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Adverse Reactions definition

Adverse ReactionsÌýmeans any adverse event associated with the use of a drug in humans, whether or not considered drug related, including the following: an adverse event occurring in the course of the use of a drug product in professional practice; an adverse event occurring from drug overdose, whether accidental or intentional; an adverse event occurring from drug abuse; an adverse event occurring from drug withdrawal; and any failure of pharmacological action.
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Adverse Reactions.ÌýThe most commonly reported (â‰�25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, hypertension, vomiting, weight decreased, and constipation. Drug Interactions: Xxxxxx XXX0X0 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided.
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Adverse ReactionsÌýmeans the suspected or alleged adverse reactions to the Product.
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Examples of Adverse Reactions in a sentence

  • Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and reported to the competent authorities and relevant ethics committees in accordance with Directive 2001/20/EC or as per national regulatory requirements in participating countries.

  • This form is used to submit adverse event information to the Centre for Adverse Reactions Monitoring (CARM).

  • In clinical trials, hypersensitivity reactions were reported in fewer than 1 percent of patients [see Adverse Reactions (6.1)].

  • Suspected Unexpected Serious Adverse Reactions (SUSARs) will be collected and reported to the competent authorities and relevant ethics committees in accordance with EU Guidance 2011/C 172/01 or as per national regulatory requirements in participating countries.

  • In: Food Allergy: Adverse Reactions to Foods and Food Additives (Metcalfe DD, Sampson HA, Simon RA, ed).

  • In: Food Allergy: Adverse Reactions to Foods and Food Additives (Metcalfe DD, Samson HA, Simon RA, eds).

  • In: Food Allergy: Adverse Reactions to Foods and Food Additives (Metcalfe DD, Sampson HA, Simon RA, eds).

  • In addition to recording Suspected Serious Adverse Reactions (see section 4.1), information will be collected on all deaths and efforts will be made to ascertain the underlying cause.

  • Malignancies were observed in clinical studies of XELJANZ [see Adverse Reactions (6.1)].

  • Some of these adverse events appear to be dose related (see WARNINGS AND PRECAUTIONS; ADVERSE REACTIONS, Clinical Trial Adverse Reactions).


More Definitions of Adverse Reactions

Adverse ReactionsÌýinclude anaphylaxis and any other adverse reactions, whether foreseeable or not, including, but not limited to: i. Adverse reactions resulting from the administration of the vaccine, vaccine placebo, or other materials involved in the development of the vaccine or crude bulk, including challenge materials, ii. The failure of the vaccine to function as intended or to fail to confer immunity, iii. Side effects or performance of the vaccine in a manner not intended, and iv. Reactions that may be manifested long after exposure to the vaccine, vaccine placebo, or other materials associated with the development or manufacture of the vaccine or crude bulk (including challenge materials), which reactions are directly attributable to or result from the administration of such vaccine, vaccine placebo, or other materials.
Adverse Reactions.ÌýThe most commonly reported (â‰�25%) adverse reactions are: diarrhea, fatigue, nausea, decreased appetite, PPES, Drug Interactions: Strong CYP3A4 inhibitors and inducers: Reduce the dosage of CABOMETYX if concomitant use with strong CYP3A4 inhibitors cannot be avoided. Increase the dosage of CABOMETYX if concomitant use with strong CYP3A4 inducers cannot be avoided. Lactation: Advise a lactating woman not to breastfeed during treatment with CABOMETYX and for 4 months after the final dose. Reproductive Potential: Contraception―Advise females of reproductive potential to use effective contraception during treatment with Hepatic Impairment: Reduce the CABOMETYX dose in patients with mild (Child-Xxxx score [C-P] A) or moderate (C-P B) hepatic impairment. CABOMETYX is not recommended for use in patients with severe hepatic impairment. About Exelixis Exelixis Forward-Looking Statements
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Adverse ReactionsÌýmeans the definitions as set forth in EXHIBIT D.
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Related to Adverse Reactions

  • Adverse drug reaction means any undesirable or unexpected medication related event that requires discontinuing a medication or modifying the dose, requires or prolongs hospitalization, results in disability, requires supportive treatment, is life-threatening or results in death, results in congenital anomalies, or occurs following vaccination.

  • Adverse system impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Adverse Event means any untoward medical occurrence in a human clinical trial subject or in a patient who is administered a Product, whether or not considered related to the Product including, without limitation, any undesirable sign (including abnormal laboratory findings of clinical concern), symptom or disease associated with the use of such Product.

  • Adverse impact means any deleterious effect on waters or wetlands, including their quality, quantity, surface area, species composition, aesthetics or usefulness for human or natural uses which are or may potentially be harmful or injurious to human health, welfare, safety or property, to biological productivity, diversity, or stability or which unreasonably interfere with the enjoyment of life or property, including outdoor recreation.

  • Adverse action means a home or remote state action.