Seglentis Side Effects

Generic name: celecoxib / tramadol

Medically reviewed by Drugs.com. Last updated on Jun 15, 2023.

Note: This document provides detailed information about Seglentis Side Effects associated with celecoxib / tramadol. Some dosage forms listed on this page may not apply specifically to the brand name Seglentis.

Applies to celecoxib / tramadol: oral tablet.

Precautions

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 celecoxib / tramadol 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.

Serious side effects of Seglentis

Along with its needed effects, celecoxib / tramadol may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking celecoxib / tramadol:

Get emergency help immediately if any of the following symptoms of overdose occur while taking celecoxib / tramadol:

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

For healthcare professionals

Applies to celecoxib / tramadol: oral tablet.

General adverse events

In a post-bunionectomy acute pain trial, patients received this combination drug (200 mg every 12 hours), celecoxib (100 mg every 12 hours), tramadol (50 mg every 6 hours), or placebo orally for 48 hours. The most common side effects reported with this combination drug were nausea, vomiting, dizziness, headache, and somnolence. Discontinuation due to side effects occurred in 1.6% of patients treated with this combination drug (3 out of 183); the side effects that led to discontinuation included nausea and pruritus/rash.^[Ref]

Gastrointestinal

• Very common (10% or more): Nausea (30.1%), vomiting (15.8%)

Celecoxib:

• Very common (10% or more): Nausea (16.5%)
• Common (1% to 10%): Vomiting
• Frequency not reported: Serious gastrointestinal adverse events (including inflammation, bleeding, ulceration, perforation of the esophagus/stomach/small intestine/large intestine)

Tramadol:

• Very common (10% or more): Nausea (37.7%), vomiting (16.4%)

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs):

• Frequency not reported: Serious upper gastrointestinal adverse events (including ulcers, gross bleeding, perforation), complicated symptomatic ulcer^[Ref]

Nervous system

• Very common (10% or more): Dizziness (16.9%), headache (11.5%)
• Common (1% to 10%): Somnolence

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Aseptic meningitis, ageusia, anosmia, fatal intracranial hemorrhage, movement disorder, speech disorder

Celecoxib:

• Very common (10% or more): Headache (11%)
• Common (1% to 10%): Dizziness, somnolence
• Frequency not reported: Stroke

Tramadol:

• Very common (10% or more): Dizziness (18.6%), headache (18%)
• Common (1% to 10%): Somnolence
• Frequency not reported: Sedation, serotonin syndrome, seizures

Opioids:

• Postmarketing reports: Serotonin syndrome^[Ref]

Serotonin syndrome has been reported during concomitant use of opioids (including tramadol) with serotonergic drugs.^[Ref]

Metabolic

• Common (1% to 10%): Decreased appetite

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Hypoglycemia, hyponatremia

Celecoxib:

• Uncommon (0.1% to 1%): Decreased appetite

Tramadol:

• Common (1% to 10%): Decreased appetite
• Postmarketing reports: Hypoglycemia, hyponatremia

NSAIDs:

• Frequency not reported: Fluid retention, increased serum potassium level (including hyperkalemia)^[Ref]

Cases of tramadol-associated hypoglycemia have been reported, some resulted in hospitalization. In most cases, patients had predisposing risk factors (including diabetes, renal insufficiency) or were elderly.

Hyponatremia (serum sodium less than 135 mmol/L) has been reported with the use of tramadol; many cases were severe (sodium level less than 120 mmol/L). Most cases of hyponatremia occurred in females older than 65 years and within the first week of therapy.^[Ref]

Respiratory

Opioids:

• Frequency not reported: Respiratory depression, sleep-related breathing disorders (including central sleep apnea, sleep-related hypoxemia)^[Ref]

Serious, life-threatening, or fatal respiratory depression has been reported with opioid use, even when used as recommended.^[Ref]

Other

Tramadol:

• Frequency not reported: Death, overdose, withdrawal syndrome

Celecoxib:

• Common (1% to 10%): Peripheral edema

NSAIDs:

• Frequency not reported: Edema^[Ref]

Hepatic

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Liver necrosis, hepatitis, jaundice, hepatic failure

Celecoxib:

• Common (1% to 10%): Elevated liver associated enzymes
• Uncommon (0.1% to 1%): Elevated ALT, elevated AST

NSAIDs:

• Frequency not reported: Elevated ALT, elevated AST, severe hepatic injury (including fulminant hepatitis)^[Ref]

In controlled clinical trials of celecoxib, borderline elevations (at least 1.2 times and less than 3 times the upper limit of normal) of liver associated enzymes were reported in 6% of patients taking celecoxib and 5% of patients taking placebo; notable elevations of ALT and AST were reported in about 0.2% of patients taking celecoxib and 0.3% of patients taking placebo.^[Ref]

Hematologic

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Agranulocytosis, aplastic anemia, pancytopenia, leukopenia

Celecoxib:

• Uncommon (0.1% to 1%): Anemia

NSAIDs:

• Frequency not reported: Anemia^[Ref]

Cardiovascular

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Vasculitis, deep venous thrombosis

Celecoxib:

• Frequency not reported: Cardiovascular death (including hemorrhagic death), myocardial infarction

Tramadol:

• Postmarketing reports: QT prolongation, torsade de pointes^[Ref]

Cases of QT prolongation and/or torsade de pointes have been reported with tramadol use. Many of these cases were reported in patients taking another drug labeled for QT prolongation, in patients with a risk factor for QT prolongation (e.g., hypokalemia), or in the overdose setting.^[Ref]

Dermatologic

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Angioedema

Celecoxib:

• Frequency not reported: Serious skin reactions (including erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms [DRESS], acute generalized exanthematous pustulosis)

NSAIDs:

• Frequency not reported: DRESS (including fatal or life-threatening cases)^[Ref]

Hypersensitivity

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Anaphylactoid reaction

Celecoxib:

• Frequency not reported: Anaphylactic reactions

Tramadol:

• Frequency not reported: Anaphylactic reactions, other allergic reactions (including pruritus, hives, bronchospasm, angioedema, toxic epidermal necrolysis, Stevens-Johnson syndrome)^[Ref]

Ocular

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Miosis, mydriasis^[Ref]

Psychiatric

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Delirium^[Ref]

Renal

Celecoxib- or Tramadol-Containing Products:

• Postmarketing reports: Interstitial nephritis

NSAIDs:

• Frequency not reported: Renal papillary necrosis, other renal injury^[Ref]

Endocrine

Tramadol:

• Postmarketing reports: Syndrome of inappropriate antidiuretic hormone secretion (SIADH)

Opioids:

• Postmarketing reports: Adrenal insufficiency, androgen deficiency^[Ref]

Cases of SIADH have been reported in patients taking tramadol, most often in females older than 65 years, and within the first week of therapy.

Cases of adrenal insufficiency have been reported with opioid use, more often when used beyond 1 month. Cases of androgen deficiency have occurred with chronic opioid use.^[Ref]

See also:

Further information

Seglentis side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

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