Fluvoxamine Maleate

Last Reviewed: Nov 07, 2024

Warnings


Fluvoxamine Risks, Warnings, and Complications


Fluvoxamine can cause or worsen health problems in certain high-risk individuals. Talk to your doctor or pharmacist about other treatment options for your mental illness if you are at increased risk of adverse reactions from fluvoxamine use. Some of the risks of taking fluvoxamine include:

  • SUICIDAL THOUGHTS AND BEHAVIOR: Taking fluvoxamine can cause sudden and unexpected changes in mental health, including suicidal thoughts or behaviors (thinking about harming yourself or trying to kill yourself). This risk is especially high in children, adolescents, and young adults under 24 years of age. Tell your doctor immediately if you develop new or worsening depression or suicidal thoughts or behavior, especially when you first start fluvoxamine treatment and after dosage adjustments. Your family members should know when and how to seek care for any unusual changes in mood or behavior if you are unable to do so yourself. 

  • INTERFERENCE WITH MOTOR PERFORMANCE AND COGNITION: Fluvoxamine can cause drowsiness and impaired thinking, judgment, and motor skills. Be careful while driving a motor vehicle or doing other potentially hazardous activities until you know how this medication affects you. 

  • SEROTONIN SYNDROME: Fluvoxamine works by increasing serotonin levels in the brain. Taking this medicine can put you at risk of a condition called serotonin syndrome. This is a rare but potentially life-threatening condition that occurs when there is too much serotonin in the body. The risk of serotonin syndrome is higher in people who are taking other medications that also affect serotonin levels, for example, antidepressants, migraine medicines called triptans, lithium, and herbal products like St. John's wort. 

    Symptoms of excess serotonin include fever, sweating, an irregular or fast heart rate, muscle stiffness or twitching, and confusion. Seek immediate medical attention if you develop these symptoms.

  • INTERACTIONS WITH OTHER DRUGS: Fluvoxamine can interact with other medications and cause serious adverse effects, including life-threatening health problems. Fluvoxamine can interact with thioridazine, tizanidine, pimozide, alosetron, ramelteon, a benzodiazepine, methadone, mexiletine, theophylline, warfarin, an MAO inhibitor, and a nonsteroidal anti-inflammatory drug.

    Give your doctor and pharmacist a complete list of all the medications you are on, including prescription drugs, over-the-counter medicines, dietary supplements, and herbal remedies, before starting fluvoxamine.

  • NARROW-ANGLE GLAUCOMA: Fluvoxamine and other antidepressants can cause changes in the eyes that are usually harmless. However, these drugs can cause worsening narrow-angle glaucoma in people with this eye condition. Tell your doctor without delay if you notice any vision changes, such as colored rings around lights, eye pain, swelling, or redness while on fluvoxamine.

  • WITHDRAWAL SYMPTOMS: Suddenly stopping fluvoxamine can cause withdrawal symptoms such as dizziness, headache, fatigue, uneasiness, irritability, agitation, anxiety, confusion, insomnia, mood changes, nausea, flu-like symptoms, and burning, pain, or numbness and tingling in the hands and feet. Your doctor will tell you how to gradually reduce the dose to come off fluvoxamine safely.

  • ABNORMAL BLEEDING: Fluvoxamine can increase the risk of unusual or abnormal bleeding or bruising. The risk is higher if you are on other medications that also increase bleeding risk, such as aspirin, NSAIDs, or blood thinners. Tell your healthcare provider if you develop nosebleeds, bleeding gums, blood in vomit, blood in urine, or blood in stool. 

  • ACTIVATION OF MANIA OR HYPOMANIA: Depression can be the presenting symptom of bipolar disorder. Taking an antidepressant medication such as fluvoxamine can activate mania or hypomania in people with undiagnosed bipolar disorder. Symptoms of mania may include overactivity, abnormal excitement, euphoria, and delusions. Before starting fluvoxamine, tell your doctor if you have a personal or family history of bipolar disorder. 

  • SEIZURES: Rarely, fluvoxamine can trigger seizures. People with a history of seizures or risk factors for seizures are at a higher risk of this occurring. Before starting fluvoxamine therapy, tell your healthcare provider if you have ever had seizures in the past. 

  • HYPONATREMIA: Very rarely, fluvoxamine can cause hyponatremia( low blood sodium levels). Risk factors include older age, taking diuretics or water pills, and dehydration. Your provider may order regular blood tests while you are taking fluvoxamine to keep an eye on your sodium levels. Keep all your medical and laboratory appointments while on this medicine. Tell your doctor if you experience hyponatremia symptoms such as headache, weakness, confusion, or problems with concentration or memory. 

  • SEXUAL DYSFUNCTION: Fluvoxamine and other SSRIs can cause sexual problems such as erectile dysfunction and ejaculation failure in men, delayed or absent orgasm in women, and lower sex drive in both men and women. Tell your doctor if you experience sexual problems while taking fluvoxamine.


Precautions Before Starting Fluvoxamine

Tell your doctor if you have ever had an allergic reaction to fluvoxamine, any of the active or inactive ingredients in fluvoxamine tablets and extended-release capsules, other SSRIs, or any other drugs. Your pharmacy can give you a list of ingredients.

Give your doctor and pharmacist a complete list of your medications, including prescription drugs, over-the-counter medicines, vitamins, supplements, and herbal products. This can help avoid possible drug interactions.

Give your doctor a complete medical history. Fluvoxamine may not be safe for people with certain medical conditions such as alcohol or drug abuse, recent heart attack, low sodium, bleeding problems, seizure disorders, heart disease, kidney disease, or liver disease.

Tell your doctor if you are pregnant, could be pregnant, plan to get pregnant, or are planning a pregnancy in the near future. Also, tell your healthcare provider if you are nursing an infant with breast milk.

Precautions During Use of Fluvoxamine

Keep all your medical and lab appointments while on fluvoxamine. Your doctor may want to adjust your dose based on your response and monitor you for side effects.

Fluvoxamine can cause drowsiness and affect your thinking, judgment, and motor skills. Do not drive or do any activity that requires your full concentration until you know how this medicine affects you. Remember, alcohol can make drowsiness worse, so avoid drinking alcohol while on fluvoxamine.

Avoid smoking while taking fluvoxamine. Tobacco products can decrease the effectiveness of this drug.

Tell all your healthcare providers you are on fluvoxamine, especially before any surgery, including dental treatments.

Tell your doctor if you become pregnant while on fluvoxamine. This drug can cause harm to the baby if it is taken during the last few months of pregnancy.

Fluvoxamine Drug Interactions

Certain other drugs can affect how fluvoxamine works. Possible interactions between fluvoxamine and other medicines can increase the risk of severe side effects. Your doctor may change your dose, switch you to a different medication, or monitor you closely for adverse effects if there are known interactions between fluvoxamine and your other medications.

You should not take fluvoxamine at the same time as the following drugs:

  • Thioridazine
  • Tizanidine (Zanaflex)
  • Alosetron (Lotronex)
  • Pimozide (Orap)
  • Ramelteon (Rozerem)

Also, tell your doctor if you are currently taking or have taken within the past 14 days medications called monoamine oxidase inhibitors (MAOIs). Examples include methylene blue, linezolid (Zyvox), isocarboxazid (Marplan), phenelzine (Nardil), selegiline (Emsam, Zelapar), rasagiline (Azilect), and tranylcypromine (Parnate). 

Fluvoxamine can also have interactions with the following medications:

  • Anti-anxiety medications called benzodiazepines, such as alprazolam (Xanax), triazolam (Halcion), midazolam (Seizalam), and diazepam (Valium, others)
  • Stimulants such as amphetamines
  • Dextromethorphan (found in cough medicines) 
  • Aspirin, aspirin-containing medicines, and other nonsteroidal anti-inflammatory drugs such as ibuprofen (Motrin, Advil) and naproxen (Naprosyn, Aleve)
  • Anticoagulants or blood thinners, such as warfarin (Coumadin)
  • Beta-blockers such as propranolol (Inderal, Innopran, Hemangeol) and metoprolol (Lopressor, Toprol)
  • Anti-anxiety medications such as buspirone
  • Antiepileptic drugs such as carbamazepine (Carbatrol, Equetro, Tegretol, others) and phenytoin (Dilantin, Phenytek)
  • Antipsychotic drugs such as clozapine (Clozaril, Versacloz) and haloperidol (Haldol)
  • Immunosuppressants such as cyclosporine (Neoral, Sandimmune)
  • Diuretics or water pills
  • Calcium channel blockers such as diltiazem (Cartia, Cardizem, Tiazac, others)
  • Opioid medicines such as fentanyl (Actiq, Abstral, Fentora, Onsolis, others), tramadol (Ultram, Conzip, Qdolo, in Ultracet), and methadone (Methadose)
  • Antifungal agents such as ketoconazole
  • Antimanic agents such as lithium (Lithobid)
  • Medications called triptans are prescribed for migraine headaches, such as eletriptan (Relpax), almotriptan (Axert), frovatriptan (Frova), rizatriptan (Maxalt), sumatriptan (Imitrex), naratriptan, and zolmitriptan (Zomig)
  • Antiarrhythmic drugs such as mexiletine and quinidine
  • Drugs used to treat nausea and vomiting, such as metoclopramide
  • Proton pump inhibitors such as omeprazole (Prilosec, Zegerid)
  • Other drugs used to treat mental illnesses such as anxiety or depression
  • Alzheimer’s medications such as tacrine (Cognex)
  • Medications used to treat lung conditions, such as theophylline (Theo-24, Theochron)

Give your healthcare professional a complete list of your medications, including prescription drugs, over-the-counter medications, dietary supplements, and herbal remedies. Also, tell your doctor or pharmacist if you smoke, drink alcohol, or use recreational drugs because some of these substances can cause serious health complications when used with prescription medications.