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Actiq (fentanyl citrate) is an opioid pain medication, sometimes called a narcotic.
Actiq treats "breakthrough" cancer pain that is not controlled by other medicines. This medicine is not for treating pain that is not cancer-related, such as migraine headaches or pain after surgery.
Actiq may also be used for purposes not listed in this medication guide.
Actiq can slow or stop your breathing, and may be habit-forming. Use only your prescribed dose. Never share this medicine with another person.
MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Keep this medicine out of the reach of children.
Using this medicine during pregnancy may cause life-threatening withdrawal symptoms in the newborn.
Fatal side effects can occur if you use this medicine with alcohol, or with other drugs that cause drowsiness or slow your breathing.
You should not use Actiq if you are allergic to fentanyl, or if you are NOT already being treated with a similar opioid (narcotic) pain medicine and are tolerant to it. Do not give an Actiq unit to any person who does not have a personal prescription for this medicine.
To make sure this medicine is safe for you, tell your doctor if you have ever had:
breathing problems, sleep apnea;
a head injury, brain tumor, or mental illness;
alcoholism or drug addiction;
a seizure disorder;
liver or kidney disease; or
low blood pressure, heart disease, slow heartbeats.
Actiq is not approved for use by anyone younger than 16 years old.
If you use Actiq while you are pregnant, your baby could become dependent on the drug. This can cause life-threatening withdrawal symptoms in the baby after it is born. Babies born dependent on habit-forming medicine may need medical treatment for several weeks.
Fentanyl can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Fentanyl may also cause withdrawal symptoms in a nursing infant. Do not breast-feed while using Actiq.
Use Actiq exactly as prescribed. Follow all directions on your prescription label. Never use this medicine in larger amounts, or for longer than prescribed. Tell your doctor if the medicine seems to stop working as well in relieving your pain.
Fentanyl may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it. Selling or giving away this medicine is against the law.
Fentanyl can slow or stop your breathing. MISUSE OF ACTIQ CAN CAUSE DEATH, especially in a child who gets a hold of an Actiq unit and places it in the mouth. Read all patient instructions carefully before using this medicine.
The Actiq transmucosal unit is a fentanyl citrate lozenge attached to a plastic handle. Each unit is wrapped in a child-proof blister pack. Cut the blister pack open with scissors when you are ready to use the unit.
Place the medicine in your mouth between your cheek and gum, and hold the handle with your fingers. Twirl the handle to move the medicine around in your mouth while sucking on it.
Allow the medicine to dissolve in your mouth for 15 minutes. Swallow when needed. Do not bite or chew the lozenge. Do not eat or drink anything while the unit is in your mouth. If you need to use a second unit, wait at least 15 minutes after you have finished the first unit. Use only 1 Actiq unit at a time.
If you feel dizzy or sick to your stomach before the medicine has completely dissolved, stop using the unit and call your doctor.
Do not stop using any other pain medicines your doctor has prescribed for you.
If you switch from using Actiq to using other forms of fentanyl, you will not use the same dose. Many forms of fentanyl are given at lower doses than Actiq. If you use the same dose of each medication, you may have life-threatening overdose symptoms.
Pay special attention to your dental hygiene. Actiq can cause dry mouth leading to tooth decay.
Do not stop using fentanyl suddenly, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.
Store at room temperature away from moisture and heat. Leave each unit in its child-proof blister pack until you are ready to use it.
Keep track of your medicine. Fentanyl citrate is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.
Keep both used and unused Actiq units out of the reach of children or pets. The amount of fentanyl citrate in the Actiq unit can be fatal to a child who accidentally sucks on or swallows the unit. Seek emergency medical attention if this happens.
Actiq comes with a kit and instructions for storing and disposing of the Actiq units.
Do not keep leftover opioid medication. Just one dose can cause death in someone using this medicine accidentally or improperly. Ask your pharmacist where to locate a drug take-back disposal program. If there is no take-back program, follow the instructions provided with Actiq when disposing of unused medicine.
Since Actiq is used for pain, you are not likely to miss a dose. Skip any missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. A fentanyl overdose can be fatal, especially in a child or other person using the medicine without a prescription. Overdose symptoms may include slow breathing and heart rate, severe drowsiness, muscle weakness, cold and clammy skin, pinpoint pupils, and fainting.
Do not drink alcohol. Dangerous side effects or death could occur.
Avoid driving or operating machinery until you know how this medicine will affect you. Dizziness or severe drowsiness can cause falls or other accidents.
Grapefruit and grapefruit juice may interact with fentanyl and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Get emergency medical help if you have signs of an allergic reaction to Actiq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Like other narcotic medicines, fentanyl can slow your breathing. Death may occur if breathing becomes too weak.
Remove the Actiq unit from your mouth and call your doctor at once if you have:
slow heart rate, sighing, shallow breathing, breathing that stops during sleep;
severe drowsiness, feeling like you might pass out;
dizziness or an upset stomach before the medicine has completely dissolved;
confusion, extreme fear, unusual thoughts or behavior; or
low cortisol levels - nausea, vomiting, loss of appetite, dizziness, worsening tiredness or weakness.
Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.
Serious side effects may be more likely in older adults and those who are overweight, malnourished, or debilitated.
Long-term use of opioid medication may affect fertility (ability to have children) in men or women. It is not known whether opioid effects on fertility are permanent.
Common Actiq side effects may include:
dizziness, mild drowsiness, depressed mood;
sleep problems (insomnia);
headache, weakness, anxiety;
nausea, vomiting, constipation; or
mild rash.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Some drugs can raise or lower your blood levels of fentanyl, which may cause side effects or make Actiq less effective. Tell your doctor if you also use certain antibiotics, antifungal medications, heart or blood pressure medications, or medicines to treat HIV or AIDS.
Fentanyl can interact with many other drugs and cause dangerous side effects or death. Be sure your doctor knows if you also use:
other narcotic medications - opioid pain medicine or prescription cough medicine;
a sedative like Valium - diazepam, alprazolam, lorazepam, Ativan, Klonopin, Restoril, Tranxene, Versed, Xanax, and others;
drugs that make you sleepy or slow your breathing - a sleeping pill, muscle relaxer, tranquilizer, antidepressant, or antipsychotic medicine;
drugs that affect serotonin levels in your body - medicine for depression, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting.
This list is not complete. Other drugs may interact with fentanyl, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Actiq only for the indication prescribed.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Actiq (www.drugs.com/actiq.html).
Note: This document contains side effect information about fentanyl. Some of the dosage forms listed on this page may not apply to the brand name Actiq.
Common side effects of Actiq include: respiratory depression. See below for a comprehensive list of adverse effects.
Applies to fentanyl: lozenge/troche, spray, tablet
Other dosage forms:
Sublingual route (Spray)
Warning: Life-Threatening Respiratory Depression, Accidental Ingestion; Cytochrome P450 3A4 Interaction; Risks from Concomitant Use with Benzodiazepines or Other CNS Depressants; Risk of Medication Errors; Addiction, Abuse, and Misuse; REMS; and Neonatal Opioid Withdrawal SyndromeSerious, life-threatening, and/or fatal respiratory depression has occurred. Monitor closely, especially upon initiation or following a dose increase. Due to the risk of fatal respiratory depression, fentanyl sublingual spray is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines.Accidental ingestion of fentanyl sublingual spray, especially by children, can result in a fatal overdose of fentanyl. Keep out of reach of children. Ensure proper storage and disposal.Concomitant use with CYP3A4 inhibitors (or discontinuation of CYP3A4 inducers) can result in a fatal overdose of fentanyl.Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for use in patients for whom alternative treatment options are inadequate; limit dosages and durations to the minimum required and follow patients for signs and symptoms of respiratory depression and sedation.When prescribing, do not convert patients on a mcg per mcg basis from any other oral transmucosal fentanyl product to fentanyl sublingual spray.When dispensing, do not substitute with any other fentanyl products.Fentanyl sublingual spray exposes users to risks of addiction, abuse, and misuse, which can lead to overdose and death. Assess patient’s risk before prescribing and monitor regularly for these behaviors and conditions.Fentanyl sublingual spray is available only through a restricted program called the TIRF REMS Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program.Prolonged use of fentanyl sublingual spray during pregnancy can result in neonatal opioid withdrawal syndrome, which may be life-threatening if not recognized and treated. If prolonged opioid use is required in a pregnant woman, advise the patient of the risk of neonatal opioid withdrawal syndrome and ensure that appropriate treatment will be available..
Buccal mucosa route (Film; Lozenge/Troche; Tablet)
Due to the risk of fatal respiratory depression, transmucosal fentanyl citrate is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Monitor for respiratory depression during treatment. Accidental ingestion of fentanyl can result in a fatal overdose, especially in children; keep out of reach of children. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in a fatal overdose of fentanyl and monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Fentanyl is a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Assess risk prior to initiation and monitor for signs of misuse, abuse, and addiction during treatment. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise patient of potential fetal risk and ensure appropriate treatment will be available.
Sublingual route (Tablet)
Due to the risk of fatal respiratory depression, sublingual fentanyl citrate is contraindicated in opioid non-tolerant patients and in management of acute or postoperative pain, including headache/migraines. Monitor for respiratory depression during treatment. Accidental ingestion of fentanyl can result in a fatal overdose, especially in children; keep out of reach of children. Use with CYP3A4 inhibitors or inducers may change fentanyl plasma levels resulting in fatal overdose and monitoring is recommended. Concomitant use of opioids with benzodiazepines or other CNS depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing for patients with inadequate alternative treatment options, limit dosage and duration to the minimum required, and monitor for respiratory depression and sedation. When prescribing, do not convert patients on a mcg per mcg basis from any other fentanyl products. When dispensing, do not substitute with any other fentanyl products. Fentanyl is a Schedule II controlled substance with abuse liability similar to other opioid analgesics. Assess risk prior to initiation and monitor for signs of misuse, abuse, and addiction during treatment. Only available through a restricted program called the Transmucosal Immediate Release Fentanyl Risk Evaluation and Mitigation Strategy (TIRF REMS) Access program. Outpatients, healthcare professionals who prescribe to outpatients, pharmacies, and distributors are required to enroll in the program. Prolonged use during pregnancy may result in neonatal opioid withdrawal syndrome. If prolonged use is required in a pregnant woman, advise patient of potential fetal risk and ensure appropriate treatment will be available.
Along with its needed effects, fentanyl (the active ingredient contained in Actiq) 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 fentanyl:
More common
Less common
Get emergency help immediately if any of the following symptoms of overdose occur while taking fentanyl:
Symptoms of overdose
Some side effects of fentanyl may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common
Less common
Incidence not known
Applies to fentanyl: buccal film, buccal tablet, compounding powder, injectable solution, intravenous solution, nasal spray, oral lozenge, oral transmucosal lozenge, sublingual spray, sublingual tablet, transdermal device, transdermal film extended release
The most commonly reported adverse reactions included headache, nausea, vomiting, ,dizziness, and constipation.
Very common (10% or more): Somnolence, dizziness
Common (1% to 10%): Sedation, pyrexia, fatigue, lethargy, tremor, headache, chills, irritability, malaise, confusion, abnormal thinking, anxiety, dysphoria
Uncommon (0.1% to 1%): Hyperesthesia
Very rare (less than 0.01%): Severe hemiplegic migraine
Frequency not reported: Slurred speech, paresthesia, hypesthesia, tremor
Postmarketing reports: Loss of consciousness, vertigo, coma, shock, convulsion
Cases of seizures have occasionally been reported, but some investigators have suggested that the seizure-like events reported may have been episodes of fentanyl induced-rigidity.
One report has suggested that epidural fentanyl (the active ingredient contained in Actiq) may mask the pain of myocardial ischemia in patients treated with fentanyl for other reasons. Another report has suggested that QTc interval prolongation may occur in some patients receiving the related narcotic sufentanil. Another report has implicated fentanyl as a potential cause of pulsus alternans in a patient with aortic stenosis and congestive heart failure.
Nevertheless, fentanyl has been advocated by some as a satisfactory agent for coronary artery surgery.
Common (1% to 10%): Tachycardia
Uncommon (0.1% to 1%): Sinus tachycardia, chest pain, hypertension, hypotension, palpitations
Rare (less than 0.1%): Arrhythmias, cardiac arrest
Frequency not reported: Syncope, vasodilation, bradycardia, bigeminy, myocardial infarct
Postmarketing reports: Circulatory depression
Very common (10% or more): Nausea (18%), vomiting (10%), constipation
Common (1% to 10%): Dry mouth, abdominal distension, gastritis, dysphagia, dyspepsia, gastroesophageal reflux disease, ascites, hematemesis, taste perversion, abdominal pain, dehydration, anorexia, cachexia, vomiting, dry mouth, mouth ulcers/stomatitis, tongue edema
Uncommon (0.1% to 1%): Abdomen enlarged, flatulence
Rare (less than 0.1%): Choledochoduodenal sphincter spasm
Frequency not reported: Diarrhea
Postmarketing reports: Ileus, dental caries, tooth loss, gingival recession, gingivitis, gingival bleeding, lip edema, pharyngeal edema, gum bleeding, ulcer
Uncommon (0.1% to 1%): Urinary retention
Very rare (less than 0.01%): Priapism
Frequency not reported: Urinary tract infection, urination impaired, hematuria, urinary urgency, dysuria
Approximately 60% of patients had some redness at the skin site 24-hours after removal of the iontophoretic transdermal system. The majority of skin events were categorized as mild, erythema and papules were observed; 2 patients had hyperpigmentation at the application site lasting 2 to 3 weeks; 3 patients had a rectangular mark at the application site which persisted for up to 3 months.
Very common(10% or more): Iontophoretic transdermal system: Application site reaction-Erythema (14%)
Common (1% to 10%): Application site irritation, pruritus
Uncommon (0.1% to 1%): Hyperhidrosis, rash
Rare (less than 0.1%): Systemic rashes
Frequency not reported: vesicles, papules/pustules, dry and flaky skin, vesiculobullous rash wound site oozing/bleeding, wound site inflammation/erythema
Postmarketing reports: Application site discharge, application site bleeding, application site infection, rash and scab, erosion, hyperesthesia, application site necrosis
Rare (less than 0.1%): Anaphylaxis
The hemolysis observed may have been related to rapid injection of large volumes of hypotonic fentanyl (the active ingredient contained in Actiq) solution. The authors therefore recommend slower injection rates and/or mixture in isotonic fluid.
Common (1% to 10%): Anemia, neutropenia, lymphadenopathy, thrombocytopenia, leukopenia, aspartate aminotransferase increased, blood alkaline phosphatase increased, blood glucose increased, blood lactate increased, hypoalbuminemia, vasodilation
Uncommon (0.1% to 1%): Oral candidiasis, cellulitis, pneumonia, urinary tract infection, oral herpes, gastroenteritis, laryngitis
Very rare (less than 0.01%): Recurrent herpes simplex infection following epidural administration
Common (1% to 10%): Asthenia, peripheral edema, weight decreased, hypokalemia, hyponatremia, hypocalcemia
Very rare (less than 0.01%): Syndrome of inappropriate antidiuretic hormone
Frequency not reported: abnormal healing, dehydration
Uncommon (0.1% to 1%): Hot flush
Common (1% to 10%): Fall/accidental injury, back pain, arthralgia, joint swelling, muscular weakness, myoclonus, involuntary muscle contractions, muscle rigidity (involving the respiratory musculature including the glottis)
Frequency not reported: Leg cramps, myalgia
Postmarketing reports: Abnormal gait/incoordination
Uncommon (0.1% to 1%): Vision blurred, dry eye
Rare (less than 0.1%): Abnormal vision
Common (1% to 10%): Depression, confusional state, hallucination, insomnia
Uncommon (0.1% to 1%): Anxiety, agitation, restlessness, agitation, disorientation, abnormal dreams, depersonalization, depression, emotional lability, euphoria, delirium
Frequency not reported: Nervousness
Common (1% to 10%): Dyspnea, rhinitis, yawning, respiratory distress, apnea, bradypnea, hypoventilation, respiratory depression
Uncommon (0.1% to 1%): Cough, increased bronchial secretion, dysphonia, pharyngolaryngeal pain, wheezing, hypoxia, exertional dyspnea
Very rare (less than 0.01%): Acute noncardiogenic pulmonary edema
Frequency not reported: Asthma, hiccup, atelectasis, hyperventilation
Postmarketing reports: Respiratory arrest
Medically reviewed by USARx EDITORIAL TEAM Last updated on 1/1/2020.
Source: Drugs.com Actiq (www.drugs.com/actiq.html).
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