Actiq Generic Name: fentanyl citrate Brand Name: Actiq Drug Class: Opioid Analgesics Actiq (Fentanyl Citrate) side effects drug center Related Drugs Belbuca Besponsa Combunox Deltasone Demerol Duragesic Endocet Exalgo Fentanyl Citrate Injection Fentora Mitigo Morphabond Nucynta Olinvyk Sancuso Subsys Symproic Tivorbex Trezix Tylox Xartemis XR Yondelis Zipsor Health Resources Cancer Chronic Pain Panic Attacks Chemotherapy Related Supplements Inositol PROFESSIONAL CONSUMER SIDE EFFECTS Overview Professional Information Actiq Side Effects Center What Is Actiq? Actiq (oral transmucosal fentanyl citrate) is a narcotic pain medicine used to treat "breakthrough" cancer pain that is not controlled by other medicines. Actiq is not for short-term pain relief. Actiq is available in generic form. What Are Side Effects of Actiq? Common side effects of Actiq include: dry mouth, headache, dizziness, weakness, anxiety, nausea, vomiting, or constipation Tell your doctor if you have serious side effects of Actiq including: weak or shallow breathing, slow heart rate, extreme sleepiness, or feeling like you might pass out Dosage for Actiq The initial dose of Actiq to treat episodes of breakthrough cancer pain is always 200 mcg. The Actiq unit should be consumed over 15 minutes. The dose may be increased under a physician's supervision until pain relief is achieved. What Drugs, Substances, or Supplements Interact with Actiq? Actiq may interact with: aprepitant, diltiazem, verapamil, antibiotics, antifungal medications, or HIV medicines Tell your doctor all medications and supplements you use. Actiq During Pregnancy and Breastfeeding Tell your doctor if you are pregnant or plan to become pregnant before using Actiq; it is unknown if it would harm a fetus. Actiq could cause addiction or withdrawal symptoms in a newborn if the mother uses it during pregnancy. Actiq can pass into breast milk and may cause sleepiness or breathing problems in a nursing baby. Consult your doctor before breastfeeding. Actiq may also cause addiction and withdrawal symptoms in a nursing infant. Additional Information Actiq may be habit-forming. Withdrawal symptoms may occur if you suddenly stop taking Actiq. Our Actiq (oral transmucosal fentanyl citrate) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. Actiq Consumer Information Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Opioid medicine can slow or stop your breathing, and death may occur. A person caring for you should seek emergency medical attention if you have slow breathing with long pauses, blue colored lips, or if you are hard to wake up. Remove this medicine 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 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. Read the entire detailed patient monograph for Actiq (Fentanyl Citrate) Actiq Professional Information SIDE EFFECTSThe following serious adverse reactions are described, or described in greater detail, in other sections:Life-Threatening Respiratory Depression [see WARNINGS AND PRECAUTIONS]Interactions with Benzodiazepines and Other CNS Depressants [see WARNINGS AND PRECAUTIONS]Addiction, Abuse, and Misuse [see WARNINGS AND PRECAUTIONS]Neonatal Opioid Withdrawal Syndrome [see WARNINGS AND PRECAUTIONS]Serotonin Syndrome [see WARNINGS AND PRECAUTIONS]Adrenal Insufficiency [see WARNINGS AND PRECAUTIONS]Severe Hypotension [see WARNINGS AND PRECAUTIONS]Gastrointestinal Adverse Reactions [see WARNINGS AND PRECAUTIONS]Seizures [see WARNINGS AND PRECAUTIONS]Clinical Studies ExperienceBecause clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.The safety of ACTIQ has been evaluated in 257 opioid-tolerant chronic cancer pain patients. The duration of ACTIQ use varied during the openlabel study. Some patients were followed for over 21 months. The average duration of therapy in the open-label study was 129 days.The most serious adverse reactions associated with ACTIQ are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock.Because the clinical trials of ACTIQ were designed to evaluate safety and efficacy in treating breakthrough cancer pain, all patients were also taking concomitant opioids, such as sustained-release morphine or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received ACTIQ for breakthrough cancer pain along with a concomitant opioid for persistent cancer pain. There has been no attempt to correct for concomitant use of other opioids, duration of ACTIQ therapy, or cancer-related symptoms.Three short-term clinical trials with similar titration schemes were conducted in 257 patients with malignancy and breakthrough cancer pain. Data are available for 254 of these patients. Table 1 lists, by dose groups, adverse reactions with an overall frequency of 1% or greater that occurred during titration. The ability to assign a dose-response relationship to these adverse reactions is limited by the titration schemes used in these studies. Adverse reactions are listed in descending order of frequency within each body system.Table 1. Percent of Patients with Specific Adverse Events Commonly Associated with Opioid Administration or of Particular Clinical Interest Which Occurred During Titration (Events in 1% or More of Patients)Dose GroupPercentage of Patients Reporting Event200- 600 mcg(n=230)800- 1400 mcg(n=138)1600 mcg(n=54)>1600 mcg(n=41)Any Dose*(n=254)Body As A Whole Asthenia64079 Headache34656 Accidental Injury11402Digestive Nausea1415112223 Vomiting7661512 Constipation14204Nervous Dizziness101661517 Somnolence99112017 Confusion16204 Anxiety30203 Abnormal Gait01402 Dry Mouth11202 Nervousness11002 Vasodilatation20202 Hallucinations01221 Insomnia01201 Thinking Abnormal01201 Vertigo10001Respiratory Dyspnea23654Skin Pruritus10052 Rash11022 Sweating11222Special Senses Abnormal Vision10202* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.The following adverse reactions not reflected in Table 1 occurred during titration with an overall frequency of 1% or greater and are listed in descending order of frequency within each body system.Body as a Whole: Pain, fever, abdominal pain, chills, back pain, chest pain, infectionDigestive: Diarrhea, dyspepsia, flatulenceMetabolic and Nutritional: Peripheral edema, dehydrationNervous: Hypesthesia, migraineRespiratory: Pharyngitis, cough increasedThe following reactions occurred during titration with an overall frequency of less than 1% and are listed in descending order of frequency within each body system.Body as a Whole: bone painCardiovascular: Deep thrombophlebitis, hypertension, hypotensionDigestive: Anorexia, eructation, fecal impaction, gum hemorrhage, mouth ulceration, oral moniliasisHemic and Lymphatic: Anemia, leukopeniaMetabolic and Nutritional: Edema, hypercalcemia, weight lossMusculoskeletal: Myalgia, pathological fracture, myastheniaNervous: Abnormal dreams, urinary retention, agitation, amnesia, emotional lability, euphoria, incoordination, libido decreased, neuropathy, paresthesia, speech disorderRespiratory: Hemoptysis, pleural effusion, rhinitis, asthma, hiccup, pneumonia, respiratory insufficiency, sputum increasedSkin and Appendages: Alopecia, exfoliative dermatitisSpecial Senses: Taste perversionUrogenital: Vaginal hemorrhage, dysuria, hematuria, urinary incontinence, urinary tract infectionA long-term extension study was conducted in 156 patients with malignancy and breakthrough cancer pain who were treated for an average of 129 days. Data are available for 152 of these patients. Table 2 lists by dose groups, adverse reactions with an overall frequency of 1% or greater that occurred during the long-term extension study. Adverse reactions are listed in descending order of frequency within each body system.Table 2. Percent of Patients with Adverse Events Commonly Associated with Opioid Administration or of Particular Clinical Interest Which Occurred During Long Term Treatment (Events in 1% or More of Patients)Dose GroupPercentage of Patients Reporting Event200- 600 mcg(n=98)800- 1400 mcg(n=83)1600 mcg(n=53)>1600 mcg(n=27)Any Dose*(n=152)Body As A Whole Asthenia2530171538 Headache121713420 Accidental Injury46479 Hypertonia22203Digestive Nausea3136252645 Vomiting212815731 Constipation141113420 Intestinal Obstruction02403Cardiovascular Hypertension11001Nervous Dizziness12109016 Anxiety988715 Somnolence8138715 Confusion2513710 Depression94279 Insomnia51847 Abnormal Gait51004 Dry Mouth31244 Nervousness22043 Stupor41003 Vasodilatation11403 Thinking Abnormal21002 Abnormal Dreams11001 Convulsion01201 Myoclonus00401 Tremor01201 Vertigo00401Respiratory Dyspnea15168722Skin Rash35848 Sweating32204 Pruritus20202Special Senses Abnormal Vision22003Urogenital Urinary Retention12002* Any Dose = A patient who experienced the same adverse event at multiple doses was only counted once.The following reactions not reflected in Table 2 occurred with an overall frequency of 1% or greater in the long-term extension study and are listed in descending order of frequency within each body system.Body as a Whole: Pain, fever, back pain, abdominal pain, chest pain, flu syndrome, chills, infection, abdomen enlarged, bone pain, ascites, sepsis, neck pain, viral infection, fungal infection, cachexia, cellulitis, malaise, pelvic painCardiovascular: Deep thrombophlebitis, palpitation, vascular disorderDigestive: Diarrhea, anorexia, dyspepsia, dysphagia, oral moniliasis, mouth ulceration, rectal disorder, stomatitis, flatulence, gastrointestinal hemorrhage, gingivitis, jaundice, periodontal abscess, eructation, glossitis, rectal hemorrhageHemic and Lymphatic: Anemia, leukopenia, thrombocytopenia, ecchymosis, lymphadenopathy, lymphedema, pancytopeniaMetabolic and Nutritional: Peripheral edema, edema, dehydration, weight loss, hyperglycemia, hypokalemia, hypercalcemia, hypomagnesemiaMusculoskeletal: Myalgia, pathological fracture, joint disorder, leg cramps, arthralgia, bone disorderNervous: Hypesthesia, paresthesia, hypokinesia, neuropathy, speech disorder, migraineRespiratory: Cough increased, pharyngitis, pneumonia, rhinitis, sinusitis, bronchitis, epistaxis, asthma, hemoptysis, sputum increasedSkin and Appendages: Skin ulcer, alopeciaSpecial Senses: Tinnitus, conjunctivitis, ear disorder, taste perversionUrogenital: Urinary tract infection, urinary incontinence, breast pain, dysuria, hematuria, scrotal edema, hydronephrosis, kidney failure, urinary urgency, urination impaired, breast neoplasm, vaginal hemorrhage, vaginitisThe following reactions occurred with a frequency of less than 1% in the long-term extension study and are listed in descending order of frequency within each body system.Body as a Whole: Allergic reaction, cyst, face edema, flank pain, granuloma, bacterial infection, mucous membrane disorder, neck rigidityCardiovascular: Angina pectoris, hemorrhage, hypotension, peripheral vascular disorder, postural hypotension, tachycardiaDigestive: Cheilitis, esophagitis, fecal incontinence, gastroenteritis, gastrointestinal disorder, gum hemorrhage, hemorrhage of colon, hepatorenal syndrome, liver tenderness, tooth caries, tooth disorderHemic and Lymphatic: Bleeding time increasedMetabolic and Nutritional: Acidosis, generalized edema, hypocalcemia, hypoglycemia, hyponatremia, hypoproteinemia, thirstMusculoskeletal: Arthritis, muscle atrophy, myopathy, synovitis, tendon disorderNervous: Acute brain syndrome, agitation, cerebral ischemia, facial paralysis, foot drop, hallucinations, hemiplegia, miosis, subdural hematomaRespiratory: Hiccup, hyperventilation, lung disorder, pneumothorax, respiratory failure, voice alterationSkin and Appendages: Herpes zoster, maculopapular rash, skin discoloration, urticaria, vesiculobullous rashSpecial Senses: Ear pain, eye hemorrhage, lacrimation disorder, partial permanent deafness, partial transitory deafnessUrogenital: Kidney pain, nocturia, oliguria, polyuria, pyelonephritisPostmarketing ExperienceThe following adverse reactions have been identified during post approval use of ACTIQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.DigestiveDental decayDental decay, including dental caries, tooth loss, and gum line erosion.Nervous System DisordersSerotonin syndromeCases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.Endocrine DisordersAdrenal insufficiencyCases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.Androgen deficiencyCases of androgen deficiency have occurred with chronic use of opioids.Immune System DisordersAnaphylaxisAnaphylaxis has been reported with ingredients contained in ACTIQ.General Disorders And Administration Site ConditionsApplication site reactions including irritation, pain, and ulcer, and drug withdrawal syndrome. Read the entire FDA prescribing information for Actiq (Fentanyl Citrate) &Copy; Actiq Patient Information is supplied by Cerner Multum, Inc. and Actiq Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.
