Ensifentrine Side Effects

Applies to ensifentrine: inhalation suspension.

Important warnings This medicine can cause some serious health issues

Stop using this medicine and call your doctor at once or get emergency medical help if you have wheezing, choking, or other breathing problems after using this medicine.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, or have thoughts about suicide or hurting yourself.

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

Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Stop using this medicine and call your doctor at once or get emergency medical help if you have wheezing, choking, or other breathing problems after using this medicine.

Call your doctor at once if you have:

• suicidal thoughts or actions;

• new or worsening symptoms of depression or anxiety;

• trouble sleeping;

• mood or behavior changes; or

• if you feel impulsive, irritable, agitated, hostile, aggressive, restless.

Common side effects may include:

• diarrhea;

• high blood pressure;

• back pain; or

• pain and burning when you urinate.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For healthcare professionals

Applies to ensifentrine: inhalation suspension.

General

The most frequently reported side effects (incidence greater and equal to 1% and more common than placebo) included back pain, diarrhea, hypertension, and urinary tract infection.^[Ref]

Cardiovascular

• Common (1% to 10%): Hypertension^[Ref]

Gastrointestinal

• Common (1% to 10%): Diarrhea^[Ref]

Genitourinary

• Common (1% to 10%): Urinary tract infection^[Ref]

Musculoskeletal

• Common (1% to 10%): Back pain^[Ref]

Psychiatric

• Uncommon (0.1% to 1%): Insomnia, anxiety, depression-related reactions (including depression, major depression, adjustment disorder with depressed mood)
• Frequency not reported: Psychiatric events, suicide-related adverse reactions (including suicide attempt, suicide)^[Ref]

Further information

Ensifentrine side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer