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Prozac (fluoxetine)

Side Effect Search

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Prozac may cause autonomic nervous system effects (dry mouth, nausea, vomiting, fainting, stuffy nose, light sensitivity, constipation, blurred vision) (may not actually cause this side effect but may cause symptoms that mimic it).

This drug may also cause the following symptoms that are related to autonomic nervous system effects:

Medical Source Information
Yellow highlights indicate symptoms related to autonomic nervous system effects.

Gastrointestinal side effects have frequently included nausea (15% to 21%) and diarrhea (12%). Dry mouth, constipation, dyspepsia, stomatitis, and upper gastrointestinal bleeding have also been reported.

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: severe blistering, peeling, and red skin rash; very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes; nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops. Less serious side effects may include: cold symptoms such as stuffy nose, sneezing, sore throat; drowsiness, dizziness, feeling nervous; mild nausea, upset stomach, constipation; increased appetite, weight changes; sleep problems (insomnia); decreased sex drive, impotence, or difficulty having an orgasm; or dry mouth. 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.

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 fluoxetine, 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.

Upon discontinuation of SSRI antidepressant therapy, symptoms of withdrawal including dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood have been reported.

Nervous system side effects including headache, anxiety, nervousness, insomnia, drowsiness, sedation, tremor, dizziness, jitteriness, and fatigue have all been reported. The reported incidence of each of these effects ranges between 4% and 20% of treated patients. Cases of akathisia, neuromuscular twitching, tics, myoclonus, migraines, sleep abnormalities, dyskinesia, acute dystonic reactions, worsening of Parkinson's disease, seizures, stuttering, paresthesias, and cognitive dysfunction have also been reported.

Other side effects include a withdrawal-type reaction. In one retrospective chart review of 352 patients who were supervised during tapering and discontinuation from serotonin reuptake inhibitor therapy, dizziness, lethargy, paresthesia, nausea, vivid dreams, irritability, and lowered mood were the most common symptoms reported. Patients with at least on qualitatively new symptom were defined in the fluoxetine group at a rate of 1.5%.

Side Effects to Watch
Watch closely for the following side effects and notify your physician immediately should any of these develop:

Abnormal heart rate, fluttering in the chest, weakness, faintness, dizziness or loss of consciousness (signs of a serious condition called "torsade de pointe or QT prolongation" in which irregular heartbeats occur)
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):

Monitor serotonin
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
EKG - if abnormal heartbeats (rapid slow or irregular) develop
Platelet counts - should be monitored

Multum version: 154.0 (Jun 16, 2010)

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