Adverse reactions : תופעות לוואי

4.8   Undesirable effects

Post Marketing
The following undesirable effects may occur in patients receiving ketorolac trometamol; frequencies of reported events are not known, because they were reported voluntarily from a population of uncertain size.

Gastrointestinal disorders:
The most commonly observed adverse events are gastrointestinal in nature. Peptic ulcers, ulcers, perforation or gastrointestinal bleeding, sometimes fatal, particularly in the elderly, may occur (see section 4.4). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, / discomfort, melaena, haematemesis, ulcerative stomatitis, oesophagitis, gastro-intestinal ulceration, rectal bleeding, pancreatitis, exacerbation of colitis and Crohn's disease (see section 4.4) have been reported following administration. Less frequently, gastritis has been observed.

Infections and infestations:
Aseptic meningitis (especially in patients with existing autoimmune disorders, such as systemic lupus erythematosus, mixed connective tissue disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).

Blood and lymphatic disorders:
Thrombocytopenia

Immune system disorders:
Anaphylaxis, anaphylactoid reactions like anaphylaxis, may have a fatal outcome, hypersensitivity reactions such as bronchospasm, rash, hypotension, laryngeal oedema.

Metabolic and nutrition disorders:
Anorexia, hyperkalaemia, hyponatraemia

Psychiatric disorders:
Abnormal thinking, depression, insomnia, anxiety, nervousness, psychotic reactions, abnormal dreams, hallucinations, euphoria, impaired concentration ability, drowsiness.

Nervous system disorders:
Headache, dizziness, convulsions, paraesthesia, hyperkinesia, taste abnormalities.

Eye disorders:
Vision disorders
Ear and labyrinth disorders:
Tinnitus, hearing loss, vertigo

Renal and urinary disorders:
Acute renal failure, increased urinary frequency, interstitial nephritis, nephrotic syndrome, urinary retention, oliguria, haemolytic uremic syndrome, flank pain (with or without haematuria and/or azotemia). As with other drugs that inhibit prostaglandin synthesis, signs of renal impairment, such as (but not limited to) elevations of serum creatinine and potassium can occur even after a single dose of ketorolac trometamol.

Cardiac disorders:
Palpitations, bradycardia, cardiac failure.

Vascular disorders:
Hypertension, hypotension, haematoma, flushing, pallor, postoperative wound haemorrhage.
Clinical trial and epidemiological data suggest that the use of the coxibs and some NSAIDs (particularly at high doses) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Although ketorolac has not been shown to increase thrombotic events, such as myocardial infarction, there are insufficient data to exclude such a risk with ketorolac.

Reproductive system and breast disorders:
Female infertility.

Respiratory, thoracic and mediastinal disorders:
Bronchial asthma, dyspnoea, pulmonary oedema.
Hepatobiliary disorders:
Hepatitis, cholestatic jaundice, liver failure.

Skin and subcutaneous tissue disorders.
Exfoliative dermatitis, maculopapular rash, pruritus, purpura, angioedema, sweating, bullous reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis (very rarely).

Musculoskeletal and connective tissue disorders.
Myalgia

General disorders and administration site conditions:
Excessive thirst, asthenia, oedema, injection site reactions, fever, chest pain.
Diagnostic investigations.
Bleeding time prolonged, serum urea increased, creatinine increased, abnormal liver function tests.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization 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/.