Based on the pooled data from 46 company-sponsored patient studies including 3755 patients who received pinaverium bromide, the following undesirable effects have been reported. Adverse reactions listed as follows are classified according to frequency and SOC. Frequencies are defined as very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000 to <1/1000), or very rare (<1/10,000). (See table.)
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The following adverse reactions have been reported spontaneously during post-marketing use. A precise frequency can not be estimated from available data (not known).
Gastrointestinal disorders: Gastro-intestinal disturbances have been observed, e.g. abdominal pain, diarrhea, nausea, vomiting, and dysphagia. Oesophageal lesion may occur when not applied as advised (see Dosage & Administration).
Skin and subcutaneous tissue disorders: Cutaneous effects have been observed, e.g. rash, pruritus, urticaria, and erythema.
Immune system disorders: Hypersensitivity.