"Nov. 2, 2012 -- Safety steps taken in the wake of the fungal meningitis outbreak have worsened drug shortages, raising questions about whether the U.S. must choose between the safety and the availability of crucial medicines.
Lortab Elixir Side Effects Center
Medical Editor: Melissa Conrad Stöppler, MD
Lortab elixir (hydrocodone and acetaminophen) is a combination pain reliever medication that contains the opioid drug (narcotic) hydrocodone as well as acetaminophen. The elixir form is a solution for oral administration. It is used to treat moderate to severe pain. Side effects can include dizziness, anxiety, constipation, and depression of respiratory function, among others. Like all narcotic pain relievers, this medication may cause dependence and withdrawal reactions, especially if it has been used regularly for a long time or in high doses.
There are no well-controlled studies on the use of this drug in pregnant women. Lortab Elixir should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Babies born to mothers who have been taking opioids regularly prior to delivery will be physically dependent. Acetaminophen is excreted in human milk in small amounts. It is not known whether hydrocodone is excreted in human milk. A decision should be made whether to discontinue nursing or to discontinue the drug in breastfeeding women.
Our Lortab elixir Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What is Patient Information in Detail?
Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.
Lortab Elixir in Detail - Patient Information: Side Effects
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.
Call your doctor at once if you have any of these serious side effects:
- shallow breathing, slow heartbeat;
- feeling light-headed, fainting;
- confusion, fear, unusual thoughts or behavior;
- seizure (convulsions);
- problems with urination; or
- nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious side effects may include:
- anxiety, dizziness, drowsiness;
- mild nausea, vomiting, upset stomach, constipation;
- headache, mood changes;
- blurred vision;
- ringing in your ears; or
- dry mouth.
Read the entire detailed patient monograph for Lortab Elixir (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
What is Patient Information Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Lortab Elixir Overview - Patient Information: Side Effects
Nausea, vomiting, constipation, lightheadedness, dizziness, or drowsiness may occur. Some of these side effects may decrease after you have been using this medication for a while. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
To prevent constipation, eat a diet adequate in fiber, drink plenty of water, and exercise. Consult your pharmacist for help in selecting a laxative (such as a stimulant type with stool softener).
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: mental/mood changes, severe stomach/abdominal pain, difficulty urinating.
Seek immediate medical attention if any of these rare but serious side effects occur: fainting, seizure, slow/shallow breathing, unusual drowsiness/difficulty waking up.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Lortab Elixir (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Lortab Elixir FDA Prescribing Information: Side Effects
Potential effects of high dosage are also listed in the OVERDOSAGE section.
Central Nervous System/Psychiatric: Anxiety, dizziness, drowsiness, dysphoria, euphoria, fear, general malaise, impairment of mental and physical performance, lethargy, light-headedness, mental clouding, mood changes, psychological dependence, sedation, somnolence progressing to stupor or coma.
Endocrine: Hypoglycemic coma.
Hypersensitivity: Allergic reactions.
Musculoskeletal: Skeletal muscle flaccidity.
Special Senses: Cases of hearing impairment or permanent loss have been reported predominantly in patients with chronic overdose.
DRUG ABUSE AND DEPENDENCE
Lortab Elixir (hydrocodone bitartrate and acetaminophen oral solution) (hydrocodone bitartrate and acetaminophen oral solution) is classified as a Schedule III controlled substance.
Abuse and Dependence
Hydrocodone can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence, and tolerance may develop upon repeated administration of narcotics; therefore, this product should be prescribed and administered with caution appropriate to the use of other oral narcotic medications. However, psychological dependence is unlikely to develop when hydrocodone bitartrate and acetaminophen oral solution are used for a short time for the treatment of pain.
Physical dependence, the condition in which continued administration of the drug is required to prevent the appearance of a withdrawal syndrome, assumes clinically significant proportions only after several weeks of continued narcotic use, although some mild degree of physical dependence may develop after a few days of narcotic therapy. Tolerance, in which increasingly large doses are required in order to produce the same degree of analgesia, is manifested initially by a shortened duration of analgesic effect, and subsequently by decreases in the intensity of analgesia. The rate of development of tolerance varies among patients.
Read the entire FDA prescribing information for Lortab Elixir (Hydrocodone Bitartrate and Acetaminophen Oral Solution)
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Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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