Adverse reactions : תופעות לוואי

4.8      Undesirable effects

The following adverse reactions have been reported with the following routes of administration: Intrathecal/Epidural: Arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, headache, meningitis, paraparesis/paraplegia, seizure and sensory disturbances

Under normal circumstances methylprednisolone therapy would be considered as short-term.
However, the possibility of side-effects attributable to corticosteroid therapy should be recognised, particularly when high-dose therapy is being used (see section 4.4). Such side-effects include:


MedDRA              Frequency†           Undesirable Effects
System Organ Class
Infections and infestations   Not Known            Infection (including increased susceptibility and severity of infections with suppression of clinical symptoms and signs);
Opportunistic infection; Recurrence of dormant tuberculosis (see section 4.4),
Peritonitis#
Neoplasms benign,             Not Known            Kaposi’s sarcoma has been reported to occur malignant and unspecified                          in patients receiving corticosteroid therapy.
(including cysts and                               Discontinuation of corticosteroids may result polyps)                                            in clinical remission.
Blood and lymphatic           Not Known            Leukocytosis system disorders
Immune system disorders       Not Known            Drug hypersensitivity (Anaphylactic reaction Anaphylactoid reaction)
Endocrine disorders           Not Known            Cushingoid; Hypothalamic pituitary adrenal axis suppression , Steroid withdrawal syndrome (including, fever,
myalgia, arthralgia, rhinitis,
conjunctivitis, painful itchy skin nodules and loss of weight).


Metabolism and nutrition      Not Known            Metabolic acidosis; Sodium retention; Fluid disorders                                          retention; Glucose tolerance impaired; Alkalosis hypokalaemic; Dyslipidemia,
Increased insulin requirements (or oral hypoglycemic agents in diabetics);
Lipomatosis, Increased appetite (which may result in weight increase); Epidural lipomatosis

Psychiatric disorders         Not Known            A wide range of psychiatric reactions including affective disorders (such as irritable, euphoric, depressed and labile mood drug dependence and suicidal thoughts), psychotic reactions (including mania, delusions, hallucinations and schizophrenia), behavioural disturbances,
irritability, anxiety, sleep disturbances, and cognitive dysfunction including confusion and amnesia have been reported for all corticosteroids. Reactions may occur in both adults and children. In adults, the frequency of severe reactions was estimated to be 5%-
6%. Psychological effects have been reported on withdrawal of corticosteroids;
the frequency is unknown.
Nervous system disorders      Not Known            Increased intracranial pressure with Papilloedema [Benign intracranial hypertension]; Seizure; Amnesia; Cognitive disorder; Dizziness; Headache

Eye disorders                 Rare                 Vision blurred (see also section 4.4).
Not Known            Posterior subcapsular cataracts;
Exophthalmos; Glaucoma; Papilloedema with possible damage to the optic nerve;
Corneal or scleral thinning; Exacerbation of ophthalmic viral or fungal disease;
Chorioretinopathy.

Ear and labyrinth             Not Known            Vertigo disorders
Cardiac disorders             Not Known            Congestive heart failure in susceptible patients, Arrhythmia
Vascular disorders            Not Known            Hypertension; Hypotension; Thrombotic events, Flushing

Respiratory, thoracic and     Not Known            Hiccups; Pulmonary embolism.
mediastinal disorders
Gastrointestinal disorders    Not Known            Peptic ulcer (with possible peptic ulcer perforation and peptic ulcer haemorrhage);
Gastric haemorrhage; Intestinal perforation;
Pancreatitis; Ulcerative oesophagitis;
Oesophagitis; Oesophageal candidiasis;
Abdominal pain; Abdominal distension;
Diarrhoea; Dyspepsia; Nausea; Vomiting;
Bad taste in mouth may occur especially with rapid administration
Hepatobiliary disorders       Not Known            Hepatitis†; Increase of liver enzymes (e.g alanine aminotransferase increased (ALT,
SGPT), aspartate aminotransferase increased
(AST, SGOT)).
Skin and subcutaneous         Not Known            Ecchymosis; Skin atrophy (thin fragile skin); tissue disorders                                   Acne; Angioedema; Petechiae; Skin striae; Telangiectasia; Skin hypopigmentation or hyperpigmentation; Hirsutism; Rash;
Erythema; Pruritus; Urticaria; Hyperhidrosis
Musculoskeletal and           Not Known            Growth retardation; Osteoporosis; Muscular connective tissue disorders                        weakness; Osteonecrosis; Pathological fracture; Muscle atrophy; Myopathy;
Neuropathic arthropathy; Arthralgia;
Myalgia
Reproductive system and       Not Known            Irregular menstruation; Amenorrhoea breast disorders
General disorders and         Not Known            Impaired wound healing; Oedema administration site                                peripheral; Injection site reaction; Fatigue; conditions                                         Malaise; Withdrawal symptoms - Too rapid a reduction of corticosteroid dosage following prolonged treatment can lead to acute adrenal insufficiency, hypotension and death. However, this is more applicable to corticosteroids with an indication where continuous therapy is given (see Section 4.4)

Investigations                 Not Known               Intraocular pressure increased; Carbohydrate tolerance decreased; Blood potassium decreased (potassium loss); Urine calcium increased; Blood alkaline phosphatase increased; Blood urea increased;
Suppression of reactions to skin tests
Injury, poisoning and          Not Known               Tendon rupture (particularly of the Achilles procedural complications                               tendon); Spinal compression fracture (vertebral compression fractures)
† Common (≥1/100 to <1/10); Uncommon (≥1/1,000 to <1/100); Rare (≥1/10,000 to <1/1,000); Not known (frequency cannot be estimated from the available data)
† Hepatitis has been reported with IV administration (see section 4.4).
# Peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis (see section 4.4).

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/