Incidence greater than 1%Incidence less than 1%*Reactions occurring in 3% to 9% of patients treated with indomethacin. (Those reactions occurring in less than 3% of the patients are unmarked.)GASTROINTESTINALnausea* with or without vomiting dyspepsia* (including indigestion, heartburn and epigastric pain) diarrhea abdominal distress or pain constipationAnorexia 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 obstructiongastrointestinal bleeding without obvious ulcer formation and perforation of pre-existing 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 SYSTEMheadache (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 drowsinesslight-headedness syncope paresthesia aggravation of epilepsy and parkinsonism depersonalization coma peripheral neuropathy convulsion dysarthriaSPECIAL SENSESTinnitusocularcorneal deposits and retinal disturbances, including those of the macula, have been reported in some patients on prolonged therapy with Indomethacinblurred vision diplopia hearing disturbances, deafnessCARDIOVASCULARNoneHypertension hypotension tachycardia chest painMETABOLICnoneEdema weight gain fluid retention flushing or sweatingHyperglycemia glycosuria hyperkalemiaINTEGUMENTARYNoneexfoliative dermatitis erythema nodosum loss of hair Stevens-Johnson syndrome erythema multiforme toxic epidermal necrolysisHEMATOLOGICNoneLeucopenia bone marrow depression anemia secondary to obvious or occult gastrointestinal bleedingaplastic anemia hemolytic anemia agranulocytosis thrombocytopenic purpura disseminated intravascular coagulationHYPERSENSITIVITYNoneacute anaphylaxis acute respiratory distress rapid fall in blood pressure resembling a shock-like state angioedemaDyspnea asthma purpura angiitis pulmonary edema feverGENITOURINARYNoneHematuria vaginal bleeding proteinuria nephrotic syndrome interstitial nephritisBUN elevation renal insufficiency, including renal failureMISCELLANEOUSNoneEpistaxis breast changes, including enlargement and tenderness, or gynecomastiaCausal 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 Ahemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS, General).