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Indocin (Indomethacin) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS

In a gastroscopic study in 45 healthy subjects, the number of gastric mucosal abnormalities was significantly higher in the group receiving indomethacin capsules than in the group taking indomethacin suppositories or placebo.

In a double-blind comparative clinical study involving 175 patients with rheumatoid arthritis, however, the incidence of upper gastrointestinal adverse with indomethacin suppositories or indomethacin capsules was comparable. The incidence of lower gastrointestinal adverse effects was greater in the suppository group.

The adverse reactions for indomethacin 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 indomethacin and these adverse reactions, some of which have been reported only rarely.

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

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

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

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

indomethacin

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-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 indomethacin (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 β 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 SUSPECTED INDOCIN SIDE EFFECTS / ADVERSE REACTIONS

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 considered as verified clinical evidence.

Possible Indocin side effects / adverse reactions in 79 year old female

Reported by a consumer/non-health professional from United States on 2011-10-17

Patient: 79 year old female

Reactions: Abdominal Discomfort, Drug Effect Decreased, Overdose

Suspect drug(s):
Ibuprofen
    Dosage: 800 mg, unk
    Indication: Myalgia

Indocin
    Dosage: unk

Ibuprofen (Advil)
    Indication: Arthropathy

Ibuprofen (Advil)
    Dosage: 400 mg, 2x/day
    Indication: Osteoporosis

Ibuprofen (Advil)
    Indication: Arthritis

Mobic
    Dosage: unk
    Indication: Osteoporosis
    Start date: 2011-01-01
    End date: 2011-01-01

Ibuprofen (Advil)
    Indication: Myalgia

Mobic
    Indication: Arthritis

Naprosyn
    Dosage: unk

Ibuprofen
    Indication: Inflammation



Possible Indocin side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 59 year old male

Reactions: Blood Pressure Increased, Drug Ineffective, Stress

Suspect drug(s):
Voltaren
    Dosage: 25 mg
    Indication: Pain

Diflucan

Diclofenac Sodium

Indocin

Voltaren-XR
    Dosage: 75 mg
    Indication: Bursitis

Voltaren
    Dosage: 50 mg,



Possible Indocin side effects / adverse reactions in 59 year old male

Reported by a consumer/non-health professional from United States on 2011-12-19

Patient: 59 year old male

Reactions: Blood Pressure Increased, Drug Ineffective, Stress

Suspect drug(s):
Diflucan

Voltaren-XR
    Dosage: 75 mg
    Indication: Bursitis

Voltaren
    Dosage: 25 mg
    Indication: Pain

Voltaren
    Dosage: 50 mg,

Indocin

Diclofenac Sodium D.r. Tablets USP



See index of all Indocin side effect reports >>

Drug label data at the top of this Page last updated: 2011-10-05

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