FDA Section 5 \u2022 cited verbatim

Ivermectin - Warnings and Precautions

The following warnings and precautions are taken directly from the US FDA-approved drug label for Ivermectin. This is the same information dispensing pharmacists read.

WARNINGS Historical data have shown that microfilaricidal drugs, such as diethylcarbamazine citrate (DEC-C), might cause cutaneous and/or systemic reactions of varying severity (the Mazzotti reaction) and ophthalmological reactions in patients with onchocerciasis.

These reactions are probably due to allergic and inflammatory responses to the death of microfilariae.

Patients treated with ivermectin for onchocerciasis may experience these reactions in addition to clinical adverse reactions possibly, probably, or definitely related to the drug itself (See ADVERSE REACTIONS, Onchocerciasis ).

The treatment of severe Mazzotti reactions has not been subjected to controlled clinical trials.

Oral hydration, recumbency, intravenous normal saline, and/or parenteral corticosteroids have been used to treat postural hypotension.

Antihistamines and/or aspirin have been used for most mild to moderate cases.

Neurotoxicity with the use of ivermectin, including alteration of consciousness of variable severity (e.g., somnolence/drowsiness, stupor, and coma), confusion, disorientation and death, has been reported in patients without onchocerciasis or in patients with onchocerciasis in the absence of Loa loa infection.

These reactions have generally resolved with supportive care and the discontinuation of ivermectin.

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