What the label lists and what reports show
Upadacitinib side effects
Upadacitinib's FDA label: “The most frequently reported serious infections were pneumonia and cellulitis.” FAERS holds 81,041 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pain (5,353 reports).
- No generic listed
- Boxed warning
Check it at the source: the upadacitinib FDA label on DailyMed (effective June 30, 2026, AbbVie Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of RINVOQ /RINVOQ LQ ?RINVOQ /RINVOQ LQ may cause serious side effects, including: See “What is the most important information I should know about RINVOQ / RINVOQ LQ ?” The most common side effects of RINVOQ /RINVOQ LQ in people treated for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and p olyarticular juvenile idiopathic arthritis include: • upper respiratory tract infections (common cold, sinus infections) • shingles (herpes zoster) • herpes simplex virus infections, including cold sores • bronchitis • nausea • cough • fever • acne • headache The most common side effects of RINVOQ in people treated for giant cell arteritis include: • upper respiratory tract infections (common cold, sinus infections • headache • tiredness • swelling of the feet and hands (peripheral edema) • cough • low red blood cell count (anemia) • rash • shingles (herpes […]
Source: FDA drug label, AbbVie Inc., effective June 30, 2026 (SPL set 2966aec7-2ef0-923c-d8ff-fe1a957bf095), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most frequently reported serious infections were pneumonia and cellulitis.
Table 5: Adverse Reactions Reported in ≥ 1% of Patients with Atopic Dermatitis Treated with RINVOQ 15 mg or 30 mg
| Adverse Reaction | Placebo N = 902 (%) | RINVOQ 15 mg N = 899 (%) | RINVOQ 30 mg N = 906 (%) |
|---|---|---|---|
| Upper respiratory tract infection (URTI) | 17 | 23 | 25 |
| Acne | 2 | 10 | 16 |
| Herpes simplex | 2 | 4 | 8 |
| Headache | 4 | 6 | 6 |
| Increased blood creatine phosphokinase | 2 | 5 | 6 |
| Cough | 1 | 3 | 3 |
| Hypersensitivity | 2 | 2 | 3 |
| Folliculitis | 1 | 2 | 3 |
| Nausea | 1 | 3 | 3 |
| Abdominal pain | 1 | 3 | 2 |
| Pyrexia | 1 | 2 | 2 |
| Increased Weight | 1 | 2 | 2 |
| Herpes zoster | 1 | 2 | 2 |
| Influenza | <1 | 2 | 2 |
| Fatigue | 1 | 1 | 2 |
| Neutropenia | <1 | 1 | 2 |
| Myalgia | 1 | 1 | 2 |
| Influenza like illness | 1 | 1 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in the labeling: Serious Infections [see Warnings and Precautions ( 5.1 )] Mortality [see Warnings and Precautions ( 5.2 )] Malignancy and Lymphoproliferative Disorders [see Warnings and Precautions ( 5.3 )] Major Adverse Cardiovascular Events [see Warnings and Precautions ( 5.4 )] Thrombosis [see Warnings and Precautions ( 5.5 )] Hypersensitivity Reactions [see Warnings and Precautions ( 5.6 )] Gastrointestinal Perforations [see Warnings and Precautions ( 5.7 )] Hypoglycemia in Patients with Diabetes [see Warnings and Precautions ( 5.8 )] Laboratory Abnormalities [see Warnings and Precautions ( 5.9 )] Rheumatoid arthritis, psoriatic arthritis, ankylosi ng spondylitis, and n on-radiographic a xials pondyloarthritis: Adverse reactions (≥ 1%) were: upper respiratory tract infections, herpes zoster, herpes simplex, bronchitis, nausea, cough, pyrexia, acne, and headache. ( 6.1 ) Giant cell arteritis: Adverse reactions (≥ 5%) are upper respiratory tract infections, headache, fatigue, peripheral edema, cough, anemia, rash, herpes zoster, and nausea. …
Source: FDA drug label, AbbVie Inc., effective June 30, 2026 (SPL set 2966aec7-2ef0-923c-d8ff-fe1a957bf095), via openFDA; the full label on DailyMed
What do FAERS reports show?
81,041 reports list upadacitinib among the medicines taken, each a report of something that happened, not proof the medicine caused it; 3,016 are coded as a death and 20,108 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Reports rose sharply in 2025 (17,234, against a median of 2,841 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Upadacitinib: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions