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Onsolis Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 9/4/2015

Onsolis (fentanyl buccal) Soluble Film is a narcotic (opioid) pain medicine used to treat "breakthrough" cancer pain that is not controlled by other medicines. Onsolis is taken together with other non-fentanyl narcotic pain medicine that is used around the clock. Onsolis is not for treating pain that is not cancer-related. The brand name Onsolis is discontinued, but generic versions may be available. Common side effects of Onsolis (fentanyl buccal) include nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, headache, feeling weak or tired, swelling in your hands or feet, or pain or mouth sores where the medicine was placed.

All patients MUST begin treatment using one 200 mcg dose of Onsolis film. Onsolis may interact with other narcotics, sedatives, tranquilizers, sleeping pills, muscle relaxers, other medicines that can make you sleepy or slow your breathing, dexamethasone, imatinib, isoniazid, St. John's wort, antibiotics, antifungals, antidepressants, heart or blood pressure medications, HIV medications, or seizure medications. Tell your doctor all medications and supplements you use. Before using Onsolis, tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, Onsolis should be used only when prescribed. It may slightly increase the risk of birth defects if used during the first two months of pregnancy. Using it near the expected delivery date may harm the fetus. Tell the doctor if you notice symptoms in your newborn baby such as slow/shallow breathing, irritability, abnormal/persistent crying, vomiting, or diarrhea. 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 taking this medication.

Our Onsolis (fentanyl buccal) Soluble Film 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Onsolis in Detail - Patient Information: Side Effects

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 Onsolis (Fentanyl Buccal Soluble Film)

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Onsolis Overview - Patient Information: Side Effects

SIDE EFFECTS: Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Ask your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).

To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes (such as agitation, confusion, hallucinations), severe stomach/abdominal pain, difficulty urinating.

Get medical help right away if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Onsolis (Fentanyl Buccal Soluble Film)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Onsolis FDA Prescribing Information: Side Effects
(Adverse Reactions)


Clinical Studies Experience

The safety of Onsolis has been evaluated in 306 opioid tolerant patients with breakthrough cancer pain in the efficacy study and an open-label safety study. The mean duration of therapy was 115 days, with 32 patients treated for more than 1 year.

The adverse reactions seen with Onsolis are typical opioid side effects in a population with cancer. Frequently, opioid-associated adverse reactions will cease or decrease in intensity with continued use of Onsolis. Expect opioid side effects and manage them accordingly.

The most serious adverse reactions associated with all opioids including Onsolis are respiratory depression (potentially leading to apnea or respiratory arrest), circulatory depression, hypotension, and shock. Follow all patients for symptoms of respiratory depression.

Because the clinical trials of Onsolis were designed to evaluate safety and efficacy in treating patients with breakthrough pain associated with cancer, all patients were also taking concomitant opioids, such as sustained-release morphine, sustained-release oxycodone or transdermal fentanyl, for their persistent cancer pain. The adverse event data presented here reflect the actual percentage of patients experiencing each adverse event among patients who received Onsolis 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 Onsolis therapy, or cancer-related symptoms. Adverse reactions are included regardless of severity.

Because clinical trials are conducted under widely varying conditions, adverse event 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.

Table 1 lists, by maximum dose received, adverse reactions with an overall frequency of 5% or greater that occurred during titration. The ability to assign a dose-response relationship to these adverse reactions is limited by the titration schedules used in these studies. Adverse reactions are listed in descending order of frequency within each body system.

Table 1 : Adverse Reactions Which Occurred During Titration at a Frequency of ≥ 5%

System Organ Class, Preferred Term, n (%) Onsolis Dose (mcg) Total
> 1200
Gastrointestinal Disorders
  Nausea 16 (5) 12 (5) 6 (3) 5 (4) 4 (5) 0 42 (14)
  Vomiting 7(2) 9 (4) 8 (4) 2 (1) 0 0 26 (8)
Nervous System Disorders
  Dizziness 5 (2) 5 (2) 6 (3) 2 (1) 4 (5) 0 22 (7)
  Somnolence 6 (2) 2 (1) 4 (2) 2 (1) 4 (5) 1 (11) 17 (6)

Table 2 lists, by successful dose, adverse reactions with an overall frequency of ≥ 5% that occurred during long-term treatment (i.e., the double-blind or open-label maintenance periods).

Table 2 : Adverse Reactions Which Occurred During Long-Term Treatment at a Frequency of ≥ 5%

System Organ Class, Preferred Term, n (%) Onsolis Dose (mcg) Total
> 1200
  Nausea 2 (9) 6 (10) 8 (10) 12(13) 26 (32) 4 (14) 56 (26)
  Vomiting 1 (4) 5 (8) 9 (11) 8 (9) 23 (28) 3 (11) 45 (21)
  Constipation 2 (9) 4 (7) 4 (5) 4 (4) 6 (7) 4 (14) 23(11)
  Diarrhea 1 (4) 1 (2) 4 (5) 4 (4) 10 (12) 0 19 (9)
  Dry mouth 1 (4) 4 (7) 3 (4) 2 (2) 3 (4) 1 (4) 14 (7)
  Abdominal pain 0 0 3 (4) 1 (1) 7 (9) 1 (4) 11 (5)
General/administration site
  Asthenia 0 6 (10) 3 (4) 8 (9) 7 (9) 4 (14) 28 (13)
  Fatigue 2 (9) 6 (10) 1 (1) 7 (8) 7 (9) 3 (11) 25(12)
  Weight decreased 3 (13) 0 2 (3) 5 (5) 5 (6) 1 (4) 15 (7)
  Dehydration 1 (4) 4 (7) 6 (8) 5 (5) 10 (12) 3 (11) 28 (13)
  Decreased appetite 0 4 (7) 4 (5) 6 (7) 2 (2) 2 (7) 18 (8)
  Anorexia 2 (9) 1 (2) 3 (4) 4 (4) 6 (7) 1 (4) 17 (8)
Nervous system
  Dizziness 2 (9) 4 (7) 2 (3) 3 (3) 10 (12) 2 (7) 23(11)
  Headache 2 (9) 1 (2) 3 (4) 9 (10) 7 (9) 0 20 (9)
  Somnolence 2 (9) 0 4 (5) 2 (2) 3 (4) 3 (11) 14 (7)
  Confusional state 1 (4) 0 4 (5) 4 (4) 6 (7) 4 (14) 18 (8)
  Depression 0 3 (5) 1 (1) 4 (4) 7 (9) 3 (11) 18 (8)
  Insomnia 0 2 (3) 2 (3) 3 (3) 4 (5) 2 (7) 12 (6)
  Anxiety 1 (4) 1 (2) 2 (3) 3 (3) 3 (4) 1 (4) 11 (5)
  Dyspnea 3 (13) 4 (7) 3 (4) 8 (9) 6 (7) 3 (11) 26 (12)
  Cough 1 (4) 0 3 (4) 5 (5) 6 (7) 1 (4) 15 (7)
  Hypotension 0 3 (5) 3 (4) 1 (1) 3 (4) 1 (4) 11 (5)

In a mucositis study, a group of patients (n=7) with Grade 1 oral mucositis and a matched group of control patients (n=7) without oral mucositis were included in a clinical trial designed to support the safety of Onsolis. The adverse event profile was similar in both subsets of patients. There was no evidence that Onsolis caused or worsened oral mucosal irritation or pain in either study group.

The duration of exposure to Onsolis varied greatly, and included open-label and double-blind studies. The adverse reactions listed below represent those that were reported by ≥ 1% of patients from two clinical trials (the titration and posttitration periods) while receiving Onsolis. Events are classified by system organ class.

Cardiac disorders: tachycardia

Eye disorders: vision blurred, diplopia

Gastrointestinal disorders: nausea, vomiting, constipation, diarrhea, dry mouth, abdominal pain, dyspepsia, dysphagia, abdominal distension, intestinal obstruction, flatulence

General disorders and administration site conditions: asthenia, fatigue, malaise

Injury, poisoning and procedural complications: fall, contusion

Investigations: weight decreased, blood pressure increased

Metabolism and nutrition disorders: dehydration, decreased appetite, anorexia

Nervous system disorders: dizziness, somnolence, headache, lethargy, amnesia, sedation

Psychiatric disorders: confusional state, depression, insomnia, anxiety, hallucination, agitation, mental status changes

Renal and urinary disorders: urinary retention

Respiratory, thoracic and mediastinal disorders: dyspnea, cough

Skin and subcutaneous tissue disorders: pruritus, rash

Vascular disorders: hypotension, hot flush, deep vein thrombosis, hypertension

Read the entire FDA prescribing information for Onsolis (Fentanyl Buccal Soluble Film)

Onsolis - User Reviews

Onsolis User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Onsolis sorted by most helpful. Patient Discussions FAQs

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