Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: Hepatotoxicity [see Warnings and Precautions (5.2)] Immunosuppression [see Warnings and Precautions (5.4)] Bone marrow suppression [see Warnings and Precautions (5.4)] Stevens-Johnson syndrome and toxic epidermal necrolysis [see Warnings and Precautions (5.5)] Peripheral neuropathy [see Warnings and Precautions (5.7 )] Interstitial lung disease [see Warnings and Precautions (5.8)] The most commonly reported adverse reactions (≥10%) regardless of relation to leflunomide tablets treatment were diarrhea, respiratory infection, nausea, headache, rash, abnormal liver enzymes, dyspepsia.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Lupin Pharmaceutical Inc.
at 1-800-399-2561 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.
In clinical studies (Trials 1, 2, and 3), 1,865 patients were treated with leflunomide tablets administered as either monotherapy or in combination with methotrexate or sulfasalazine.
Patients ranged in age from 19 to 85 years, with an overall median age of 58 years.
The mean duration of RA was 6 years ranging from 0 to 45 years.
Elevation of Liver Enzymes Treatment with leflunomide tablets was associated with elevations of liver enzymes, primarily ALT and AST, in a significant number of patients;
these effects were generally reversible.
Most transaminase elevations were mild (≤ 2-fold ULN) and usually resolved while continuing treatment.
Marked elevations (>3-fold ULN) occurred infrequently and reversed with dose reduction or discontinuation of treatment.
Warnings For external use only Allergy alert: Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.
Symptoms may include: • hives • asthma (wheezing) • skin reddening • blisters • facial swelling • shock • rash If an allergic reaction occurs, stop use and seek medical help right away.
Liver warning: This product contains diclofenac.
Liver damage may occur if you apply • more or for a longer time than directed • when using other drugs containing diclofenac Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding.
The chance is small but higher if you • are age 60 or older • have had stomach ulcers or bleeding problems • take a blood thinning (anticoagulant) or steroid drug • take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • apply more or for longer than directed Heart attack and stroke warning: NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke.
Like all medications, Lefluniclo can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: