Adverse reactions : תופעות לוואי

4.8     Undesirable effects

Adverse drug reactions (ADRs) based on placebo-controlled studies with nifedipine sorted by CIOMS III categories of frequency (clinical trial data base: nifedipine n = 2,661; placebo n = 1,486; status: 22 Feb 2006 and the ACTION study: nifedipine n = 3,825; placebo n = 3,840) are listed below: ADRs listed under "common" were observed with a frequency below 3% with the exception of oedema (9.9%) and headache (3.9%).

The frequencies of ADRs reported with nifedipine-containing products are summarised in the table below.
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Frequencies are defined as common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) and rare (≥ 1/10,000 to < 1/1,000). The ADRs identified only during the ongoing postmarketing surveillance, and for which a frequency could not be estimated, are listed under “Not known”.


System Organ Class           Common            Uncommon                Rare             Not known (MedDRA)
Blood and lymphatic                                                                 Agranulocytosis system disorders                                                                    Leukopenia Immune system                               Allergic reaction Pruritus              Anaphylactic/ disorders                                                     Urticaria             anaphylactoid Allergic oedema / Rash                  reaction angioedema (incl.
larynx oedema*)
Psychiatric                                 Anxiety reactions disorders                                   Sleep disorders
System Organ Class     Common                   Uncommon              Rare             Not known (MedDRA)
Metabolism and                                                                     Hyperglycaemia nutrition disorders
Nervous system      Headache                 Vertigo            Par-/              Hypoaesthesia disorders                                    Migraine           Dysaesthesia       Somnolence Dizziness
Tremor
Eye disorders                                Visual                                Eye pain disturbances
Cardiac disorders                            Tachycardia                           Chest pain (Angina Palpitations                          pectoris)
Vascular disorders        Oedema (incl.      Hypotension peripheral
Syncope oedema)
Vasodilatation
Respiratory,                                 Nosebleed                             Dyspnoea thoracic, and                                                                      Pulmonary Nasal congestion mediastinal                                                                        oedema** disorders
Gastrointestinal          Constipation       Gastrointestinal Gingival             Vomiting disorders                                    and abdominal      hyperplasia        Gastrooesophageal pain                                  sphincter
Nausea                                insufficiency
Dyspepsia
Flatulence
Dry mouth
Hepatobiliary                                Transient increase                    Jaundice disorders                                    in liver enzymes
Skin and                                     Erythema                              Toxic Epidermal subcutaneous tissue                                                                Necrolysis disorders
Photosensitivity allergic reaction
Palpable purpura
Musculoskeletal and                          Muscle cramps                         Arthralgia connective tissue
Joint swelling                        Myalgia disorders
Renal and urinary                            Polyuria disorders
Dysuria
Reproductive system                          Erectile and breast disorders                         dysfunction
General disorders    Feeling unwell          Unspecific pain and administration
Chills site conditions

*   = may result in life-threatening outcome.
**
= cases have been reported when used as tocolytic during pregnancy (see section 4.6) In dialysis patients with malignant hypertension and hypovolaemia a distinct fall in blood pressure can occur as a result of vasodilation.


Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form: http://forms.gov.il/globaldata/getsequence/getsequence.aspx?formType=AdversEffectMedic@moh.gov.il