Adverse reactions : תופעות לוואי

4.8     Undesirable effects

The incidence of predictable undesirable side effects associated with the use of corticosteroids, including hypothalamic-pituitary-adrenal suppression correlates with the relative potency of the drug, dosage, timing of administration and duration of treatment (see section 4.4).

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; Injection site infection; Peritonitis;
Recurrence of dormant tuberculosis
Blood and lymphatic system      Not Known               Leukocytosis disorders
Immune system disorders         Not Known               Drug hypersensitivity, Anaphylactic reaction, Anaphylactoid reaction
Endocrine disorders             Not Known               Cushingoid; Hypothalamic pituitary adrenal axis suppression;; 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).
A 'withdrawal syndrome' may also occur including, fever, myalgia, arthralgia, rhinitis,
conjunctivitis, painful itchy skin nodules and loss of weight.
Metabolism and nutrition        Not Known               Metabolic acidosis; Glucose tolerance impaired; disorders                                               Sodium retention; Fluid retention; Increased requirements for insulin (or oral hypoglycemic agents in diabetics)[not a MedDRA PT];
Alkalosis hypokalaemic; Dyslipidaemia,
Increased appetite (which may result in Weight increased); Lipomatosis
Psychiatric disorders           Not Known               Affective disorder (including Depressed mood, Euphoric mood, Affect lability, Drug dependence, Suicidal ideation). The following events were most common in children: Mood swings; Abnormal behaviour; Insomnia;
Psychotic disorder (including Mania, Delusion,
Hallucination, and Schizophrenia [aggravation of]); Confusional state; Mental disorder;
Anxiety; Personality change; Mood swings;
Abnormal behaviour; Insomnia; Irritability
(children and adults)
Nervous system disorders        Not Known               Intracranial pressure increased (with Papilloedema [Benign intracranial hypertension]); Seizure; Amnesia; Cognitive disorder; Dizziness; Headache;
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         MedDRA
Frequency   Undesirable Effects
System Organ Class
Eye disorders                    Not Known   Cataract; Glaucoma; Exophthalmos; Vision blurred (see also section 4.4);
Chorioretinopathy; rare instances of blindness associated with intralesional therapy around the face and head [not a MedDRA PT]; Increased intra-ocular pressure, with possible damage to the optic nerve; Corneal or scleral thinning;
Exacerbation of ophthalmic viral or fungal disease
Ear and labyrinth disorders      Not Known   Vertigo
Cardiac disorders                Not Known   Cardiac failure congestive (in susceptible patients)
Vascular disorders               Not Known   Hypertension; Hypotension; Embolism arterial, Thrombotic events, Flushing
Respiratory, thoracic and        Not Known   Pulmonary embolism, Hiccups mediastinal disorders
Gastrointestinal disorders       Not Known   Peptic ulcer (with possible Peptic ulcer perforation and Peptic ulcer haemorrhage);
Gastric haemorrhage; Intestinal perforation;
Pancreatitis; Oesophagitis ulcerative;
Oesophagitis; Abdominal pain; Abdominal distension; Diarrhoea; Dyspepsia; Nausea
Hepatobiliary disorders          Not known   Hepatitis, Increase of liver enzymes 


Skin and subcutaneous tissue     Not Known   Angioedema; Hirsutism; Petechiae; disorders                                    Ecchymosis; Skin atrophy; Erythema; Hyperhidrosis; Skin striae; Skin hyperpigmentation; Rash; Pruritus; Urticaria;
Acne; Skin hypopigmentation;
Musculoskeletal and              Not Known   Growth retardation; Osteoporosis; Muscular connective tissue disorders                  weakness; Osteonecrosis; Pathological fracture; Muscle atrophy; Myopathy; Neuropathic arthropathy; Arthralgia; Myalgia; Post injection pain flare (following intra-articular,
periarticular, and tendon sheath injections)*

Reproductive system and          Not Known   Menstruation irregular breast disorders
General disorders and            Not Known   Abscess sterile; Impaired healing; Oedema administration site conditions               peripheral; Fatigue; Malaise; Injection site reaction;
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          MedDRA
Frequency                Undesirable Effects
System Organ Class
Investigations                  Not Known                Blood potassium decreased; Alanine aminotransferase increased; Aspartate aminotransferase increased; Blood alkaline phosphatase increased; Carbohydrate tolerance decreased; Urine calcium increased;
suppression of reactions to skin tests *; Blood urea increased;

Injury, poisoning and           Not Known                Tendon rupture (particularly of the Achilles procedural complications                                 tendon); Spinal compression fracture.
Systemic corticosteroids are not indicated for,
and therefore should not be used to treat,
traumatic brain injury.

† 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)
* Not a MedDRA PT
#Peritonitis may be the primary presenting sign or symptom of a gastrointestinal disorder such as perforation, obstruction or pancreatitis (see section 4.4).

CERTAIN SIDE EFFECTS REPORTED WITH SOME CONTRAINDICATED AND NON-
RECOMMENDED ROUTES OF ADMINISTRATION.

Intrathecal/Epidural: Usual systemic corticoid adverse reactions, headache, meningismus, meningitis, paraparesis/paraplegia, spinal fluid abnormalities, nausea, vomiting, sweating, arachnoiditis, functional gastrointestinal disorder/bladder dysfunction, seizure, sensory disturbance.

Extradural: Wound dehiscence, loss of sphincter control.

Intranasal: Permanent/temporary blindness, rhinitis.
Ophthalmic: (Subconjunctival) - Redness and itching, abscess, slough at injection site, residue at injection site, increased intra-ocular pressure, decreased vision - blindness, infection.

Miscellaneous injection sites - Scalp, tonsillar fauces, sphenopalatine ganglion: blindness.

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/