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Roweepra xr

Generic Name: Levetiracetam Extended-Release Tablets (lee va tye RA se tam)
Brand Name: Keppra XR, Roweepra XR
Easy-to-read patient leaflet for Roweepra XR. Includes indications, proper use, special instructions, precautions, and possible side effects.
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Drug Information:
This is not a list of all drugs or health problems that interact with Roweepra XR (levetiracetam extended-release tablets). Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Roweepra XR (levetiracetam extended-release tablets) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor. Use Roweepra XR (levetiracetam extended-release tablets) as ordered by your doctor. Read all information given to you. Follow all instructions closely. Learn more

Roweepra xr Side Effects

Roweepra XR Side Effects

Note: This document contains side effect information about levetiracetam. Some of the dosage forms listed on this page may not apply to the brand name Roweepra XR.

In Summary

Common side effects of Roweepra XR include: infection, asthenia, drowsiness, aggressive behavior, agitation, anxiety, apathy, depersonalization, depression, hostility, mental disorders, nervousness, outbursts of anger, emotional lability, and irritability. Other side effects include: dizziness, abnormal behavior, influenza, and nasopharyngitis. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to levetiracetam: oral solution, oral tablet, oral tablet for suspension, oral tablet extended release

Other dosage forms:

  • intravenous solution

Along with its needed effects, levetiracetam (the active ingredient contained in Roweepra XR) 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 levetiracetam:

More common

  • Aggressive or angry
  • anxiety
  • change in personality
  • chills
  • cough or hoarseness
  • crying
  • depersonalization
  • diarrhea
  • dry mouth
  • euphoria
  • fever
  • general feeling of discomfort or illness
  • headache
  • hyperventilation
  • irregular heartbeats
  • irritability
  • joint pain
  • loss of appetite
  • lower back or side pain
  • mental depression
  • muscle aches and pains
  • nausea
  • painful or difficult urination
  • paranoia
  • quick to react or overreact emotionally
  • rapidly changing moods
  • restlessness
  • shaking
  • shivering
  • shortness of breath
  • sleepiness or unusual drowsiness
  • sore throat
  • stuffy or runny nose
  • sweating
  • trouble sleeping
  • unusual tiredness or weakness
  • vomiting

Less common

  • Bloody nose
  • burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  • clumsiness or unsteadiness
  • discouragement
  • dizziness or lightheadedness
  • double vision
  • earache
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • increase in body movements
  • loss of bladder control
  • loss of memory
  • mood or mental changes
  • outburst of anger
  • pain or tenderness around the eyes and cheekbones
  • problems with memory
  • redness or swelling in the ear
  • seizures
  • sensation of spinning
  • shakiness and unsteady walk
  • shakiness in the legs, arms, hands, or feet
  • tightness of the chest
  • tiredness
  • trembling or shaking of the hands or feet
  • trouble concentrating
  • unsteadiness, trembling, or other problems with muscle control or coordination

Incidence not known

  • Attempts at killing oneself
  • being forgetful
  • bleeding gums
  • blistering, peeling, or loosening of the skin
  • bloating
  • blood in the urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • changes in vision
  • chest pain
  • constipation
  • dark urine
  • difficulty with moving
  • fast heartbeat
  • fever with or without chills
  • general feeling of tiredness or weakness
  • high fever
  • increase in body movements
  • indigestion
  • itching
  • light-colored stools
  • muscle pains or stiffness
  • painful or difficult urination
  • pains in the stomach, side, or abdomen, possibly radiating to the back
  • pale skin
  • pinpoint red spots on the skin
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • sores, ulcers, or white spots on the lips or in the mouth
  • stomach pain, continuing
  • swollen glands
  • swollen joints
  • thoughts or attempts at killing oneself
  • trouble with balance
  • twitching, twisting, or uncontrolled repetitive movements of the tongue, lips, face, arms, or legs
  • uncontrolled jerking or twisting movements of the hands, arms, or legs
  • uncontrolled movements of the lips, tongue, or cheeks
  • unexplained bleeding or bruising
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • weight loss
  • yellow eyes or skin

Some side effects of levetiracetam 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

  • Loss of strength or energy
  • muscle pain or weakness
  • pain
  • tender, swollen glands in the neck
  • trouble swallowing
  • unusual weak feeling
  • voice changes

Less common

  • Body aches or pain
  • burning, dry, or itching eyes
  • change in the color of the skin
  • congestion
  • cough increased
  • rash
  • sneezing

Incidence not known

  • Hair loss or thinning of the hair
  • skin rash, encrusted, scaly, and oozing

For Healthcare Professionals

Applies to levetiracetam: intravenous solution, oral solution, oral tablet, oral tablet dispersible, oral tablet extended release

General

The more commonly reported adverse reactions in adults have included somnolence, asthenia, and dizziness; in children, fatigue, aggression, nasal congestion, decreased appetite, and irritability.

Nervous system

Very common (10% or more): Headache (14%), somnolence (14%)

Common (1% to 10%): Dizziness, ataxia, vertigo, paresthesia, coordination difficulties

Postmarketing reports: Choreoathetosis, dyskinesia

Psychiatric

Very Common (10% or more): Non-psychotic behavioral symptoms (up to 38%), psychotic symptoms (up to 17%)

Common (1% to 10%): Depression, nervousness, amnesia, anxiety, hostility, emotional lability, irritability, mood swings, hypersomnia, insomnia, apathy, tearfulness, negativism

Postmarketing reports: Panic attack

In studies, non-psychotic behavioral symptoms (reported as aggression, agitation, anger, anxiety, apathy, depersonalization, depression, emotional lability, hostility, hyperkinesias, irritability, nervousness, neurosis, and personality disorder) were reported in 13% of adults and 38% of pediatric patients aged 4 to 16 years compared to 6% and 19%, respectively in placebo patients. In patients less than 4 years old, irritability was reported in 12% compared to 0% in placebo patients. In adult patients, behavioral symptoms resulted in dose reduction or discontinuation 0.8% and 1.7% of patients, respectively. Dose reduction or discontinuation due to behavioral symptoms occurred in 11% of pediatric patients.

In studies, psychotic symptoms were reported in 1%, 2%, and 17% of patients receiving this drug aged adult, 4 to 16 years old, and less than 4 years compared to 0.2%, 2%, and 5% in placebo patients, respectively.

Hematologic

In adults, 3.2% of patients receiving this drug had at least 1 WBC of 2.8 x 10(9)/L or lower and 2.4% had at least 1 neutrophil count of 1 x 10(9)/L or lower compared to 1.8% and 1.4% of placebo patients, respectively. Of those with a low neutrophil count, only 1 patient did not have resolution with continued treatment. No patient discontinued therapy due to a low neutrophil count. In pediatric patients 4 to 16 years old, mean decreases in WBC and neutrophils were 0.4 x 10(9)/L and 0.3 x 10(9)/L, respectively, compared to small increases in placebo patients. Mean relative lymphocyte counts increased by 1.7% in patients receiving this drug (placebo=decrease of 4%).

Common (1% to 10%): Decreased white blood cell count (WBC), decreased neutrophil count, increased lymphocyte counts, higher eosinophil counts

Frequency not reported: Decreases in white blood cell, neutrophil, and red blood cell counts; decreased in hemoglobin and hematocrit; increases in eosinophil counts

Postmarketing reports: Pancytopenia (with bone marrow suppression reported in some cases), thrombocytopenia, agranulocytosis

Hypersensitivity

Postmarketing reports: Anaphylaxis

Dermatologic

Alopecia reported with this drug resolved with discontinuation of therapy in most cases.

Frequency not reported: Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

Postmarketing reports: Erythema multiforme, alopecia, angioedema

Other

Very common (10% or more): Asthenia (15%), fatigue (10%)

Common (1% to 10%): Pain, vertigo

Respiratory

Common (1% to 10%): Pharyngitis, rhinitis, increased cough, sinusitis

Gastrointestinal

Common (1% to 10%): Diarrhea, gastroenteritis, constipation

Uncommon (0.1% to 1%): Nausea

Postmarketing reports: Pancreatitis

Ocular

Common (1% to 10%): Diplopia

Hepatic

Postmarketing reports: Abnormal liver function tests, hepatic failure, hepatitis

Musculoskeletal

Common (1% to 10%): Neck pain

Postmarketing reports: Muscular weakness

Immunologic

Very common (10% or more): Infection (13%)

Common (1% to 10%): Influenza

Postmarketing reports: Drug reaction with eosinophilia and systemic symptoms (DRESS)

Metabolic

Common (1% to 10%): Anorexia

Postmarketing reports: Weight loss, hyponatremia

Cardiovascular

Very common (10% or more): Increased diastolic blood pressure (less than 4 years of age; 17%)

In a clinical trial in patients 1 month to less than 4 years, 17% of patients had a significantly elevated diastolic blood pressure (placebo=2%). No overall difference in mean diastolic blood pressure was observed in treated patients compared with placebo nor was this effect observed in trials with older pediatric patients or adults.

Renal

Postmarketing reports: Acute kidney injury

Editorial References and Review

Medically reviewed by BestRx Medical Team Last updated on 1/1/2020.

Source: Drugs.com Roweepra Xr