Nexplanon (etonogestrel) Implants
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
WARNINGS AND PRECAUTIONS
Complications of Insertion and Removal
There have been reports of migration of the implant... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Cleocin HCl (clindamycin hydrochloride) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – November 2009 and June 2014
March 2016
ADVERSE REACTIONS
An unpleasant or metallic taste has been reported after intravenous... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Sustiva (efavirenz) Capsules and Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
March 2016
DRUG INTERACTIONS
Table 5: Established and Other Potentially Significant Drug Interactions: Alteration in Dose or... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - March 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Fosrenol (lanthanum carbonate) Chewable Tablets and Oral Powder
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS (Revisions)
Serious cases of gastrointestinal obstruction, ileus, subileus, gastrointestinal... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 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)
February 2016
WARNINGS AND PRECAUTIONS
QT Interval Prolongation
Patients initiating therapy with INVIRASE/ritonavir:
An ECG... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Avalide (irbesartan/hydrochlorothiazide) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS
Electrolyte and Metabolic Imbalances
Coadministration of AVALIDE with... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Gilenya (fingolimod) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
CONTRAINDICATIONS
Patients who have had a hypersensitivity reaction to fingolimod or any of the excipients... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Opsumit (macitentan) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Postmarketing
General disorders and administration site conditions: edema/fluid retention
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Zostavax (Zoster Vaccine, Live)
Detailed View: Safety Labeling Changes Approved By FDA Center for Biologics Evaluation and Research (CBER)
February 2016
ADVERSE REACTIONS
Postmarketing
Eye Disorders: necrotizing retinitis (patients on... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Simponi Aria (golimumab) Injection
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Post-Marketing Experience
Hypersensitivity Reactions
In postmarketing experience, serious... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Effexor XR (venlafaxine Extended-Release) Capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Post-Marketing Experience
Dyspnea
interstitial lung disease
July 2014
... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Anoro Ellipta (umeclidinium and vilanterol inhalation powder), for Oral Inhalation
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Postmarketing Experience
In addition to adverse reactions reported from clinical trials,... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Atacand (candesartan cilexetil) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
WARNINGS AND PRECAUTIONS
Hyperkalemia
Concomitant use of ATACAND with drugs that may increase potassium levels may... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Stribild (elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate) Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
DRUG INTERACTIONS
Antipsychotics:
quetiapine
Initiation of STRIBILD in patients taking quetiapine: Consider... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
Depakene (valproic acid) CapsulesDepakene (valproic acid) Oral Solution Depakote (divalproex sodium) Delayed Release TabletsDepakote Sprinkle CapsulesDepacon (valproate sodium) InjectionDepakote ER (divalproex sodium) Extended Release Tablets
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
February 2016
ADVERSE REACTIONS
Postmarketing
Dermatologic: nail and nail bed disorders
Metabolism and nutrition: weight... (Source: Drugs.com - Labeling Changes)
Source: Drugs.com - Labeling Changes - February 1, 2016 Category: Drugs & Pharmacology Source Type: alerts
