Side Effects of FENTORA
FENTORA may cause side effects. The most common side effects of FENTORA are nausea, vomiting, dizziness, sleepiness, headache, and constipation.
Constipation (not often enough or hard bowel movements) is a very common side effect of opioid pain medicines and may happen with FENTORA. Constipation is unlikely to go away without treatment. Talk with your doctor about changes in your diet and the use of special medicines to prevent or treat constipation while taking FENTORA.
- FENTORA can cause pain or sores at the application site (on your gum or inside your cheek). Tell your doctor if this is a problem for you
- FENTORA can cause your blood pressure to drop. This can make you feel dizzy if you get up too fast from sitting or lying down
- FENTORA can cause physical dependence. Do not stop taking FENTORA or any other opioid without talking to your doctor. You could become sick with uncomfortable withdrawal symptoms because your body has become used to these medicines. Physical dependence is not the same as drug addiction
- There is a chance of abuse or addiction with FENTORA. The chance is higher if you are or have been addicted to or abused other medications, street drugs, or alcohol, or if you have a history of mental health issues
These are not all the possible side effects of FENTORA. For a complete list, ask your doctor.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
When you need emergency help
FENTORA can cause serious side effects — including slow, shallow breathing that can become life-threatening — especially if FENTORA is used the wrong way.
Call your doctor or get emergency medical help right away if you
- Have trouble breathing
- Have slow, shallow breathing (little chest movement while breathing)
- Have extreme drowsiness, with slowed breathing
- Feel faint, very dizzy, confused, or have unusual symptoms
These can be symptoms that you have taken too much (overdose) FENTORA or the dose is too high for you. These symptoms may lead to serious problems or death if not treated right away.
If you experience these symptoms, call 9-1-1 or call emergency help immediately.
IMPORTANT:
- DO NOT USE FENTORA unless you are regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is used to these medicines.
- Keep FENTORA in a safe place away from children. Accidental use by a child is a medical emergency and can result in death. If a child accidentally takes FENTORA, get emergency help right away.
Read the Medication Guide that comes with FENTORA before you start taking it and each time you get a new prescription. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or your treatment. Share this important information with members of your household.
The most important information you should know about FENTORA is:
- FENTORA can cause life-threatening breathing problems which can lead to death:
- If you are not regularly using other opioid pain medicines around-the-clock for your constant cancer pain and your body is not used to these medicines. This means that you are not opioid tolerant
- If you do not use it exactly as prescribed by your doctor
- Your doctor will prescribe a starting dose of FENTORA that is different than other fentanyl containing medicines you may have been taking. Do not substitute FENTORA for other fentanyl medicines, including Actiq®, without talking with your doctor.