Naclo-R Adverse Reactions

Aceclofenac: The majority of adverse reactions reported have been reversible and of a minor nature. The most frequent are gastrointestinal disorders, in particular dyspepsia, abdominal pain, nausea and diarrhoea, and occasional occurrence of dizziness. Dermatological complaints including pruritis and rash and abnormal hepatic enzyme and serum creatinine levels have also been reported. If serious adverse reactions occur, aceclofenac should be withdrawn.
The following is a table of adverse reactions reported during clinical studies and after authorisation, grouped by system-organ class and estimated frequencies (see Table 1).

Click on icon to see table/diagram/image

Other rare or very rare class effects reported with NSAIDs in general are: Blood and Lymphatic Disorders: Aplastic anaemia.
Psychiatric Disorders: Hallucination, confusional state.
Nervous System Disorder/s: Optic neuritis, somnolence.
Ear and Labyrinth Disorders: Tinnitus.
Respiratory, Thoracic and Mediastinal Disorders: Aggravated Asthma.
Gastrointestinal System: Duodenal ulcer, gastrointestinal perforation.
Skin and Subcutaneous Tissue Disorders: Toxic epidermal necrolysis, erythema multiforme, exfoliative dermatitis, photosensitivity reaction.
Renal and Urinary Disorders: Interstitial nephritis.
General Disorders and Administration Site Conditions: Malaise.
Rabeprazole: Rabeprazole were generally well-tolerated during clinical trials. The observed adverse reactions have been generally mild/moderate and transient in nature. The most common adverse events are headache, diarrhoea and nausea. Adverse reactions reported as more than isolated cases are listed as follows, by system organ class and by frequency.
The following adverse events have been reported from clinical trials and post-marketed experience. However of those adverse reactions reported in company sponsored clinical trials, only headache, diarrhoea, abdominal pain, asthenia, flatulence, rash and dry mouth were associated with the use of rabeprazole.
Frequencies are defined as: Common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1/1000); and very rare (<1/10,000) (see Table 2).

Click on icon to see table/diagram/image