Atorvastatin and Perindopril


Based on existing data with the individual components as described below, atorvastatin/perindopril combination is contraindicated during pregnancy.


Safety in pregnant women has not been established. No controlled clinical trials with atorvastatin have been conducted in pregnant women. Rare reports of congenital anomalies following intrauterine exposure to HMG-CoA reductase inhibitors have been received. Animal studies have shown toxicity to reproduction.

Maternal treatment with atorvastatin may reduce the foetal levels of mevalonate which is a precursor of cholesterol biosynthesis. Atherosclerosis is a chronic process, and ordinarily discontinuation of lipid-lowering medicinal products during pregnancy should have little impact on the long-term risk associated with primary hypercholesterolaemia.

For these reasons, atorvastatin should not be used in women who are pregnant, trying to become pregnant or suspected to be pregnant.


Epidemiological evidence regarding the risk of teratogenicity following exposure to ACE inhibitors during the first trimester of pregnancy has not been conclusive; however a small increase in risk cannot be excluded. Patients planning pregnancy should be changed to alternative anti-hypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with ACE inhibitors should be stopped immediately, and, if appropriate, alternative therapy should be started.

Exposure to ACE inhibitor therapy during the second and third trimesters is known to induce human foetoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalaemia).

For these reasons the use of ACE inhibitors is not recommended during the first trimester of pregnancy. The use of ACE inhibitors is contraindicated during the 2nd and 3rd trimester of pregnancy.

Should exposure to ACE inhibitor have occurred from the second trimester of pregnancy, ultrasound check of renal function and skull is recommended. Infants whose mothers have taken ACE inhibitors should be closely observed for hypotension.

Nursing mothers

Based on existing data with the individual components as described below, atorvastatin/perindopril combination is contra-indicated during breast-feeding.


It is not known whether atorvastatin or its metabolites are excreted in human milk. In rats, plasma concentrations of atorvastatin and its active metabolites are similar to those in milk. Because of the potential for serious adverse reactions, women taking atorvastatin should not breast-feed their infants. Atorvastatin is contraindicated during breastfeeding.


Because no information is available regarding the use of perindoprilduring breastfeeding, perindopril is not recommended and alternative treatments with better established safety profiles during breast-feeding are preferable, especially while nursing a newborn or preterm infant.

Carcinogenesis, mutagenesis and fertility

Women of childbearing potential

Women of child-bearing potential should use appropriate contraceptive measures during treatment with atorvastatin/perindopril.


There are no clinical data on fertility with the use of atorvastatin/perindopril.


In animal studies atorvastatin had no effect on male or female fertility.


There was no effect on reproductive performance or fertility.

Effects on ability to drive and use machines

No studies have been performed on the effect of atorvastatin/perindopril on the ability to drive and use machines.

  • Atorvastatin has negligible influence on the ability to drive and use machines.
  • Perindopril has no direct influence on the ability to drive and use machines but individual reactions related to low blood pressure may occur in some patients, particularly at the start of treatment or in combination with another antihypertensive medication.

As a result the ability to drive or operate machinery may be impaired in patients taking atorvastatin/perindopril.

Adverse reactions

Summary of the profile

The most commonly reported adverse reactions with atorvastatin and perindopril given separately include: nasopharyngitis, hypersensitivity, hyperglycaemia, dizziness, headache, dysgeusia, paraesthesia, visual impairment, tinnitus, vertigo, hypotension, pharyngolaryngeal pain, epistaxis, cough, dyspnoea, nausea, vomiting, abdominal pain upper and lower, dyspepsia, diarrhoea, constipation, flatulence, rash, pruritus, joint swelling, pain in extremity, arthralgia, muscle spasms, myalgia, back pain, asthenia, liver function test abnormal, blood creatine kinase increased.

Tabulated list of adverse reactions

The following undesirable effects have been observed during treatment with atorvastatin and perindopril, or given separately and ranked under the MedDRA classification by body system and under heading of frequency using the following convention: Very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data)).

System Organ
Undesirable effects Frequency
Atorvastatin Perindopril
Infections and
Nasopharyngitis Common-
Rhinitis- Very rare
Blood and
system disorders
Thrombocytopenia Rare Very rare
Leukopenia/Neutropenia - Very rare
Eosinophilia- Uncommon*
Agranulocytosis /Pancytopenia  Very rare
Haemolytic anaemia in patients with a congenital deficiency of
- Very rare
Immune system
Hypersensitivity Commo-
Anaphylaxis Very rare-
Syndrome of inappropriate antidiuretic hormone secretion (SIADH) - Rare
Metabolism and
Hyperglycaemia Common-
Hypoglycaemia Uncommon Uncommon*
Hyponatraemia- Uncommon*
Hyperkalaemia reversible on discontinuation - Uncommon*
Anorexia Uncommon-
Depression- Uncommon*
Mood altered- Uncommon
Sleep disorder Uncommon
Confusional state- Very rare
Nervous system
Somnolence- Uncommon*
Dizziness Uncommon Common
Headache CommonCommon
Dysgeusia UncommonCommon
Syncope- Uncommon*
Hypoaesthesia Uncommon-
ParaesthesiaUncommon Common
Peripheral neuropathy Rare-
Stroke possible secondary to excessive hypotension in high-risk patients - Very rare
Amnesia Uncommon-
Eye disorders Visual impairment RareCommon
Vision blurred Uncommon-
Ear and
Tinnitus Uncommon Common
Vertigo- Common
Hearing loss Very Rare-
Myocardial infarction, possibly secondary to excessive hypotension in
high-risk patients
- Very rare
Angina pectoris- Very rare
Arrhythmia- Very rare
Tachycardia- Uncommon*
Palpitations- Uncommon*
Hypotension (and effects related to hypotension) - Common
Vasculitis - Uncommon*
Flushing- Rare*
Raynaud’s phenomenon- Not known
thoracic and
Pharyngolaryngeal pain Common-
Epistaxis Common-
Dyspnoea- Common
Bronchospasm- Uncommon
Eosinophilic pneumonia- Very rare
Nausea Common Common
Vomiting Uncommon Common
Abdominal pain upper and lower Uncommon Common
DyspepsiaCommon Common
DiarrhoeaCommon Common
ConstipationCommon Common
Dry mouth- Uncommon
Pancreatitis Uncommon Very rare
Flatulence Common-
Hepatitis either cytolytic or cholestatic Uncommon Very rare
Cholestasis Rare-
Hepatic failure Very rare-
Skin and
tissue disorders
Rash UncommonCommon
Pruritus Uncommon Common
Urticaria Uncommon Uncommon
Hyperhidrosis- Uncommon
Psoriasis aggravation- Rare*
Alopecia Uncommon-
Angioedema Rare Uncommon
Pemphigoid- Uncommon*
Stevens-Johnson syndrome Rare-
Photosensitivity reaction- Uncommon*
Toxic epidermal necrolysis Rare-
Erythema multiforme Rare Very rare

* Frequency calculated from clinical trials for adverse events detected from spontaneous report.

As with other HMG-CoA reductase inhibitors elevated serum transaminases have been reported in patients receiving atorvastatin. These changes were usually mild, transient, and did not require interruption of treatment. Clinically important (>3 times upper normal limit) elevations in serum transaminases occurred in 0.8% patients on atorvastatin. These elevations were dose related and were reversible in all patients.

Elevated serum creatine kinase (CK) levels greater than 3 times upper limit of normal occurred in 2.5% of patients on atorvastatin, similar to other HMG-CoA reductase inhibitors in clinical trials. Levels above 10 times the normal upper range occurred in 0.4% atorvastatin -treated patients.

The following adverse events have been reported with some statins:

  • Sexual dysfunction.
  • Depression.
  • Exceptional cases of interstitial lung disease, especially with long term therapy.
  • Diabetes Mellitus: Frequency will depend on the presence or absence of risk factors (fasting blood glucose ≥5.6 mmol/L, BMI >30 kg/m², raised triglycerides, history of hypertension).

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