Atostin

Atostin Adverse Reactions

atorvastatin

Manufacturer:

Y.S.P. Industries

Distributor:

Y.S.P. Industries
Full Prescribing Info
Adverse Reactions
Atorvastatin is generally well-tolerated. Adverse reactions have usually been mild and transient.
The most frequent adverse effects that may be associated with atorvastatin therapy include: Infections and infestations: nasopharyngitis.
Metabolism and nutrition disorders: hyperglycaemia.
Respiratory, thoracic and mediastinal disorders: pharyngolaryngeal pain, epistaxis.
Gastrointestinal disorders: diarrhoea, dyspepsia, nausea, flatulence.
Musculoskeletal and connective tissue disorders: arthralgia, pain in extremity, musculoskeletal pain, muscle spasms, myalgia, joint swelling, frequency not known: Immune-mediated necrotizing myopathy.
Investigations: liver function test abnormal, blood creatine kinase increased.
Additional adverse effects reported: Psychiatric disorders: nightmare.
Eye disorders: vision blurred.
Ear and labyrinth disorders: tinnitus.
Gastrointestinal disorders: abdominal discomfort, eructation.
Hepatobiliary disorders: hepatitis, cholestasis.
Skin and subcutaneous tissue disorders: urticarial.
Musculoskeletal and connective tissue disorders: muscle fatigue, neck pain.
General disorders and administration site conditions: malaise, pyrexia.
Investigations: white blood cell urine positive.
Not all effects listed previously have been causally associated with atorvastatin therapy.
Pediatric patients: The most common adverse experiences observed, regardless of causality assessment, were infections.
The following additional undesirable effects have been reported: Blood and lymphatic system disorders: thrombocytopenia.
Immune system disorders: allergic reactions (including anaphylaxis).
Injury, poisoning and procedural complications: tendon rupture.
Metabolism and nutrition disorders: weight gain.
Nervous system disorders: hypoaesthesia, amnesia, dizziness, dysgeusia.
Gastrointestinal disorders: pancreatitis.
Skin and subcutaneous tissue disorders: Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, bullous rashes.
Musculoskeletal and connective tissue disorders: rhabdomyolysis, immune mediated necrotising myopathy, back pain.
General disorders and administration site conditions: chest pain, peripheral oedema, fatigue.
There have been rare post-marketing 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 non-serious and reversible upon statin discontinuation, with variable times to symptom onset (1 day to years) and symptom resolution (median 3 weeks).
Increases in HbA1c and fasting blood glucose have been reported with statins. The risk of hyperglycemia, however, is outweighed by the reduction in vascular risk with statins.
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