Indocin (Indomethacin) - Side Effects and Adverse Reactions

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ADVERSE REACTIONS

The adverse reactions for Capsules INDOCIN 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 Capsules INDOCIN may occur with use of the suppositories. In addition, rectal irritation and tenesmus have been reported in patients who have received the suppositories.

The adverse reactions reported with Capsules INDOCIN may also occur with use of the suspension.


*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 distention) 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 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 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 distur- bances including psychotic episodes mental confusion drowsiness	light-headedness syncope paresthesia aggravation of epilepsy and parkinsonism depersonalization coma peripheral neuropathy convulsions dysarthria
SPECIAL SENSES
tinnitus	ocular--corneal deposits and retinal distur- bances, including those of the macula, have been reported in some patients on pro- longed therapy with INDOCIN	blurred vision diplopia hearing disturbances, deafness


*Incidence greater than 1%*	*Incidence less than 1%*
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-Johnson 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 A (beta)-hemolytic streptococcus, has been described in persons treated with non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome (see also PRECAUTIONS, General).

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO INDOCIN

Below is a sample of reports where side effects / adverse reactions may be related to Indocin. The information is not vetted and should not be cosidered as verified clinical evidence.

Possible Indocin side effects / adverse reactions in 54 year old male

Reported by a health professional (non-physician/pharmacist) from France on 2007-02-16

Patient: 54 year old male

Reactions: Chest Pain, Coronary Artery Stenosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Indocin
    Administration route: Oral
    Indication: Ankylosing Spondylitis
    Start date: 2003-01-01

Infliximab
Indication: Ankylosing Spondylitis
Start date: 2004-01-29

Other drugs received by patient: Bromazepam; Perindopril; Atorvastatin Calcium; Candesartan

Possible Indocin side effects / adverse reactions in 87 year old male

Reported by a lawyer from United States on 2007-02-19

Patient: 87 year old male

Reactions: Vomiting, Renal Failure, Syncope, Anaemia Macrocytic, Atrioventricular Block First Degree

Adverse event resulted in: hospitalization

Suspect drug(s):
Indocin

Other drugs received by patient: Vasotec

Possible Indocin side effects / adverse reactions in 56 year old male

Reported by a physician from Japan on 2007-02-22

Patient: 56 year old male weighing 58.0 kg (127.6 pounds)

Reactions: Cardio-Respiratory Arrest, Tachycardia, Compartment Syndrome, Depressed Level of Consciousness, Acquired Haemophilia, Blood Pressure Decreased, Haematoma

Adverse event resulted in: death

Suspect drug(s):
Indocin
Administration route: Oral
Indication: Pustular Psoriasis

Tigason
Administration route: Oral
Indication: Pustular Psoriasis

Roxithromycin
Administration route: Oral
Indication: Pustular Psoriasis

Tacalcitol
Administration route: Topical
Indication: Pustular Psoriasis

Difluprednate
Administration route: Topical
Indication: Pustular Psoriasis

Betamethasone Butyrate Propionate
Administration route: Topical
Indication: Pustular Psoriasis

[therapy Unspecified]
Administration route: Topical
Indication: Pustular Psoriasis

Furosemide
Administration route: Oral
Indication: Oedema Peripheral

See index of all Indocin side effect reports >>

Drug label data at the top of this Page last updated: 2006-04-08

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