Trokendi XR Side Effects
Generic name: topiramate
Note: This document provides detailed information about Trokendi XR.
Applies to topiramate: oral capsule, oral capsule extended release, oral solution, oral tablet Side Effects associated with topiramate. Some dosage forms listed on this page may not apply specifically to the brand name Trokendi XR.
Applies to topiramate: oral capsule, oral capsule extended release, oral solution, oral tablet.
Precautions
It is very important that your doctor check your or your child's progress at regular visits to see if the medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.
Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.
Birth control pills containing estrogen may not work properly if you take them with topiramate (the active ingredient contained in Trokendi XR) To keep from getting pregnant, use an additional form of birth control (eg, condoms, spermicide) together with your birth control pill. If you have any questions about this, check with your doctor or pharmacist.
This medicine may cause vision changes, clumsiness or unsteadiness, dizziness, drowsiness, or trouble with thinking or speaking. Make sure you know how you or your child react to this medicine before you drive, use machines, climb in high places, swim, or do anything else that could be dangerous if you are not alert, well-coordinated, or able to think or see well.
Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system. The use of alcohol or other medicines that affect the CNS with topiramate may worsen the side effects of this medicine, such as dizziness, poor concentration, drowsiness, unusual dreams, and trouble with sleeping. Some examples of medicines that affect the CNS are antihistamines or medicine for allergies or colds, sedatives, tranquilizers, or sleeping medicines, medicine for depression, medicine for anxiety, prescription pain medicine or narcotics, medicine for attention deficit and hyperactivity disorder, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics.
Check with your doctor right away if you or your child have changes in vision or pain around the eyes during and after treatment with this medicine. Your doctor may want your eyes to be checked by an ophthalmologist (eye doctor).
This medicine may make you sweat less which will cause your body temperature to increase. Use extra care not to become overheated during exercise or hot weather with this medicine. Overheating may result in heat stroke and hot baths or saunas may make you dizzy or feel faint.
Topiramate may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you, your child, or your caregiver notice any of these side effects, tell your doctor right away.
This medicine may cause nausea, muscle tremors, breathing problems, eating problems, a fast heartbeat, restlessness, and stomach pain. Tell your doctor right away if you or your child have any of these symptoms. You might have a serious condition called metabolic acidosis (too much acid in the blood).
This medicine may decrease the density of bones, which can make your bones weak. Talk with your doctor if you have any concerns about this.
This medicine may cause slow growth. For children, the doctor will need to keep track of height and weight to make sure that the child is growing properly.
Do not suddenly stop using this medicine without checking first with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often. Your doctor may want you or your child to gradually reduce the amount you are using before stopping it completely.
Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur with Topamax® and Eprontia™. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, chills, cough, diarrhea, itching, joint or muscle pain, red irritated eyes, red skin lesions, often with a purple center, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness with this medicine.
Check with your doctor right away if you or your child are having unusual drowsiness, dullness, tiredness, weakness, feelings of sluggishness, mental depression or anxiety, nightmares or unusually vivid dreams, or vomiting. These may be symptoms of a serious condition called hyperammonemic encephalopathy.
Check with your doctor right away if you or your child have sudden back pain, stomach pain, pain while urinating, or bloody or dark urine. These may be symptoms of kidney stones.
Tell your doctor if your or your child's skin feels like it is burning, crawling, itching, or if you have numbness, prickling, "pins and needles", or tingling feeling after using topiramate.
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.
Serious side effects of Trokendi XR
Along with its needed effects, topiramate 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 topiramate:
More common side effects
- blurred vision
- burning, prickling, or tingling sensations
- clumsiness or unsteadiness
- confusion
- continuous, uncontrolled back-and-forth or rolling eye movements
- dizziness
- double vision
- drowsiness
- eye redness or pain
- generalized slowing of mental and physical activity
- increased eye pressure
- memory problems
- menstrual changes or pain
- nervousness
- speech or language problems
- trouble in concentrating or paying attention
- unusual tiredness or weakness
Less common side effects
- aggression
- agitation
- chest pain
- chills
- discouragement
- feeling sad or empty
- fever
- irritability
- lack of feeling or emotion
- lessening of sensations or perception
- loss of appetite
- loss of interest or pleasure
- red, irritated, or bleeding gums
- sore throat
- stomach pain
- trouble sleeping
- weight loss
Rare side effects
- blood in the urine
- difficult or painful urination
- frequent urination
- hearing loss
- itching, skin rash
- loss of bladder control
- lower back or side pain
- nosebleeds
- pale skin
- ringing or buzzing in the ears
- swelling
- trouble breathing
Incidence not known
- blistering, peeling, or loosening of the skin
- bloating
- bone fractures, especially of the thigh bone
- bone pain, tenderness, or aching
- clay-colored stools
- constipation
- cough
- decrease in height
- diarrhea
- increased rate of breathing
- joint or muscle pain
- muscle weakness
- pain in the back, ribs, arms, or legs
- pain or tenderness in the upper stomach
- red skin lesions, often with a purple center
- sores, ulcers, or white spots in the mouth or on the lips
- yellow eyes or skin
Get emergency help immediately if any of the following symptoms of overdose occur while taking topiramate:
Symptoms of overdose
- decreased awareness or responsiveness
- dizziness, fainting, or lightheadedness when getting up suddenly from a lying or sitting position
- severe sleepiness
- unusual drowsiness, dullness, or feeling of sluggishness
Other side effects of Trokendi XR
Some side effects of topiramate 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 side effects
- breast pain in women
- tremors
Less common side effects
- constipation
- feeling of warmth
- heartburn
- increased sweating
- redness of the face, neck, arms, and occasionally, upper chest
Rare side effects
- decrease in sexual performance or desire
For healthcare professionals
Applies to topiramate: oral capsule, oral capsule extended release, oral solution, oral tablet.
General adverse events
The more commonly reported adverse reactions for use as an antiepileptic have included paresthesia, anorexia, weight loss, speech disorders/related speech problems, fatigue, dizziness, somnolence, nervousness, psychomotor slowing, abnormal vision and fever. For use in migraine, the more commonly reported adverse events have included paresthesia, anorexia, weight loss, difficulty with memory, taste perversion, diarrhea, hypoesthesia, nausea, abdominal pain and upper respiratory tract infection.
Cardiovascular
- Uncommon (0.1% to 1%): Bradycardia, sinus bradycardia, palpitations, hypotension, orthostatic hypotension, flushing, hot flush
- Rare (less than 0.1%): Raynaud's phenomenon[Ref]
Dermatologic
- Common (1% to 10%): Alopecia, rash, pruritus
- Uncommon (0.1% to 1%): Anhidrosis, hypoesthesia facial, urticaria, erythema, pruritus generalized, rash macular, skin discoloration, dermatitis allergic, swelling face
- Rare (less than 0.1%): Stevens-Johnson syndrome, erythema multiforme, skin odor abnormal, periorbital edema, urticaria localized
- Frequency not reported: Toxic epidermal necrolysis, oligohidrosis
- Postmarketing reports: Bullous skin reactions, pemphigus[Ref]
Hematologic
- Common (1% to 10%): Anemia, epistaxis
- Uncommon (0.1% to 1%): Leucopenia, thrombocytopenia lymphadenopathy, white blood cell count decreased, eosinophilia
- Rare (less than 0.1%): Neutropenia[Ref]
Hypersensitivity
- Common (1% to 10%): Hypersensitivity
- Frequency not reported: Allergic edema, conjunctival edema[Ref]
Hepatic
- Rare (less than 0.1%): Hepatitis, hepatic failure, increase in liver enzymes
- Postmarketing reports: Hepatic failure including fatalities[Ref]
Nervous system
- Very common (10% or more): Paraesthesia, somnolence, dizziness
- Common (1% to 10%): Disturbance in attention, memory impairment, amnesia, cognitive disorder, mental impairment, psychomotor skills impaired, convulsion, coordination abnormal, tremor, lethargy, hypethesia, nystagmus, dysgeusia, balance disorder, dysarthria, intention tremor, sedation
- Uncommon (0.1% to 1%): Depressed level of consciousness, grand mal convulsion, visual field defect, complex partial seizures, speech disorder, psychomotor hyperactivity, syncope, sensory disturbance, drooling, hypersomnia, aphasia, repetitive speech, hypokinesia, dyskinesia, dizziness postural, poor quality sleep, burning sensation, sensory loss, parosmia, cerebellar syndrome, dysesthesia, hypogeusia, stupor, clumsiness, aura, ageusia, dysgraphia, dysphasia, neuropathy peripheral, presyncope, dystonia, formication
- Rare (less than 0.1%): Apraxia, circadian rhythm sleep disorder, hyperesthesia, hyposmia, anosmia, essential tremor, akinesia, unresponsive to stimuli[Ref]
Most CNS adverse reactions can be classified into 3 categories: cognitive-related dysfunction (e.g. confusion psychomotor slowing, difficulty with concentration/attention, difficulty with memory, speech, or language problems, particularly word-finding difficulties); psychiatric/behavioral disturbances (e.g. depression or mood problems); and somnolence or fatigue. Most were mild to moderate in severity and frequently occurred in isolation. Rapid titration rate and higher initial dose was associated with a higher occurrence.[Ref]
Psychiatric
- Very common (10% or more): Somnolence (15%), memory loss (10%), depression
- Common (1% to 10%): Depression, difficulty with concentration/attention, anxiety psychomotor slowing, altered mood, confusion, cognitive difficulty, bradyphrenia, decreased libido, expressive language disorder, disorientation, aggression, aggression, anger, abnormal behavior
- Uncommon (0.1% to 1%): Suicidal ideation, suicide attempt, hallucination, psychotic disorder, hallucination auditory, hallucination visual, apathy, lack of spontaneous speech, sleep disorder, affect lability, restlessness, crying, dysphemia, euphoria, paranoia, perseveration, panic attack, tearfulness, reading disorder, flat affect, thinking abnormal, listlessness, middle insomnia, distractibility, early morning awakening, panic reaction, elevated mood
- Rare (less than 0.1%): Mania, panic disorder, feelings of despair, hypomania[Ref]
Antiepileptic drugs increased the risk of suicidal thoughts or behaviors when taken for any indication. Pooled analyses of 199 placebo-controlled clinical trials of 11 different antiepileptic drugs showed patients on antiepileptics had approximately twice the risk compared to placebo. In these trials (median duration 12 weeks; most less than 24 weeks), the estimated incidence rate of suicidal behavior or ideation was 0.43% compared to 0.24% which represents an increase of approximately 1 case for every 530 patients treated.[Ref]
Gastrointestinal
- Very common (10% or more): Nausea, diarrhea
- Common (1% to 10%): Vomiting, constipation, abdominal pain upper, dyspepsia, abdominal pain, dry mouth, stomach discomfort, paresthesia oral, gastritis, abdominal discomfort
- Uncommon (0.1% to 1%): Pancreatitis, flatulence, gastroesophageal reflux disease, abdominal pain lower, hypoesthesia oral, gingival bleeding, abdominal distension, epigastric discomfort, abdominal tenderness, salivary hypersecretion, oral pain, breath odor, glossodynia[Ref]
Genitourinary
- Uncommon (0.1% to 1%): Erectile dysfunction, sexual dysfunction, renal calculus, intermenstrual bleeding, leucorrhoea, menorrhagia, vaginitis, amenorrhea, urinary tract infections, micturition frequency, urinary incontinence, dysuria
- Postmarketing reports: Kidney stones, nephrocalcinosis[Ref]
Immunologic
- Very common (10% or more): Nasopharyngitis
- Frequency not reported: Genital moniliasis[Ref]
Metabolic
- Very common (10% or more): Weight decreased
- Common (1% to 10%): Anorexia, decreased appetite, weight increased
- Uncommon (0.1% to 1%): Metabolic acidosis, hypokalemia, increased appetite, polydipsia
- Rare (less than 0.1%): Acidosis hyperchloremic, blood bicarbonate decreased
- Postmarketing reports: Hyperammonemia with or without encephalopathy[Ref]
Metabolic Acidosis:
Generally, topiramate-induced metabolic acidosis occurs early in treatment; however, it can occur any time. Average decreases of serum bicarbonate of 4 mEq/L have been observed in adults receiving 400 mg/day and pediatrics receiving approximately 6 mg/kg/day. Values below 10 mEq/L have been rarely reported. In adult trials for adjunctive treatment of epilepsy, persistent serum bicarbonate decreases to less than 20 meq/L were reported in 32% of patients receiving 400 mg/day versus 1% of placebo-treated patients. In pediatric trials, adjunctive therapy yielded persistent decreases in serum bicarbonate of 67% for doses of approximately 6 mg/kg/day and 10% for placebo. In monotherapy trials for patients 6 to 15 years, the incidence of persistent decreases in serum bicarbonate was 9% for 50 mg per day and 25% for 400 mg per day. In adult migraine trials, persistent decreases in serum bicarbonate occurred in 44%, 39%, 23%, and 7% of patients receiving 200 mg/day, 100 mg/day, 50 mg/day, and placebo, respectively. In adolescent migraine trials, this was 77%, 27%, 30%, and 9% for those receiving 200 mg/day, 100 mg/day, 50 mg/day, and placebo, respectively.
Hyperammonemia:
The incidence of hyperammonemia (above the upper limit of normal) for adolescent patients receiving this drug for migraine prophylaxis was 26%, 14%, and 9% for doses of 100 mg, 50, mg, or placebo, respectively. Hyperammonemia with and without encephalopathy has been reported in the post-marketing period. Hyperammonemia appears to be more common when used concomitantly with valproic acid.[Ref]
Musculoskeletal
- Common (1% to 10%): Arthralgia, muscle spasms, myalgia, muscle twitching, muscular weakness, musculoskeletal chest pain
- Uncommon (0.1% to 1%): Joint swelling, musculoskeletal stiffness, flank pain, muscle fatigue
- Rare (less than 0.1%): Limb discomfort[Ref]
Ocular
- Common (1% to 10%): Vision blurred, diplopia, visual disturbance
- Uncommon (0.1% to 1%): Visual acuity reduced, scotoma, myopia, abnormal sensation in eye, dry eye, photophobia, blepharospasm, lacrimation increased, photopsia, mydriasis, presbyopia
- Rare (less than 0.1%): Blindness unilateral, blindness transient, glaucoma, accommodation disorder, altered visual depth perception, scintillating scotoma, eyelid edema, night blindness, amblyopia
- Frequency not reported: Angle closure glaucoma, maculopathy, eye movement disorder[Ref]
Other
- Very common (10% or more): Fatigue
- Common (1% to 10%): Vertigo, tinnitus, ear pain pyrexia, asthenia, irritability, gait disturbance, feeling abnormal, malaise
- Uncommon (0.1% to 1%): Deafness, deafness unilateral, deafness neurosensory, ear discomfort, hearing impaired, hyperthermia, thirst, influenza like illness, sluggishness, peripheral coldness, feeling drunk, feeling jittery, tandem gait test abnormal
- Rare (less than 0.1%): Face edema, calcinosis, learning disability
- Frequency not reported: Hypothermia, hyperthermia (associated with oligohidrosis)[Ref]
Renal
- Common (1% to 10%): Nephrolithiasis, pollakiuria, dysuria
- Uncommon (0.1% to 1%): Calculus urinary, urinary incontinence, hematuria, incontinence, micturition urgency, renal colic, renal pain
- Rare (less than 0.1%): Calculus ureteric, renal tubular acidosis[Ref]
In clinical trials, 1.5% of adult patients receiving this drug developed kidney stones (approximately 2 to 4 times more than expected). The incidence was higher in men. Kidney stone have been reported in pediatric patients taking this drug for epilepsy or migraine.[Ref]
Respiratory
- Common (1% to 10%): Bronchitis, rhinitis, dyspnea, epistaxis, nasal congestion, rhinorrhea, cough
- Uncommon (0.1% to 1%): Dyspnea exertional, paranasal sinus hypersecretion, dysphonia[Ref]
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References
1. Cerner Multum, Inc. "UK Summary of Product Characteristics."
2. Cerner Multum, Inc. "Australian Product Information."
3. (2017) "Product Information. Qudexy XR Sprinkle (topiramate)." Upsher-Smith Laboratories Inc
4. (2017) "Product Information. Trokendi XR (topiramate)." Supernus Pharmaceuticals Inc
5. (2017) "Product Information. Topiramate (topiramate)." Cipla USA Inc.
Frequently asked questions
- How does Trokendi XR help with weight loss?
- Are Topamax and Trokendi XR the same thing?
- When is the best time of day to take Trokendi XR?
- How fast does Trokendi XR work for migraines?
- Does Trokendi XR cause hair loss?
- Does this drug cause weight loss?
- Does topiramate cause hair loss?
- How long do you stay on Topamax for migraines?
- How long does it take for Topamax to start working?
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Further information
Trokendi XR side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.