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Vilazodone

Side Effects

Along with its needed effects, a medicine 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:

Less common

  • Actions that are out of control
  • Anxiety
  • Burning, crawling, itching, numbness, prickling, “pins and needles”, or tingling feelings
  • Chest pain or discomfort
  • Extra heartbeat
  • Fast, irregular, pounding, or racing heartbeat or pulse
  • Irritability
  • Nervousness
  • Shakiness in the legs, arms, hands, or feet
  • Sweating
  • Talking, feeling, and acting with excitement
  • Trembling or shaking of the hands or feet

Some side effects 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

  • Diarrhea
  • Dizziness
  • Dry mouth
  • Nausea
  • Sleeplessness
  • Trouble sleeping
  • Unable to sleep

Less common

  • Abdominal or stomach pain
  • Abnormal dreams
  • Aching or discomfort in the lower legs or sensation of crawling in the legs
  • Acid or sour stomach
  • Belching
  • Blindness
  • Bloated
  • Blurred vision
  • Change in taste
  • Decreased interest in sexual intercourse
  • Decreased vision
  • Difficulty with moving
  • Drowsiness
  • Dry eyes
  • Excess air or gas in the stomach or intestines
  • Feeling jittery
  • Full feeling
  • Headache, severe and throbbing
  • Heartburn
  • Inability to have or keep an erection
  • Increased or decreased appetite
  • Increased sweating
  • Indigestion
  • Loss in sexual ability, desire, drive, or performance
  • Loss of appetite
  • Loss of taste
  • Muscle pain or stiffness
  • Night sweats
  • Not able to have an orgasm
  • Pain in the joints
  • Passing gas
  • Relaxed and calm
  • Restlessness
  • Sleepiness or unusual drowsiness
  • Stomach discomfort, upset, or pain
  • Unusual tiredness or weakness
  • Vomiting
  • Weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Precautions

It is important that your doctor check your progress at regular visits to allow for changes in your dose and to help prevent any unwanted effects.

Do not take this medicine if you have used an MAO inhibitor (MAOI) such as Eldepryl®, Marplan®, Nardil®, or Parnate® within the past 14 days. Do not start taking a MAO inhibitor within 14 days of stopping vilazodone. If you do, you may develop confusion, agitation, restlessness, stomach or intestinal symptoms, sudden high body temperature, sweating, extremely high blood pressure, or severe convulsions.

Vilazodone 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.

Make sure your doctor knows about all the other medicines you are using. Vilazodone may cause a serious condition called serotonin syndrome or neuroleptic malignant syndrome (NMS)-like reactions if taken with certain medicines such as St. John’s wort, lithium (Eskalith®, Lithobid®), tryptophan, or some pain medicines (e.g., tramadol [Ultram®], sumatriptan [Imitrex®], zolmitriptan [Zomig®], or rizatriptan [Maxalt®]). Check with your doctor first before taking any other medicines.

If you develop a skin rash, hives, difficulty with breathing, or any allergic reaction to this medicine, stop taking the medicine and check with your doctor as soon as possible.

This medicine may increase your risk for bleeding problems. Make sure your doctor knows if you are also taking other medicines that thin the blood, such as aspirin, nonsteroidal anti-inflammatory agents also called NSAIDs (e.g., ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, or Motrin®), or warfarin (Coumadin®).

Do not suddenly stop taking this medicine without checking first with your doctor. If you have been instructed to stop taking vilazodone, ask your doctor how to slowly decrease the dose. This will decrease your chance of having withdrawal symptoms such as dizziness, nausea, headaches, vomiting, increased sweating, irritability, nightmares, or prickling or tingling feelings.

Hyponatremia (low sodium in the blood) may occur with this medicine. Stop using the medicine and check with your doctor right away if you have confusion, difficulty concentrating, headaches, memory problems, weakness, and unsteadiness.

Avoid drinking alcohol while taking this medicine.

Vilazodone may cause some people to become dizzy or drowsy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert.

Proper Use

Take this medicine only as directed by your doctor to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine comes with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

It is best to take this medicine with food.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor’s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (tablets):
    • For treatment of depression:
      • Adults—At first, 40 milligrams (mg) once a day. Some patients may start at 10 mg once a day for one week before increasing the dose to 40 mg once a day. Your doctor may increase your dose as needed.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of vilazodone in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of vilazodone in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood) which may require caution in patients receiving vilazodone.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Clorgyline
  • Isocarboxazid
  • Lazabemide
  • Linezolid
  • Methylene Blue
  • Moclobemide
  • Pargyline
  • Phenelzine
  • Procarbazine
  • Rasagiline
  • Selegiline
  • Tranylcypromine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Almotriptan
  • Aspirin
  • Bromfenac
  • Buspirone
  • Celecoxib
  • Citalopram
  • Desvenlafaxine
  • Diclofenac
  • Diflunisal
  • Duloxetine
  • Eletriptan
  • Escitalopram
  • Etodolac
  • Fluoxetine
  • Flurbiprofen
  • Fluvoxamine
  • Frovatriptan
  • Ibuprofen
  • Ibuprofen Lysine
  • Indomethacin
  • Ketoprofen
  • Ketorolac
  • Magnesium Salicylate
  • Mefenamic Acid
  • Meloxicam
  • Milnacipran
  • Nabumetone
  • Naproxen
  • Nefazodone
  • Nepafenac
  • Oxaprozin
  • Paroxetine
  • Piroxicam
  • Rizatriptan
  • Salsalate
  • Sertraline
  • Sibutramine
  • Sulindac
  • Sumatriptan
  • Tolmetin
  • Tramadol
  • Tryptophan
  • Venlafaxine
  • Warfarin
  • Zolmitriptan

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bipolar disorder (mood disorder with alternating episodes of mania and depression), or risk—Should not be used in patients with this condition.
  • Bleeding problems or
  • Hyponatremia (low sodium in the blood) or
  • Mania, history of or
  • Seizures, history of—Use with caution. May make these conditions worse.

Description

Vilazodone is used to treat major depressive disorder (MDD) in adults. It belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of chemicals called serotonin in the brain.

This medicine is available only with your doctor’s prescription.