Fesoterodine

Fesoterodine is a prescription medication used to treat overreactive bladder.  

• Fesoterodine is available under the following different brand names: Toviaz 

Common side effects of Fesoterodine include:

• Dry mouth, and
• Constipation

Serious side effects of Fesoterodine include:

• Chest pain,
• Fast or uneven heart rate,
• Swelling of the hands or feet,
• Severe stomach pain,
• Constipation,
• Confusion,
• Hallucinations,
• Little or no urination,
• Pain or burning while urinating,
• Feeling very thirsty or hot,
• Being unable to urinate,
• Heavy sweating, and
• Hot and dry skin

Rare side effects of Fesoterodine include:

• none 

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Tablet extended-release

• 4 mg
• 8 mg

Overactive Bladder

Adult dosage

• 4 mg orally once a day; may increase to 8 mg orally once a day based upon individual response and tolerability

Pediatric Neurogenic Detrusor Overactivity

Pediatric dosage

• Children below 6 years: Not established
• Children above 6 years and below 25 kg: Not established
• Children below 6 years and above 25-35 kg: 4 mg once a day; may increase the dose to 8 mg once a day if needed
• Children above 6 years and above 35 kg: 4 mg once a day, initially; increase to 8 mg once a day after one week

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Fesoterodine has severe interactions with the following drug:
  • Itraconazole
• Fesoterodine has serious interactions with the following drug:
  • carbamazepine
  • cimetidine
  • clarithromycin
  • erythromycin base
  • erythromycin ethylsuccinate
  • erythromycin lactobionate
  • erythromycin stearate
  • givosiran
  • glycopyrronium tosylate topical
  • ketoconazole
  • levoketoconazole
  • pramlintide
  • referencing 
  • rifabutin
  • rifampin
  • secretin
  • St John's Wort
• Fesoterodine has moderate interactions with at least 159 other drugs.
• Fesoterodine has minor interactions with at least 31 other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to drugs or ingredients
• Urinary or gastric retention
• Uncontrolled narrow-angle glaucoma 

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Fesoterodine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Fesoterodine?”

Cautions

• Use caution in reduced hepatic/renal function, and autonomic neuropathy
• Therapy can worsen controlled narrow-angle glaucoma; contraindicated in patients with uncontrolled narrow-angle glaucoma; should be used with caution in patients being treated for narrow-angle glaucoma; use only when potential benefits outweigh risks
• Anticholinergic CNS effects (. g, headache, dizziness, somnolence) reported; monitor for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing dose; advise patients not to drive or operate heavy machinery until they adjust to therapy; consider dose reduction or drug discontinuation if a patient experiences anticholinergic CNS effect
• Caution with myasthenia gravis, a disease characterized by decreased cholinergic activity at the neuromuscular junction and, bladder flow obstruction; therapy may worsen symptoms
• Heat prostration may occur in the presence of increased environmental temperature
• Angioedema
  • Angioedema of the face, lips, tongue, and/or larynx reported
  • In some cases, angioedis ema is reported to occur after the first dose; however, may also occur after multiple doses
  • Angioedema associated with upper airway swelling may be life-threatening
  • If the involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue the drug and promptly provide appropriate therapy and/or measures to ensure the patient’s airway
  • Urinary retention in adults with bladder outlet obstruction
  • Use in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury
  • Use is not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention
• Gastric motility
  • Therapy is associated with decreased gastric motility
  • Use is not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation
• Drug interactions overview
  • Anticholinergic agents may potentially alter the absorption of fesoterodine owing to decreased GI motility
  • Coadministration of potent CYP3A4 inhibitors ketoconazole with fesoterodine led to approximately a doubling of peak plasma concentration and area under the concentration versus time curve of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine (see Dosage Modifications)
  • Coadministration of moderate CYP3A4 inhibitors had no clinically relevant effect on the pharmacokinetics of fesoterodine
  • Coadministration of rifampin 600 mg/day, a CYP3A4 inducer, Cmax and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75% after fesoterodine 8 mg dose

Pregnancy and Lactation

• There are no data on fesoterodine use in pregnant women to inform a drug-associated risk for major birth defects, miscarriage, or adverse maternal or fetal outcomes
• In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively, the maximum recommended human dose (MRHD) of 8 mg/day based on AUC
• Lactation
  • There is no information on the presence of fesoterodine in human milk, the effects on the breastfed child, or the effects on milk production