Caution is required in patients who have had hypersensitivity or allergic reactions to other
substances, as they could be at an increased risk of hypersensitivity reactions occurring with
ibuprofen.
Caution is required in patients who suffer from hayfever, nasal polyps or chronic obstructive
respiratory disorders as an increased risk exists for them of allergic reactions occurring. These may
present as asthma attacks (so-called analgesic asthma), Quincke’s edema or urticaria.
Ophthalmological effects
Adverse ophthalmological effects have been observed with non-steroidal anti-inflammatory agents.
Any patient who develops visual disturbances during treatment with ibuprofen should have an
ophthalmological examination.
Impaired liver function or a history of liver disease
Patients with impaired liver function or a history of liver disease who are on long term ibuprofen
therapy should have hepatic function monitored at regular intervals. Ibuprofen has been reported to
have a minor and transient effect on liver enzymes.
Severe hepatic reactions, including jaundice and cases of fatal hepatitis, though rare, have been
reported with ibuprofen as with other NSAIDs. If abnormal liver tests persist or worsen, or if clinical
signs and symptoms consistent with liver disease develop, or if systemic manifestations occur (e.g.
eosinophilia, rash, etc.), ibuprofen should be discontinued.
Impaired renal function
Caution should be used when initiating treatment with ibuprofen in patients with considerable
dehydration. There is a risk of renal impairment especially in dehydrated elderly, children and
adolescents.
As with other NSAIDs, long-term administration of ibuprofen has resulted in renal papillary necrosis
and other renal pathologic changes. Renal toxicity has also been seen in patients in whom renal
prostaglandins have a compensatory role in the maintenance of renal perfusion. In these patients,
administration of NSAIDs may cause a dose-dependent reduction in prostaglandin formation and,
secondarily, in renal blood flow, which may cause renal failure. Patients at greatest risk of this
reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics,
ACE inhibitors and the elderly. Discontinuation of NSAIDs therapy is usually followed by recovery to
the pretreatment state..
Caution is required in patients with renal, hepatic or cardiac impairment since the use of NSAIDs
may result in deterioration of renal function. The habitual concomitant intake of similar painkillers
further increases this risk.. For patients with renal, hepatic or cardiac impairment, use the lowest
effective dose, for the shortest possible duration (see Section 4.3).
Combination use of ACE inhibitors or angiotensin receptor antagonists, anti-
inflammatory drugs and thiazide diuretics
The use of an ACE inhibiting drug (ACE-inhibitor or angiotensin receptor antagonist), an anti-
inflammatory drug (NSAID or COX-2 inhibitor) and thiazide diuretic at the same time increases the
risk of renal impairment. This includes use in fixed-combination products containing more than one
class of drug. Combined use of these medications should be accompanied by increased monitoring
of serum creatinine, particularly at the institution of the combination. The combination of drugs from
these three classes should be used with caution particularly in elderly patients or those with pre-
existing renal impairment.
Aseptic meningitis
Aseptic meningitis has been reported only rarely, usually but not always in patients with systemic
lupus erythematosus (SLE) or other connective tissue disorders.