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          Common         Uncommon           Rare         Not Known Organ Class
(MedDRA)
Blood and                                                      Agranulocytosis Lymphatic                                                      Leucopenia System
Disorders
Immune                        Allergic reaction Pruritus       Anaphylactic/ System                        Allergic          Urticaria      anaphylactoid Disorders                     oedema/angioede Rash             reaction ma (incl. larynx oedema*)
Psychiatric                   Anxiety reactions
Disorders                     Sleep disorders
Metabolism                                                     Hyperglycaemia and Nutrition
Disorders
Nervous       Headache        Vertigo Migraine  Par-           Hypoaesthesia System                        Dizziness Tremor /Dysaesthesi    Somnolence Disorders                                      a
Eye Disorders                 Visual                           Eye pain disturbances
Cardiac                       Tachycardia                      Chest pain Disorders                     Palpitations                     (Angina pectoris) Vascular      Oedema (incl. Hypotension
Disorders     peripheral     Syncope oedema)
Vasodilatation
Respiratory,                  Nosebleed                        Dyspnoea Thoracic, and                Nasal congestion                  Pulmonary Mediastinal                                                    oedema** Disorders
Gastrointestina Constipation    Gastrointestinal    Gingival      Bezoar l Disorders                     and abdominal       hyperplasia   Dysphagia pain Nausea                       Intestinal
Dyspepsia                          obstruction
Intestinal ulcer
Flatulence Dry                     Vomiting mouth                              Gastroesophagea l sphincter insufficiency

Hepatobiliary                  Transient increase                 Jaundice Disorders                      in liver enzymes
Skin and                       Erythema                           Toxic Epidermal Subcutaneous                                                      Necrolysis Tissue                                                            Photosensitivity Disorders                                                         allergic reaction Palpable purpura
Musculoskelet                  Muscle cramps                      Arthralgia al and                         Joint swelling                     Myalgia Connective
Tissue
Disorders
Renal and                      Polyuria Dysuria
Urinary
Disorders
Reproductive                   Erectile
System and                     dysfunction
Breast
Disorders
General         Feeling unwell Unspecific pain
Disorders and                  Chills
Administration
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 of suspected adverse reactions:
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 https://sideeffects.health.gov.il/