Merrem IV

Pregnancy category: B

Lactation: Unknown whether drug is excreted in breast milk; use with caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

• Redness and swelling at the injection site

• Bluish lips or skin
• chills
• cold, clammy skin
• confusion
• dizziness
• fainting
• fast heartbeat
• fast, weak pulse
• fever
• lightheadedness
• not breathing
• pain at the injection site
• rapid, shallow breathing
• skin rash and itching
• sweating

• Abdominal or stomach cramps and severe pain
• agitation
• black, bloody, or tarry stools
• black, bloody vomit
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blurred vision
• burning while urinating
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• convulsions (seizures)
• cough
• dark urine
• decreased urine output
• depression
• diarrhea (watery and severe), which may also be bloody
• difficult or painful urination
• difficulty with breathing
• dilated neck veins
• extreme fatigue
• fever with or without chills
• headache
• hostility
• irregular breathing
• irritability
• lethargy
• light-colored stools
• loss of consciousness
• muscle twitching
• nausea
• no blood pressure or pulse
• nosebleed
• pale skin
• pounding in the ears
• rapid weight gain
• severe constipation
• severe vomiting
• slow, irregular heartbeat
• stopping of the heart
• stupor
• tightness in the chest
• troubled breathing with exertion
• unconsciousness
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• unusual weight gain or loss
• vomiting of blood or material that looks like coffee grounds
• weight gain
• yellow eyes or skin

• Back, leg, or stomach pains
• bleeding gums
• blistering, peeling, or loosening of the skin
• chest pain
• confusion as to time, place, or person
• cough or hoarseness
• general body swelling
• general feeling of tiredness or weakness
• holding false beliefs that cannot be changed by fact
• joint or muscle pain
• large, hive-like swelling on the face, eyelids, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• lower back or side pain
• red skin lesions, often with a purple center
• red, irritated eyes
• seeing, hearing, or feeling things that are not there
• sore throat
• sores, ulcers, or white spots in the mouth or on the lips
• swollen glands
• unusual excitement, nervousness, or restlessness

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Constipation

• Body aches or pain
• cold hands and feet
• cold sweats
• congestion
• cool pale skin
• dryness or soreness of the throat
• increased hunger
• indigestion
• nightmares
• passing of gas
• redness, swelling, or soreness of the tongue
• runny nose
• shakiness
• slurred speech
• sneezing
• stomach pain, fullness, or discomfort
• trouble swallowing
• vaginal yeast infection
• voice changes

• Acid or sour stomach
• belching
• excess air or gas in the stomach or intestines
• full feeling
• heartburn
• hives or welts
• redness of the skin
• sleepiness or unusual drowsiness
• trouble sleeping
• white patches in the mouth, tongue, or throat

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.