Table 3.

Frequency of adverse reactions in patients treated with teriflunomide in placebo-controlled trials

System organ classa	Very common (≥1/10)	Common (≥1/100 to <1/10)	Uncommon (≥1/1000 to <1/100)	Rare (≥1/10,000 to <1/1000)	Very rare (<1/10,000)
Investigations	ALT increase	Increase: GGT and AST Decrease: weight, neutrophil count, WBC count
Gastrointestinal disorders	Diarrhea, nausea	Abdominal pain upper, vomiting, toothache			Pancreatitisb
Skin and subcutaneous tissue disorders	Alopecia (hair thinning)	Rash, acne
Infections and infestations		Influenza, upper respiratory tract infection, urinary tract infection, bronchitis, sinusitis, pharyngitis, cystitis, gastroenteritis viral, oral herpes, tooth infection, laryngitis, tinea pedis
Blood and lymphatic system disorders		Neutropenia, anemia	Mild thrombocytopenia (platelets <100 G/l)
Immune system disorders		Mild allergic reactions
Psychiatric disorders		Anxiety
Nervous system disorders		Paraesthesia, sciatica, carpal tunnel syndrome	Hyperesthesia, neuralgia, peripheral neuropathy
Vascular disorders		Hypertension
Respiratory, thoracic and mediastinal disorders					Interstitial lung diseaseb
Musculoskeletal and connective tissue disorders		Musculoskeletal pain, myalgia
Renal and urinary disorders		Pollakiuria
Reproductive system and breast disorders		Menorrhagia
General disorders and administration site conditions		Pain
Injury, poisoning and procedural complications			Post-traumatic pain

ALT alanine aminotransferase, AST aspartate aminotransferase, GGT gamma-glutamyltransferase, WBC, white blood cell

^aWithin each frequency grouping, adverse reactions are ranked in order of decreasing seriousness

^bBased on leflunomide data only