Adverse reactions : תופעות לוואי

4.8. Undesirable effects
Clinical studies and epidemiological data suggest that the use of certain NSAIDs (particularly when administered at high doses and over a long period) can be associated with a slight increase in the risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see Section 4.4).

The most commonly observed adverse effects are gastrointestinal. Peptic ulcers, gastrointestinal perforations or bleeding, sometimes fatal, may occur, particularly in elderly subjects (see Section 4.4).
Nausea, vomiting, diarrhea, flatulence, constipation, dyspepsia, ulcerative stomatitis, abdominal pain, melena, hematemesis, exacerbation of colitis or Crohn’s disease (see Section 4.4) have been reported further to administration of NSAIDs. Cases of gastritis have been observed less commonly.
Edema, hypertension and heart failure have been reported in patients treated with NSAIDs.
Bullous reactions (Stevens-Johnson syndrome and Lyell’s syndrome) have been observed in very rare cases.

Undesirable effects have been ranked by incidence, using the following system: 
Very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000) and very rare (< 1/10,000), frequency unknown (cannot be estimated from the available data)
Gastrointestinal disorders
•   common: dyspepsia, nausea, abdominal pain, gastric pain, vomiting,
•   uncommon: diarrhea, constipation, flatulence, gastritis,
•   rare: stomatitis, peptic ulcer, colitis,
•   frequency unknown: exacerbation of colitis, Crohn's disease, gastrointestinal bleeding, and perforation.

At a dose of 200 mg per day, oral ketoprofen causes an increase in occult gastrointestinal bleeding. The incidence of this effect increases with dose and treatment duration.

Immune system disorders
• frequency unknown: angioedema, anaphylactic reactions (including anaphylactic shock).

Skin and subcutaneous tissue disorders
• uncommon: eruption, rash, pruritus,
• frequency unknown: urticaria, exacerbation of chronic urticaria, photosensitivity, alopecia, and bullous dermatoses (Stevens-Johnson syndrome and Lyell’s syndrome).


Respiratory, thoracic and mediastinal disorders
• rare: asthma attack,
• frequency unknown: bronchospasm, particularly in subjects allergic to aspirin and to other NSAIDs, rhinitis.

Nervous system disorders
• uncommon: headache, dizziness, drowsiness,
• rare: paresthesia,
• frequency unknown: seizures, taste disorders.

Psychiatric disorders
• frequency unknown: mood disorders.
Eye disorders
• rare: blurred vision.

Ear and labyrinth disorders
• rare: tinnitus.

Renal and urinary disorders
• water and sodium retention, hyperkalemia (see Sections 4.4 and 4.5),
• functional acute renal failure (ARF) in patients with risk factors (see Section 4.4),
• organic impairment of the kidneys which may result in ARF: isolated cases of interstitial nephritis, acute tubular necrosis, nephrotic syndrome and papillary necrosis have been reported.

Blood and lymphatic system disorders
• rare: anemia due to bleeding, leukopenia,
• frequency unknown: agranulocytosis, thrombocytopenia, bone marrow depression.

Hepatobialiary disorders
• rare: transaminases increased, hepatitis, bilirubin increased related to hepatic disorders.
Cardiac disorders
• uncommon: edema,
• frequency unknown: heart failure.

Vascular disorders
• frequency unknown: hypertension, vasodilation.

General disorders
• uncommon: fatigue,
• rare: weight gain.
Effects related to the route of administration - suppositories

Risk of local toxicity, increasing in frequency and intensity the longer the treatment duration, and the higher the dose and rate of administration. Rectal irritation, such as burning sensations, may occur