Pitator Adverse Reactions



Orient Pharma




OEP Phils
Full Prescribing Info
Adverse Reactions
Rhabdomyolysis accompanied by myoglobinuria and acute renal failure and myopathy (including myositis); Liver enzyme abnormalities.
Other adverse reactions reported were arthralgia, headache, influenza, and nasopharyngitis.
The following abnormal laboratory tests were also reported: elevated creatine phosphokinase, hepatic transaminases, alkaline phosphatase, bilirubin, and glucose.
Hypersensitivity reactions including rash, pruritus, and urticaria have been reported with Pitavastatin.
Postmarketing Experiences: The following adverse reactions were observed during post-approval use of Pitavastatin. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Adverse reactions associated with Pitavastatin therapy reported since marketing introduction, regardless of causality assessment, include the following: abdominal discomfort, abdominal pain, dyspepsia, nausea, asthenia, fatigue, malaise, hepatitis, jaundice, fatal and non-fatal hepatic failure, dizziness, hypoesthesia, insomnia, depression, interstitial lung disease, erectile dysfunction, muscle spasms and peripheral neuropathy.
There have been rare postmarketing reports of cognitive impairment (e.g., memory loss, forgetfulness, amnesia, memory impairment, confusion) associated with statin use. These cognitive issues have been reported for all statins. The reports are generally nonserious, and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median of 3 weeks).
There have been rare reports of immune-mediated necrotizing myopathy associated with statin use.
Patient should seek medical attention immediately at the first sign of any adverse drug reaction.
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