Ruxolitinib: Opzelura Side Effects and Warnings

Opzelura Side Effects

Opzelura is the brand name of Ruxolitinib topical cream. The oral tablet formulation is marketed under the brand name, Jakafi which is indicated for the treatment of Myelofibrosis, Polycythemia vera, and graft-vs-host disease.

Ruxolitinib, available as a topical cream of 1.5%, is indicated for the treatment of non-segmental vitiligo and atopic dermatitis in adults and children aged more than 12 years of age.

The topical treatment is indicated only for immunocompetent individuals who do not have active tuberculosis, fungal infections, or active bacterial or viral infections.

Because Ruxolitinib, Opzelura, is a Janus Kinase Inhibitor, it has strong immunomodulatory effects.

Hence, most Opzelura Side Effects are related to a dysfunctional immune system resulting in frequent infections.


Serious Opzelura Side Effects:

  • Infections:

The most serious Opzelura Side Effects are caused by infections, especially invasive fungal, bacterial, and mycobacterial infections.

Opzelura topical cream should not be applied over infected skin. Common skin infections where Opzelura application may lead to rapid spread include active varicella infection including herpes zoster, bacterial infections such as cellulitis caused by staphylococcus species, and fungal infections.

In addition, individuals who have active pulmonary or non-pulmonary tuberculosis should not use Opzelura cream.

The same goes for individuals with systemic bacterial, viral, or fungal infections.

Opzelura may also result in the reactivation of hepatitis B and C infections. Before treatment initiation, Hepatitis B virus DNA, Hepatitis B Core Ig M, and Hepatitis C Virus PCR may be tested.

  • Cardiovascular Diseases:

Like all other JAK inhibitors, Ruxolitinib use is associated with adverse cardiovascular outcomes.

People using JAK inhibitors, including Ruxolitinib (Opzelura) are at risk of developing stroke, a myocardial infarction, or death from a cardiovascular cause.

  • Thrombosis:

Thrombosis is one of the side effects of JAK inhibitors. It is recommended to avoid Opzelura, and oral Ruxolitinib in particular in individuals who have a clotting disorder.

These patients are at risk of developing thrombosis including clot formation in blood vessels of major organs such as the heart, lungs, and the brain.

  • Risk of Cancers:

The risk of lymphoma is increased with the use of JAK inhibitors. There is also an increased risk of non-melanoma skin cancers such as squamous cell and basal cell carcinoma.

Patients who report unusual symptoms of weight loss or other systemic symptoms should be investigated for the development of cancer.

  • Blood Disorders:

Opzelura cream is associated with hematological problems including anemia, low platelet counts, and neutropenia.

Patients who have preexisting blood-related problems such as anemia, thrombocytopenia, and leukopenia should be advised of the drug with caution.

In addition, periodic monitoring for symptoms and signs of anemia and thrombocytopenia along with laboratory workup is recommended.

  • Lipid Abnormalities:

Ruxolitinib may cause abnormalities in lipid parameters. It has been associated with an increase in total cholesterol, LDL (low-density lipoprotein), and triglyceride levels.

Patients should have a baseline lipid profile done along with periodic monitoring at regular intervals to detect lipid abnormalities earlier.


Other common but less serious side effects associated with Opzelura include [Ref]:

Common Infections:

  • Nasopharyngitis
  • Bronchitis
  • Ear infection
  • Diarrhea
  • Folliculitis
  • Tonsillitis
  • Urinary tract infection

Allergic reactions:

  • Eosinophil count increased
  • Urticaria
  • Rhinorrhea

Local Reactions:

  • Local site acne
  • Local site pruritus
  • Application site erythema
  • Hair loss
Redness bumps and burning of skin with opzelura cream use opzelura side effects
Opzelura Side Effects: Bumps, Redness, and Skin Rash in a Young Woman Getting Treatment for Vitiligo With Opzelura

Other Non-specific Side Effects:

  • Pyrexia
  • Headache

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Written by Dr. Ahmed

I am Dr. Ahmed (MBBS; FCPS Medicine), an Internist and a practicing physician. I am in the medical field for over fifteen years working in one of the busiest hospitals and writing medical posts for over 5 years.

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