What is the most important information I should know about fluvoxamine?

You should not take fluvoxamine if you are allergic to it, or if you are also taking alosetron (Lotronex), linezolid (Zyvox), ramelteon (Rozerem), tizanidine (Zanaflex), thioridazine (Mellaril), pimozide (Orap), or an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate). Some of these medications can cause serious or life-threatening drug interactions when taken within 14 days before or after taking fluvoxamine.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Report any new or worsening symptoms to your doctor, 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.

Many other drugs can interact with fluvoxamine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Tell your doctor right away if you become pregnant while taking this medication. Fluvoxamine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of OCD symptoms if you stop taking fluvoxamine. Do not start or stop taking the medication during pregnancy without your doctor's advice.

What is fluvoxamine?

Fluvoxamine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluvoxamine affects chemicals in the brain that may become unbalanced and cause obsessive-compulsive symptoms.

Fluvoxamine is used to treat social anxiety disorder (social phobia), or obsessive-compulsive disorders involving recurring thoughts or actions.

Fluvoxamine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking fluvoxamine?

You should not take this medication if you are allergic to fluvoxamine, or if you are also taking:

• alosetron (Lotronex);
• ramelteon (Rozerem);
• tizanidine (Zanaflex);
• thioridazine (Mellaril);
• pimozide (Orap); or
• an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), linezolid (Zyvox), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam, Zelapar), or tranylcypromine (Parnate).

Some of these medications can cause serious or life-threatening drug interactions when taken together with fluvoxamine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluvoxamine. After you stop taking fluvoxamine, you must wait at least 14 days before you can start taking an MAOI.

To make sure you can safely take fluvoxamine, tell your doctor if you have any of these other conditions:

• liver or kidney disease;
• heart disease, high blood pressure, or a history of stroke;
• a bleeding or blood clotting disorder;
• seizures or epilepsy;
• bipolar disorder (manic depression); or
• low levels or sodium in your blood (an electrolyte imbalance).

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

You may have thoughts about suicide when you first start taking fluvoxamine, especially if you are younger than 24 years old. Tell your doctor if you have symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

FDA pregnancy category C. Tell your doctor right away if you become pregnant while taking this medication. Fluvoxamine may cause heart defects or serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of OCD symptoms if you stop taking fluvoxamine. Do not start or stop taking the medication during pregnancy without your doctor's advice.

Fluvoxamine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are using fluvoxamine.

Do not give fluvoxamine to anyone younger than 18 years old without the advice of a doctor.

How should I take fluvoxamine?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Do not crush, chew, or open an extended-release capsule. Swallow the pill whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

You may take fluvoxamine with or without food.

Do not stop using fluvoxamine without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include blurred vision, lack of coordination, extreme drowsiness, nausea and vomiting, fast heart rate, trouble breathing, fainting, and coma.

What should I avoid while taking fluvoxamine?

Drinking alcohol can increase certain side effects of fluvoxamine.

This medication may impair your thinking or reactions. Avoid driving or operating machinery until you know how fluvoxamine will affect you.

What are the possible side effects of fluvoxamine?

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.

Report any new or worsening symptoms to your doctor, 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 a serious side effect such as:

• seizure (convulsions);
• changes in weight or appetite;
• easy bruising or unusual bleeding;
• racing thoughts, feelings of extreme happiness or irritability;
• agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination, fainting;
• very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out; or
• headache, trouble concentrating, memory problems, weakness, feeling unsteady, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:

• decreased sex drive, abnormal ejaculation, trouble having an orgasm;
• mild nausea, upset stomach, loss of appetite;
• dizziness, drowsiness, weakness, yawning;
• increased sweating;
• anxiety, sleep problems (insomnia);
• muscle pain; or
• sore throat.

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.

What other drugs will affect fluvoxamine?

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Cambia, Cataflam, Voltaren, Flector Patch, Pennsaid, Solareze), indomethacin (Indocin), meloxicam (Mobic), and others. Using an NSAID with fluvoxamine may cause you to bruise or bleed easily.

Before using fluvoxamine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression, or anxiety). They can add to sleepiness caused by fluvoxamine.

Many drugs can interact with fluvoxamine. Below is just a partial list. Tell your doctor if you are using:

• clopidogrel (Plavix);
• a diuretic (water pill);
• lithium (Lithobid, Eskalith);
• methadone (Dolophine, Methadose);
• omeprazole (Prilosec);
• St. John's wort;
• tacrine (Cognex);
• tramadol (Ultram);
• tryptophan (also called L-tryptophan);
• theophylline (Elixophyllin, Theo-24, Uniphyl);
• warfarin (Coumadin, Jantoven);
• an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Tofranil), and others;
• a heart or blood pressure medication such as diltiazem (Cardizem, Cartia, Dilacor, Diltia, Diltzac, Taztia, Tiazac), mexiletine (Mexitil), metoprolol (Dutoprol, Lopressor, Toprol), propranolol (Inderal), or quinidine (Quin-G);
• migraine headache medication such as almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig);
• medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (Clozaril, FazaClo), haloperidol (Haldol), perphenazine (Trilafon), and others;
• a sedative such as diazepam (Valium), alprazolam (Xanax), midazolam (Versed), or triazolam (Halcion); or
• seizure medication such as carbamazepine (Carbatrol, Equetro, Tegretol) or phenytoin (Dilantin).

This list is not complete and there are many other medicines that can cause serious medical problems if you take them together with fluvoxamine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about fluvoxamine.