Seglentis (celecoxib/tramadol) - Uses, Side Effects, and More

What are the most common side effects of Seglentis?

The most common side effects of Seglentis are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

• Nausea or vomiting
• Dizziness
• Headache
• Sleepiness or tiredness
• Constipation or diarrhea
• Stomach pain 
• Gas or heartburn

There may be other side effects of Seglentis that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Seglentis?

While less common, the most serious side effects of Seglentis are described below, along with what to do if they happen.

Severe Allergic Reactions. Seglentis may cause allergic reactions, including a specific type of allergic reaction called DRESS. DRESS stands for Drug Reaction with Eosinophilia and Systemic Symptoms. It is also sometimes called multi-organ hypersensitivity. This is a reaction that can affect multiple parts of the body including your liver, kidneys, and heart. Get emergency help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Itching, skin rash, or pale red bumps on the skin called hives
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Shortness of breath, trouble swallowing, or throat tightness
• Swelling in your feet, ankles, or legs
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain
• Dark-colored pee
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Risk of Misuse and Addiction. Misusing Seglentis can lead to serious side effects like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take Seglentis exactly as prescribed. Tell your healthcare provider if you feel that Seglentis is not working. Call your healthcare provider right away or go to the nearest emergency room if you have any of the following serious symptoms.

• Sudden confusion or feeling disoriented
• Feeling paranoid
• Suicidal thoughts or actions
• Seizures
• Trouble breathing

Breathing Problems. Seglentis may cause slow or shallow breathing, especially if you have breathing problems from another condition or take other medicines that can slow your breathing. Tell your healthcare provider if you develop severe sleepiness or trouble breathing, especially when you start Seglentis or when your dose is increased. Get emergency help right away if you have any of the following symptoms.

• Changes in the color of your skin, including bluish color to your lips and fingernails
• Confusion
• Shortness of breath
• Feeling dizzy, lightheaded, or fainting
• Changes in your heart rate or rhythm, such as a fast, slow, pounding or skipping heartbeat 
• Slow or shallow breathing
• Excessive sleepiness or trouble staying awake

Heart Attack and Stroke. Seglentis can increase your risk of a heart attack or stroke that can lead to death. This risk is increased in people with existing heart disease and with longer use of Seglentis and higher doses. Do not take Seglentis if you have had a recent heart attack without talking to your healthcare provider. This could increase your risk of having another heart attack. Get emergency help if you have any of the following symptoms of a heart attack or stroke.

• Chest pain or pressure
• Fast or abnormal heartbeat
• Trouble breathing
• Pain in your back, jaw, throat, or arm
• Sweating, upset stomach, vomiting, or dizziness
• Sudden weakness on one side of your body
• Sudden and severe headache
• Slurred speech or trouble understanding speech

Bleeding. Seglentis can increase your risk of bleeding, especially if you have a bleeding disorder or take other medicines that increase your risk for bleeding. Tell your healthcare provider right away if you notice any signs of bleeding, including easy bruising or bleeding.

Stomach Bleeding. Seglentis can increase your risk of bleeding, ulcers, and tears (perforation) in your gut. The risk is higher if you have a history of stomach ulcers, bleeding problems, take higher doses of Seglentis or take it for longer than directed, have poor health, are age 60 or older, have liver disease, smoke, drink alcohol, or take certain other medicines. Stop Seglentis and get emergency help right away if you have any of the following symptoms.

• Vomit blood
• Black or tarry poop
• Stomach pain that does not go away
• Upset stomach
• Feel faint

Increased Pain Sensitivity (Hyperalgesia). Seglentis can cause an increased sensitivity to pain. It can cause things that normally cause pain to feel more painful than usual. Seglentis can also cause allodynia. This happens when things that normally do not cause pain, such as wearing glasses or brushing your hair, become painful. If your pain increases, do not take extra doses of Seglentis. This could cause you to overdose or develop other serious side effects. Call your healthcare provider right away if your pain increases, you feel more sensitive to pain, or if you develop pain in other areas of the body. 

Serotonin Syndrome. Serotonin syndrome is when there is too much of a substance called serotonin in your body. Seglentis can cause serotonin syndrome when it is taken alone or with other medicines that affect serotonin. This condition can be life-threatening. Get emergency help right away if you have any of the following symptoms of serotonin syndrome.

• Sweating, fever, or flushing
• Confusion
• Feeling agitated or restless
• Seeing or hearing unusual things
• Dizziness
• Fast or racing heartbeat
• Nausea, vomiting, or diarrhea
• Muscle twitching, stiffness, or tremor
• Seizures

Seizures. Some people who have taken Seglentis have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Get emergency help right away if you have any of the following signs that a seizure is happening or could happen.

• Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
• Stiffening of your arms and legs
• Feeling anxious, nervous, confused, or a sense of dread
• Feeling dizzy or lightheaded
• Falling or losing consciousness

Suicidal Thoughts and Actions. Seglentis may cause suicidal thoughts or actions in a small number of people. If you are about to harm yourself, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

• New or increased thoughts of suicide or death
• Suicide attempt 
• New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Reduced Adrenal Function. Long-term use of Seglentis can cause your body’s adrenal glands to stop making as much cortisol (the stress hormone). This is known as adrenal insufficiency. Adrenal insufficiency can get worse if your body is under stress because of fever, surgery, or trauma. Tell your healthcare provider if you have any of the following symptoms of adrenal insufficiency.

• Nausea and vomiting
• Weakness, tiredness, or lack of energy
• Low blood pressure

Low Blood Pressure (Hypotension). Seglentis may cause low blood pressure. If you feel faint or dizzy, lie down. Drink enough water to stay hydrated. Tell your healthcare provider right away if you have any of the following symptoms of low blood pressure.

• Dizziness, feeling lightheaded, or fainting
• Confusion
• Feeling weak or tired

Sphincter of Oddi Spasm. The sphincter of Oddi is a muscular valve in your body that controls the flow of bile and digestive juices from the pancreas into the small intestine. When this valve spasms, it may feel like getting a tight muscle cramp, causing pain and blocking the flow of these juices, which can lead to discomfort and digestive problems. This is more likely to happen if you do not have a gallbladder. Get emergency medical help if you have new or worse stomach pain or pain in the upper right side of your stomach-area that travels to your back or shoulder, with or without nausea and vomiting.

Liver Damage. Liver damage, also called hepatotoxicity, can happen when taking Seglentis. Stop Seglentis and call your healthcare provider right away if you have any of the following symptoms of liver damage.

• Nausea or vomiting
• Stomach or belly pain
• Fever
• Weakness or unusual tiredness
• Itching
• Loss of appetite
• Light-colored poop
• Dark-colored urine (pee)
• Your skin or the whites of your eyes turning yellowish in color (also called jaundice)

Increased Blood Pressure (Hypertension). Seglentis may increase your blood pressure or make it worse if you have a history of high blood pressure. Call your healthcare provider if your blood pressure increases while taking this medicine.

If you measure your blood pressure and the top number (systolic) is 180 mm Hg or higher or the bottom number (diastolic) is 120 mm Hg or higher, get medical attention right away. Increases in blood pressure may not be noticeable but look out for any of the following symptoms of severely high blood pressure.

• Sudden severe headache
• Chest pain
• Dizziness or confusion
• Trouble breathing
• Nausea/vomiting
• Blurry or other changes to vision
• Anxiety
• Buzzing in the ears
• Nosebleed
• Feeling of skipped heartbeats

Heart Failure. Seglentis may increase your risk of heart failure. Stop Seglentis and tell your healthcare provider right away if you have any of the following symptoms of heart failure.

• Shortness of breath or trouble breathing, especially while lying down
• Swelling in your feet, ankles, or legs
• Unusually fast weight gain
• Unusual tiredness

Kidney Damage. Kidney damage can happen when taking Seglentis. Call your healthcare provider right away if you have any of the following symptoms of kidney damage.

• Reduced need to pee
• Swelling in your feet, ankles, or legs
• Weakness or unusual tiredness
• Difficulty catching your breath or chest pain/pressure
• Confusion
• Nausea
• Seizures

High Potassium Level (Hyperkalemia). Seglentis can cause a high potassium level (hyperkalemia), which can be serious and may lead to death. Your healthcare provider may check your potassium levels, especially if you take certain other medicines. Call your healthcare provider right away if you have any of the following symptoms of a high potassium level.

• Muscle weakness or unusual tiredness
• Slow heartbeat or feeling of skipped heartbeats
• Nausea or vomiting
• Trouble breathing
• Abnormal heart rhythm

Severe Skin Reactions. Seglentis can cause severe skin reactions, such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN) that can lead to death if not treated. If you develop a rash, call your healthcare provider right away. Stop Seglentis and get emergency help right away if you have any of the following symptoms of a severe skin reaction.

• Painful red or purple skin that looks burned and peels off
• Flat red rash or blisters on your skin, mouth, nose, and genitals
• Red, painful, watery eyes
• Fever or general ill feeling
• Areas of thickened skin
• Sores that are crusted over

Anemia. Seglentis may cause anemia, which is a condition that causes low levels of red blood cells. Tell your healthcare provider if you have any of the following symptoms of anemia.

• Unusual weakness or tiredness
• Cold hands and feet
• Fast or abnormal heartbeat
• Pale or yellowish skin
• Dizziness, lightheadedness, or feeling like you are about to pass out
• Shortness of breath

Low Sodium Level (Hyponatremia). Seglentis may cause low sodium levels. Call your healthcare provider if you have any of the following symptoms of a low sodium level.

• Headache
• Drowsiness
• Muscle weakness or cramps
• Nausea, vomiting, or loss of appetite
• Tiredness or sleepiness
• Dizziness
• Weight gain
• Restlessness or irritability
• Change in your mental condition such as hallucinations, confusion, decreased awareness, or alertness
• Seizures

Low Blood Sugar (Hypoglycemia). Seglentis can cause low blood sugar, which can be serious and may lead to death. You may need to check your blood sugar more often if you have changes to your diet, exercise regimen, or medicines for diabetes. Call your healthcare provider right away if you have any of the following symptoms of hypoglycemia.

• Headache
• Crankiness or anxiety
• Hunger
• Dizziness or confusion
• Blurry vision
• Slurred speech
• Sweating
• Feeling jittery or shakiness
• Fast heartbeat
• Seizures