July 23, 2016
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Indocin Oral Suspension

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Indocin Oral Suspension




Indocin Oral Suspension Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Last reviewed on RxList 6/8/2016

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. 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

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. 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.

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.

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.

Indocin Oral Suspension 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.

Stop taking indomethacin 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; or
  • bruising, severe tingling, numbness, pain, muscle weakness.

Less serious side effects may include:

  • upset stomach, mild heartburn, diarrhea, constipation;
  • bloating, gas;
  • dizziness, nervousness, headache;
  • skin rash, itching;
  • 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. 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)

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Indocin Oral Suspension FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The following adverse reactions are discussed in greater detail in other sections of the labeling:

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)

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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