"The U.S. Food and Drug Administration today approved Opsumit (macitentan), a new drug to treat adults with pulmonary arterial hypertension (PAH), a chronic, progressive and debilitating disease that can lead to death or the need for lung transpla"...
Ventavis Side Effects Center
Medical Editor: John P. Cunha, DO, FACOEP
Ventavis (iloprost) Inhalation Solution is used as an inhalant to treat pulmonary arterial hypertension. It is a synthetic prostacyclin that works by opening blood vessels in the lungs. Common side effects include nausea, vomiting, diarrhea, headache, dizziness, jaw pain, muscle spasms of the jaw, flushing, or trouble sleeping.
Ventavis is inhaled using either of two pulmonary drug delivery devices: the I-neb AAD System or the Prodose AAD System. The first inhaled dose should be 2.5 mcg (as delivered at the mouthpiece). If this dose is well tolerated, dosing is increased to 5.0 mcg and maintained at that dose; otherwise maintain the dose at 2.5 mcg. Ventavis should be taken 6 to 9 times per day (no more than once every 2 hours). Other drugs may interact with Ventavis. Tell your doctor all medications and supplements you use. During pregnancy, Ventavis should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.
Our Ventavis (iloprost) 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.
Ventavis in Detail - Patient Information: Side Effects
Serious side effects from iloprost inhalation are not likely to occur. Seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat, swelling of your lips, tongue, or face; or hives).
Other, less serious side effects may also occur. Continue to use iloprost inhalation and talk to your doctor if you experience
- dry mouth, nose, or throat after use;
- coughing or throat irritation;
- hoarseness or deepening of the voice;
- headache, dizziness, or lightheadedness;
- flushing; or
- jaw tightness or pain.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Read the entire detailed patient monograph for Ventavis (Iloprost) »
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Ventavis Overview - Patient Information: Side Effects
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: wheezing, sudden weight gain, worsening breathing, chest pain, fainting.
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 Ventavis (Iloprost)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Ventavis FDA Prescribing 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.
Pre-marketing safety data on Ventavis were obtained from 215 patients with pulmonary arterial hypertension receiving iloprost in two 12-week clinical trials and two long-term extensions. Patients received inhaled Ventavis for periods of from 1 day to more than 3 years. The median number of weeks of exposure was 15. Forty patients completed 12 months of open-label treatment with iloprost.
The following table shows adverse events reported by at least 4 Ventavis patients and reported at least 3% more frequently for Ventavis patients than placebo patients in the 12week placebo-controlled study.
Table 1: Adverse Events in Phase 3 Clinical Trial
n = 101
n = 102
|Placebo subtracted %|
|Alk phos increased||6||1||5|
Pre-marketing serious adverse events reported with the use of inhaled Ventavis and not shown in Table 1 include congestive heart failure, chest pain, supraventricular tachycardia, dyspnea, peripheral edema, and kidney failure.
In a small clinical trial (the STEP trial) [see Clinical Studies], safety trends in patients receiving concomitant bosentan and Ventavis were consistent with those observed in the larger experience of the Phase 3 study in patients receiving only Ventavis or bosentan.
Adverse events with higher doses
In a study in healthy subjects (n=160), inhaled doses of iloprost solution were given every 2 hours, beginning with 5 mcg and increasing up to 20 mcg for a total of 6 dose inhalations (total cumulative dose of 70 mcg) or up to the highest dose tolerated in a subgroup of 40 subjects. There were 13 subjects (32%) who failed to reach the highest scheduled dose (20 mcg). Five were unable to increase the dose because of (mild to moderate) transient chest pain/discomfort/tightness, usually accompanied by headache, nausea, and dizziness. The remaining 8 subjects discontinued for other reasons.
The following adverse reactions have been identified during the postapproval use of Ventavis. 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.
Cases of bronchospasm and wheezing have been reported, particularly in patients with a history of hyperreactive airways [see WARNINGS AND PRECAUTIONS]. Bleeding events most commonly reported as epistaxis and hemoptysis were observed on Ventavis treatment [see DRUG INTERACTIONS]. Cases of thrombocytopenia, dizziness, diarrhea, mouth and tongue irritation, nasal congestion, dysgeusia, hypersensitivity, and rash have also been reported with the use of Ventavis.
Read the entire FDA prescribing information for Ventavis (Iloprost) »
Additional Ventavis Information
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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