamine antagonists. Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Serotonin syndrome, in its most severe form can resemble neuroleptic malignant syndrome, which includes hyperthermia, muscle rigidity, autonomic instability with possible rapid fluctuation of vital signs, and mental status changes. Patients should be monitored for the emergence of serotonin syndrome or NMS-like signs and symptoms.
The development of a potentially life-threatening serotonin syndrome may occur with agents that inhibit serotonin reuptake, including milnacipran, particularly with concomitant use of serotonergic drugs (including triptans and tramadol) and with drugs which impair metabolism of serotonin (including MAOIs). Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).
Side Effects to Watch Watch closely for the following side effects and notify your physician immediately should any of these develop: - Abnormal bruising or signs of bleeding such as bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash (signs of problems with blood clot formation)
Lab and Diagnostic Tests If certain symptoms develop, ask your physician whether you need the following lab tests or other diagnostic tests (if you've not already had them): - Blood pressure - whenever dose is increased
- Blood pressure - periodically
- Blood tests to assess normal clotting - in people who develop signs of bleeding such as abnormal bruising or signs of bleeding including bleeding from the gums, nose, digestive tract, vagina (females), faintness, dizziness, loss of consciousness, or rash
- Blood pressure - when the drug is first started
- Monitor blood tests
- Monitor serotonin and serotonin
Multum version: 154.0
(Jun 16, 2010)
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