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Solifenacin (Vesicare): Uses, Side Effects and Dosage

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Source: FDA drug labeling via NLM DailyMed · About this document

Patient information: uses, side effects, how to take - Solifenacin

What are solifenacin succinate tablets?

Solifenacin succinate tablets are a prescription medicine for adults used to treat the following symptoms due to a condition called overactive bladder:

  • Urge urinary incontinence: a strong need to urinate with leaking or wetting accidents
  • Urgency: a strong need to urinate right away
  • Frequency: urinating often

Solifenacin succinate tablets 5 mg and 10 mg tablets are not approved for use in children.

Who should not take solifenacin succinate tablets?

Do not take solifenacin succinate tablets if you:

  • are not able to empty your bladder (urinary retention)
  • have delayed or slow emptying of your stomach (gastric retention)
  • have an eye problem called “uncontrolled narrow-angle glaucoma”
  • are allergic to solifenacin succinate or any of the ingredients in solifenacin succinate tablets. See the end of this leaflet for a complete list of ingredients.

What should I tell my doctor before taking solifenacin succinate tablets?

Before you take solifenacin succinate tablets, tell your doctor if you:

  • have any stomach or intestinal problems or problems with constipation
  • have trouble emptying your bladder or you have a weak urine stream
  • have an eye problem called “narrow-angle glaucoma”
  • have liver problems
  • have kidney problems
  • have a rare heart problem called “QT prolongation”

  • are pregnant or plan to become pregnant. It is not known if solifenacin succinate will harm your unborn baby. Talk to your doctor if you are pregnant or plan to become pregnant.

  • are breastfeeding or plan to breastfeed. It is not known if solifenacin succinate passes into your breast milk. You and your doctor should decide if you will take solifenacin succinate tablets or breastfeed.

Tell your doctor about all the medicines you take,including prescription and nonprescription medicines, vitamins, and herbal supplements. Solifenacin succinate may affect the way other medicines work, and other medicines may affect how solifenacin succinate works.

How should I take solifenacin succinate tablets?

  • Take solifenacin succinate tablets exactly as your doctor tells you to take it.
  • You should take 1 solifenacin succinate tablet 1 time a day.
  • You should take solifenacin succinate tablets with water and swallow the tablet whole.

  • You can take solifenacin succinate tablets with or without food.

  • If you miss a dose of solifenacin succinate tablets, begin taking solifenacin succinate tablets again the next day. Do not take 2 doses of solifenacin succinate tablets the same day.

  • If you take too much solifenacin succinate tablets, call your doctor or go to the nearest hospital emergency room

    right away.

What should I avoid while taking solifenacin succinate tablets?

Solifenacin succinate can cause blurred vision or drowsiness. Do not drive or operate heavy machinery until you know how solifenacin succinate affects you.

What are the possible side effects of solifenacin succinate?

Solifenacin succinate may cause serious side effects including:

  • Serious allergic reaction.Stop taking solifenacin succinate tablets and get medical help right away if you have:

    • hives, skin rash or swelling
    • severe itching
    • swelling of your face, mouth or tongue
    • trouble breathing

The most common side effects of solifenacin succinate tablets include:

  • dry mouth
  • constipation. Call your doctor if you get severe stomach area (abdominal) pain or become constipated for 3 or more days.
  • urinary tract infection
  • blurred vision

Other side effects have been observed with anticholinergic drugs such as Solifenacin succinate tablets and may include:

  • dry skin due to decreased sweating. Heat exhaustion or heat stroke can happen due to decreased sweating when solifenacin succinate tablets are used in hot environments. Symptoms may include:

    • decreased sweating
    • dizziness
    • tiredness
    • nausea
    • increase in body temperature

Tell your doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of solifenacin succinate tablets are. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088.

How should I store solifenacin succinate tablets?

  • Store solifenacin succinate tablets between 59°F to 86°F (15°C to 30°C). Keep the bottle closed.
  • Safely throw away medicine that is out of date or no longer needed.

Keep solifenacin succinate tablets and all medicines out of the reach of children.

General information about the safe and effective use of solifenacin succinate tablets

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use solifenacin succinate tablets for a condition for which it was not prescribed. Do not give solifenacin succinate tablets to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about solifenacin succinate tablets. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about solifenacin succinate tablets that is written for health professionals.

What are the ingredients in solifenacin succinate tablets?

Active ingredient:solifenacin succinate

Inactive ingredients:hypromellose, lactose anhydrous, magnesium stearate, silicified microcrystalline cellulose, lactose monohydrate, titanium dioxide and triacetin.

What is overactive bladder?

Overactive bladder occurs when you cannot control your bladder contractions. When these muscle contractions happen too often or cannot be controlled you can get symptoms of overactive bladder, which are urinary frequency, urinary urgency, and urinary incontinence (leakage).

Manufactured by:

Sunshine Lake Pharma Co., Ltd.

No. 1, Northern Industry Road,

Northern Industry Park of Song Shan Lake,

Dongguan, Guangdong 523808, China

Distributed by:

HEC Pharm USA Inc.

Plainsboro, NJ 08536

For more information, contact HEC Pharm USA Inc. at 1-800-610-5709.

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: 07/2026

About this document

Source: FDA drug labeling via NLM DailyMed · Application number: ANDA 213346 · View the label on DailyMed

Revision date stated in the text: July 2026

Found a mistake? Write to us via the contact page.

The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Solifenacin

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Cholinergic Muscarinic Antagonist
Active ingredient Solifenacin succinate
Dosage form Tablet, film coated
Route Oral
Marketing status listed in the FDA NDC Directory
Company (applicant) SUNSHINE
FDA approval ANDA 213346Abbreviated New Drug Application (ANDA) – generic drug Approved April 13, 2020
Therapeutic equivalence (TE) code ABCodes starting with A mean the FDA rates the drug therapeutically equivalent to its reference drug (Orange Book).
Manufacturers 15 labelers list this drug on DailyMed
Recalls
  • March 13, 2025: Class II recall: CGMP Deviations
  • March 13, 2025: Class II recall: CGMP Deviations
Packages (NDC)
Package
5 mg – 30 in 1 bottle NDC 72303-0831-1
5 mg – 90 in 1 bottle NDC 72303-0831-2
10 mg – 30 in 1 bottle NDC 72303-0832-1
10 mg – 90 in 1 bottle NDC 72303-0832-2

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.