Elevit Adverse Reactions

The following adverse reactions have been identified during post-approval use of Elevit. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency.
Gastrointestinal Disorders: Gastrointestinal and abdominal pain, constipation, diarrhea, nausea and vomiting may occur.
Immune system disorders: In isolated cases this product may cause allergic or anaphylactic reaction. Symptoms may include hives, facial swelling, wheezing, skin reddening, rash, blisters, and shock. If an allergic reaction occurs, treatment must be stopped and a health care professional consulted.
In a placebo controlled clinical trial in 2471 pregnant women who took Elevit (one tablet daily for 1 to 6 months), the percent of subjects reporting adverse events was as follows: Constipation (1.8%), diarrhea (1.4%) and exanthema (0.08%). The percentages of subjects reporting these events in the placebo group were not statistically different.
A slight yellow discoloration of urine may be noticed. This effect is harmless and is due to the vitamin B2 contained in the preparation.
The product contains iron, which may lead to a black colouring of the stool. This effect is harmless and does not have any clinical relevance.
Metabolism and nutrition disorders: Hypercalciuria.
Nervous system disorders: Headache, dizziness, insomnia, nervousness may occur.