Xeljanz (tofacitinib) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Serious Infections
diverticulitis
ADVERSE REACTIONS
Clinical Trial... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Exparel (bupivacaine liposome) Injectable Suspension
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS Specific for EXPAREL
Using EXPAREL followed by other bupivacaine formulations has not been... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Clolar (clofarabine) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Hepatotoxicity
including hepatitis and hepatic failure,
ADVERSE REACTIONS
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Xolair (omalizumab) Powder for Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Anaphylaxis
A case-control study showed that, among Xolair users, patients with a history... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Zosyn (piperacillin and tazobactam for injection)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Skin Reactions
drug reaction with eosinophilia and systemic symptoms (DRESS), and acute... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Astagraf XL (tacrolimus extended-release capsules)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
DRUG INTERACTIONS
schisandra sphenanthera extracts
February 2014
5 WARNINGS AND PRECAUTIONS
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Oxtellar XR (oxcarbazepine) Extended-release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
Association with HLA-B*1502
Patients carrying the HLA-B*1502 allele may be at... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Ortho-Cept (desogestrel/ethinyl estradiol) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS
Thromboembolic Disorder and Other Vascular Problems
Thromboembolism
VTE risk is highest in the... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Invirase (saquinavir mesylate) Capsules and Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
December 2015
WARNINGS AND PRECAUTIONS
INVIRASE is not recommended for use in combination with cobicistat. Dosing recommendations... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - December 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Methotrexate Injection (Preservative) and (Preservative-Free)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
BOXED WARNING
WARNING
FOR INTRATHECAL AND HIGH-DOSE THERAPY, USE THE PRESERVATIVE-FREE FORMULATION OF... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Cefepime for Injection, USP and Dextrose Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Neurotoxicity
During postmarketing surveillance, serious adverse reactions have... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Aggrenox (aspirin/extended release dipyridamole) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Risk of Bleeding
Risk factors for bleeding include the use of other drugs that increase... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Avagard Surgical and Healthcare Personnel Hand Antiseptic (chlorhexidine gluconate 1 percent solution and ethyl alcohol 61 percent w/w)
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS
For external use only.
Flammable, keep away from fire or flames.
May 2012
DRUG... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Rapamune (sirolimus) Oral Solution and Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease/Non-Infectious Pneumonitis
In some cases, the ILD was reported... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
Opdivo (nivolumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
November 2015
WARNINGS AND PRECAUTIONS
Immune-Mediated Pneumonitis
Across clinical trial experience with solid tumors... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - November 1, 2015 Category: Drugs & Pharmacology Source Type: alerts
