Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The adverse effects of papaverine described in the literature are listed below and classified by system organ class and frequency. The frequencies are defined as follows: very common (≥1/10); common (≥1/100, <1/10); uncommon (≥1/1,000, <1/100); rare (≥1/10,000, <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).

Table: Known side effects
System organ class                     Undesirable effects                 Frequency Nervous system disorders               increased depth of breathing,       Rare (Autonomic Nervous System)             depression, dizziness,
lightheadedness, headache,
drowsiness, sedation, lassitude,
alertness disorder, malaise,
weakness and lethargy.
Cardiac disorders                      increased heart rate, arrhythmias   Rare (too rapid injection or injection of too high doses),
atrioventricular block,
tachycardia
Vascular disorders                     hypotension or increased blood      Rare pressure
Gastrointestinal disorders*            constipation, nausea, diarrhea,     Rare abdominal distress and anorexia,
vomiting
Skin and subcutaneous                  pruritus, rash,                     Rare disorders
Hepatobiliary disorders          Hepatotoxicity: Hepatitis and        Not known increased hepatic enzymes
(alkaline phosphatase, SGOT) suggesting hepatotoxicity.
General disorders and            Hypersensitivity reactions           Very rare administration site conditions   General discomfort, redness in       Rare the face, sweating, dry mouth and throat
Thrombosis at the injection site.    Not known
* subjects with bowel movement disorders are more easily exposed to digestive disorders.

Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation 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