adverse drug reaction

(redirected from Adverse Drug Experience)

adverse drug reaction (ADR),

"a response to a drug which is noxious and unintended and which occurs at doses normally used in man [sic] for prophylaxis, diagnosis, or therapy of disease or for the modification of physiologic function." [International Conference on Harmonisation of Technical Requirements of Pharmaceuticals for Human Use.]

adverse drug reaction

any unintended effect on the body as a result of the use of therapeutic drugs, drugs of abuse, or the interaction of two or more pharmacologically active agents. Also called drug reaction.

adverse drug reaction

Any noxious and unintended response associated with the use of a drug in humans.

Adverse Drug Reaction

Any noxious, undesired, or unintended response to a therapeutic agent, which may be expected or unexpected, and may occur at dosages used for the prophylaxis, diagnosis, or therapy of disease, or for modifying physiologic function. ADRs do not include therapeutic failures, poisoning, accidental or intentional overdoses. ADRs occur in up to 15% of all drug administrations, but are rarely fatal. They can be divided into type A—dose-dependent or predictable—or type B—idiosyncratic or allergic—reactions.
Clinical findings Pruritus, nausea, vomiting, rash, confusion, lethargy, etc.
Culprits ADR are most commonly caused by analgesics and narcotics, antibiotics, cardiovascular agents, anticoagulants, and psychotherapeutics.
Regulatory process In the preapproval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established, all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions; a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility—i.e., the relationship cannot be ruled out.

adverse drug reaction

Adverse drug event Pharmacology Any noxious, undesired, or unintended response to a drug, which occurs at dosages used for prophylaxis, diagnosis, therapy, or modification of physiologic functions; ADEs do not include therapeutic failures, poisoning, or intentional overdoses; ADEs occur in 1-15% of all drug administrations, but are rarely fatal

ad·verse drug re·ac·tion

(ADR) (ad-vĕrs' drŭg rē-ak'shŭn)
Any noxious, unintended, and undesired effect of a drug after its administration for prophylaxis, diagnosis, or therapy.
Synonym(s): adverse drug effect.

adverse drug reaction,

n a detrimental outcome from a drug. Two types of ADRs exist: Type 1 results from dosage mismatch and Type 2 from rare conditions often as a consequence of a small dose. See also risk or sensitive type.

ad·verse drug re·ac·tion

(ADR) (ad-vĕrs' drŭg rē-ak'shŭn)
Any noxious, unintended, and undesired effect of a drug after its administration for prophylaxis, diagnosis, or therapy. Also called adverse drug effect.

Patient discussion about adverse drug reaction

Q. I am worried about the allergic reactions I had from the Chinese herbal drug. I am worried about the allergic reactions I had from the Chinese herbal drug that I took for my arthritis…..are these safe?

A. Many people have some type of reaction to either a drug and even a supplement. You can check with your doc to get tested to see what your sensitivities are. Regarding arthritis, no milk, cheese, yogurt, butter, anything with milk for starters, AVOID like the plague! Suagr consumption too will raise hell with it. There is a product that someone I knew took, called, "Cell Guard" which he bought at a health food store or Whole Foods. After a couple of months, he was pain free. Its worth a try! Cell Guard is made with SOD or "superoxide dismutase"
Studies have shown that SOD can play a critical role in reducing internal inflammation and lessening pain associated with conditions such as arthritis! Check it out! Let me know how you do!

Q. Is this drug safe? Will there be any side effects? Can anyone update me on this? Hi, My doctor prescribed me Taxol and Herceptin. Is this drug safe? Will there be any side effects? Can anyone update me on this?

A. I want to share my experience with you. It’s not a big deal to try with Taxom and Herception. It does have Side effects and in my case I had bone pain for few days but I didn’t take anything for it really. Herception is a wonderful drug and I have no Side effects as many do not. I did lose the hair...and that did not bother me. Now I need to have correct treatment for survival and to me hair is only an accessory.. Try with wigs if there be severe hair loss?. Don’t rely on self-medication as the illness is deadly and not a simple cold or cough.

Q. Let me know, will there be any side effect by starting new medication. Medication is needed for my friend who is affected by bipolar disorder. We are also searching for some medication guidelines. Let me know, will there be any side effect by starting new medication.

A. There are possible side effects to all medications. Whenever anyone starts a new medication it is important to watch closely for side effects. Some side effects are mild and can be lived with. The pharmacy should provide a printout about the new medications and their possible side effects. It will also have instruction on what to do in the event the patient experiences some of the more serious side effects. Make sure your friend reads the printout, however most people only experience the minor side effects and find that they can live with them.
Good luck with the new meds, I hope your friend is feeling better very soon!

More discussions about adverse drug reaction
References in periodicals archive ?
NASDAQ: ACOR) violated shareholder protection laws by allegedly breaching compliance matters concerning adverse drug experience reporting, prompting an investigation by the FDA.
Robbins Umeda LLP is investigating whether officers and directors of Acorda Therapeutics breached their fiduciary duties to shareholders by permitting insufficient controls and improper procedures concerning adverse drug experience ("ADE") reporting and related compliance matters with the Food and Drug Administration ("FDA").
Serious adverse events (SAEs) are defined as any adverse drug experience, occurring at any dose that results in any of the following outcomes: (1) death (2) a life-threatening adverse drug experience (3) inpatient hospitalization or prolongation of existing hospitalization (4) a persistent or significant disability/incapacity, or a congenital anomaly/birth defect or (5) other important medical events as judged by the investigator.
Arc Pharma will implement Pilgrim's solutions to manage all aspects of its document systems; training on cGMP requirements; controlled documentation; internal, external, third-party and FDA audits; Complaint and Adverse Drug Experience reporting; and, CAPA tasks including investigations, implementations and dispositions.
Wyeth-Ayerst is working with investigators at Columbia University College of Physicians and Surgeons, the Mayo Clinic, and the Harvard School of Public Health to conduct postmarketing studies to better understand the clinical relevance of adverse drug experience reports.
a leading specialty pharmaceutical company, announced today the issuance by the United States Patent and Trademark Office of patent number 6,743,441, entitled "Compositions and Methods for Minimizing Adverse Drug Experiences Associated with Oxybutynin Therapy.
Various studies have shown that adverse drug experiences or events affect between 2 and 35 percent of hospitalized patients.
While narcotic analgesics provide excellent pain relief, the issue with narcotics is that they also generate unfortunate side effects and adverse drug experiences which may prolong recovery following surgery.