Table 11.

Frequency, organ class and adverse effects of lovastatin as reported in the SPC on the basis of clinical studies and post‐marketing data (SCP, online)

Frequency	Organ class	Adverse effect
Common (≥ 1/100 to < 1/10)	Metabolism and nutrition disorders	Digestive disorders
	Nervous system disorders	Vertigo, cephalagia
	Eye disorders	Blurred vision
	Gastrointestinal disorders	Flatulence, diarrhoea, constipation, nausea, dyspepsia, abdominal pains
	Skin and subcutaneous tissue disorders	Rash
	Musculoskeletal and connective tissue disorders	Muscle cramps and myalgia
Uncommon (≥ 1/1,000 to < 1/100)	Psychiatric disorders	Insomnia, sleeping difficulties
	Nervous system disorders	Dysgeusia
	Skin and subcutaneous tissue disorders	Pruritus, xerostomia
	General disorders and administration site conditions	Tiredness
Rare (≥ 1/10,000 to < 1/1,000)	Immune system disorders	Hypersensitivity syndrome associated with one or more of the following symptoms: anaphylaxis, angioedema, lupus‐like syndrome, polymyalgia rheumatica, dermatomyositis, vasculitis, thrombocytopenia, leucopenia, eosinophilia, haemolytic anaemia, positive antinuclear antibodies (ANA), increased sedimentation rate, arthritis, arthralgia, urticaria, asthenia, photosensitivity, fever, flushes, chills, dyspnoea and malaise
	Metabolism and nutrition disorders	Anorexia
	Psychiatric disorders	Psychological disturbances including restlessness/anxiety
	Nervous system disorders	Peripheral neuropathy, in particular if used for a long period of term, paraesthesia
	Gastrointestinal disorders	Vomiting
	Hepatobiliary disorders	Hepatitis, cholestatic jaundice
	Skin and subcutaneous tissue disorders	Hair loss, toxic epidermal necrolysis and erythema multiforme including Stevens‐Johnson syndrome
	Musculoskeletal and connective tissue disorders	Myopathia and rhabdomyolysis, erectile dysfunction
	Investigations	Marked and persistent increases in serum transaminase concentrations Other irregularities in liver function tests, including elevated alkaline phosphatase and bilirubin have been reported. Increases in the serum concentration of CK (which may be attributed to the non‐cardiac fraction of CK) have been seen. These have usually been slight and transient; marked increases have only occurred in rare cases
Not known	Psychiatric disorders	Depression