Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
Is Aluminum Hydroxide Gel approved in United States?
Yes. FDA has authorised it.
Who is the marketing authorisation holder for Aluminum Hydroxide Gel in United States?
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez is the originator. The local marketing authorisation holder may differ — check the official source linked above.