Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Cerebyx

Descriptions


Fosphenytoin injection is used to control certain types of seizures (convulsions) in the treatment of epilepsy. It is also used to prevent and treat seizures that occur during brain surgery. This medicine is an anticonvulsant that works in the brain tissue to stop seizures.

Fosphenytoin injection also used for short-term substitution for oral phenytoin. This medicine should only be used when taking phenytoin by mouth is not possible.

This medicine is to be given only by or under the direct supervision of a doctor.

This product is available in the following dosage forms:

  • Solution

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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Cerebyx® injection in children.

Appropriate studies have not been performed on the relationship of age to the effects of fosphenytoin injection in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Sesquient™ injection for short-term substitution for oral phenytoin in children 2 years of age and older. Safety and efficacy have been established.

Geriatric

Appropriate studies on the relationship of age to the effects of fosphenytoin injection have not been performed in the geriatric population. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution and an adjustment in the dose for patients receiving fosphenytoin injection.

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 receiving 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.

  • Artemether
  • Atazanavir
  • Bepridil
  • Boceprevir
  • Cisapride
  • Cobicistat
  • Daclatasvir
  • Darunavir
  • Dasabuvir
  • Delamanid
  • Delavirdine
  • Doravirine
  • Dronedarone
  • Elbasvir
  • Elvitegravir
  • Fostemsavir
  • Grazoprevir
  • Isavuconazonium
  • Lenacapavir
  • Levoketoconazole
  • Lorlatinib
  • Lurasidone
  • Maraviroc
  • Mavacamten
  • Mesoridazine
  • Nirmatrelvir
  • Ombitasvir
  • Pacritinib
  • Paritaprevir
  • Pimozide
  • Piperaquine
  • Praziquantel
  • Ranolazine
  • Rilpivirine
  • Ritonavir
  • Sparfloxacin
  • Telaprevir
  • Tenofovir Alafenamide
  • Terfenadine
  • Thioridazine
  • Ziprasidone

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Abemaciclib
  • Abiraterone Acetate
  • Acalabrutinib
  • Adagrasib
  • Afatinib
  • Alfentanil
  • Alpelisib
  • Amiodarone
  • Amisulpride
  • Anagrelide
  • Apazone
  • Apixaban
  • Apomorphine
  • Apremilast
  • Aprepitant
  • Aripiprazole
  • Arsenic Trioxide
  • Asciminib
  • Aspirin
  • Atogepant
  • Avacopan
  • Avapritinib
  • Axitinib
  • Beclamide
  • Bedaquiline
  • Belumosudil
  • Bendamustine
  • Benzhydrocodone
  • Berotralstat
  • Betrixaban
  • Bictegravir
  • Bortezomib
  • Bosutinib
  • Brexpiprazole
  • Brigatinib
  • Buprenorphine
  • Bupropion
  • Buserelin
  • Cabozantinib
  • Calcifediol
  • Cannabidiol
  • Capecitabine
  • Capivasertib
  • Capmatinib
  • Carbamazepine
  • Cariprazine
  • Cenobamate
  • Ceritinib
  • Chloroquine
  • Chlorpheniramine
  • Cisatracurium
  • Citalopram
  • Clarithromycin
  • Clofazimine
  • Clothiapine
  • Clozapine
  • Cobimetinib
  • Codeine
  • Copanlisib
  • Crizotinib
  • Cyclophosphamide
  • Dabigatran Etexilate
  • Dabrafenib
  • Daridorexant
  • Darolutamide
  • Dasatinib
  • Deferasirox
  • Deflazacort
  • Degarelix
  • Deslorelin
  • Desogestrel
  • Deutetrabenazine
  • Dexamethasone
  • Dexmedetomidine
  • Diazepam
  • Diazoxide
  • Dienogest
  • Dihydrocodeine
  • Dolutegravir
  • Domperidone
  • Donepezil
  • Dopamine
  • Doxifluridine
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Drospirenone
  • Duvelisib
  • Edoxaban
  • Efavirenz
  • Elacestrant
  • Elexacaftor
  • Eliglustat
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Eravacycline
  • Erdafitinib
  • Erlotinib
  • Escitalopram
  • Eslicarbazepine Acetate
  • Estetrol
  • Estradiol
  • Ethinyl Estradiol
  • Ethosuximide
  • Ethynodiol
  • Etonogestrel
  • Etrasimod
  • Etravirine
  • Everolimus
  • Exemestane
  • Ezogabine
  • Fedratinib
  • Fenfluramine
  • Fentanyl
  • Fexinidazole
  • Finerenone
  • Fingolimod
  • Fluconazole
  • Fluorouracil
  • Fluoxetine
  • Fluvastatin
  • Formoterol
  • Fosaprepitant
  • Foscarnet
  • Fosnetupitant
  • Fostamatinib
  • Fruquintinib
  • Futibatinib
  • Gefitinib
  • Gepirone
  • Gestodene
  • Gilteritinib
  • Glasdegib
  • Glecaprevir
  • Gonadorelin
  • Goserelin
  • Halothane
  • Hemin
  • Histrelin
  • Hydrocodone
  • Hydroxychloroquine
  • Hydroxyzine
  • Ibrexafungerp
  • Ibrutinib
  • Idelalisib
  • Ifosfamide
  • Imatinib
  • Infigratinib
  • Infliximab
  • Inotuzumab Ozogamicin
  • Irinotecan
  • Irinotecan Liposome
  • Istradefylline
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Ixabepilone
  • Ixazomib
  • Ketoconazole
  • Lamotrigine
  • Lapatinib
  • Larotrectinib
  • Ledipasvir
  • Lefamulin
  • Lemborexant
  • Leniolisib
  • Lenvatinib
  • Letermovir
  • Leuprolide
  • Levofloxacin
  • Levoleucovorin
  • Levonorgestrel
  • Lidocaine
  • Linagliptin
  • Lofexidine
  • Lopinavir
  • Lumateperone
  • Lurbinectedin
  • Macimorelin
  • Macitentan
  • Manidipine
  • Maribavir
  • Medroxyprogesterone
  • Meperidine
  • Mestranol
  • Methadone
  • Methotrexate
  • Methylphenidate
  • Metronidazole
  • Miconazole
  • Midostaurin
  • Mifepristone
  • Mirtazapine
  • Mitapivat
  • Mobocertinib
  • Moxifloxacin
  • Nafarelin
  • Naloxegol
  • Neratinib
  • Netupitant
  • Nifedipine
  • Nilotinib
  • Nimodipine
  • Nintedanib
  • Nirogacestat
  • Nitisinone
  • Nomegestrol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olanzapine
  • Olaparib
  • Olutasidenib
  • Omaveloxolone
  • Omeprazole
  • Ondansetron
  • Orlistat
  • Osilodrostat
  • Osimertinib
  • Oxaliplatin
  • Oxcarbazepine
  • Oxycodone
  • Ozanimod
  • Paclitaxel
  • Palbociclib
  • Paliperidone
  • Palovarotene
  • Panobinostat
  • Paroxetine
  • Pasireotide
  • Pazopanib
  • Pemigatinib
  • Pentazocine
  • Perampanel
  • Pexidartinib
  • Phenobarbital
  • Pibrentasvir
  • Pimavanserin
  • Pirtobrutinib
  • Pitolisant
  • Ponatinib
  • Ponesimod
  • Posaconazole
  • Pralsetinib
  • Pretomanid
  • Primidone
  • Quetiapine
  • Quizartinib
  • Regorafenib
  • Relugolix
  • Repotrectinib
  • Reserpine
  • Ribociclib
  • Rifampin
  • Rimegepant
  • Ripretinib
  • Risperidone
  • Ritlecitinib
  • Rivaroxaban
  • Rocuronium
  • Roflumilast
  • Rolapitant
  • Romidepsin
  • Ruxolitinib
  • Samidorphan
  • Saquinavir
  • Segesterone
  • Selpercatinib
  • Selumetinib
  • Sertraline
  • Sevoflurane
  • Sildenafil
  • Simeprevir
  • Siponimod
  • Sirolimus Protein-Bound
  • Sofosbuvir
  • Solifenacin
  • Sonidegib
  • Sorafenib
  • Sotalol
  • Sotorasib
  • Sparsentan
  • Stiripentol
  • St John's Wort
  • Sufentanil
  • Sulfamethoxazole
  • Sulpiride
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tasimelteon
  • Tazemetostat
  • Tegafur
  • Temsirolimus
  • Tezacaftor
  • Theophylline
  • Thiotepa
  • Ticagrelor
  • Tivozanib
  • Tocilizumab
  • Tofacitinib
  • Tolvaptan
  • Topiramate
  • Trabectedin
  • Tramadol
  • Trazodone
  • Triclabendazole
  • Trimethoprim
  • Triptorelin
  • Tucatinib
  • Ubrogepant
  • Ulipristal
  • Upadacitinib
  • Valbenazine
  • Valproic Acid
  • Vandetanib
  • Velpatasvir
  • Vemurafenib
  • Venetoclax
  • Venlafaxine
  • Vilanterol
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voclosporin
  • Vonoprazan
  • Vorapaxar
  • Voriconazole
  • Vortioxetine
  • Voxelotor
  • Voxilaprevir
  • Zanubrutinib
  • Zolpidem
  • Zuclopenthixol
  • Zuranolone

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.

  • Acetaminophen
  • Acetazolamide
  • Acyclovir
  • Amitriptyline
  • Amprenavir
  • Atorvastatin
  • Betamethasone
  • Bexarotene
  • Bleomycin
  • Busulfan
  • Carboplatin
  • Caspofungin
  • Chloramphenicol
  • Cimetidine
  • Ciprofloxacin
  • Cisplatin
  • Clobazam
  • Clopidogrel
  • Cortisone
  • Cyclosporine
  • Dicumarol
  • Digitoxin
  • Diltiazem
  • Disopyramide
  • Disulfiram
  • Doxepin
  • Felbamate
  • Fludrocortisone
  • Fluvoxamine
  • Folic Acid
  • Fosamprenavir
  • Ginkgo
  • Imipramine
  • Isoniazid
  • Levodopa
  • Levomethadyl
  • Levothyroxine
  • Methoxsalen
  • Methsuximide
  • Midazolam
  • Nafimidone
  • Nelfinavir
  • Nilutamide
  • Nisoldipine
  • Ospemifene
  • Pancuronium
  • Phenprocoumon
  • Piperine
  • Prednisolone
  • Prednisone
  • Progabide
  • Quinidine
  • Quinine
  • Remacemide
  • Rifapentine
  • Rufinamide
  • Sabeluzole
  • Shankhapulshpi
  • Simvastatin
  • Sirolimus
  • Sulfamethizole
  • Sulfaphenazole
  • Sulthiame
  • Telithromycin
  • Tenidap
  • Tiagabine
  • Ticlopidine
  • Ticrynafen
  • Tirilazad
  • Tizanidine
  • Tolbutamide
  • Triamcinolone
  • Tubocurarine
  • Valacyclovir
  • Vecuronium
  • Verapamil
  • Vigabatrin
  • Viloxazine

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. 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 may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

  • Ethanol

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:

  • Blood or bone marrow problems (eg, agranulocytosis, leukopenia, or thrombocytopenia) or
  • Diabetes or
  • Heart failure or
  • Hypotension (low blood pressure) or
  • Lymphadenopathy (lymph node problems) or
  • Porphyria (an enzyme problem)—Use with caution. May make these conditions worse.
  • Heart block (eg, Adams-Stokes syndrome, AV block, or sinoatrial block) or
  • Liver problems from using fosphenytoin or phenytoin, history of or
  • Sinus bradycardia (slow heartbeat)—Should not be used in patients with these conditions.
  • Hypoalbuminemia (low albumin in the blood) or
  • Kidney disease or
  • Liver disease—Use with caution. The effects may be increased because of slower removal from the body.

Proper Use

A nurse or other trained health professional will give you this medicine in a hospital. This medicine is given as a shot into one of your muscles or through a needle placed in one of your veins.

Your doctor will only give you a few doses of this medicine until your condition improves. You will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Precautions

It is very important that your doctor check your progress closely while you are receiving this medicine. This is to see if the medicine is working properly and to allow for a change in the dose. Blood tests may be needed to check for any 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 the medicine, tell your doctor right away. Your doctor may want you to join a pregnancy registry for patients taking a seizure medicine.

Do not receive this medicine while you are also taking delavirdine (Rescriptor®). Using these medicines together may cause delavirdine to not work as well for you.

This medicine may increase your risk for heart or blood vessel problems. Check with your doctor right away if you have blurred vision, chest pain, confusion, lightheadedness, dizziness, or fainting, fast or irregular heartbeat, trouble breathing, or unusual tiredness or weakness.

This medicine may cause some people to become dizzy, lightheaded, faint, or less alert than they are normally. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or are not alert and able to see well.

Do not stop using this medicine without first checking with your doctor. Stopping the medicine suddenly may cause your seizures to return or to occur more often.

Serious skin reactions (eg, toxic epidermal necrolysis, Stevens-Johnson syndrome, acute-generalized exanthematous pustulosis) can occur with this medicine. Check with your doctor right away if you or your child have blistering, peeling, or loose 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 while you are using this medicine.

Tell your doctor right away if you or your child develop a black, tarry stools, chest pain, chills, cough, fever, rash, swollen, painful, or tender lymph glands in the neck, armpit, or groin, painful or difficult urination, sore throat, sores, ulcers, or white spots on the lips or in the mouth, unusual bleeding or bruising, or yellow eyes or skin after using this medicine. These may be symptoms of a serious and life-threatening condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

This medicine may cause serious allergic reactions, including angioedema. These can be life-threatening and require immediate medical attention. Tell your doctor right away if you or your child have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after using this medicine.

This medicine may cause liver problems. Check with your doctor right away if you or your child have a dark-colored urine, general feeling of tiredness or weakness, headache, light-colored stools, stomach pain continuing, vomiting, or yellow eyes or skin.

Fosphenytoin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

  • If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.
  • Check with your doctor immediately if you notice any unusual bleeding or bruising, black, tarry stools, blood in the urine or stools, or pinpoint red spots on your skin.
  • Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.
  • Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.
  • Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.
  • Avoid contact sports or other situations where bruising or injury could occur.

Tell your doctor right away if your skin feels like it is burning, crawling, or itching, or if you have numbness, prickling, "pins and needles", or tingling feelings after receiving fosphenytoin injection.

This medicine may cause purple glove syndrome. Tell your doctor right away if you have skin discoloration, pain, or swelling at the injection site after receiving this medicine.

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Birth control pills may not work while you are using this medicine. To keep from getting pregnant, use another form of birth control along with your birth control pills. Other forms include a condom, a diaphragm, or a contraceptive foam or jelly.

Avoid drinking alcohol while you are receiving this medicine.

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.

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 or nurse immediately if any of the following side effects occur:

More common

  1. Blurred vision
  2. confusion
  3. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  4. feeling of warmth or heat
  5. flushing or redness of the skin, especially on the face and neck
  6. headache
  7. sweating
  8. unusual tiredness or weakness

Less common

  1. Anxiety
  2. bruising
  3. burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
  4. changes in patterns and rhythms of speech
  5. dark-colored urine
  6. difficulty with speaking
  7. drooling
  8. dry mouth
  9. fast, pounding, or irregular heartbeat or pulse
  10. hyperventilation
  11. irritability
  12. itching skin
  13. lack of coordination
  14. large, flat, blue, or purplish patches in the skin
  15. light-colored stools
  16. loss of balance control
  17. muscle trembling, jerking, or stiffness
  18. nervousness
  19. problems with movement, walking, or speech
  20. restlessness
  21. seizures
  22. shakiness in the legs, arms, hands, or feet
  23. shuffling walk
  24. slurred speech
  25. stiffness of the limbs
  26. trouble breathing
  27. trouble with sleeping
  28. twisting movements of the body
  29. uncontrolled movements, especially of the face, neck, and back
  30. unsteadiness, trembling, or other problems with muscle control or coordination
  31. vomiting
  32. yellow eyes or skin

Rare

  1. Absence of or decrease in body movement
  2. aggressive or angry
  3. agitation
  4. black, tarry stools
  5. bleeding gums
  6. bleeding, blistering, burning, coldness, discoloration of the skin, feeling of pressure, hives, infection, inflammation, itching, lumps, numbness, pain, rash, redness, scarring, soreness, stinging, swelling, tenderness, tingling, ulceration, or warmth at the injection site
  7. blistering, burning, crusting, dryness, or flaking of the skin
  8. blood in the urine or stools
  9. bloody nose
  10. bluish color of the fingernails, lips, skin, palms, or nail beds
  11. body aches or pain
  12. bone pain
  13. burning while urinating
  14. change in consciousness
  15. change in personality
  16. change in the ability to see colors, especially blue or yellow
  17. change in the color of the treated skin
  18. chest pain, discomfort, or tightness
  19. cloudy urine
  20. cold, clammy skin
  21. congestion
  22. cough or hoarseness
  23. cough producing mucus
  24. coughing or spitting up blood
  25. crying
  26. decrease in frequency of urination
  27. decrease in the amount of urine
  28. deep or fast breathing with dizziness
  29. delusions
  30. dementia
  31. depression
  32. diarrhea
  33. difficulty in passing urine (dribbling)
  34. difficulty with breathing
  35. difficulty with moving
  36. difficulty with swallowing
  37. dilated neck veins
  38. dizziness, fainting, or lightheadedness
  39. drowsiness
  40. dryness or soreness of the throat
  41. dysphoria
  42. euphoria
  43. eye pain
  44. feeling of unreality
  45. feeling that others are watching you or controlling your behavior
  46. feeling that others can hear your thoughts
  47. feeling, seeing, or hearing things that are not there
  48. fever or chills
  49. flushed, dry skin
  50. frequent urination
  51. fruit-like breath odor
  52. general feeling of discomfort or illness
  53. general physical wasting or malnutrition associated with severe illness
  54. greatly increased frequency of urination or amount of urine
  55. headache, severe and throbbing
  56. hives or welts
  57. inability to move the legs or arms
  58. inability to sit still
  59. increase in body movements
  60. increase in heart rate
  61. increased hunger
  62. increased sensitivity of the skin to sunlight
  63. increased thirst
  64. increased urination
  65. increased volume of pale, dilute urine
  66. increased watering of the mouth
  67. irregular breathing
  68. itching, scaling, severe redness, soreness, or swelling of the skin
  69. joint pain
  70. leg cramps
  71. loss of appetite
  72. loss of bladder control
  73. loss of consciousness
  74. loss of memory
  75. loss of strength or energy
  76. lower back or side pain
  77. muscle aches, pains, or stiffness
  78. muscle twitching or jerking
  79. muscular tenderness, wasting, or weakness
  80. nausea or vomiting
  81. need to keep moving
  82. no blood pressure or pulse
  83. not breathing
  84. numbness of the feet, hands, and around the mouth
  85. numbness or tingling in the face, arms, hands, feet, or lips
  86. pain or tenderness around the eyes and cheekbones
  87. pale skin
  88. paralysis of one side of the body
  89. paranoia
  90. pinpoint red spots on the skin
  91. pounding in the ears
  92. problems with memory
  93. quick to react or overreact emotionally
  94. rapid breathing
  95. rapid heartbeat
  96. rapid weight gain
  97. rapidly changing moods
  98. rash with flat lesions or small raised lesions on the skin
  99. redness or other discoloration of the skin
  100. rhythmic movement of the muscles
  101. seizures
  102. sense of detachment from self or body
  103. severe constipation
  104. severe headache
  105. severe mood or mental changes
  106. severe pain in the chest
  107. severe sunburn
  108. severe vomiting
  109. shivering
  110. sleeplessness
  111. small lumps under the skin
  112. small red or purple spots on the skin
  113. sneezing
  114. sores, ulcers, or white spots on the lips or in the mouth
  115. spots on your skin resembling a blister or pimple
  116. stiff neck
  117. stomach pain
  118. stopping of heart
  119. stuffy or runny nose
  120. sudden onset of severe breathing difficulty
  121. sunken eyes
  122. swelling of the face, fingers, feet, ankles, or lower legs
  123. swelling of the tongue
  124. swollen joints
  125. swollen, painful, or tender lymph glands in the neck, armpit, or groin
  126. twisting movements of body
  127. unable to sleep
  128. unconsciousness
  129. uncontrolled movements, especially of the face, neck, and back
  130. unexplained weight loss
  131. unusual behavior
  132. unusual bleeding or bruising
  133. unusual weak feeling
  134. voice changes
  135. vomiting of blood or material that looks like coffee grounds
  136. weakness or heaviness of the legs
  137. weight gain
  138. wrinkled skin

Incidence not known

  1. Puffiness or swelling of the eyelids or around the eyes, face, lips or tongue
  2. twitching, twisting, uncontrolled repetitive movements of the tongue, lips, face, arms, or legs

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

  1. Continuing ringing or buzzing or other unexplained noise in the ears
  2. decreased awareness or responsiveness
  3. hearing loss
  4. severe sleepiness
  5. sleepiness or unusual drowsiness
  6. uncontrolled eye movements

Less common

  1. Back pain
  2. change in taste or bad, unusual, or unpleasant (after) taste
  3. change in vision
  4. double vision
  5. feeling of constant movement of self or surroundings
  6. impaired vision
  7. lack or loss of strength
  8. pelvic pain
  9. seeing double
  10. sensation of spinning

Rare

  1. Acid or sour stomach
  2. belching
  3. bigger, dilated, or enlarged pupils (black part of eye)
  4. bloated
  5. burning feeling in the chest or stomach
  6. burning, dry, or itching eyes
  7. change in color vision
  8. difficulty having a bowel movement (stool)
  9. difficulty seeing at night
  10. discharge, excessive tearing
  11. ear pain
  12. excess air or gas in the stomach or bowels
  13. frequent urge to defecate
  14. full feeling
  15. heartburn
  16. increased sense of hearing
  17. increased sensitivity of the eyes to light
  18. indigestion
  19. itching of the vagina or genital area
  20. loss of taste
  21. pain during sexual intercourse
  22. passing gas
  23. redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
  24. stomach discomfort, upset, or pain
  25. straining while passing stool
  26. tenderness in the stomach area
  27. thick, white vaginal discharge with no odor or with a mild odor
  28. transient, mild, or pleasant aromatic odor
  29. vaginal yeast infection
  30. weight loss

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.