Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Rifater

Descriptions


Rifampin, isoniazid, and pyrazinamide combination is used to treat tuberculosis (TB) infection. It may be taken alone or with one or more other medicines for TB. Rifampin belongs to the class of medicines called antibiotics and works to kill or prevent the growth of bacteria. However, it will not work for colds, flu, or other virus infections.

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

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 rifampin, isoniazid, and pyrazinamide combination in children younger than 15 years of age. 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 rifampin, isoniazid, and pyrazinamide combination in the elderly.

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.

  • Artemether
  • Atazanavir
  • Bictegravir
  • Boceprevir
  • Cabotegravir
  • Cobicistat
  • Daclatasvir
  • Darunavir
  • Dasabuvir
  • Delamanid
  • Doravirine
  • Elbasvir
  • Elvitegravir
  • Fosamprenavir
  • Fostemsavir
  • Glecaprevir
  • Grazoprevir
  • Isavuconazonium
  • Lenacapavir
  • Lopinavir
  • Lorlatinib
  • Lurasidone
  • Maraviroc
  • Mavacamten
  • Nelfinavir
  • Nirmatrelvir
  • Ombitasvir
  • Pacritinib
  • Paritaprevir
  • Pibrentasvir
  • Praziquantel
  • Ranolazine
  • Rilpivirine
  • Ritonavir
  • Saquinavir
  • Sofosbuvir
  • Telaprevir
  • Tenofovir Alafenamide
  • Tipranavir
  • Velpatasvir
  • Voriconazole
  • Voxilaprevir

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
  • Abrocitinib
  • Acalabrutinib
  • Acetaminophen
  • Adagrasib
  • Afatinib
  • Alfentanil
  • Alpelisib
  • Amifampridine
  • Amiodarone
  • Amlodipine
  • Amprenavir
  • Apixaban
  • Apremilast
  • Aprepitant
  • Aripiprazole
  • Atogepant
  • Atovaquone
  • Avacopan
  • Avapritinib
  • Avatrombopag
  • Axitinib
  • Bedaquiline
  • Belumosudil
  • Bendamustine
  • Benzhydrocodone
  • Berotralstat
  • Betrixaban
  • Bortezomib
  • Bosutinib
  • Brexpiprazole
  • Brigatinib
  • Brivaracetam
  • Buprenorphine
  • Bupropion
  • Cabozantinib
  • Cannabidiol
  • Capivasertib
  • Capmatinib
  • Carbamazepine
  • Cariprazine
  • Ceritinib
  • Cholera Vaccine, Live
  • Clarithromycin
  • Clopidogrel
  • Clozapine
  • Cobimetinib
  • Codeine
  • Copanlisib
  • Crizotinib
  • Cyclosporine
  • Dabigatran Etexilate
  • Daprodustat
  • Daridorexant
  • Darolutamide
  • Dasatinib
  • Deferasirox
  • Deflazacort
  • Delavirdine
  • Desogestrel
  • Dexamethasone
  • Dienogest
  • Digoxin
  • Dihydrocodeine
  • Dolutegravir
  • Domperidone
  • Donepezil
  • Doxorubicin
  • Doxorubicin Hydrochloride Liposome
  • Dronedarone
  • Drospirenone
  • Duvelisib
  • Edoxaban
  • Efavirenz
  • Elacestrant
  • Elagolix
  • Elexacaftor
  • Eliglustat
  • Eluxadoline
  • Encorafenib
  • Entrectinib
  • Enzalutamide
  • Eravacycline
  • Erdafitinib
  • Erlotinib
  • Estetrol
  • Estradiol
  • Ethinyl Estradiol
  • Ethionamide
  • Ethynodiol
  • Etonogestrel
  • Etrasimod
  • Etravirine
  • Everolimus
  • Exemestane
  • Fedratinib
  • Fenfluramine
  • Fentanyl
  • Fexinidazole
  • Finerenone
  • Fosaprepitant
  • Fosnetupitant
  • Fosphenytoin
  • Fostamatinib
  • Fruquintinib
  • Futibatinib
  • Gefitinib
  • Gepirone
  • Gestodene
  • Gilteritinib
  • Glasdegib
  • Glimepiride
  • Halothane
  • Hemin
  • Hydrocodone
  • Hydroxychloroquine
  • Ibrexafungerp
  • Ibrutinib
  • Idelalisib
  • Ifosfamide
  • Imatinib
  • Indinavir
  • Infigratinib
  • Iptacopan
  • Irinotecan
  • Irinotecan Liposome
  • Isoniazid
  • Istradefylline
  • Itraconazole
  • Ivabradine
  • Ivacaftor
  • Ivosidenib
  • Ixabepilone
  • Ixazomib
  • Ketoconazole
  • Lamotrigine
  • Lapatinib
  • Larotrectinib
  • Ledipasvir
  • Lefamulin
  • Lemborexant
  • Leniolisib
  • Letermovir
  • Levodopa
  • Levoketoconazole
  • Levonorgestrel
  • Linagliptin
  • Lorcainide
  • Lumateperone
  • Lurbinectedin
  • Macimorelin
  • Macitentan
  • Manidipine
  • Maribavir
  • Medroxyprogesterone
  • Meperidine
  • Mestranol
  • Methadone
  • Methotrexate
  • Metoprolol
  • Midostaurin
  • Mifepristone
  • Mirtazapine
  • Mitapivat
  • Mobocertinib
  • Momelotinib
  • Mycophenolate Mofetil
  • Mycophenolic Acid
  • Naloxegol
  • Neratinib
  • Netupitant
  • Nevirapine
  • Nifedipine
  • Nilotinib
  • Nimodipine
  • Nintedanib
  • Nirogacestat
  • Nomegestrol
  • Norelgestromin
  • Norethindrone
  • Norgestimate
  • Norgestrel
  • Olanzapine
  • Olaparib
  • Olutasidenib
  • Omaveloxolone
  • Omeprazole
  • Osimertinib
  • Oxcarbazepine
  • Oxycodone
  • Ozanimod
  • Palbociclib
  • Paliperidone
  • Palovarotene
  • Panobinostat
  • Pazopanib
  • Pemigatinib
  • Pentazocine
  • Perampanel
  • Pexidartinib
  • Phenobarbital
  • Phenytoin
  • Pimavanserin
  • Piperaquine
  • Pirtobrutinib
  • Pitavastatin
  • Pitolisant
  • Ponatinib
  • Ponesimod
  • Posaconazole
  • Pralsetinib
  • Pretomanid
  • Primidone
  • Pyrazinamide
  • Quetiapine
  • Quinine
  • Quizartinib
  • Regorafenib
  • Relugolix
  • Repotrectinib
  • Revefenacin
  • Ribociclib
  • Rifampin
  • Rimegepant
  • Ripretinib
  • Risperidone
  • Ritlecitinib
  • Rivaroxaban
  • Roflumilast
  • Rolapitant
  • Romidepsin
  • Ruxolitinib
  • Samidorphan
  • Segesterone
  • Selexipag
  • Selpercatinib
  • Selumetinib
  • Sildenafil
  • Simeprevir
  • Siponimod
  • Sirolimus
  • Sirolimus Protein-Bound
  • Sonidegib
  • Sorafenib
  • Sotagliflozin
  • Sotorasib
  • Sparsentan
  • Stiripentol
  • Sufentanil
  • Sunitinib
  • Tacrolimus
  • Tamoxifen
  • Tasimelteon
  • Tazemetostat
  • Tegafur
  • Telithromycin
  • Temsirolimus
  • Tezacaftor
  • Thiotepa
  • Ticagrelor
  • Tivozanib
  • Tofacitinib
  • Tolvaptan
  • Trabectedin
  • Tramadol
  • Tucatinib
  • Ubrogepant
  • Ulipristal
  • Upadacitinib
  • Valbenazine
  • Vandetanib
  • Vemurafenib
  • Venetoclax
  • Vilazodone
  • Vincristine
  • Vincristine Sulfate Liposome
  • Vinflunine
  • Voclosporin
  • Vonoprazan
  • Vorapaxar
  • Vortioxetine
  • Voxelotor
  • Zanubrutinib
  • Zavegepant
  • Zidovudine
  • Zolpidem
  • 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.

  • Acetyldigoxin
  • Aliskiren
  • Aminosalicylic Acid
  • Anisindione
  • Aripiprazole Lauroxil
  • Atorvastatin
  • Betamethasone
  • Bexarotene
  • Bosentan
  • Buspirone
  • Carbamazepine
  • Carvedilol
  • Caspofungin
  • Chloramphenicol
  • Chlorpropamide
  • Citalopram
  • Clofibrate
  • Cortisone
  • Diazepam
  • Dicumarol
  • Diltiazem
  • Disopyramide
  • Disulfiram
  • Doxycycline
  • Enalaprilat
  • Enalapril Maleate
  • Enflurane
  • Etoricoxib
  • Fluconazole
  • Fludrocortisone
  • Fosphenytoin
  • Gliclazide
  • Glyburide
  • Haloperidol
  • Isradipine
  • Levomethadyl
  • Levothyroxine
  • Linezolid
  • Losartan
  • Mefloquine
  • Meperidine
  • Metformin
  • Methylprednisolone
  • Morphine
  • Morphine Sulfate Liposome
  • Moxifloxacin
  • Nisoldipine
  • Ospemifene
  • Phenprocoumon
  • Phenytoin
  • Pioglitazone
  • Pirmenol
  • Prednisolone
  • Prednisone
  • Propafenone
  • Raltegravir
  • Repaglinide
  • Rofecoxib
  • Rosiglitazone
  • Sertraline
  • Simvastatin
  • Tadalafil
  • Theophylline
  • Tocainide
  • Triazolam
  • Trimetrexate
  • Valproic Acid
  • Warfarin
  • Zaleplon
  • Zidovudine

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 is usually not recommended, 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

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.

  • food
  • Tyramine Containing Food

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:

  • Adrenal gland problem or
  • Blood clotting problems or
  • Diabetes, history of or
  • Porphyria (an enzyme problem) or
  • Vitamin K deficiency—Use with caution. May make these conditions worse.
  • Alcohol abuse, or history of—Use with caution. There may be an increased chance of getting liver problems (eg, hepatitis) if you take this medicine and drink alcohol daily.
  • Gout, acute or
  • Liver disease, acute or severe or
  • Meningococcal disease (including infections of the lining of the brain and spinal cord [meningitis] and bloodstream [eg, bacteremia, septicemia)—Should not be used in patients with these conditions.
  • Liver disease, chronic or
  • Patients with poor nutrition status—Use with caution. May increase risk for vitamin K deficiency, which may lead to excessive bleeding.

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 of side effects.

This medicine should be taken on an empty stomach, 1 hour before or 2 hours after a meal, with a full of glass of water. It is important to take this medicine on a regular schedule.

If this medicine upsets your stomach, take it with food. Antacids may also help. However, do not take aluminum-containing antacids (eg, Maalox®, Mylanta®) within 1 hour of the time you take rifampin, isoniazid, and pyrazinamide combination. They may keep this medicine from working properly.

To help clear up your tuberculosis (TB) infection completely, it is very important that you keep taking this medicine for the full time of treatment, even if you begin to feel better after a few weeks. It is important that you do not miss any doses.

Your doctor may also want you to take pyridoxine (eg, Hexa-Betalin, vitamin B6) everyday to help prevent or lessen some of the side effects of isoniazid. If it is needed, it is very important to take pyridoxine everyday along with this medicine. Do not miss any doses.

If you are taking itraconazole, do not use rifampin, isoniazid, and pyrazinamide combination 2 weeks before and during itraconazole treatment.

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):
    • For the treatment of tuberculosis:
      • Adults and children 15 years of age and older weighing 55 kilograms (kg) (121 pounds) or more—6 tablets per day.
      • Adults and children 15 years of age and older weighing between 45 and 54 kg (99 and 119 pounds)—5 tablets per day.
      • Adults and children 15 years of age and older weighing 44 kg (97 pounds) or less—4 tablets per day.
      • Children younger than 15 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

If rifampin, isoniazid, and pyrazinamide combination is taken on an irregular schedule, side effects may occur more often and may be more serious than usual. If you have any questions about this, check with your doctor.

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.

Precautions

It is very important that your doctor check your or your child's progress at regular visits. Blood and urine tests may be needed to check for unwanted effects.

If your symptoms do not improve within 2 to 3 weeks, or if they become worse, check with your doctor.

Do not use this medicine if you are also receiving lurasidone (Latuda®) or certain medicines to treat HIV infection (eg, atazanavir, darunavir, fosamprenavir, ritonavir, ritonavir-boosted saquinavir, saquinavir, tipranavir, Aptivus®, Fortovase®, Invirase®, Lexiva®, Norvir®, Prezista®, or Reyataz®).

Do not use this medicine together with praziquantel. If you need to take praziquantel, you should stop using this medicine 4 weeks before starting praziquantel. You may restart this medicine one day after the last dose of praziquantel.

Liver problems may be more likely to occur if you drink alcoholic beverages regularly while you are using this medicine. Also, the regular use of alcohol may keep this medicine from working properly. Therefore, you should strictly limit the amount of alcoholic beverages you drink while you are using this medicine.

Check with your doctor right away if you have a fever, chills, cough, sore throat, swollen, painful, or tender lymph glands in the neck, armpit, or groin, or yellow skin or eyes while using this medicine. These could be symptoms of a serious condition called drug reaction with eosinophilia and systemic symptoms (DRESS).

Serious skin reactions (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, and acute generalized exanthematous pustulosis) can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin, red skin lesions, severe acne or a skin rash, sores or ulcers on the skin, or fever or chills with this medicine.

Tell your doctor right away if you have chest pain, cough, coughing or spitting up blood, difficulty in breathing, sore throat, muscle aches, night sweats, sudden high fever, or unusual tiredness. These could be symptoms of a paradoxical drug reaction to this medicine. If your symptoms do not improve within a few days or if they become worse, check with your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

Check with your doctor right away if you have joint pain, stiffness, or swelling, lower back, side, or stomach pain, or swelling of the feet or lower legs. These could be symptoms of an acute gout.

This medicine may cause blood clotting problems, which may lead to bleeding. Check with your doctor right away if you cough up blood, have bleeding gums, difficulty in breathing or swallowing, dizziness, headache, increased menstrual flow or vaginal bleeding, nosebleeds, prolonged bleeding from cuts, red or dark brown urine, or red or black, tarry stools after using this medicine.

This medicine will cause urine, stool, saliva, sputum, sweat, teeth, and tears to turn reddish-orange to reddish-brown. This is to be expected while you are using this medicine. This effect may cause soft contact lenses to become permanently discolored. Standard cleaning solutions may not take out all the discoloration. Therefore, it is best not to wear soft contact lenses while using this medicine. Hard contact lenses are not discolored by this medicine. This condition will return to normal once you stop using this medicine. If you have any questions about this, check with your doctor.

This medicine may cause lung or breathing problems (eg, interstitial lung disease, pneumonitis, pneumonia, respiratory failure, pulmonary fibrosis, acute respiratory distress syndrome), which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest pain, chills, dry cough, fever, general feeling of discomfort or illness, thickening of bronchial secretions, or trouble breathing.

Check with your doctor right away if you feel very tired or very weak, or if you have clumsiness, unsteadiness, loss of appetite, nausea, numbness, tingling, burning, or pain in the hands and feet, or vomiting. These may be early warning symptoms of more serious liver or nerve problems that could develop later.

Rifampin, isoniazid, and pyrazinamide combination may cause blood problems. These problems may result in a greater chance of certain infections, slow healing, and bleeding of the gums. Therefore, you should be careful when using regular toothbrushes, dental floss, and toothpicks. Dental work should be delayed until your blood counts have returned to normal. Check with your medical doctor or dentist if you have any questions about proper oral hygiene (mouth care) during treatment.

This medicine may cause thrombotic microangiopathy (damage in the smallest blood vessels), including hemolytic uremic syndrome and thrombotic thrombocytopenic purpura. Tell your doctor right away if you have a change in mental status, dark or bloody urine, decreased urine output, difficulty speaking, fever, pale color of the skin, pinpoint red spots on the skin, seizures, severe chest pain, sudden weakness in the arms or legs, unusual bleeding or bruising, or yellow eyes or skin.

If you develop a skin rash, hives, or any allergic reaction to this medicine, check with your doctor right away.

Before you have any medical tests, tell the medical doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Eating certain foods (eg, Cheshire cheese, Swiss cheese, skipjack, tuna, or Sardinella) or drinking red wine may cause reactions in some patients using isoniazid-containing medicines. Check with your doctor if flushing, fast or pounding heartbeat, headache, redness or itching of the skin, sweating, dizziness, or lightheadedness occurs while you are using this medicine.

Birth control pills may not work properly 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 condoms, diaphragms, or contraceptive foams or jellies.

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 immediately if any of the following side effects occur:

More common

  1. Chest pain or tightness
  2. clumsiness or unsteadiness
  3. coughing or spitting up blood
  4. dark urine
  5. fast, irregular, pounding, or racing heartbeat or pulse
  6. loss of appetite
  7. nausea
  8. numbness, tingling, burning, or pain in the hands and feet
  9. pain in the large and small joints
  10. sneezing
  11. trouble breathing
  12. unusual tiredness or weakness
  13. vomiting
  14. yellow eyes or skin

Less common

  1. Chills
  2. difficulty in breathing
  3. dizziness
  4. fever
  5. headache
  6. hearing loss
  7. muscle and bone pain
  8. ringing or buzzing or other unexplained noise in the ears
  9. shivering
  10. skin rash, itching, or redness

Rare

  1. Agitation
  2. bleeding gums
  3. blistering, peeling, or loosening of the skin
  4. blood in the urine or stools
  5. blurred vision or loss of vision, with or without eye pain
  6. bruising
  7. confusion
  8. darkening of the skin
  9. difficulty in swallowing
  10. fainting
  11. feeling that others are watching you or controlling your behavior
  12. feeling that others can hear your thoughts
  13. feeling, seeing, or hearing things that are not there
  14. fever with or without chills
  15. general feeling of tiredness or weakness
  16. heavier menstrual periods
  17. hives
  18. hoarseness
  19. hostility
  20. increased blood pressure
  21. increased thirst
  22. irritability
  23. light-colored stools
  24. lower back or side pain
  25. mental depression
  26. muscle tenderness, wasting, or weakness
  27. persistent bleeding or oozing from puncture sites, mouth, or nose
  28. pinpoint red spots on the skin
  29. puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  30. seizures
  31. severe mood or mental changes
  32. swelling of the face, ankles, fingers, hands, or lower legs
  33. unusual behavior
  34. unusual drowsiness, dullness, or feeling of sluggishness
  35. weight gain

Incidence not known

  1. Ankle, knee, or great toe pain
  2. back pain
  3. being forgetful
  4. black, tarry stools
  5. bleeding under the skin
  6. blemishes on the skin
  7. bloating
  8. bloody, severe, or watery diarrhea
  9. blue-yellow color blindness
  10. bone pain
  11. burning while urinating
  12. cloudy urine
  13. cold, clammy skin
  14. constipation
  15. cough
  16. difficulty seeing at night
  17. difficulty with speaking
  18. double vision
  19. dry mouth
  20. fast, weak pulse
  21. flushed, dry skin
  22. fruit-like breath odor
  23. general feeling of discomfort or illness
  24. greatly decreased frequency of urination or amount of urine
  25. hair loss
  26. inability to move the arms, legs, or facial muscles
  27. inability to speak
  28. increased hunger
  29. increased menstrual flow or vaginal bleeding
  30. increased sensitivity of the eyes to sunlight
  31. increased urination
  32. indigestion
  33. joint pain, stiffness, or swelling
  34. large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  35. lightheadedness
  36. muscle aches, pains, and tremors
  37. night sweats
  38. nosebleeds
  39. painful or difficult urination
  40. pains in the stomach, side, or abdomen, possibly radiating to the back
  41. pale skin
  42. paralysis
  43. pimple
  44. prolonged bleeding from cuts
  45. rapid, deep breathing
  46. red or dark brown urine
  47. red skin lesions, often with a purple center
  48. red, irritated eyes
  49. restlessness
  50. runny nose
  51. slow speech
  52. sore throat
  53. sores, ulcers, or white spots on the lips or in the mouth
  54. stiff neck
  55. stomach cramps or pain
  56. sweating
  57. swollen glands
  58. trouble sleeping
  59. unpleasant breath odor
  60. unusual bleeding or bruising
  61. unusual weight loss

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

Symptoms of overdose

  1. Blurred vision
  2. confusion
  3. decreased awareness or responsiveness
  4. dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  5. fainting
  6. fast, pounding, or irregular heartbeat or pulse
  7. feeling of fullness in the upper abdomen or stomach
  8. loss of consciousness
  9. low blood pressure or slow pulse
  10. pain in the upper abdomen or stomach
  11. reddish-orange to reddish-brown color of the urine, stool, saliva, sputum, sweat, and tears
  12. seeing, hearing, or feeling things that are not there
  13. seizures
  14. severe sleepiness
  15. slurring of speech
  16. swelling around the eyes and face
  17. unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness
  18. yellow eyes or skin

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:

Less common

  1. Sore mouth or tongue

Incidence not known

  1. Belching
  2. bloated or full feeling
  3. excess air or gas in the stomach or bowels
  4. not able to concentrate
  5. pain or discomfort in the chest, upper stomach, or throat
  6. swelling of the breasts or breast soreness in both females and males
  7. tooth discoloration

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.