Celecoxib and tramadol (Oral route)

Pronunciation:

sel-e-KOX-ib, TRAM-a-dol hye-droe-KLOR-ide

Brand Names:

Seglentis

Dosage Forms:

Tablet

Warnings:

Oral route(Tablet)

Addiction, Abuse, and MisuseCelecoxib/traMADol exposes patients and other users to the risk of opioid addiction, abuse, and misuse, which can lead to overdose and death. Assess each patient's risk prior to prescribing celecoxib/traMADol and monitor all patients regularly for the development of these behaviors and conditions.Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS)To ensure that the benefits of opioid analgesics outweigh the risks of addiction, abuse, and misuse, the Food and Drug Administration (FDA) has required a REMS for these products. Under the requirements of the REMS, drug companies with approved opioid analgesic products must make REMS-compliant education programs available to healthcare providers. Healthcare providers are strongly encouraged to: complete a REMS-compliant education program, counsel patients and/or caregivers, with every prescription, on safe use, serious risks, storage, and disposal of these products, emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist, and consider other tools to improve patient, household, and community safety.Life-Threatening Respiratory DepressionSerious, life-threatening, or fatal respiratory depression may occur with use of celecoxib/traMADol. Monitor for respiratory depression, especially during initiation of celecoxib/traMADol.Accidental IngestionAccidental ingestion of even one dose celecoxib/traMADol, especially by children, can be fatal.Cardiovascular Thrombotic EventsNonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in the treatment and may increase with duration of use.Celecoxib/traMADol is contraindicated in the setting of coronary artery bypass graft (CABG) surgery.Gastrointestinal Bleeding, Ulceration, and PerforationNSAIDs cause an increased risk of serious gastrointestinal (GI) adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients and patients with a prior history of peptic ulcer disease and/or GI bleeding are at greater risk for serious (GI) events.Ultra-Rapid Metabolism of TraMADol and Other Risk Factors for Life-Threatening Respiratory Depression in ChildrenLife-threatening respiratory depression and death have occurred in children who received traMADol. Some of the reported cases followed tonsillectomy and/or adenoidectomy; in at lease one case, the child had evidence of being an ultra-rapid metabolizer of traMADol due to a CYP2D6 polymorphism. Celecoxib/traMADol is contraindicated in children younger than 12 years of age an in children younger than 18 years of age following tonsillectomy and/or adenoidectomy. Avoid use of celecoxib/traMADol in adolescents 12 to 18 years of age who have other risk factors that may increase their sensitivity to the respiratory depressant effects of traMADol.Neonatal Opioid Withdrawal SyndromeProlonged use of celecoxib/traMADol during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated, and requires management according to protocols developed by neonatology experts. 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.Interactions with Drugs Affecting Cytochrome P450 IsoenzymesThe effects of concomitant use or discontinuation of cytochrome P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with traMADol are complex. Use of cytochrome P450 P450 3A4 inducers, 3A4 inhibitors, or 2D6 inhibitors with celecoxib/traMADol requires careful consideration of the effects on the parent drug, traMADol, and the active metabolite, M1.Risks from Concomitant Use with Benzodiazepines or Other CNS DepressantsConcomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death.Reserve concomitant prescribing of celecoxib/traMADol and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate.Limit treatment to the minimum duration.Follow patients for signs and symptoms of respiratory depression and sedation .

Classifications:

Therapeutic—

Analgesic

Pharmacologic—

Cyclooxygenase-2 Inhibitor

Chemical—

Tramadol

Uses of This Medicine:

Celecoxib and tramadol combination is used to relieve acute pain severe enough to require an opioid treatment and when other pain medicines did not work well enough or cannot be tolerated. When used together, the combination provides better pain relief than either medicine used alone. In some cases, you may get relief with lower doses of each medicine.

Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID). Tramadol belongs to the group of medicines called opioid analgesics (narcotics). It acts in the central nervous system (CNS) to relieve pain. When tramadol is used for a long time, it may become habit-forming (causing mental or physical dependence). Mental dependence (addiction) is not likely to occur when narcotics are used for this purpose. Physical dependence may lead to side effects when you suddenly stop taking the medicine. Since this medicine is only used for short-term relief of pain, mental and physical dependence will probably not occur.

This medicine is available only under a restricted distribution program called the Opioid Analgesic REMS (Risk Evaluation and Mitigation Strategy) program.

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 celecoxib and tramadol combination in the pediatric population. It should not be used in children younger than 12 years of age. Safety and efficacy have not been established.

This medicine should not be used to relieve pain after surgery removal of tonsils or adenoids in any children. Severe breathing problems and deaths have been reported in some children who received codeine after tonsil or adenoid surgery.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of celecoxib and tramadol combination in the elderly. However, elderly patients are more likely to have age-related liver, kidney, heart, stomach, or lung problems which may require caution and an adjustment in the dose for patients receiving celecoxib and tramadol combination.

Breast-feeding—

Celecoxib

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.

Tramadol

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.

Furazolidone
Iproniazid
Isocarboxazid
Ketorolac
Linezolid
Methylene Blue
Moclobemide
Nalmefene
Naltrexone
Nialamide
Phenelzine
Procarbazine
Rasagiline
Safinamide
Samidorphan
Selegiline
Tranylcypromine

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
Adagrasib
Alfentanil
Almotriptan
Alprazolam
Amifampridine
Amiloride
Amineptine
Amiodarone
Amitriptyline
Amitriptylinoxide
Amobarbital
Amoxapine
Amphetamine
Amprenavir
Amtolmetin Guacil
Anagrelide
Anileridine
Apixaban
Aprepitant
Ardeparin
Argatroban
Aripiprazole
Armodafinil
Asciminib
Asenapine
Aspirin
Atazanavir
Baclofen
Balsalazide
Bemetizide
Bemiparin
Bendroflumethiazide
Benperidol
Benzhydrocodone
Benzphetamine
Benzthiazide
Betamethasone
Betrixaban
Bismuth Subsalicylate
Bivalirudin
Boceprevir
Bosentan
Bromazepam
Bromfenac
Bromopride
Bromperidol
Brompheniramine
Budesonide
Bufexamac
Bumetanide
Buprenorphine
Bupropion
Buspirone
Butabarbital
Butorphanol
Calcium Oxybate
Cangrelor
Cannabidiol
Cannabis
Capecitabine
Carbamazepine
Carbinoxamine
Carisoprodol
Carphenazine
Ceritinib
Certoparin
Cetirizine
Chloral Hydrate
Chlordiazepoxide
Chlorothiazide
Chlorpheniramine
Chlorpromazine
Chlorthalidone
Chlorzoxazone
Choline Magnesium Trisalicylate
Choline Salicylate
Cilostazol
Cimetidine
Cinacalcet
Ciprofloxacin
Citalopram
Clarithromycin
Clobazam
Clomipramine
Clonazepam
Clonixin
Clopamide
Clopidogrel
Clorazepate
Clozapine
Cobicistat
Cocaine
Codeine
Conivaptan
Cortisone
Crizotinib
Cyclobenzaprine
Cyclopenthiazide
Cyclosporine
Cyclothiazide
Dabigatran Etexilate
Dabrafenib
Dalteparin
Danaparoid
Daridorexant
Darunavir
Deflazacort
Delavirdine
Desipramine
Desirudin
Desmopressin
Desvenlafaxine
Dexamethasone
Dexibuprofen
Dexketoprofen
Dexmedetomidine
Dextroamphetamine
Dextromethorphan
Dezocine
Diazepam
Diazoxide
Dibenzepin
Dichloralphenazone
Difenoxin
Diflunisal
Digoxin
Dihydrocodeine
Diltiazem
Diphenhydramine
Diphenoxylate
Dipyridamole
Dipyrone
Dolasetron
Donepezil
Dothiepin
Doxepin
Doxylamine
Dronedarone
Droperidol
Droxicam
Duloxetine
Edoxaban
Efavirenz
Eletriptan
Emtricitabine
Enflurane
Enoxaparin
Enzalutamide
Eplerenone
Epoprostenol
Eptifibatide
Erythromycin
Escitalopram
Esketamine
Eslicarbazepine Acetate
Estazolam
Eszopiclone
Ethacrynic Acid
Ethchlorvynol
Ethopropazine
Ethylmorphine
Etodolac
Etofenamate
Etoricoxib
Etozolin
Etravirine
Fedratinib
Felbinac
Fenfluramine
Fenoprofen
Fentanyl
Fepradinol
Feprazone
Feverfew
Flibanserin
Floctafenine
Fluconazole
Flufenamic Acid
Fluocortolone
Fluoxetine
Fluphenazine
Flurazepam
Flurbiprofen
Fluspirilene
Fluvoxamine
Fondaparinux
Fosamprenavir
Fosaprepitant
Fosphenytoin
Fospropofol
Frovatriptan
Furosemide
Gabapentin
Gabapentin Enacarbil
Gepirone
Ginkgo
Gossypol
Granisetron
Halazepam
Haloperidol
Halothane
Heparin
Hexobarbital
Hydrochlorothiazide
Hydrocodone
Hydrocortisone
Hydroflumethiazide
Hydromorphone
Hydroxyamphetamine
Hydroxytryptophan
Hydroxyzine
Ibuprofen
Idelalisib
Iloprost
Imatinib
Imipramine
Indapamide
Indinavir
Inotersen
Isoflurane
Itraconazole
Ivacaftor
Ivosidenib
Ketamine
Ketazolam
Ketobemidone
Ketoconazole
Ketoprofen
Lacosamide
Lasmiditan
Lemborexant
Lenacapavir
Lepirudin
Levocetirizine
Levoketoconazole
Levomilnacipran
Levorphanol
Lisdexamfetamine
Lithium
Lofepramine
Lofexidine
Lomitapide
Lopinavir
Lorazepam
Lorcaserin
Lornoxicam
Loxapine
Loxoprofen
Lumacaftor
Lumiracoxib
Magnesium Oxybate
Magnesium Salicylate
Mavacamten
Meadowsweet
Meclizine
Meclofenamate
Mefenamic Acid
Melitracen
Meloxicam
Melperone
Melphalan
Meperidine
Mephobarbital
Meprobamate
Meptazinol
Mesalamine
Mesoridazine
Metaxalone
Methadone
Methamphetamine
Methocarbamol
Methohexital
Methotrexate
Methotrimeprazine
Methyclothiazide
Methylprednisolone
Metoclopramide
Metolazone
Mibefradil
Midazolam
Mifepristone
Milnacipran
Mirabegron
Mirtazapine
Mitotane
Modafinil
Molindone
Moricizine
Morniflumate
Morphine
Morphine Sulfate Liposome
Nabumetone
Nadroparin
Nafcillin
Nalbuphine
Naproxen
Naratriptan
Nefazodone
Nelfinavir
Nepafenac
Nevirapine
Nicomorphine
Niflumic Acid
Nilotinib
Nimesulide
Nimesulide Beta Cyclodextrin
Nitisinone
Nitrazepam
Nitrous Oxide
Nortriptyline
Olanzapine
Olsalazine
Ondansetron
Opipramol
Opium
Opium Alkaloids
Orphenadrine
Oxaprozin
Oxazepam
Oxcarbazepine
Oxycodone
Oxymorphone
Oxyphenbutazone
Ozanimod
Palbociclib
Palonosetron
Papaveretum
Paramethasone
Parecoxib
Paregoric
Parnaparin
Paroxetine
Peginterferon Alfa-2b
Pemetrexed
Pentazocine
Pentobarbital
Pentosan Polysulfate Sodium
Pentoxifylline
Perampanel
Periciazine
Perphenazine
Phenindione
Phenobarbital
Phenprocoumon
Phenylbutazone
Phenyl Salicylate
Phenytoin
Piketoprofen
Pimozide
Piperacetazine
Pipotiazine
Piretanide
Piritramide
Piroxicam
Polythiazide
Posaconazole
Potassium Citrate
Potassium Oxybate
Prasugrel
Prazepam
Prednisolone
Prednisone
Pregabalin
Primidone
Prochlorperazine
Proglumetacin
Promethazine
Propofol
Propyphenazone
Proquazone
Protein C
Protriptyline
Quazepam
Quetiapine
Quinethazone
Quinidine
Quinine
Ramelteon
Ranitidine
Ranolazine
Remifentanil
Remimazolam
Remoxipride
Reviparin
Rifabutin
Rifampin
Rifapentine
Ritonavir
Rivaroxaban
Rizatriptan
Rofecoxib
Rolapitant
Ropeginterferon Alfa-2b-njft
Salicylamide
Salicylic Acid
Salsalate
Saquinavir
Scopolamine
Secobarbital
Selexipag
Sertindole
Sertraline
Sibutramine
Sodium Oxybate
Sodium Salicylate
Sparsentan
Spironolactone
St John's Wort
Sufentanil
Sulfasalazine
Sulfinpyrazone
Sulindac
Sulodexide
Sulpiride
Sumatriptan
Suvorexant
Tacrolimus
Tapentadol
Telaprevir
Telithromycin
Temazepam
Tenofovir Alafenamide
Tenofovir Disoproxil Fumarate
Tenoxicam
Terbinafine
Thiethylperazine
Thiopental
Thiopropazate
Thioridazine
Tianeptine
Tiaprofenic Acid
Ticagrelor
Ticlopidine
Tilidine
Tinzaparin
Tirofiban
Tizanidine
Tocilizumab
Tolfenamic Acid
Tolmetin
Tolonium Chloride
Topiramate
Torsemide
Trazodone
Treprostinil
Triamterene
Triazolam
Trichlormethiazide
Trifluoperazine
Trifluperidol
Triflupromazine
Trimeprazine
Trimipramine
Trolamine Salicylate
Tryptophan
Valdecoxib
Venlafaxine
Verapamil
Vilazodone
Vorapaxar
Voriconazole
Vortioxetine
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
Atenolol
Azilsartan
Azilsartan Medoxomil
Benazepril
Betaxolol
Bisoprolol
Candesartan
Captopril
Carteolol
Carvedilol
Celiprolol
Digoxin
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
Telmisartan
Timolol
Trandolapril
Valsartan
Warfarin

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

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 problems or
Alcohol abuse, or history of or
Brain tumor or
Depression, history of or
Diabetes or
Drug dependence, especially narcotic abuse or dependence, or history of or
Head injuries or
Increased pressure in the head or
Lung or breathing problems (eg, COPD, hypercapnia, hypoxia, sleep apnea) or
Mental illness (eg, suicidal ideation), history of or
Obesity (overweight) or
Seizures, history of or
Stomach problems, severe—Use with caution. May increased risk for more side effects.

Anemia or
Bleeding problems or
Congestive heart failure or
Edema (fluid retention or body swelling) or
Heart attack, history of or
Heart disease or
Hypertension (high blood pressure) or
Kidney disease or
Pancreatitis (swelling of the pancreas) or
Stroke, history of—Use with caution. May make these conditions worse.

Aspirin-sensitive asthma, history of or
Aspirin sensitivity, history of or
Asthma, acute or severe or
Lung or breathing problems, severe or
Stomach or bowel blockage (eg, paralytic ileus)—Should not be used in patients with these conditions.

Certain genetic conditions (poor CYP2C9 (a liver enzyme) metabolizers) or
Liver disease, mild or moderate—Use with caution. You may need a reduced dose of this medicine.

Dehydration or
Hypovolemia—Must be corrected first before using this medicine.

Heart surgery (eg, coronary artery bypass graft [CABG] surgery)—This medicine should not be used to relieve pain right before or after the surgery.

Kidney disease, severe or
Liver disease, moderate to severe—Use is not recommended 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. This is especially important for elderly patients, who may be more sensitive to the effects of pain medicines. If too much of this medicine is taken for a long time, it may increase the chance of unwanted effects, may become habit-forming (causing mental or physical dependence), or cause an overdose.

It is very important that you understand the rules of the Opioid Analgesic REMS program to prevent addiction, abuse, and misuse of celecoxib and tramadol combination. This medicine should come with a Medication Guide. Read and follow the 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 acute pain:
  - Adults—2 tablets every 12 hours as needed.
  - Children 12 years of age and older—Use and dose must be determined by your doctor.
  - Children younger than 12 years of age—Should not be used in these patients.

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.

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 or your child's progress at regular visits, especially within the first 24 to 72 hours of treatment, to make sure the medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Using this medicine during the later part of pregnancy can harm your unborn baby. If you think you have become pregnant while using the medicine, tell your doctor right away.

Using this medicine while you are pregnant may cause neonatal withdrawal syndrome in your newborn baby. Check with 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. Tell your doctor right away if you think you are pregnant or if you plan to become pregnant while using this medicine.

Do not use this medicine if you are using or have used an MAO inhibitor (MAOI), such as isocarboxazid [Marplan®], linezolid [Zyvox®], phenelzine [Nardil®], selegiline [Eldepryl®], or tranylcypromine [Parnate®] within the past 14 days. Do not use this medicine together with other products containing celecoxib or tramadol.

Do not change the dose or suddenly stop taking this medicine without first checking with your doctor. Your doctor may want you to gradually reduce the amount you are using before stopping it completely. This may help prevent worsening of your condition and reduce the possibility of withdrawal symptoms, such as anxiety, diarrhea, headache, nausea, shivering, sweating, tremors, or trouble sleeping.

This medicine may be habit-forming. If you feel that the medicine is not working as well, do not use more than your prescribed dose. Call your doctor for instructions.

This medicine may cause some people to become drowsy, dizzy, or lightheaded. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

Check with your doctor right away if you have bloody urine, a decrease in frequency or amount of urine, an increase in blood pressure, increased thirst, loss of appetite, lower back or side pain, nausea, swelling of the face, fingers, or lower legs, trouble breathing, unusual tiredness or weakness, vomiting, or weight gain. These could be symptoms of a serious kidney problem.

Check with your doctor before using this medicine with alcohol or other medicines that affect the central nervous system (CNS). The use of alcohol or other medicines that affect the CNS with Seglentis® 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.

Using narcotics for a long time can cause severe constipation. To prevent this, your doctor may direct you to take laxatives, drink a lot of fluids, or increase the amount of fiber in your diet. Be sure to follow the directions carefully, because continuing constipation can lead to more serious problems.

This medicine may cause sleep-related breathing problems (eg, sleep apnea, sleep-related hypoxemia). Your doctor may decrease your dose if you have sleep apnea (stop breathing for short periods during sleep) while using this medicine.

If you think you or someone else may have taken an overdose of this medicine, get emergency help at once. Your doctor may also give naloxone and other medicines to treat an overdose. Signs of an overdose include: dark urine, difficult or trouble breathing, irregular, fast or slow, or shallow breathing, nausea, vomiting, pain in the upper stomach, pale or blue lips, fingernails, or skin, pinpoint pupils of the eyes, or yellow eyes or skin.

This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.

This medicine may cause bleeding in your stomach or bowels. These problems can happen without warning signs. This is more likely if you or your child 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 using certain other medicines (eg, steroids or a blood thinner).

Tramadol is highly metabolized in the body. Some people change tramadol to a stronger product (O-desmethyltramadol) more quickly than others. These individuals are called "ultra-rapid metabolizers of tramadol". Contact your doctor immediately if you experience extreme sleepiness, confusion, or shallow breathing. These symptoms may indicate that you are an "ultra-rapid metabolizer of tramadol." As a result, there is too much O-desmethyltramadol in the body and more side effects of O-desmethyltramadol than usual. Children may be especially sensitive to this effect (eg, serious breathing problems, death). Do not give this medicine to:

Children younger than 12 years of age.
Children younger than 18 years of age who have had surgery removal of tonsils or adenoids.
Children 12 to 18 years of age who have a high risk for breathing problems (eg, obstructive sleep apnea, obesity, lung disease).

If a nursing mother is an ultra-rapid metabolizer of tramadol, it could lead to an overdose in the nursing baby and cause very serious side effects.

For nursing mothers using this medicine

Talk to your doctor if you have any questions about taking tramadol or about how this medicine may affect your baby.
Call your doctor if you become extremely tired and have difficulty caring for your baby.
Your baby should generally nurse every 2 to 3 hours and should not sleep more than 4 hours at a time.
Check with your doctor, hospital emergency room, or local emergency services (eg, "call 9-1-1") immediately if your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, difficulty breathing, or limpness. These may be symptoms of an overdose and need immediate medical attention.

This medicine 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 your doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also, tell your doctor if you have any sudden or strong feelings, including feeling nervous, angry, restless, violent, or scared. Let your doctor know if you or anyone in your family has tried to commit suicide.

This medicine may cause adrenal gland problems. Check with your doctor right away if you have darkening of the skin, diarrhea, dizziness, fainting, loss of appetite, mental depression, nausea, skin rash, unusual tiredness or weakness, or vomiting.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. Also, lying down for a while may relieve dizziness or lightheadedness. If this problem continues or gets worse, check with your doctor right away.

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

Check with your doctor right away if you or your child 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.

Tell your doctor if you or your child have unexplained weight gain or edema (fluid retention or body swelling) with this medicine.

Hyperkalemia (high potassium in the blood) may occur while you are using this medicine. Check with your doctor right away if you have stomach pain, confusion, difficulty with breathing, irregular heartbeat, nausea or vomiting, nervousness, numbness or tingling in the hands, feet, or lips, or weakness or heaviness of the legs.

Serious skin reactions, including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) can occur with this medicine. Check with your doctor right away if you have black, tarry stools, blistering, peeling, or loosening of the skin, chest pain, chills, cough, diarrhea, fever, itching, joint or muscle pain, painful or difficult urination, red irritated eyes, red skin lesions, sore throat, sores, ulcers, or white spots in the mouth or on the lips, swollen glands, unusual bleeding or bruising, or unusual tiredness or weakness.

This medicine may cause hyponatremia (low sodium levels in the blood). Check with your doctor right away if you have coma, confusion, decreased urine output, dizziness, fast or irregular heartbeat, headache, increased thirst, muscle pain or cramps, nausea or vomiting, swelling of the face, ankles, or hands, trouble breathing, or unusual tiredness or weakness.

Check with your doctor right away if you have anxiety, blurred vision, chills, cold sweats, coma, confusion, cool, pale skin, depression, dizziness, fast heartbeat, headache, increased hunger, nausea, nervousness, nightmares, seizures, shakiness, slurred speech, or unusual tiredness or weakness. These may be symptoms of hypoglycemia (low blood sugar level).

This medicine may cause a delay in ovulation for women and may affect their ability 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:

Incidence not known: Agitation; anxiety; bigger, dilated, or enlarged pupils (black part of eye); black, tarry stools; blistering, peeling, or loosening of the skin; bloating of the stomach; bloody or cloudy urine; blurred vision; chest pain, discomfort, or tightness; chills; cold sweats; coma; confusion; confusion as to time, place, or person; constricted, pinpoint, or small pupils (black part of eye); cool, pale skin; cough or hoarseness; dark urine; darkening of the skin; depression; diarrhea; difficulty in speaking; difficulty swallowing; dizziness; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; fainting; fast heartbeat; fever; greatly decreased frequency of urination or amount of urine; hallucinations; headache, sudden or severe; heartburn; hives, itching, skin rash; holding false beliefs that cannot be changed by fact; increased hunger; increased sensitivity of the eyes to light; increased thirst; indigestion; irregular or slow heart rate; joint or muscle pain; large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs; light-colored stools; loss of appetite; loss of sense of smell or taste; lower back or side pain; mental depression; muscle pain or cramps; nausea; nervousness; nightmares; numbness or tingling in the hands, feet, or lips; overactive reflexes; pain, redness, or swelling in the arm or leg; painful or difficult urination; pain or discomfort in the arms, jaw, back, or neck; pale or blue lips, fingernails, or skin; poor coordination; puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue; red irritated eyes; red skin lesions, often with a purple center; seizures; shakiness; shivering; slurred speech; sore throat; sores, ulcers, or white spots on the lips or in the mouth; stiff neck or back; stomach cramps or pain; sweating; swelling of the face, ankles, or hands; swelling of the feet or lower legs; swollen glands; talking or acting with excitement you cannot control; trouble breathing; twitching; unpleasant breath odor; unusual bleeding or bruising; unusual excitement, nervousness, or restlessness; unusual or incomplete body or facial movements; unusual tiredness or weakness; vomiting; vomiting of blood or material that looks like coffee grounds; weakness or heaviness of the legs; weight gain; yellow eyes or skin

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

Symptoms of overdose: Black, tarry stools; dark urine; depression; disorientation; dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position; drowsiness to profound coma; fever; headache; irregular, fast or slow, or shallow breathing; lightheadedness; loss of appetite; mood or other mental changes; nausea; pale or blue lips, fingernails, or skin; seeing, hearing, or feeling things that are not there; stomach pain; trouble sleeping; unpleasant breath odor; unusual drowsiness, dullness, tiredness, weakness, or feeling of sluggishness; vomiting of blood; yellow eyes or skin

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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