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. 2007 Jan 11;66(8):1026–1032. doi: 10.1136/ard.2006.060905

Table 2 All reported and/or observed adverse events in the 15 patients treated with leflunomide, indicated per individual patient.

Patients
Adverse event 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 Total n (%)
Diarrhoea + + + + + + + 7 (47)
GI discomfort + + + + + + 6 (40)
Anorexia + + 2 (13)
Oral ulcers + + 2 (13)
Hair loss + + + + + + + 7 (47)
Headache + + + + + 5 (33)
Fatigue/lethargy + + + 3 (20)
Dysaesthesia + + 2 (13)
Dizziness + + + + 4 (26)
Alcohol intolerance + 1 (6)
Weight loss >2 kg + + + + + 5 (33)
Dyspnoea + 1 (6)
↑Transpiration + 1 (6)
↑Conjunctivitis + + 2 (13)
Pharyngitis + + 2 (13)
↓Libido + 1 (6)
Mood changes + 1 (6)
↓Taste + 1 (6)
ALAT 1–2* ULN + + 2 (13)
ALAT >2* ULN +* +† 2 (13)
↑Pre‐existing ↑RR + + 2 (13)
LE skin lesions +‡§ +¶** +1,2 +1,2 + 1 5 (33)
Other skin lesions + +†† +‡‡ + 3 (20)
Leucopenia 3–4×109/l + + + + 4 (26)
Leucopenia <3×109/l + + 2 (13)
Anaemia <7.4 mmol/l + + + + + 5 (33)

ALAT, alanine aminotransferase; GI, gastrointestinal; LE, lupus erythematosus; ULN, upper limit of normal; ↑RR, hypertension; ↓, decrease; +, present.

*Requiring temporary stop of leflunomide (LEF) treatment. After normalisation of ALAT, LEF was restarted at a dose of 10 mg OD.

†Requiring temporary stop of LEF treatment twice. After first normalisation of ALAT, LEF was restarted at a dose of 10 mg. After second normalisation, LEF 10 mg OD was restarted without subsequent increase of ALAT again.

‡Causing permanent withdrawal at 17 weeks.

§Biopsy proven.

¶Not biopsy proven.

**Reactivation of lesions that had been occurring before LEF treatment.

††Itching maculopapular rash.

‡‡Oral lesions, self‐reported, not confirmed.