Drug Information
Side Effects > Indocin

Indocin Side Effects

Generic Name: Indomethacin

Please note - some side effects for Indocin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA at http://www.fda.gov/medwatch/ or 1-800-FDA-1088 (1-800-332-1088).


For the consumer

For the professional

Side Effects of Indocin - for the consumer


Indocin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Indocin:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.


Indocin IV

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin IV:

Redness, pain, or oozing at the injection site.

Seek medical attention right away if any of these SEVERE side effects occur when using Indocin IV:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in vomit, stool, or urine; dark, tarry stools; decreased urination; slow heartbeat; unusual bruising or bleeding; unusual weight gain.


Indocin Suppositories

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin Suppositories:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; rectal irritation; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Indocin Suppositories:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; inability to urinate or pass a stool even though you have the urge; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.


Indocin Suspension

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin Suspension:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Indocin Suspension:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.


Indocin SR Sustained-Release Capsules

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Indocin SR Sustained-Release Capsules:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Seek medical attention right away if any of these SEVERE side effects occur when using Indocin SR Sustained-Release Capsules:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

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For the professional


Indocin

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

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

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%
*
Reactions occurring in 3% to 9% of patients treated with Indocin. (Those reactions occurring in less than 3% of the patients are unmarked.)
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 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-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

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 non-steroidal anti-inflammatory agents, including indomethacin, sometimes with fatal outcome.

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More resources:

Cerner Multum Indocin

PDR Indocin

MedFacts Indocin SR Sustained-Release Capsules

MedFacts Indocin

MedFacts Indomethacin

Micromedex Indocin - Includes detailed dosage instructions.

FDA Indomethacin

Facts & Comparisons Indomethacin

FDA Indocin

Disclaimer: Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. In addition, the drug information contained herein may be time sensitive and should not be utilized as a reference resource beyond the date hereof. This information does not endorse drugs, diagnose patients, or recommend therapy. This drug information is a reference resource designed as supplement to, and not a substitute for, the expertise, skill , knowledge, and judgement of healthcare practitioners in patient care. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug of drug combination is safe, effective, or appropriate for any given patient. Drugs.com does not assume any responsibility for any aspect of healthcare administered with the aid of information provided. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse, or pharmacist.


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