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Serious adverse reactions, including excessive weakness, dysphagia, and aspiration pneumonia, with some adverse reactions associated with fatal outcomes, have been reported in patients who received BOTOX injections for unapproved uses. In these cases, the adverse reactions were not necessarily related to distant spread of toxin, but may have resulted from the administration of BOTOX to the site of injection and/or adjacent structures.

Tell your doctor if you are pregnant, intending to become pregnant, or breastfeeding before being administered Botox because it may not be suitable for you.

Determining the right number of Botox units is a personalized process, and several factors influence the final dosage decided upon by you and your qualified injector. Here are the key things that affect how many units you'll need:

Delayed-onset inflammation near the sitio of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment sitio following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.

In general, the initial effect of the injections is seen within three days and reaches a peak at one to two weeks post-treatment. Each treatment lasts approximately three months, following which the procedure can be repeated. At repeat treatment sessions, the dose may be increased up to two-fold if the response from the initial treatment is considered insufficient, usually defined as an effect that does not last longer than two months.

Patients should discontinue anti-platelet therapy at least 3 days before the injection procedure. Patients on anti-coagulant therapy need to be managed appropriately to decrease the risk of bleeding. Appropriate caution should be exercised when performing a cystoscopy.

Delayed-onset inflammation near the site of injection is one of the known adverse events associated with dermal fillers. Cases of delayed-onset inflammation have been reported to occur at the treatment site following viral or bacterial illnesses or infections, vaccinations, or dental procedures. Typically, the reported inflammation was responsive to treatment or resolved on its own.

The duration of post-injection catheterization for those who developed urinary retention is also shown.

Do not start any new medicines until you have told your doctor that you have received onabotulinumtoxinA in the past. Especially tell your doctor if you:

There are no data on the presence of Botox in human milk or adverse effects on the developing infant. Consider the benefits of Botox versus the risks, and advise against breastfeeding unless the risk is justified.

In adult spasticity patients with reduced lung function, upper respiratory tract infections were also reported more frequently as adverse reactions in patients treated with BOTOX than in patients treated with placebo [see Warnings liftera and Precautions (5.10)].

Several other types of spastic movement disorders and some other long-term conditions not effectively treated by other types of medical treatment also have reported success with botulinum toxins. The medical uses for botulinum toxins are likely to expand in the future.

The more significant side effects like drooping eyelids are also more likely with improper dosage or technique.

Clinical improvement generally begins within the first two weeks after injection with maximum clinical benefit at approximately six weeks post-injection. In the double-blind, placebo-controlled study most subjects were observed to have returned to pre-treatment status by 3 months post-treatment.

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