Urbanol Side effects

• Side effects of Urbanol in details
• Urbanol contraindications
• Urbanol reviews

What are the possible side effects of Urbanol?

Get emergency medical help if you have signs of an allergic reaction to Urbanol (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

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.

Urbanol can slow or stop your breathing, especially if you have recently used an opioid medication, alcohol, or other drugs that can slow your breathing. A person caring for you should seek emergency medical attention if you have weak or shallow breathing, if you are hard to wake up, or if you stop breathing.

Call your doctor at once if you have:

• severe drowsiness, feeling like you might pass out;

• unusual changes in mood or behavior;

• aggression, thoughts of hurting yourself; or

• problems with balance or muscle movement.

The sedative effects of Urbanol may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking Urbanol.

Common Urbanol side effects may include:

• constipation;

• drowsiness, lack of energy;

• fever; or

• drooling.

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.

Urbanol side effects (more detail)

Side effects of Urbanol in details

Applies to Urbanol: oral suspension, oral tablet

Along with its needed effects, Urbanol (the active ingredient contained in Urbanol) 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 while taking Urbanol:

More Common

• Difficulty with swallowing
• fever
• shakiness and unsteady walk
• unsteadiness, trembling, or other problems with muscle control or coordination

Less Common

• Change in speech pattern
• restlessness
• slurred speech
• trouble sitting still
• trouble speaking

Incidence Not Known

• Agitation
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chest pain
• chills
• confusion as to time, place, or person
• cough
• diarrhea
• difficult or troubled breathing
• holding false beliefs that cannot be changed by fact
• irregular, fast or slow, or shallow breathing
• itching
• joint or muscle pain
• lack of feeling or emotion
• painful or difficult urination
• pale or blue lips, fingernails, or skin
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• troubled breathing with exertion
• unusual bleeding or bruising
• unusual excitement, nervousness, or restlessness
• unusual tiredness or weakness

Some side effects of Urbanol 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

• Aggressive
• body aches or pain
• decreased appetite
• difficulty having a bowel movement (stool)
• drooling
• ear congestion
• irritability
• loss of voice
• nasal congestion
• runny nose
• sleepiness or unusual drowsiness
• sneezing
• vomiting

Less Common

• Bladder pain
• cloudy urine
• cough with mucus
• frequent urge to urinate
• increased appetite
• lower back or side pain

Incidence Not Known

• Double vision
• full or bloated feeling
• headache
• muscle spasms
• pressure in the stomach
• rash, hives, or welts
• red skin
• swelling of the stomach area

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

• Urbanol suspension may cause drowsiness, dizziness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Urbanol suspension with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Check with your doctor before you drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Urbanol suspension; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
• Do NOT change your dose or use more often than prescribed without checking with your doctor.
• Do not suddenly stop taking Urbanol suspension without first talking with your doctor, especially if you have been taking Urbanol suspension regularly over a long period of time. You may have an increased risk of seizures or side effects (eg, mood changes, trouble sleeping). If you need to stop Urbanol suspension, your doctor may need to gradually lower your dose.
• Carry an ID card at all times that says you have a seizure disorder and you take Urbanol suspension.
• Patients who take Urbanol suspension may be at increased risk of suicidal thoughts or actions. The risk may be greater in patients who have had suicidal thoughts or actions in the past. Watch patients who take Urbanol suspension closely. Contact your doctor at once if new, worsened, or sudden symptoms, such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior, occur. Contact your doctor right away if any signs of suicidal thoughts or actions occur.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.
• Hormonal birth control (eg, birth control pills) may not work as well while you are using Urbanol suspension and for 28 days after you stop taking it. To prevent pregnancy, use an extra nonhormonal form of birth control (eg, condoms). Talk with your doctor or pharmacist about effective birth control.
• Tell your doctor or dentist that you take Urbanol suspension before you receive any medical or dental care, emergency care, or surgery.
• Use Urbanol suspension with caution in the ELDERLY; they may be more sensitive to its effects.
• Urbanol suspension should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Urbanol suspension may cause harm to the fetus. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Urbanol suspension while you are pregnant. Using Urbanol suspension late in pregnancy may increase the risk of breathing or feeding problems, very low body temperature, or withdrawal symptoms in the newborn. Urbanol suspension is found in breast milk. Do not breast-feed while using Urbanol suspension.

Some people who use Urbanol suspension for a long time may develop a need to continue taking it. People who take high doses are also at risk. This is known as DEPENDENCE or addiction. If you stop taking Urbanol suspension suddenly, you may have WITHDRAWAL symptoms. These may include diarrhea, dry heaving, hallucinations, headache, irregular heartbeat, mental or mood problems (eg, anxiety, irritability, nervousness, panic attacks, restlessness), muscle pain and stiffness, nausea, seizures, stomach and muscle cramps, sweating, trouble concentrating or sleeping, tremor, weight loss, or vision changes (eg, blurred vision, sensitivity to light). Do not suddenly stop taking Urbanol suspension without first checking with your doctor.

Urbanol contraindications

Hypersensitivity to Urbanol or any component of the formulation.

Canadian labeling: Additional contraindications (not in US labeling): Myasthenia gravis; narrow-angle glaucoma; severe hepatic or respiratory disease; sleep apnea; history of substance abuse; use in the first trimester of pregnancy; breast-feeding

References

1. DailyMed. "CLOBAZAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
2. DTP/NCI. "Clobazam: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "Clobazam: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

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Information checked by Dr. Sachin Kumar, MD Pharmacology