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FDA Alerts
Oct 31, 2009 - FDA has approved four vaccines for immunization against the 2009 H1N1 influenza virus. Three of them are inactivated virus vaccines for injection, manufactured by CSL Limited, Sanofi Pasteur, Inc, and Novartis Vaccines and Diagnostics Limited. The ...
Oct 31, 2009 - Covidien is recalling certain lots of its End-Tidal CO2 Detectors, the Pedi-Cap and Pedi-Cap 6, because a modification made by the manufacturer may occlude the patient's airway. This could make it difficult to manually ventilate a patient, and lead ...
Oct 31, 2009 - Tibotec Therapeutics is notifying healthcare professionals of severe and potentially life-threatening skin reactions from Intelence (etravirine), an antiretroviral drug used in HIV combination therapy. Intelence has been associated with cases of Ste...
Oct 31, 2009 - Boston Scientific has changed the name of the company's Liberté Bare-Metal coronary stent to VeriFLEX. The company took this action after reports that Liberté Bare-Metal stents were inadvertently implanted instead of TAXUS Liberté Drug-Eluting stent...
Oct 31, 2009 - Philips Healthcare has alerted healthcare professionals about the possibility of inaccurate fetal heart rate readings from the company's Avalon fetal monitors, which use ultrasound to measure fetal heart rate. Inaccurate readings could result in unn...
Oct 31, 2009 - Healthcare professionals have been notified by the manufacturers of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) that these drugs, in combination with other immunosuppressive agents, have been associated with cases of pure red ce...
Oct 31, 2009 - The device company ConMed Linvatec is recalling certain surgical handpieces and cables. The handpieces are battery-powered devices used with drills, blades and other cutting devices during surgical procedures. This action affects certain model an...
Oct 31, 2009 - FDA is requiring stronger warnings about an increased risk of lymphoma and other cancers in children and adolescents who are treated with drugs that block tumor necrosis factor. TNF blockers include Remicade (infliximab), Enbrel (etancercept), Humir...
Oct 31, 2009 - Smiths Medical is recalling certain Portex uncuffed tracheal tubes in pediatric sizes. The recall affects several models of 2.5, 3.0 and 3.5 mm tubes manufactured before September 2009. The internal diameter of some of these tracheal tubes is sli...
Oct 31, 2009 - Emergency response help buttons are often worn by seniors to call for help in an emergency. The Philips Lifeline emergency button that is worn around the neck, may pose a choking hazard if the cord becomes accidentally entangled, and this can result...
Recalls (Drug & Food)
Consumer Health Info
Nov 24, 2009 - In this Consumer Update video, FDA Product Safety Expert Deborah Autor, J.D., helps explain the agency's warning, issued July 28, 2009, to stop using body building products that claim to contain steroids or steroid-like substances.
Nov 24, 2009 - FDA gives consumers practical food safety tips to help prevent foodborne illness
Nov 24, 2009 - FDA expands its reach to millions of consumers through a new partnership with Everyday Health.
Nov 23, 2009 - The posting of FDA staff in overseas regions is a key part of the agency's strategy for expanding oversight of imported food and medical products.
Nov 18, 2009 - Concerns about the health and safety hazards posed by caffeinated alcoholic beverages have prompted FDA action.
Nov 18, 2009 - Los consumidores tienen una función que cumplir, sobre todo cuando manipulan los alimentos en el hogar.
Nov 16, 2009 - A federal, state, and industry cooperative program helps protect the public from contaminated shellfish.
Nov 13, 2009 - A new program aims to reduce unnecessary injuries from medication misuse, errors, and other problems.
Nov 13, 2009 - As Halloween approaches, FDA reminds consumers that non-prescription decorative contact lenses may harm their vision.
Nov 4, 2009 - FDA has issued recent safety alerts on these medical products.
Nov 3, 2009 - FDA and WebMD have expanded their unique partnership to provide increased access to FDA’s consumer health information.
Oct 28, 2009 - FDA reminds people, in time for Halloween, that non-prescription decorative contact lenses may harm their vision.
Oct 27, 2009 - FDA has stepped up its campaign to inform consumers of—and protect them against—potential harm associated with unapproved products claiming to diagnose, prevent, or otherwise act against the H1N1 flu virus.
Oct 27, 2009 - Medical X-rays are an important tool for diagnosing and treating diseases, but they pose a small risk from radiation. This FDA Consumer Update video includes information on what you can do to reduce the risk.
Oct 23, 2009 - A federal, state, and industry cooperative program helps protect the public from contaminated shellfish.
Oct 23, 2009 - FDA recently issued guidelines on important differences between hearing aides and personal sound amplifying devices.
Oct 23, 2009 - FDA launches a new Web site that focuses on hearing aids.
Oct 22, 2009 - On October 15, 2009, the U.S. Food and Drug Administration (FDA) launched a study of the impact of LASIK on patients' quality of life, and issued warning letters to 17 LASIK surgery centers that release patients the same day as their surgery.
Oct 2, 2009 - FDA and more than 3,000 state, local, tribal, and territorial organizations work cooperatively to protect the nation’s food supply.
Sep 30, 2009 - FDA has issued recent safety alerts on these medical products.
News Releases
Nov 24, 2009 - The U.S. Food and Drug Administration (FDA) is seeking a permanent injunction against Sharkco Seafood International Inc., located in Venice, La. The injunction is intended to stop the seafood processing company from distributing scombrotoxin-forming fish in interstate commerce. Consumption of scombrotoxin-forming fish that are not properly preserved or refrigerated can result in scombroid food poisoning, a foodborne illness that results from eating spoiled or decayed fish. Scombrotoxin-forming fish most commonly include mackerel, sardines, tuna, bluefish, and mahi mahi.
Nov 20, 2009 - MICHAEL RALPH WORLEY, 43, of Camano Island, Washington, and DONALD ALAN PEPIN, 55, of Jupiter, Florida, were charged late yesterday by a federal grand jury in Seattle, Washington, with Conspiracy to Commit Wire Fraud and Engage in Interstate Transportation of Stolen Property and six counts of Wire Fraud. WORLEY is also charged with two counts of Interstate Transportation of Stolen Goods, while PEPIN is charged with two counts of Receipt of Stolen Goods. The conspiracy involved the theft of diabetic supplies, including insulin, from an Everett, Washington, Pharmacy. The insulin and other supplies were then sold to PEPIN for distribution to the public. Both men will be summoned to appear in federal court in Seattle for arraignment.
Nov 19, 2009 - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against William F. Nickle of North East, Md., for allegedly selling veal calves for human consumption that contained illegal drug residues in edible tissues.
Nov 19, 2009 - The U.S. Food and Drug Administration today completed a coordinated, weeklong, international effort, called the International Internet Week of Action (IIWA), intended to curb illegal actions involving medical products.
Nov 18, 2009 - On Nov. 16, 2009, Judge Marvin J. Garbis of the United States District Court for the District of Maryland entered a Consent Decree of Permanent Injunction (Decree) against Old Carolina Farm and its owner, Francis Roderick, of Ijamsville, Md. The Decree prohibits the defendants from selling animals for slaughter for human consumption until they have implemented record keeping systems that will identify and track animals that have been treated with drugs.
Nov 18, 2009 - Patients should avoid using the stomach acid reducer Prilosec/Prilosec OTC (omeprazole) with the anti-clotting drug Plavix (clopidogrel), the U.S. Food and Drug Administration warned on Nov. 17.
Nov 17, 2009 - The Food and Drug Administration (FDA) has approved the approval of Qutenza (capsaicin) 8% patch, a medicated skin patch that relieves the pain of post-herpetic neuralgia (PHN), a serious complication that can occur after a bout with shingles.
Nov 17, 2009 - The U.S. Food and Drug Administration (FDA) and Everyday Health today announced a collaboration that will expand the delivery of the agency’s vital consumer health information to the 30 million unique users who visit Everyday Health each month. This joint effort reflects FDA's emphasis on using innovative, technology-based strategies to carry out its mission of protecting and promoting the public health.
Nov 16, 2009 - The U.S. Food and Drug Administration announced that it has approved a fifth vaccine for protection against the 2009 H1N1 influenza virus. The vaccine is manufactured by ID Biomedical Corp. of Quebec, Canada, owned by GlaxoSmithKline PLC.
Nov 13, 2009 - The Food and Drug Administration's Center for Food Safety and Applied Nutrition (CFSAN) today released a report from the Institute of Food Technologists (IFT), which recommends clear objectives be set for all users of a simpler, globally accepted food supply chain that can benefit from existing commercial systems.
Nov 13, 2009 - The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.
Nov 13, 2009 - Several weeks ago, the FDA announced its intent to change, by summer 2011, its policy regarding the post-harvest processing of raw Gulf Coast oysters harvested in the warmer months. The intent of this change in policy, which would affect about 25% of the total annual harvest, would be to substantially reduce the number of Americans who suffer severe and painful illness and death from the Vibrio vulnificus bacteria. The FDA's announced change in policy was modeled on a successful California initiative that was implemented in 2003.
Nov 13, 2009 - The U.S. Food and Drug Administration today cleared for marketing the Platelet PGD Test System, the first rapid test for the detection of bacterial contamination in pooled platelets derived from whole blood.
Nov 13, 2009 - The Food and Drug Administration today notified nearly 30 manufacturers of caffeinated alcoholic beverages that it intends to look into the safety and legality of their products.
Nov 13, 2009 - The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against seafood processor Haifa Smoked Fish Inc. of Jamaica, N.Y., and two of its top officers for violations of the Federal Food, Drug and Cosmetic Act.
Nov 12, 2009 - Toan Le, 51, and Hang Ho, 41, a married couple residing in Burien, Washington, pleaded guilty today in U.S. District Court in Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration. LE pleaded guilty to providing an Illegal Gratuity to Public Official and HO pleaded guilty to Introduction or Delivery for Introduction Into Interstate Commerce of Adulterated Device. When sentenced by U.S. District Judge Ricardo S. Martinez, LE faces up to two years in prison and HO faces up to one year in prison.
Nov 12, 2009 - The U.S. Food and Drug Administration has approved the use of the CSL Limited’s 2009 H1N1 influenza vaccine to include children ages 6 months and older. This vaccine was previously approved only for use in adults, ages 18 years and older.
Nov 11, 2009 - Ming Yan, who operates a computer store in North Providence, has pleaded guilty to causing the misbranding of the prescription drug sildenafil citrate, which is marketed as Viagara, and to copyright infringement. Immigration and FDA agents seized counterfeit sildenafil citrate pills and more than 1,000 pirated movie DVDs from Yan’s store and home in March 2008.
Nov 10, 2009 - Dr. Margaret Hamburg, Commissioner of Food and Drugs, today sent a letter to America’s doctors thanking them for their efforts during the 2009 H1N1 influenza outbreak and providing information on the safety of the 2009 H1N1 vaccines.
Nov 9, 2009 - Cutaneous T-cell lymphoma affects about 1,500 Americans annually The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).
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