- Clinician Information:
Prolixin Consumer (continued)
To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (such as depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration, butterfly-shaped facial rash, joint pain, seizures.
In rare instances, this medication may increase your level of a certain hormone (prolactin). For females, this rare increase in prolactin may result in unwanted breast milk, missing/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.
Rarely, males may have a painful or prolonged erection lasting 4 or more hours. If this occurs, stop using this drug and get medical help right away, or permanent problems could occur.
Fluphenazine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face, mouth, tongue, arms, or legs).
This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.
This drug may infrequently cause serious blood problems (such as agranulocytosis, leukopenia) or liver problems. Get medical help right away if you notice any of the following rare but very serious side effects: signs of infection (such as fever, persistent sore throat), easy bruising/bleeding, severe stomach/abdominal pain, yellowing of the eyes/skin.
A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the Prolixin (fluphenazine) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: Before taking fluphenazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (such as chlorpromazine, perphenazine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: brain damage, nervous system problems (such as CNS depression, cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), blood problems (such as leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (such as glaucoma), heart problems (such as very high or very low blood pressure, mitral valve insufficiency), kidney problems, certain types of tumors (pheochromocytoma), seizures, exposure to phosphorus insecticides, chronic breathing problems (such as asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye's syndrome, dehydration.
Before having surgery or any diagnostic testing, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors.
This medication may decrease your ability to sweat, making you more likely to get heat stroke. Avoid activities that may cause you to overheat (such as doing strenuous work/exercise in hot weather, using hot tubs). When the weather is hot, drink plenty of fluids and dress lightly. If you become overheated, promptly seek cooler shelter and stop exercising. Get medical help right away if you develop a fever, mental/mood changes, headache, or dizziness.
Avoid being exposed to very cold temperatures (such as swimming in cold water). Severe lowering of your body temperature may occur.
Children may be more sensitive to the side effects of this drug, especially the side effect of uncontrolled movements. This is especially true if the child is sick (such as has chickenpox, measles, stomach flu).
Older adults may be more sensitive to the side effects of this drug, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia), drowsiness, confusion, and possible effects on blood pressure. Drowsiness and confusion can increase the risk of falling.
During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. Do not stop taking this medication unless directed by your doctor. Liver problems or birth defects may occur in infants exposed to this type of medication in the womb. Tell the doctor right away if you notice yellowing of the eyes/skin or dark urine in your infant. Babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.
It is unknown if this medication passes into breast milk. However, similar drugs pass into breast milk. Consult your doctor before breast-feeding.
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