Solifenacin

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

  • Bladder pain
  • Bloody or cloudy urine
  • Chills
  • Decrease in frequency of urination
  • Decrease in urine volume
  • Difficult, burning, or painful urination
  • Difficulty in passing urine (dribbling)
  • Fever
  • Frequent urge to urinate
  • Painful urination
  • Swelling of the lower legs
  • Unusual tiredness or weakness

Incidence not known

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • Chest pain or discomfort
  • Fainting
  • Irregular heartbeat recurrent
  • Irregular or slow heart rate
  • Large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • Rapid weight gain
  • Shortness of breath
  • Tingling of the hands or feet
  • Unusual weight gain or loss

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

  • Blurred vision
  • Confusion
  • Constipation
  • Delirium or hallucinations
  • Dizziness
  • Drowsiness
  • Dry eyes, mouth, nose, or throat
  • Dry skin
  • Eye pain
  • Failure of heel-to-toe exam
  • Fast heartbeat
  • Fixed and dilated pupils
  • Flushing or redness of the face
  • Nausea
  • Tremors
  • Troubled breathing
  • Vomiting

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

  • Dry mouth

Less common

  • Acid or sour stomach
  • Belching
  • Body aches or pain
  • Congestion
  • Cough
  • Diarrhea
  • Discouragement
  • Dizziness
  • Feeling sad or empty
  • General feeling of discomfort or illness
  • Headache
  • Heartburn
  • Hoarseness
  • Indigestion
  • Irritability
  • Joint pain
  • Lack of appetite
  • Loss of interest or pleasure
  • Lower back or side pain
  • Muscle aches and pains
  • Nervousness
  • Pounding in the ears
  • Runny nose
  • Shivering
  • Slow or fast heartbeat
  • Sore throat
  • Stomach discomfort, upset, or pain
  • Sweating
  • Tender, swollen glands in the neck
  • Tiredness
  • Trouble concentrating
  • Trouble with sleeping
  • Trouble with swallowing
  • Upper abdominal or stomach pain
  • Voice changes

Incidence not known

  • Hives or welts
  • Itching
  • Redness of the skin
  • Skin rash

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 very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Solifenacin may cause a serious type of allergic reaction called angioedema. Angioedema may be life-threatening and requires immediate medical attention. Stop taking this medicine and check with your doctor right away if you have a rash; itching; a large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; trouble with breathing; or chest tightness while you are using this medicine.

This medicine may cause some people to have vision problems. Make sure your vision is clear before you drive, use machines, or do anything else that could be dangerous if you are not able to see well.

This medicine may make you sweat less, causing your body temperature to increase. Use extra care not to become overheated during exercise or hot weather while you are taking this medicine, since overheating may result in heat stroke.

This medicine may cause constipation. Call your doctor if you get severe stomach pain or become constipated for 3 or more days.

This medicine may cause dry mouth. For temporary relief of mouth dryness, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if your mouth continues to feel dry for more than 2 weeks, check with your medical doctor or dentist.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Proper Use

Take this medicine only as directed by your doctor. 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. To do so may increase the chance for side effects.

This medicine comes with a patient information insert. Read and follow the instructions in the insert carefully. Ask your doctor if you have any questions.

You may take this medicine with or without food.

Swallow the tablet whole with liquids. Do not break, crush, or chew it.

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):
    • To treat bladder problems:
      • Adults—5 milligrams (mg) once per day. Your doctor may increase your dose if needed. However, the dose is usually not more than 10 mg once per day.
      • Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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 solifenacin 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 solifenacin in the elderly. However, elderly patients are more likely to have age-related kidney or liver problems, which may require caution and an adjustment in the dose for patients receiving solifenacin.

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.

  • Potassium

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Ketoconazole

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

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:

  • Glaucoma, narrow-angle and uncontrolled or
  • Stomach retention (food does not pass easily) or
  • Urinary retention (not passing urine)—Should not be used in patients with these conditions.
  • Bladder blockage (hard to urinate) or
  • QT prolongation (a heart rhythm problem), history of or
  • Slow bowels or constipation—Use with caution. May make these conditions worse.
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

Description

Solifenacin is used to treat symptoms of an overactive bladder, such as incontinence (loss of bladder control), a strong need to urinate right away, or a frequent need to urinate. Solifenacin works on the muscles of the bladder to prevent them from causing incontinence.

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