There are limited amount of data (less than 300 pregnancy outcomes) from the use of ispaghula husk in pregnant women. Animal studies are insufficient with respect to reproductive toxicity.
The use of ispaghula husk may be considered during pregnancy and lactation, if necessary, and if change of nutrition is not successful. Laxative bulk producers should be used before using other purgatives.
There is no evidence of an effect on the fertility in the rat following oral application.
Ispaghula has no or negligible influence on the ability to drive and use machines.
Special attention should be given to individuals manipulating the powder formulations routinely.
Adverse events which have been associated with ispaghula husk are given below, tabulated by system organ class and frequency. Frequencies are defined as: Very common (≥1/10); Common (≥1/100 and <1/10); Uncommon (≥1/1000 and <1/100); Rare (≥1/10,000 and <1/1000); Very rare (<1/10,000); Not known (cannot be estimated from the available data). Within each frequency grouping, adverse events are presented in order of decreasing seriousness.
| System Organ Class | Frequency | Adverse Events |
|---|---|---|
| Immune System Disorders | Not known | Hypersensitivity disorders1,2 |
| Eye Disorders | Not known | Conjunctivitis2 |
| Respiratory, Thoracic and Mediastinal Disorders | Not known | Rhinitis2 |
| Gastrointestinal Disorders | Not known | Flatulence, abdominal distension, intestinal obstruction, oesophageal obstruction, faecal impaction3 |
| Skin and Subcutaneous Tissue Disorders | Not known | Skin rash2 |
1 Including rash, anaphylaxis, pruritus, and bronchospasm
2 Ispaghula/psyllium husk contains potent allergens. The exposure to these allergens is possible through oral administration, contact with the skin and, in the case of powder formulations, also by inhalation. As a consequence to this allergic potential, individuals exposed to the product can develop hypersensitivity reactions such as rhinitis, conjunctivitis, bronchospasm and in some cases, anaphylaxis. Cutaneous symptoms such as exanthema and/or pruritus have also been reported.
3 A small amount of flatulence and abdominal distension may sometimes occur during the first few days of treatment, but should diminish during continued treatment. Abdominal distension and risk of intestinal or oesophageal obstruction and faecal impaction may occur, particularly if swallowed with insufficient fluid.
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