Indocin Oral Suspension
- Generic Name: indomethacin oral suspension
- Brand Name: Indocin Oral Suspension
Indocin Oral Suspension (Indomethacin Oral Suspension) side effects drug center
Indocin Oral Suspension Side Effects Center
What Is Indocin Oral Suspension?
Indocin (indomethacin) for oral use is a nonsteroidal anti-inflammatory drug (NSAID) used to treat severe rheumatoid arthritis, ankylosing spondylitis, osteoarthritis, acute gouty arthritis, bursitis, and tendinitis. Indocin is available in generic form.
What Are Side Effects of Indocin Oral Suspension?
Common side effects of Indocin include:
- vomiting
- upset stomach
- heartburn
- diarrhea
- feeling of bowel fullness
- constipation
- bloating
- gas
- rectal irritation
- headache
- ringing in your ears
- dizziness
- nervousness
- skin rash
- itching, or
- blurred vision
Serious side effects of Indocin may include:
- heart attack
- stroke
- skin changes (paleness, blisters, rash, and hives)
- weight gain
- swelling
- shortness of breath
- tachycardia
- unusual bleeding (including GI bleeding)
- yellowing of skin or eyes (jaundice)
- stomach pain
- pain with urination
- bloody urine
- blurry vision, and
- back pain
Dosage for Indocin Oral Suspension
Indocin is available in capsules in strengths of 25 and 50 mg, in suspension strength of 25 mg per 5 ml and as a suppository in strength of 50 mg per suppository. Initial doses usually start at 25 mg three times daily. Indocin IV (indomethacin) for Injection Sterile Vial contains 1 mg Indocin and is used by specialists in infants to close a patent ductus arteriosus in the heart and is not commonly prescribed. Indocin (indomethacin) ordinarily should not be prescribed for pediatric patients under 15 years old.
Indocin Oral Suspension During Pregnancy and Breastfeeding
In late pregnancy, Indocin (indomethacin and other NSAIDs) should be avoided because it may cause premature closure of the ductus arteriosus. Indocin may interact with antidepressants, blood thinners, cyclosporine, digoxin, diuretics (water pills), lithium, methotrexate, probenecid, steroids, aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs), or beta-blockers. Tell your doctor all medications and supplements you use. In late pregnancy, Indocin (indomethacin and other NSAIDs) should be avoided because it may cause premature closure of the ductus arteriosus. Indocin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and infant; it is not recommended for use in breastfeeding women.
Additional Information
Our Indocin and Indocin, IV (indomethacin) for Injection Sterile Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
Indocin Oral Suspension Consumer Information
Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).
Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.
Stop using indomethacin and call your doctor at once if you have:
- a skin rash, no matter how mild;
- changes in your vision;
- heart problems--swelling, rapid weight gain, feeling short of breath;
- signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea, vomiting, diarrhea, unusual tiredness, itching, flu-like symptoms, dark urine, jaundice (yellowing of the skin or eyes);
- signs of stomach bleeding--bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
- kidney problems--little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
- low red blood cells (anemia)--pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.
Common side effects may include:
- indigestion, nausea;
- headache; or
- dizziness.
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.
Read the entire detailed patient monograph for Indocin Oral Suspension (Indomethacin Oral Suspension)
Indocin Oral Suspension Professional Information
SIDE EFFECTS
The following adverse reactions are discussed in greater detail in other sections of the labeling:
- Cardiovascular Thrombotic Events [see WARNINGS AND PRECAUTIONS]
- GI Bleeding, Ulceration and Perforation [see WARNINGS AND PRECAUTIONS]
- Hepatotoxicity [see WARNINGS AND PRECAUTIONS]
- Hypertension [see WARNINGS AND PRECAUTIONS]
- Heart Failure and Edema [see WARNINGS AND PRECAUTIONS]
- Renal Toxicity and Hyperkalemia [see WARNINGS AND PRECAUTIONS]
- Anaphylactic Reactions [see WARNINGS AND PRECAUTIONS]
- Serious Skin Reactions [see WARNINGS AND PRECAUTIONS]
- Hematologic Toxicity [see WARNINGS AND PRECAUTIONS]
Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving INDOCIN Capsules than in the group taking INDOCIN Suppositories or placebo.
In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse effects with INDOCIN Suppositories or Capsules was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.
The adverse reactions for INDOCIN Capsules listed in the following table have been arranged into two groups: (1) incidence greater than 1%; and (2) incidence less than 1%. The incidence for group (1) was obtained from 33 double-blind controlled clinical trials reported in the literature (1,092 patients). The incidence for group (2) was based on reports in clinical trials, in the literature, and on voluntary reports since marketing. The probability of a causal relationship exists between INDOCIN and these adverse reactions, some of which have been reported only rarely.
The adverse reactions reported with INDOCIN Capsules may also occur with use of the suspension.
Table 1 : Summary of Adverse Reactions for INDOCIN
Capsules
| Incidence greater than 1 % | Incidence less than 1% | |
| GASTROINTESTINAL | ||
| nausea* with or without vomiting dyspepsia* (including indigestion, heartburn and epigastric pain) diarrhea abdominal distress or pain constipation |
anorexia bloating (includes distension) flatulence peptic ulcer gastroenteritis rectal bleeding proctitis single or multiple ulcerations, including perforation and hemorrhage of the esophagus, stomach, duodenum or small and large intestines intestinal ulceration associated with stenosis and obstruction |
gastrointestinal bleeding without obvious ulcer formation and perforation of preexisting sigmoid lesions (diverticulum, carcinoma, etc.) development of ulcerative colitis and regional ileitis ulcerative stomatitis toxic hepatitis and jaundice (some fatal cases have been reported) intestinal strictures (diaphragms) |
| CENTRAL NERVOUS SYSTEM | ||
| headache (11.7%) dizziness* vertigo somnolence depression and fatigue (including malaise and listlessness) |
anxiety (includes nervousness) muscle weakness involuntary muscle movements insomnia muzziness psychic disturbances including psychotic episodes mental confusion drowsiness |
light-headedness syncope paresthesia aggravation of epilepsy and parkinsonism depersonalization coma peripheral neuropathy convulsion dysarthria |
| SPECIAL SENSES | ||
| tinnitus | ocular — corneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with INDOCIN | blurred vision diplopia hearing disturbances, deafness |
| CARDIOVASCULAR | ||
| None | hypertension hypotension tachycardia chest pain |
congestive heart failure arrhythmia; palpitations |
| METABOLIC | ||
| None | edema weight gain fluid retention flushing or sweating |
hyperglycemia glycosuria hyperkalemia |
| INTEGUMENTARY | ||
| none | pruritus rash; urticaria petechiae or ecchymosis |
exfoliative dermatitis erythema nodosum loss of hair Stevens-Jonnson syndrome erythema multiforme toxic epidermal necrolysis |
| HEMATOLOGIC | ||
| None | leukopenia bone marrow depression anemia secondary to obvious or occult gastrointestinal bleeding |
aplastic anemia hemolytic anemia agranulocytosis thrombocytopenic purpura disseminated intravascular coagulation |
| HYPERSENSITIVITY | ||
| None | acute anaphylaxis acute respiratory distress rapid fall in blood pressure resembling a shock-like state angioedema |
dyspnea asthma purpura angiitis pulmonary edema fever |
| GENITOURINARY | ||
| None | hematuria vaginal bleeding proteinuria nephrotic syndrome interstitial nephritis |
BUN elevation renal insufficiency, including renal failure |
| MISCELLANEOUS | ||
| None | epistaxis breast changes, including enlargement and tenderness, or gynecomastia | |
| *Reactions occurring in 3% to 9% of patients treated with INDOCIN. (Those reactions occurring in less than 3% of the patients are unmarked.) | ||
Causal relationship unknown: Other reactions have been reported but occurred under circumstances where a causal relationship could not be established. However, in these rarely reported events, the possibility cannot be excluded. Therefore, these observations are being listed to serve as alerting information to physicians:
Cardiovascular: Thrombophlebitis
Hematologic: Although there have been several reports of leukemia, the supporting information is weak
Genitourinary: Urinary frequency
A rare occurrence of fulminant necrotizing fasciitis, particularly in association with Group Aβ hemolytic streptococcus, has been described in persons treated with nonsteroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome
Read the entire FDA prescribing information for Indocin Oral Suspension (Indomethacin Oral Suspension)
&Copy; Indocin Oral Suspension Patient Information is supplied by Cerner Multum, Inc. and Indocin Oral Suspension Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.