Drug Notebook

FDA Alerts

Special Alerts:

[Posted 01/17/2008] FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough and http://www.fda.gov/cder/drug/advisory/cough_cold_2008.htm.

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ibuprofen
(eye byoo PROE fen)

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with ibuprofen may cause you to bruise or bleed easily.

Before taking ibuprofen, tell your doctor if you are taking any of the following drugs:

  • aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others;

  • an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  • lithium (Eskalith, Lithobid);

  • diuretics (water pills) such as furosemide (Lasix);

  • methotrexate (Rheumatrex, Trexall);

  • steroids (prednisone and others); or

  • a blood thinner such as warfarin (Coumadin).

This list is not complete and there may be other drugs that can interact with ibuprofen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

  • chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

  • black, bloody, or tarry stools;

  • coughing up blood or vomit that looks like coffee grounds;

  • swelling or rapid weight gain;

  • urinating less than usual or not at all;

  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

  • bruising, severe tingling, numbness, pain, muscle weakness; or

  • fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

  • upset stomach, mild heartburn, diarrhea, constipation;

  • bloating, gas;

  • dizziness, headache, nervousness;

  • skin itching or rash;

  • blurred vision; or

  • ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

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