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Actiq

Last reviewed on RxList: 9/26/2017
Actiq Side Effects Center

Last reviewed on RxList 09/26/2017

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. 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.

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. Actiq may interact with aprepitant, diltiazem, verapamil, antibiotics, antifungal medications, or HIV medicines. Tell your doctor all medications and supplements you use. 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. Actiq may also cause addiction and withdrawal symptoms in a nursing infant. Consult your doctor before breastfeeding. 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.

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.

Actiq Consumer Information

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using fentanyl citrate and call your doctor at once if you have any of these serious side effects:

  • weak or shallow breathing, slow heart rate;
  • extreme sleepiness; or
  • feeling like you might pass out.

Less serious side effects may include:

  • dry mouth;
  • headache, dizziness, weakness, anxiety; or
  • nausea, vomiting, or constipation.

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 EFFECTS

The following serious adverse reactions are described, or described in greater detail, in other sections:

Clinical Studies Experience

Because 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 open-label 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 Group Percentage of Patients Reporting Event
200- 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
  Asthenia 6 4 0 7 9
  Headache 3 4 6 5 6
  Accidental Injury 1 1 4 0 2
Digestive
  Nausea 14 15 11 22 23
  Vomiting 7 6 6 15 12
  Constipation 1 4 2 0 4
Nervous
  Dizziness 10 16 6 15 17
  Somnolence 9 9 11 20 17
  Confusion 1 6 2 0 4
  Anxiety 3 0 2 0 3
  Abnormal Gait 0 1 4 0 2
  Dry Mouth 1 1 2 0 2
  Nervousness 1 1 0 0 2
  Vasodilatation 2 0 2 0 2
  Hallucinations 0 1 2 2 1
  Insomnia 0 1 2 0 1
  Thinking Abnormal 0 1 2 0 1
  Vertigo 1 0 0 0 1
Respiratory
  Dyspnea 2 3 6 5 4
Skin
  Rash 1 1 0 2 2
  Sweating 1 1 2 2 2
  Pruritus 1 0 0 5 2
Special Senses
  Abnormal Vision 1 0 2 0 2
*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, infection

Digestive: Diarrhea, dyspepsia, flatulence

Metabolic and Nutritional: Peripheral edema, dehydration

Nervous: Hypesthesia, migraine

Respiratory: Pharyngitis, cough increased

The 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 pain

Cardiovascular: Deep thrombophlebitis, hypertension, hypotension

Digestive: Anorexia, eructation, fecal impaction, gum hemorrhage, mouth ulceration, oral moniliasis

Hemic and Lymphatic: Anemia, leukopenia

Metabolic and Nutritional: Edema, hypercalcemia, weight loss

Musculoskeletal: Myalgia, pathological fracture, myasthenia

Nervous: Abnormal dreams, urinary retention, agitation, amnesia, emotional lability, euphoria, incoordination, libido decreased, neuropathy, paresthesia, speech disorder

Respiratory: Hemoptysis, pleural effusion, rhinitis, asthma, hiccup, pneumonia, respiratory insufficiency, sputum increased

Skin and Appendages: Alopecia, exfoliative dermatitis

Special Senses: Taste perversion

Urogenital: Vaginal hemorrhage, dysuria, hematuria, urinary incontinence, urinary tract infection

A 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 Group Percentage of Patients Reporting Event
200- 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
  Asthenia 25 30 17 15 38
  Headache 12 17 13 4 20
  Accidental Injury 4 6 4 7 9
  Hypertonia 2 2 2 0 3
Digestive
  Nausea 31 36 25 26 45
  Vomiting 21 28 15 7 31
  Constipation 14 11 13 4 20
  Intestinal Obstruction 0 2 4 0 3
Cardiovascular
  Hypertension 1 1 0 0 1
Nervous
  Dizziness 12 10 9 0 16
  Anxiety 9 8 8 7 15
  Somnolence 8 13 8 7 15
  Confusion 2 5 13 7 10
  Depression 9 4 2 7 9
  Insomnia 5 1 8 4 7
  Abnormal Gait 5 1 0 0 4
  Dry Mouth 3 1 2 4 4
  Nervousness 2 2 0 4 3
  Stupor 4 1 0 0 3
  Vasodilatation 1 1 4 0 3
  Thinking Abnormal 2 1 0 0 2
  Abnormal Dreams 1 1 0 0 1
  Convulsion 0 1 2 0 1
  Myoclonus 0 0 4 0 1
  Tremor 0 1 2 0 1
  Vertigo 0 0 4 0 1
Respiratory
  Dyspnea 15 16 8 7 22
Skin
  Rash 3 5 8 4 8
  Sweating 3 2 2 0 4
  Pruritus 2 0 2 0 2
Special Senses
  Abnormal Vision 2 2 0 0 3
Urogenital
  Urinary Retention 1 2 0 0 2
*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 pain

Cardiovascular: Deep thrombophlebitis, palpitation, vascular disorder

Digestive: Diarrhea, anorexia, dyspepsia, dysphagia, oral moniliasis, mouth ulceration, rectal disorder, stomatitis, flatulence, gastrointestinal hemorrhage, gingivitis, jaundice, periodontal abscess, eructation, glossitis, rectal hemorrhage

Hemic and Lymphatic: Anemia, leukopenia, thrombocytopenia, ecchymosis, lymphadenopathy, lymphedema, pancytopenia

Metabolic and Nutritional: Peripheral edema, edema, dehydration, weight loss, hyperglycemia, hypokalemia, hypercalcemia, hypomagnesemia

Musculoskeletal: Myalgia, pathological fracture, joint disorder, leg cramps, arthralgia, bone disorder

Nervous: Hypesthesia, paresthesia, hypokinesia, neuropathy, speech disorder, migraine

Respiratory: Cough increased, pharyngitis, pneumonia, rhinitis, sinusitis, bronchitis, epistaxis, asthma, hemoptysis, sputum increased

Skin and Appendages: Skin ulcer, alopecia

Special Senses: Tinnitus, conjunctivitis, ear disorder, taste perversion

Urogenital: Urinary tract infection, urinary incontinence, breast pain, dysuria, hematuria, scrotal edema, hydronephrosis, kidney failure, urinary urgency, urination impaired, breast neoplasm, vaginal hemorrhage, vaginitis

The 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 rigidity

Cardiovascular: Angina pectoris, hemorrhage, hypotension, peripheral vascular disorder, postural hypotension, tachycardia

Digestive: Cheilitis, esophagitis, fecal incontinence, gastroenteritis, gastrointestinal disorder, gum hemorrhage, hemorrhage of colon, hepatorenal syndrome, liver tenderness, tooth caries, tooth disorder Metabolic and Nutritional: Acidosis, generalized edema, hypocalcemia, hypoglycemia, hyponatremia, hypoproteinemia, thirst

Hemic and Lymphatic: Bleeding time increased

Musculoskeletal: Arthritis, muscle atrophy, myopathy, synovitis, tendon disorder

Nervous: Acute brain syndrome, agitation, cerebral ischemia, facial paralysis, foot drop, hallucinations, hemiplegia, miosis, subdural hematoma

Respiratory: Hiccup, hyperventilation, lung disorder, pneumothorax, respiratory failure, voice alteration

Skin and Appendages: Herpes zoster, maculopapular rash, skin discoloration, urticaria, vesiculobullous rash

Special Senses: Ear pain, eye hemorrhage, lacrimation disorder, partial permanent deafness, partial transitory deafness

Urogenital: Kidney pain, nocturia, oliguria, polyuria, pyelonephritis

Postmarketing Experience

The 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.

Digestive

Dental decay: Dental decay, including dental caries, tooth loss, and gum line erosion.

Nervous System Disorders

Serotonin syndrome: Cases of serotonin syndrome, a potentially life-threatening condition, have been reported during concomitant use of opioids with serotonergic drugs.

Endocrine Disorders

Adrenal insufficiency: Cases of adrenal insufficiency have been reported with opioid use, more often following greater than one month of use.

Androgen deficiency: Cases of androgen deficiency have occurred with chronic use of opioids.

Immune System Disorders

Anaphylaxis: Anaphylaxis has been reported with ingredients contained in ACTIQ.

General Disorders And Administration Site Conditions: Application site reactions including irritation, pain, and ulcer, and drug withdrawal syndrome.

Read the entire FDA prescribing information for Actiq (Fentanyl Citrate)

Related Resources for Actiq

© 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.

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