Nucynta (tapentadol) - Uses, Side Effects, and More

What are the most common side effects of Nucynta?

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

• Nausea or vomiting
• Constipation (see below)
• Drowsiness or sleepiness
• Dizziness
• Headache
• Fever (children)
• Itching (children)

There may be other side effects of Nucynta 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 Nucynta?

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

Risk of Misuse and Addiction. Misusing Nucynta may lead to serious side effects, like coma or death. Misuse means taking a medicine in a way other than how it was prescribed. Take Nucynta exactly as prescribed. Tell your healthcare provider if you feel that Nucynta 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 disorientation
• Feeling paranoid
• Suicidal thoughts or actions
• Seizures
• Trouble breathing

Suicidal Thoughts and Actions. Nucynta may cause suicidal thoughts or actions in a small number of people. If you’re 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 attempts
• New or increased feelings of anxiety, depression, or other unusual changes in mood or behavior

Breathing Problems. Nucynta 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 Nucynta or when your dose is increased. Get emergency help 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

Low Blood Pressure (Hypotension). Nucynta may cause low blood pressure, which may be severe. It may also cause a sudden drop in blood pressure when standing up from a seated or lying position. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Your risk for low blood pressure may be higher if you already have low blood pressure, take blood pressure medicine, or if you are dehydrated. Stop taking Nucynta and get help right away if you have any of the following symptoms of hypotension.

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

Increased Pain Sensitivity (Hyperalgesia). Nucynta can cause an increased sensitivity to pain. It can cause things that normally cause pain to feel more painful than usual. Nucynta 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 Nucynta. 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. Nucynta 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 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 Nucynta have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Nucynta and call your healthcare provider if you experience 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

Reduced Adrenal Function. Long-term use of Nucynta can cause your 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

Severe Allergic Reactions. Nucynta may cause allergic reactions, which can be serious. Stop taking Nucynta and get help right away if you have any of the following symptoms of a serious allergic reaction.

• Breathing problems or wheezing
• Racing heart
• Fever or general ill feeling
• Swollen lymph nodes
• Swelling of the face, lips, mouth, tongue, or throat
• Trouble swallowing or throat tightness
• Itching, skin rash, or pale red bumps on the skin called hives
• Nausea or vomiting
• Dizziness, feeling lightheaded, or fainting
• Stomach cramps
• Joint pain

Constipation. Some people taking Nucynta have had severe constipation. Some needed to go to the hospital. Stop taking Nucynta and get help right away if you have severe constipation.

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.

Decreased Alertness or Coordination. Nucynta can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Nucynta affects you.