Oxycodone and ibuprofen (Oral route)

Pronunciation:

eye-bue-PROE-fen, ox-i-KOE-done hye-droe-KLOR-ide

Brand Names:

Combunox

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Oxycodone hydrochloride/ibuprofen has the potential for addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk before prescribing, and monitor for development of these behaviors or conditions. Serious, life-threatening, or fatal respiratory depression may occur. Monitor closely, especially upon initiation or following a dose increase. Accidental ingestion of oxycodone hydrochloride/ibuprofen, especially in children, can result in fatal overdose of oxycodone hydrochloride and ibuprofen. Prolonged use of oxycodone hydrochloride/ibuprofen during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If opioid use is required for a prolonged period in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available. Concomitant use of cytochrome P450 3A4 inhibitors or discontinuation of concomitantly used cytochrome P450 3A4 inducers may affect the plasma levels of oxycodone and lead to increased adverse reactions and fatal respiratory depression. Monitor patients carefully when oxycodone hydrochloride/ibuprofen and cytochrome P450 3A4 inhibitors and inducers are concurrently used. Concomitant use of benzodiazepines and opioids may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options. Limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation. NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may be increased in patients with cardiovascular disease or risk factors for cardiovascular disease. Oxycodone hydrochloride/ibuprofen is contraindicated for use in the setting of coronary artery bypass graft (CABG) surgery. NSAIDs can also increase the risk of serious gastrointestinal (GI) adverse events (eg, bleeding, ulceration, and perforation of the stomach or intestines) especially in the elderly and patients with a prior history of ulcer disease and/or GI bleeding, which can be fatal .

Classifications:

Therapeutic—

Opioid/NSAID Combination

Pharmacologic—

NSAID

Chemical—

Propionic Acid (class)

Uses of This Medicine:

Ibuprofen and oxycodone combination is used to relieve acute, moderate to severe pain.

Ibuprofen is a nonsteroidal antiinflammatory drug (NSAID) that is used to relieve inflammation, swelling, and pain. Oxycodone is a narcotic analgesic that acts in the central nervous system to relieve pain. If oxycodone is used for a long time, it may become habit-forming (causing mental or physical dependence). Physical dependence may lead to withdrawal side effects when you stop taking the medicine. Since ibuprofen and oxycodone combination is only used for short-term (7 days or less) relief of pain, physical dependence probably will not occur.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ibuprofen and oxycodone combination in children younger than 14 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of oxycodone and ibuprofen combination in the elderly. However, elderly patients who may be more sensitive than younger adults to the effects of ibuprofen and oxycodone combination, are more likely to have kidney, lung, or stomach problems, which may require caution in patients receiving oxycodone and ibuprofen combination.

Breast-feeding—

Studies in women breastfeeding have demonstrated harmful infant effects. An alternative to this medication should be prescribed or you should stop breastfeeding while using this medicine.

Other medicines—

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.

Ketorolac
Levoketoconazole
Nalmefene
Naltrexone
Safinamide
Samidorphan

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.

Abciximab
Abiraterone Acetate
Aceclofenac
Acemetacin
Acenocoumarol
Acepromazine
Aclidinium
Adagrasib
Alfentanil
Almotriptan
Alosetron
Alprazolam
Alvimopan
Amantadine
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Amtolmetin Guacil
Anagrelide
Anileridine
Apalutamide
Apixaban
Aprepitant
Ardeparin
Argatroban
Aripiprazole
Aripiprazole Lauroxil
Armodafinil
Asciminib
Asenapine
Aspirin
Atazanavir
Atropine
Avacopan
Baclofen
Balsalazide
Belladonna
Belzutifan
Bemetizide
Bemiparin
Bendroflumethiazide
Benperidol
Bentazepam
Benzhydrocodone
Benzphetamine
Benzthiazide
Benztropine
Berotralstat
Betamethasone
Betrixaban
Biperiden
Bismuth Subsalicylate
Bivalirudin
Boceprevir
Bosentan
Bromazepam
Bromfenac
Bromopride
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cangrelor
Cannabidiol
Cannabis
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Celecoxib
Cenobamate
Ceritinib
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clemastine
Clidinium
Clobazam
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Cloxazolam
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Cortisone
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclopentolate
Cyclosporine
Cyclothiazide
Cyproheptadine
Dabigatran Etexilate
Dabrafenib
Dalteparin
Danaparoid
Dantrolene
Daridorexant
Darifenacin
Darunavir
Deflazacort
Delavirdine
Delorazepam
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diacetylmorphine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Diclofenac
Dicyclomine
Difenoxin
Diflunisal
Digoxin
Dihydrocodeine
Diltiazem
Dimenhydrinate
Diphenhydramine
Diphenoxylate
Dipyridamole
Dipyrone
Dolasetron
Donepezil
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Efavirenz
Elagolix
Eletriptan
Emtricitabine
Enflurane
Enoxaparin
Enzalutamide
Eplerenone
Epoprostenol
Eptifibatide
Erdafitinib
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etravirine
Fedratinib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Fesoterodine
Feverfew
Fexinidazole
Flavoxate
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Flunitrazepam
Fluocortolone
Fluoxetine
Fluphenazine
Flurazepam
Flurbiprofen
Fluspirilene
Fluvoxamine
Fondaparinux
Fosamprenavir
Fosaprepitant
Fosnetupitant
Fosphenytoin
Fospropofol
Frovatriptan
Furazolidone
Furosemide
Gabapentin
Gabapentin Enacarbil
Gepirone
Ginkgo
Glycopyrrolate
Glycopyrronium Tosylate
Gossypol
Granisetron
Halazepam
Haloperidol
Halothane
Heparin
Hexobarbital
Homatropine
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Hydroxyzine
Hyoscyamine
Idelalisib
Iloprost
Imatinib
Imipramine
Indapamide
Indinavir
Indomethacin
Inotersen
Ipratropium
Iproniazid
Isocarboxazid
Isoflurane
Itraconazole
Ivacaftor
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Lanreotide
Larotrectinib
Lasmiditan
Lefamulin
Lemborexant
Lenacapavir
Lepirudin
Letermovir
Levocetirizine
Levomilnacipran
Levorphanol
Linezolid
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Loprazolam
Lorazepam
Lorcaserin
Lorlatinib
Lormetazepam
Lornoxicam
Loxapine
Loxoprofen
Lumacaftor
Lumiracoxib
Magnesium Oxybate
Mavacamten
Meadowsweet
Meclizine
Meclofenamate
Medazepam
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Melphalan
Mepenzolate
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesalamine
Mesoridazine
Metaclazepam
Metaxalone
Methadone
Methamphetamine
Methdilazine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylene Blue
Methylnaltrexone
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Mobocertinib
Moclobemide
Modafinil
Molindone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Nalbuphine
Nalorphine
Naloxone
Naproxen
Naratriptan
Nefazodone
Nelfinavir
Nepafenac
Netupitant
Nevirapine
Nialamide
Nicomorphine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitrazepam
Nitrous Oxide
Nordazepam
Nortriptyline
Octreotide
Olanzapine
Olsalazine Sodium
Omaveloxolone
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxitropium Bromide
Oxybutynin
Oxymorphone
Oxyphenbutazone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paroxetine
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Perazine
Periciazine
Perphenazine
Phenelzine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenytoin
Piketoprofen
Pimozide
Pinazepam
Pipenzolate Bromide
Piperacetazine
Pipotiazine
Pirenzepine
Piretanide
Piritramide
Piroxicam
Pirtobrutinib
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Pranoprofen
Prasugrel
Prazepam
Prednisolone
Prednisone
Pregabalin
Primidone
Procarbazine
Prochlorperazine
Procyclidine
Proglumetacin
Promazine
Promethazine
Propantheline
Propiverine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Ramelteon
Ranitidine
Ranolazine
Rasagiline
Remifentanil
Remimazolam
Remoxipride
Reviparin
Ribociclib
Rifabutin
Rifampin
Rifapentine
Ritlecitinib
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Selegiline
Selexipag
Selpercatinib
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Solifenacin
Sotorasib
Spironolactone
Stramonium
Sufentanil
Sulfasalazine
Sulfinpyrazone
Sulindac
Sulodexide
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Taurursodiol
Telaprevir
Telithromycin
Temazepam
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Terbinafine
Terodiline
Tetrazepam
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Thiothixene
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tiotropium
Tirofiban
Tizanidine
Tocilizumab
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Tolterodine
Topiramate
Torsemide
Tramadol
Tranylcypromine
Trazodone
Treprostinil
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trihexyphenidyl
Trimeprazine
Trimipramine
Trofinetide
Tropicamide
Trospium
Tryptophan
Tucatinib
Umeclidinium
Valdecoxib
Venlafaxine
Verapamil
Vilazodone
Vorapaxar
Voriconazole
Vortioxetine
Voxelotor
Warfarin
Xipamide
Zaleplon
Ziprasidone
Zolmitriptan
Zolpidem
Zopiclone
Zotepine
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.

Acebutolol
Amikacin
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Enalapril
Enalaprilat
Eprosartan
Esmolol
Fosinopril
Irbesartan
Labetalol
Levobunolol
Lisinopril
Losartan
Metipranolol
Metoprolol
Moexipril
Nadolol
Nebivolol
Olmesartan
Oxprenolol
Penbutolol
Perindopril
Pindolol
Propranolol
Quinapril
Ramipril
Sotalol
Spirapril
St John's Wort
Telmisartan
Timolol
Trandolapril
Valsartan

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
Grapefruit Juice
Tobacco

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:

Addison's disease (adrenal gland problem) or
Alcohol abuse, history of or
Brain tumor or
Breathing or lung problems (eg, asthma, COPD, cor pulmonale, hypercapnia, hypoxia) or
Depression, history of or
Drug abuse or dependence, especially narcotic abuse or dependence, or history of or
Enlarged prostate (BPH, prostatic hypertrophy) or
Head injury or
Hypothyroidism (underactive thyroid) or
Kidney disease, severe or
Kyphoscoliosis (curvature of spine that can cause breathing problems) or
Liver disease, severe or
Problems with urination or
Psychosis (mental illness) or
Systemic lupus erythematosus (SLE) or
Weakened physical condition—Use with caution. May increase risk for more serious side effects.

Anemia or
Bleeding problems or
Dehydration or
Edema (fluid retention) or
Heart attack, recent or
Heart disease (eg, congestive heart failure) or
Hypertension (high blood pressure) or
Hypotension (low blood pressure) or
Kidney disease or
Liver disease or
Pancreatitis (inflammation of the pancreas) or
Seizures, history of or
Stomach ulcers or bleeding, history of or
Stroke, history of—Use with caution. May make these conditions worse.

Aspirin-sensitive asthma or
Aspirin sensitivity, history of or
Heart surgery (eg, coronary artery bypass graft [CABG]) or
Lung or breathing problems (eg, asthma, respiratory depression), severe or
Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

Proper Use of This Medicine:

For safe and effective use of this medicine, 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. Taking too much of this medicine may increase the chance of unwanted effects.

This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor if you have any questions.

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 pain:
  - Adults and children 14 years of age and older—1 tablet every 4 to 6 hours as needed. However, the dose is usually not more than 4 tablets per day, and should not be taken for longer than 7 days, unless directed by your doctor.
  - Children and children younger than 14 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.

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.

Drop off any unused narcotic medicine at a drug take-back location right away. If you do not have a drug take-back location near you, flush any unused narcotic medicine down the toilet. Check your local drug store and clinics for take-back locations. You can also check the DEA web site for locations. Here is the link to the FDA safe disposal of medicines website: www.fda.gov/drugs/resourcesforyou/consumers/buyingusingmedicinesafely/ensuringsafeuseofmedicine/safedisposalofmedicines/ucm186187.htm

Precautions While Using This Medicine:

It is very important that your doctor check your progress while you are taking this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to take it.

Your doctor will want to check your blood pressure at the beginning of treatment and monitor it throughout treatment with this medicine. If high blood pressure occurs or worsens while taking this medicine, it may lead to serious heart problems.

Do not use more of this medicine or take it more often than your doctor tells you to. This can be life-threatening. Symptoms of an overdose include extreme dizziness or weakness, slow heartbeat or breathing, seizures, trouble breathing, and cold, clammy skin. Call your doctor right away if you notice these symptoms.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn babies. Tell your doctor right away if your baby has an abnormal sleep pattern, diarrhea, a high-pitched cry, irritability, shakiness or tremors, weight loss, vomiting, or fails to gain weight.

This medicine may increase your risk of having a heart attack or stroke. This is more likely to occur in people who already have heart disease. People who use this medicine for a long time might also have a higher risk. Some signs of serious heart problems are chest pain, tightness in the chest, fast or irregular heartbeat, or unusual flushing or warmth of the skin. Check with your doctor right away if you notice any of these warning signs.

Ibuprofen and oxycodone combination will add to the effects of alcohol and other central nervous system (CNS) depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicines for hay fever, allergies, or colds, sedatives, tranquilizers, sleeping medicine, or other prescription pain medicine or narcotics, medicine for seizures or barbiturates, muscle relaxants, or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and check with your medical doctor or dentist before taking any of the medicines listed above, while you are using this medicine.

This medicine may cause bleeding in your stomach or intestines. This is more likely to occur if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are over 60 years of age, are in poor health, or are using certain other medicines (such as steroids or a blood thinner). These problems can occur at any time with or without warning, and can be fatal. You should contact your doctor immediately if any of the following symptoms occur including black, tarry stools, bloody stools, vomiting of blood or material that looks like coffee grounds, severe or continuing stomach pain, cramping, or burning, trouble breathing, severe or continuing nausea, heartburn and/or indigestion.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

This medicine may cause serious allergic reactions, including anaphylaxis, angioedema, or certain skin conditions (Stevens-Johnson syndrome). These reactions can be life-threatening and require immediate medical attention. Call your doctor right away if you have a rash, itching, blistering, peeling, or loosening of the skin, fever or chills, trouble breathing or swallowing, or any swelling of your hands, face, mouth, or throat while you are using this medicine.

This medicine may cause some people to become drowsy, dizzy, lightheaded, or to feel a false sense of well-being. 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 clearheaded. If these reactions are especially bothersome, check with your doctor.

Dizziness, lightheadedness, or fainting may occur, especially when getting up suddenly from a lying or sitting position. Getting up slowly may lessen this problem.

Before having any kind of surgery (including dental surgery) or emergency treatment, tell the medical doctor or dentist in charge that you are taking this medicine.

Ibuprofen and oxycodone combination may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, check with your dentist. Continuing dryness of the mouth may increase the chance of dental disease, including tooth decay, gum disease, and fungus infections.

Call your doctor right away if you have confusion, drowsiness, fever, a general feeling of illness, a headache, loss of appetite, nausea, a stiff neck or back, or vomiting. These could be symptoms of a serious condition called aseptic meningitis.

If you have heart disease or congestive heart failure (CHF), tell your doctor if you have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Check with your doctor right away if you have anxiety, restlessness, a fast heartbeat, fever, sweating, muscle spasms, twitching, nausea, vomiting, diarrhea, or see or hear things that are not there. These may be symptoms of a serious condition called serotonin syndrome. Your risk may be higher if you also take certain other medicines that affect serotonin levels in your body.

Using too much of this medicine may cause infertility (unable to have children). Talk with your doctor before using this medicine if you plan to have children.

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 of This Medicine:

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:

Less common: Feeling faint, dizzy, or lightheaded; feeling of warmth or heat; flushing or redness of the skin, especially on the face and neck; headache; sweating

Rare: Abdominal or stomach pain; blurred vision; changes in skin color; chest pain; confusion; convulsions; decrease in frequency of urination; decreased urine; difficulty in passing urine (dribbling); difficulty with breathing; dizziness; dizziness, faintness, or lightheadedness when getting up from a lying position; dry mouth; excessive muscle tone; fainting; fast, pounding, or irregular heartbeat or pulse; increased need to urinate; increased thirst; loss of appetite; mood changes; muscle pain or cramps; muscle stiffness; muscle tension or tightness; nausea or vomiting; numbness or tingling in the hands, feet, or lips; pain, tenderness, or swelling of the foot or leg; painful urination; pale skin; passing urine more often; severe constipation; severe vomiting; troubled breathing with exertion; unusual bleeding or bruising; unusual tiredness or weakness

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

Symptoms of overdose: Change in consciousness; chest pain or discomfort; cold and clammy skin; constricted pupils; continuing ringing or buzzing or other unexplained noise in the ears; decreased awareness or responsiveness; difficult or troubled breathing; difficulty with sleeping; disorientation; drowsiness to profound coma; fainting; hearing loss; irregular, fast or slow, or shallow breathing; lethargy; loss of bladder control; loss of consciousness; muscle spasm or jerking of all extremities; pale or blue lips, fingernails, or skin; seeing, hearing, or feeling things that are not there; severe sleepiness; skeletal muscle flaccidity; sleepiness or unusual drowsiness; sudden fainting; sudden loss of consciousness

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: Acid or sour stomach; belching; bloated or full feeling; diarrhea; difficulty having a bowel movement (stool); excess air or gas in the stomach or intestines; fever; heartburn; indigestion; lack or loss of strength; passing gas; stomach discomfort, upset, or pain

Rare: Back pain; body aches or pain; bruising, large, flat, blue or purplish patches in the skin; changes in vision; chills; congestion; cough or hoarseness; delusions; dementia; difficult urination; difficulty with moving; dryness or soreness of the throat; enlarged abdomen or stomach; false or unusual sense of well-being; fear; hoarseness; impaired vision; increase in body movements; lower back or side pain; nervousness; pain, swelling, or redness in the joints; rash; runny nose; swelling; taste perversion; tender, swollen glands in the neck; trouble with sleeping; trouble with swallowing; voice changes

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.

Last Updated: 11/16/2023

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