Upadacitinib Side Effects
Applies to upadacitinib: oral tablet extended release.
Important warnings
This medicine can cause some serious health issues
Serious side effects of upadacitinib
Along with its needed effects, upadacitinib may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur while taking upadacitinib:
More common side effects
- body aches or pain
- chills
- cough
- ear congestion
- fever
- headache
- itching, pain, redness, swelling, tenderness, warmth on the skin
- loss of voice
- runny or stuffy nose
- sneezing
- sore throat
- unusual tiredness or weakness
Less common side effects
- black, tarry stools
- burning or stinging of the skin
- chest tightness
- difficulty swallowing
- dizziness
- fast heartbeat
- hives, itching, skin rash
- large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
- lower back or side pain
- painful blisters on the trunk of the body
- painful cold sores or blisters on the lips, nose, eyes, or genitals
- painful or difficult urination
- pale skin
- puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
- ulcers, sores, or white spots in the mouth or tongue
- unusual bleeding or bruising
Rare side effects
- coughing or spitting up blood
- difficulty with breathing
- heartburn
- indigestion
- muscle aches
- nausea
- night sweats
- pale skin
- persistent non-healing sore
- pink growth
- reddish patch or irritated area
- severe stomach pain, cramping, or burning
- shiny bump
- sudden high fever or low-grade fever for months
- trouble breathing
- vomiting of material that looks like coffee grounds, severe and continuing
- white, yellow or waxy scar-like area
Incidence not known
- chest pain or discomfort
- confusion
- difficulty in speaking
- double vision
- inability to move the arms, legs, or facial muscles
- inability to speak
- no blood pressure or pulse
- pain or discomfort in the arms, jaw, back, or neck
- slow speech
- stopping of heart
- sweating
- unconsciousness
Other side effects of upadacitinib
Some side effects of upadacitinib may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.
Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
More common side effects
- blemishes on the skin
- pimples
Less common side effects
- burning, itching, and pain in hairy areas, pus at the root of hair
- difficulty in moving
- muscle cramps, pains, or stiffness
For healthcare professionals
Applies to upadacitinib: oral liquid, oral tablet extended release.
Cardiovascular adverse events
- Frequency not reported: Thrombosis (e.g., deep venous thrombosis), pulmonary embolism, arterial thrombosis[Ref]
Gastrointestinal
- Common (1% to 10%): Nausea, abdominal pain, gastroenteritis
- Frequency not reported: GI perforation[Ref]
Dermatologic
- Very common (10% or more): Acne (10% to 16%)
- Common (1% to 10%): Folliculitis, rash
- Frequency not reported: Eczema herpeticum/Kaposi's varicelliform eruption
Hematologic
- Common (1% to 10%): Anemia, leukopenia, neutropenia[Ref]
Hepatic
- Common (1% to 10%): Liver enzyme elevation[Ref]
Hypersensitivity
- Common (1% to 10%): Hypersensitivity (including anaphylactic reactions, shock, angioedema, drug hypersensitivity, eyelid edema, face and pharyngeal swelling, skin eruption and urticaria)
Immunologic
- Common (1% to 10%): Lymphopenia[Ref]
Metabolic
- Common (1% to 10%): Increased blood creatinine phosphokinase, increased weight, hyperlipidemia, hypercholesterolemia[Ref]
Musculoskeletal
- Common (1% to 10%): Myalgia
Nervous system
- Common (1% to 10%): Headache
Ocular
- Uncommon (0.1% to 1%): Retinal detachment
Oncologic
- Uncommon (0.1% to 1%): Non-melanoma skin cancer[Ref]
Other
- Common (1% to 10%): Pyrexia, herpes Zoster, herpes simplex (including oral herpes and oral candidiasis), fatigue, influenza-like illness, fatigue[Ref]
Respiratory
- Very common (10% or more): Upper respiratory tract infection (up to 25%)
- Common (1% to 10%): Bronchitis, cough
- Frequency not reported: Pneumonia[Ref]
References
1. (2019) "Product Information. Rinvoq (upadacitinib)." AbbVie US LLC
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Further information
Upadacitinib 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.
Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.