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Drug Side Effects

Recognizing and Reporting Drug Side Effects

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Updated May 16, 2014

Recognizing Drug Side Effects

Although parents often blame new symptoms on medications, how do you know if a symptom is actually a side effect of a medication and is not being caused by something else?

For example, say your child is sick with a sinus infection, starts taking an Amoxil and starts having diarrhea three days later. Is the diarrhea a specific side effect of Amoxil, a general side effect of taking an antibiotic, or the stomach flu that is also going through your child's daycare at the same time?

To help you recognize if your child is having a side effect to a medication, it can help to:

  • keep a detailed record of when your child starts, stops or changes dosages of any medication he takes
  • record any new symptoms when starting a new medication or changing dosages
  • ask your pediatrician and pharmacist about common side effects of medications your child is prescribed so that you know what to watch for
  • compare any unexplained symptoms that your child is having to the list of common side effects and uncommon side effects that are included on the medication's package insert
  • follow the directions when you give your child a medication, especially for medications such as Lindane which is an FDA approved second line treatment used to treat head lice, but can cause serious side effects even when used properly
  • tell your pediatrician and pharmacist about all other medications your child is taking, including over-the-counter medications, alternative therapies and vitamins to help them recognize any possible drug interactions that may lead to worsening drug side effects

Reporting Drug Side Effects

In addition to reporting drug side effects to your pediatrician, so that you can make a medication change, parents and pediatricians can report drug side effects directly to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Medwatch is just for FDA-regulated drugs, medical devices and some other products, but does not include vaccines. Vaccine side effects should instead be reported to the Vaccine Adverse Event Reporting System (VAERS).



Sources:

FDA Public Health Advisory. Nonprescription Cough and Cold Medicine Use in Children. August 15, 2007.

Physicians' Desk Reference. PDR 62. 2008.

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