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Fentora

Last reviewed on RxList: 10/20/2017
Fentora Side Effects Center

Last reviewed on RxList 10/20/2017

Fentora (fentanyl citrate) is a narcotic (opioid) pain medicine used to treat "breakthrough" cancer pain that is not controlled by other medicines. Fentora is available in generic form. Common side effects of Fentora include:

  • nausea,
  • vomiting,
  • constipation,
  • lightheadedness,
  • dizziness,
  • drowsiness,
  • headache,
  • weakness,
  • tiredness, or
  • swelling in your hands or feet.

Other side effects of Fentora include pain, mouth sores, or irritation in the mouth where the medication has been applied. Some side effects of Fentora may decrease after using this medication for a while. Tell your doctor if you have unlikely but serious side effects of Fentora including:

  • mental/mood changes (such as agitation, confusion, hallucinations),
  • severe stomach or abdominal pain, or
  • difficulty urinating.

The initial dose of Fentora is always 100 mcg with the only exception being patients already using Actiq. Place the Fentroa tablet in your mouth above a rear molar tooth between your upper cheek and gum, and leave it in place until it is dissolved (usually 14 to 25 minutes). Do not break, bite, chew, suck, or swallow the tablet whole. Fentora may interact with cold or allergy medicine, sedatives, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety, aprepitant, diltiazem, verapamil, antibiotics, antifungal medications, or HIV medicines. Tell your doctor all medications you use. During pregnancy, Fentora should be used only when prescribed. Using it near the expected delivery date is not recommended because of potential for harm to the fetus. Babies born to mothers who have used this medication may have withdrawal symptoms such as irritability, abnormal/persistent crying, vomiting, or diarrhea. If you notice symptoms in your newborn, tell the doctor. This drug passes into breast milk and may rarely have undesirable effects on a nursing infant. Tell the doctor if your baby develops unusual sleepiness, difficulty feeding, or trouble breathing. Consult your doctor before breastfeeding. Withdrawal symptoms may occur if you suddenly stop using this medication.

Our Fentora (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.

Fentora 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 and call your doctor at once if you have a serious side effect such as:

  • weak or shallow breathing;
  • pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin.

Less serious side effects may include:

  • nausea, vomiting, constipation;
  • dizziness, drowsiness;
  • headache;
  • feeling weak or tired;
  • swelling in your hands or feet; or
  • pain or mouth sores where the medicine was placed.

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 Fentora (Fentanyl Buccal Tablet)

Fentora Professional Information

SIDE EFFECTS

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 FENTORA has been evaluated in 304 opioid-tolerant cancer patients with breakthrough pain. The average duration of therapy was 76 days with some patients being treated for over 12 months.

The most commonly observed adverse events seen with FENTORA are typical of opioid side effects. Opioid side effects should be expected and managed accordingly.

The clinical trials of FENTORA were designed to evaluate safety and efficacy in treating patients with cancer and breakthrough pain; all patients were taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent pain.

The adverse event data presented here reflect the actual percentage of patients experiencing each adverse effect among patients who received FENTORA for breakthrough pain along with a concomitant opioid for persistent pain. There has been no attempt to correct for concomitant use of other opioids, duration of FENTORA therapy or cancer-related symptoms.

Table 2 lists, by maximum dose received, adverse events with an overall frequency of 5% or greater within the total population that occurred during titration. The ability to assign a dose-response relationship to these adverse events is limited by the titration schemes used in these studies.

Table 2: Adverse Events Which Occurred During Titration at a Frequency of ≥ 5%

System Organ Class MeDRA preferred term, n (%) 100 mcg
(N=45)
200 mcg
(N=34)
400 mcg
(N=53)
600 mcg
(N=56)
800 mcg
(N=113)
Total
(N=304)*
Gastrointestinal disorders
  Nausea 4 (9) 5 (15) 10 (19) 13 (23) 18 (16) 50 (17)
  Vomiting 0 2 (6) 2 (4) 7 (13) 3 (3) 14 (5)
General disorders and administration site conditions
  Fatigue 3 (7) 1 (3) 9 (17) 1 (2) 5 (4) 19 (6)
Nervous system disorders
  Dizziness 5 (11) 2 (6) 12 (23) 18 (32) 21 (19) 58 (19)
  Somnolence 2 (4) 2 (6) 6 (12) 7 (13) 3 (3) 20 (7)
  Headache 1 (2) 3 (9) 4 (8) 8 (14) 10 (9) 26 (9)
* Three hundred and two (302) patients were included in the safety analysis.

Table 3 lists, by successful dose, adverse events with an overall frequency of ≥ 5% within the total population that occurred after a successful dose had been determined.

Table 3: Adverse Events Which Occurred During Long-Term Treatment at a Frequency of ≥ 5%

System Organ Class MeDRA preferred term, n (%) 100 mcg
(N=19)
200 mcg
(N=31)
400 mcg
(N=44)
600 mcg
(N=48)
800 mcg
(N=58)
Total
(N=200)
Blood and lymphatic system disorders
  Anemia 6 (32) 4 (13) 4 (9) 5 (10) 7 (13) 26 (13)
  Neutropenia 0 2 (6) 1 (2) 4 (8) 4 (7) 11 (6)
Gastrointestinal disorders
  Nausea 8 (42) 5 (16) 14 (32) 13 (27) 17 (31) 57 (29)
  Vomiting 7 (37) 5 (16) 9 (20) 8 (17) 11 (20) 40 (20)
  Constipation 5 (26) 4 (13) 5 (11) 4 (8) 6 (11) 24 (12)
  Diarrhea 3 (16) 0 4 (9) 3 (6) 5 (9) 15 (8)
  Abdominal pain 2 (11) 1 (3) 4 (9) 7 (15) 4 (7) 18 (9)
General disorders and administration site conditions
  Edema peripheral 6 (32) 5 (16) 4 (9) 5 (10) 3 (5) 23 (12)
  Asthenia 3 (16) 5 (16) 2 (5) 3 (6) 8 (15) 21 (11)
  Fatigue 3 (16) 3 (10) 9 (20) 9 (19) 8 (15) 32 (16)
Infections and infestations
  Pneumonia 1 (5) 5 (16) 1 (2) 1 (2) 4 (7) 12 (6)
Investigations
  Weight decreased 1 (5) 1 (3) 3 (7) 2 (4) 6 (11) 13 (7)
Metabolism and nutrition disorders
  Dehydration 4 (21) 0 4 (9) 6 (13) 7 (13) 21 (11)
  Anorexia 1 (5) 2 (6) 4 (9) 3 (6) 6 (11) 16 (8)
  Hypokalemia 0 2 (6) 0 1 (2) 8 (15) 11 (6)
Musculoskeletal and connective tissue disorders
  Back pain 2 (11) 0 2 (5) 3 (6) 2 (4) 9 (5)
  Arthralgia 0 1 (3) 3 (7) 4 (8) 3 (5) 11 (6)
Neoplasms benign, malignant and unspecified (including cysts and polyps)
  Cancer pain 3 (16) 1 (3) 3 (7) 2 (4) 1 (2) 10 (5)
Nervous system disorders
  Dizziness 5 (26) 3 (10) 5 (11) 6 (13) 6 (11) 25 (13)
  Headache 2 (11) 1 (3) 4 (9) 5 (10) 8 (15) 20 (10)
  Somnolence 0 1 (3) 4 (9) 4 (8) 8 (15) 17 (9)
Psychiatric disorders
  Confusional state 3 (16) 1 (3) 2 (5) 3 (6) 5 (9) 14 (7)
  Depression 2 (11) 1 (3) 4 (9) 3 (6) 5 (9) 15 (8)
  Insomnia 2 (11) 1 (3) 3 (7) 2 (4) 4 (7) 12 (6)
Respiratory, thoracic, and mediastinal disorders
  Cough 1 (5) 1 (3) 2 (5) 4 (8) 5 (9) 13 (7)
  Dyspnea 1 (5) 6 (19) 0 7 (15) 4 (7) 18 (9)

In addition, a small number of patients (n=11) with Grade 1 mucositis were included in clinical trials designed to support the safety of FENTORA. There was no evidence of excess toxicity in this subset of patients.

The duration of exposure to FENTORA varied greatly, and included open-label and double-blind studies. The frequencies listed below represent the ≥ 1% of patients (and not listed in Tables 2 and 3 above) from three clinical trials (titration and post-titration periods combined) who experienced that event while receiving FENTORA. Events are classified by system organ class.

Adverse Events ( ≥ 1%)

Blood and Lymphatic System Disorders: Thrombocytopenia, Leukopenia

Cardiac Disorders: Tachycardia

Gastrointestinal Disorders: Stomatitis, Dry Mouth, Dyspepsia, Upper Abdominal Pain, Abdominal Distension, Dysphagia, Gingival Pain, Stomach Discomfort, Gastroesophageal Reflux Disease, Glossodynia, Mouth Ulceration

General Disorders and Administration Site Conditions: Pyrexia, Application Site Pain, Application Site Ulcer, Chest Pain, Chills, Application Site Irritation, Edema, Mucosal Inflammation, Pain

Hepatobiliary Disorders: Jaundice

Infections and Infestations: Oral Candidiasis, Urinary Tract Infection, Cellulitis, Nasopharyngitis, Sinusitis, Upper Respiratory Tract Infection, Influenza, Tooth Abscess

Injury, Poisoning and Procedural Complications: Fall, Spinal Compression Fracture

Investigations: Decreased Hemoglobin, Increased Blood Glucose, Decreased Hematocrit, Decreased Platelet Count

Metabolism and Nutrition Disorders: Decreased Appetite, Hypoalbuminemia, Hypercalcemia, Hypomagnesemia, Hyponatremia, Reduced Oral Intake

Musculoskeletal and Connective Tissue Disorders: Pain in Extremity, Myalgia, Chest Wall Pain, Muscle Spasms, Neck Pain, Shoulder Pain

Nervous System Disorders: Hypoesthesia, Dysgeusia, Lethargy, Peripheral Neuropathy, Paresthesia, Balance Disorder, Migraine, Neuropathy

Psychiatric Disorders: Anxiety, Disorientation, Euphoric Mood, Hallucination, Nervousness

Renal and Urinary Disorders: Renal Failure

Respiratory, Thoracic and Mediastinal Disorders: Pharyngolaryngeal Pain, Exertional Dyspnea, Pleural Effusion, Decreased Breathing Sounds, Wheezing

Skin and Subcutaneous Tissue Disorders: Pruritus, Rash, Hyperhidrosis, Cold Sweat

Vascular Disorders: Hypertension, Hypotension, Pallor, Deep Vein Thrombosis

Read the entire FDA prescribing information for Fentora (Fentanyl Buccal Tablet)

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© Fentora Patient Information is supplied by Cerner Multum, Inc. and Fentora Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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