There may be a slightly increased risk of serious, possibly fatal side effects (e.g., pneumonia, heart failure) when this medication is used in older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

This medication is used to treat symptoms of a certain type of mental/mood condition (schizophrenia). Fluphenazine belongs to a class of medications called phenothiazines and is also referred to as a neuroleptic. It works by affecting the balance of natural chemicals (neurotransmitters) in the brain.

Some of the benefits of continued use of this medication include reduced episodes of hallucinations, delusions, or bizarre behaviors that occur in patients with schizophrenia.

This medication is not recommended for use in children under 12 years of age. Also, it should not be used to manage behavioral problems in patients with mental retardation.

Take with food or milk if stomach upset occurs unless directed otherwise by your doctor.

This medication must be taken as prescribed. Do not stop taking this drug suddenly without consulting your doctor. Some conditions may worsen if the medication is suddenly stopped.

Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time(s) each day. Dosage is based on your medical condition and response to therapy.

It may take up to two weeks for the full benefit of this medication to take effect. Inform your doctor if your condition does not improve or worsens.

Drowsiness, lethargy, dizziness, nausea, loss of appetite, sweating, dry mouth, blurred vision, headache, or constipation may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

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 immediately if any of these unlikely but serious side effects occur: feelings of restlessness, mask-like facial expression, greatly increased saliva, tremors, unusual mental/mood changes (e.g., depression, worsening of psychosis), confusion, unusual dreams, frequent urination or difficulty urinating, vision problems, weight change, swelling of the feet/ankles, fainting, skin discoloration.

Tell your doctor immediately if any of these rare but very serious side effects occur: 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.

For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, 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 (e.g., agranulocytosis, leukopenia) or liver problems. Seek immediate medical attention if you notice any of the following rare but very serious side effects: signs of infection (e.g., 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 unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: 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.

Before taking fluphenazine, tell your doctor or pharmacist if you are allergic to it; or to other phenothiazines (e.g., 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.

This medication should not be given to patients who are unconscious.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: brain damage, severe nervous system problems (severe CNS depression).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., leukopenia, thrombocytopenia, agranulocytosis), liver problems, breast cancer, eye problems (e.g., glaucoma), heart problems (e.g., 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 (e.g., asthma, emphysema, frequent infections), low blood calcium, enlarged prostate, drug or alcohol dependency, Reye's syndrome, other nervous system problems (e.g., cerebrovascular insufficiency, brain tumors, encephalitis, encephalopathy), dehydration.

Before having surgery or any diagnostic testing, tell your doctor or dentist that you are taking fluphenazine.

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.

To minimize dizziness and lightheadedness, get up slowly when rising from a seated or lying position.

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.

The medication can reduce sweating, making you more susceptible to heat stroke. Avoid strenuous work or exercise in hot weather.

Avoid being exposed to very cold temperatures (e.g., swimming in cold water). Severe lowering of your body temperature may occur.

Caution is advised when using this drug in children because they may be more sensitive to its effects, especially the side effect of uncontrolled movements. This is especially true if the child is sick (e.g., has chickenpox, measles, stomach flu).

Caution is advised when using this drug in the elderly, because they may be more sensitive to its effects, especially to facial or muscle twitching, muscle spasms/stiffness, uncontrolled movements (tardive dyskinesia) and possible effects on blood pressure.

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.

Based on information for similar drugs, fluphenazine may pass into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding while using this medication is not recommended. Consult your doctor before breast-feeding.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anticholinergics (e.g., atropine), dopamine agonists (e.g., cabergoline, pergolide), guanadrel, guanethidine, lithium.

Also report the use of drugs which might increase seizure risk (decrease seizure threshold) when combined with fluphenazine decanoate, such as isoniazid (INH), theophylline, or tramadol, among others. Consult your doctor or pharmacist for more details.

Tell your doctor or pharmacist if you also take drugs that cause drowsiness such as: antihistamines that cause drowsiness (e.g., diphenhydramine), anti-anxiety drugs (e.g., diazepam), anti-seizure drugs (e.g., carbamazepine), medicine for sleep (e.g., zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), other psychiatric medicines (e.g., other phenothiazines such as chlorpromazine, or tricyclics such as amitriptyline), tranquilizers.

Check the labels on all your medicines (e.g., cold-and-cough products) because they may contain drowsiness-causing ingredients. Ask your pharmacist about the safe use of those products.

This drug may interfere with certain laboratory tests (pregnancy test, phenylketonuria test, some urine tests). Make sure laboratory personnel and your doctors know you use this drug.

This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: loss of consciousness, seizures, fast/irregular heartbeat, or slow/shallow breathing.

Do not share this medication with others.

Laboratory and/or medical tests (e.g., liver function, kidney function, complete blood counts, eye exams, AIMS test) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

If you miss a dose and take 1 dose daily: take as soon as remembered unless it is almost time for the next dose. In that case, skip the missed dose and resume your usual schedule. If you take more than 1 dose daily: take as soon as possible if it is within an hour or so of the missed dose. If not remembered within an hour, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Store at room temperature between 59-86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Do not freeze. Keep tightly closed. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

Information last revised April 2013. Copyright(c) 2013 First Databank, Inc.