- NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk (see WARNINGS).
- MOTRIN Suspension is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery (see WARNINGS).
- NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events (see WARNINGS).
MOTRIN® (ibuprofen) Suspension 100 mg/5 mL
The active ingredient in MOTRIN is ibuprofen, which is a member of the propionic acid group of nonsteroidal anti-inflammatory drugs (NSAIDs). Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers. It is a white to off-white crystalline powder, with a melting point of 74° to 77°C. It is practically insoluble in water (<0.1 mg/mL), but readily soluble in organic solvents such as ethanol and acetone. Ibuprofen has a pKa of 4.43±0.03 and an n-octanol/water partition coefficient of 11.7 at pH 7.4. The chemical name for ibuprofen is (±)-2-(p-isobutylphenyl) propionic acid.
In Children MOTRIN is indicated:
For reduction of fever in patients aged 6 months and older.
For relief of mild to moderate pain in patients aged 6 months and older.
For relief of signs and symptoms of juvenile arthritis.
In Adults MOTRIN is indicated:
For relief of mild to moderate pain.
For treatment of primary dysmenorrhea.
For relief of the signs and symptoms of rheumatoid arthritis and osteoarthritis.
Since there have been no controlled trials to demonstrate whether there is any beneficial effect or harmful interaction with the use of ibuprofen in conjuction with aspirin, the combination cannot be recommended (see PRECAUTIONS -- Drug Interactions).
Published Studies Related to Motrin (Ibuprofen)
A prospective randomized study to evaluate the antipyretic effect of the combination of acetaminophen and Ibuprofen in neurological ICU patients. [2011.12]
BACKGROUND: To compare the antipyretic effect of simultaneously administered acetaminophen (APAP) plus ibuprofen (IBU) to either APAP or IBU alone in critically ill febrile neurological and neurosurgical patients... CONCLUSION: The combination of IBU and APAP produces significantly greater fever control than APAP alone, with trends favoring the combination over IBU alone and IBU over APAP alone.
A randomised controlled trial of ibuprofen, paracetamol or a combination tablet of ibuprofen/paracetamol in community-derived people with knee pain. [2011.09]
OBJECTIVES: To compare the efficacy and safety of single versus combination non-prescription oral analgesics in community-derived people aged 40 years and older with chronic knee pain... CONCLUSIONS: Ibuprofen/paracetamol combination analgesia, at non-prescription doses, confers modest short-term benefits for knee pain/osteoarthritis. However, in this population, paracetamol 3 g/day may cause similar degrees of blood loss as ibuprofen 1200 mg/day, and the combination of the two appears to be additive. Study no ISRCTN77199439.
Randomized, open-label, 5-way crossover study to evaluate the pharmacokinetic/pharmacodynamic interaction between furosemide and the non-steroidal anti-inflammatory drugs diclofenac and ibuprofen in healthy volunteers. [2011.08]
OBJECTIVE: Nonsteroidal anti-inflammatory drugs (NSAIDs) can induce renal complications in patients taking loop diuretics. This study investigated the pharmacokinetic/pharmacodynamic effects and safety profile of orally administered diclofenac sodium, ibuprofen and diclofenac epolamine topical patch (DETP) on furosemide in healthy adult subjects... CONCLUSIONS: Pharmacodynamic effects were seen with oral diclofenac (urine output) and ibuprofen (urine sodium excretion). Furosemide also affected plasma and urine pharmacokinetic profiles. Pharmacologic effects of DETP on furosemide were not observed under these conditions. Additional research is warranted to delineate the potential interactions of other NSAIDs with furosemide and other loop diuretics.
A randomized controlled trial comparing acetaminophen, acetaminophen and ibuprofen, and acetaminophen and codeine for postoperative pain relief after Mohs surgery and cutaneous reconstruction. [2011.07]
BACKGROUND: There are no population-based data comparing analgesics after Mohs micrographic surgery (MMS) and reconstruction. OBJECTIVE To compare the efficacy in pain management of three analgesic combinations... CONCLUSIONS: The combination of Ac+Ib is superior to Ac alone or Ac+Co in controlling postoperative pain after MMS and cutaneous reconstruction. (c) 2011 by the American Society for Dermatologic Surgery, Inc.
Comparison of pre-emptive ibuprofen, paracetamol, and placebo administration in reducing post-operative pain in primary tooth extraction. [2011.07]
BACKGROUND: This study investigates preliminary investigations that a pre-emptive analgesia administration may reduce post-extraction pain. AIM: This prospective, placebo-controlled, randomized, double-blind trial was planned to compare the efficacy of the pre-emptive administration of ibuprofen, paracetamol, and placebo in reducing post-extraction pain in children... CONCLUSIONS: Preoperative use of ibuprofen and paracetamol may provide a pre-emptive analgesic effect in paediatric patients who receive adequate analgesia during mandibular primary tooth extraction. (c) 2011 The Authors. International Journal of Paediatric Dentistry (c) 2011 BSPD, IAPD and Blackwell Publishing Ltd.
Clinical Trials Related to Motrin (Ibuprofen)
Comparative Study of Efficacy and Safety of Oral Ibuprofen and Intravenous Ibuprofen in Closure of Patent Ductus Arteriosus in Very Low Birth Weight Infants [Completed]
it is a prospective randomized simple-blinded pilot trial with the principal aim to compare
efficacy and tolerance between oral ibuprofen and intravenous ibuprofen in early curative
closure of PDA in very low birth weight infants. The likelihood of ductal closure with only
one or two doses of treatment is a secondary objective.
Early Versus Late Use of Ibuprofen for PDA Closure [Recruiting]
The primary objective is to evaluate the PDA closure rate of early vs. late use of Ibuprofen
(Ibu). The investigators believe that early use of Ibu will have a higher PDA closure rate
than later use of Ibu. Early use is defined as medication given before the infant reaches
96 hrs old. Late use is defined as medication given when infant is more than 96 hrs old.
The secondary objective is to measure the stress hormone and metabolic response (plasma
catecholamines, glucose, and lactate) of neonates undergoing Ibu treatment of the PDA. The
investigators believe that early ibuprofen will blunt the stress response greater than later
Comparison of Oral and Intravenous Ibuprofen for PDA Treatment in Premature Infants [Recruiting]
Patent ductus arteriosus (PDA) continues to be one of the most common problems in premature
infants. Pharmacological closure of PDA with intravenous (IV) indomethacin was first
reported in 1976, however, concern remains regarding the safety of indomethacin, which
affects renal, GI and cerebral perfusion and may lead to complications such as transient or
permanent renal dysfunction, NEC, GI hemorrhage, and reduced cerebral oxygenation. Recently,
IV ibuprofen has been shown to be effective for the closure of patent ductus arteriosus in
premature infants, without reducing mesenteric, renal, or cerebral blood flow. We have
developed the echocardiographic PDA flow pattern as a guide for PDA treatment, fewer doses
of drugs were needed to achieve acceptable closing rates. We have also reported that IV
ibuprofen is as effective as IV indometacin for the PDA treatment in extremely premature
infants, without increasing the incidence of complications in a randomised controlled trial.
Several studies reported that oral ibuprofen may be effective for PDA treatment. To date
there is no firm conclusion as to the efficacy and safety of oral ibuprofen compared with IV
ibuprofen for PDA closure in extremely premature infants.
Since the efficacy of pharmacological closure of PDA is related to gestational age, and
extremely premature infants carry the highest rate of mortality and morbidity. We intend to
conduct a randomized controlled trial to compare oral and intravenous ibuprofen for
treatment of PDA in this high-risk population of extremely premature infants.
Extremely premature infants (gestational age < 28 weeks) admit to the NICU will be eligible
for enrollment. Informed parental consent will be obtained according to the Institutional
Review Board's instructions. Extremely premature infants with respiratory distress syndrome
(RDS) and PDA confirmed by echocardiography will be randomly assigned to receive either oral
or IV ibuprofen. The subsequent doses of ibuprofen are also determined according to our
specific echocardiographic PDA flow patterns at intervals of once every 24 hours from the
last dose. The dosage of oral or ibuprofen is 10 mg/kg (1 ml) and then 5 mg/kg at 24-hour
intervals as indicated by echocardiographic PDA flow pattern.
Sample Size Calculation and Length of the Study Period:
About 50-60 extremely premature infants will be admitted to our NICU each year. To prove
with McNemar's Test at a one-sided significance level of 5% and a power of 90% that using
oral ibuprofen instead of IV ibuprofen results in comparable PDA closure rates, only 31
extremely premature infants with RDS and PDA have to be enrolled. Allowing for attrition and
exclusion from the final study groups, the length of the study period will be safe to set to
We expect to determine whether oral ibuprofen is effective and safe in inducing PDA closure
in extremely premature infants and to compare the complications between infants treated with
oral ibuprofen and those with IV ibuprofen.
Efficacy and Safety Study to Compare Ibuprofen + Caffeine With Ibuprofen Alone in the Treatment of Headache [Not yet recruiting]
Based on established therapeutic effect of ibuprofen in the treatment of headache attacks,
and the action of caffeine in promoting better results when combined with treatments of
first choice in the treatment of headache, this study is designed to:
- evaluate the efficacy of therapy with ibuprofen + caffeine in headache patients
compared to ibuprofen alone;
- evaluate the tolerability of the association ibuprofen + caffeine compared to ibuprofen
The hypothesis is that the association is superior to treatment with ibuprofen alone in
terms of efficacy, while maintaining good tolerability.
Oral Ibuprofen Prophylaxis for Patent Ductus Arterioses in Very Extremely Low Birth Weight Infants [Recruiting]
Patent ductus arterioses (PDA) is a major morbidity in preterm infants, especially in
extremely premature infants less than 28 weeks. The clinical signs and symptoms of PDA in
preterm infants are non specific and insensitive for making an early diagnosis of
significant ductal shunting. Functional echocardiography is emerging as a new valuable
bedside tool for early diagnosis of hemodynamically significant ductus, even though there
are no universally accepted criteria for grading the hemodynamic significance.
Echocardiography has also been used for early targeted treatment of ductus arterioses,
though the long term benefits of such strategy are debatable. The biomarkers like BNP and N-
terminal pro-BNP are currently under research as diagnostic marker of PDA. The primary mode
of treatment for PDA is pharmacological closure using cyclo-oxygenase inhibitors with
closure rate of 70-80%. Oral ibuprofen is emerging as a better alternative especially in
Indian scenario where parenteral preparations of indomethacin are unavailable and side
effects are comparatively lesser. Though pharmacological closure of PDA is an established
treatment modality, there is still lack of evidence for long term benefits of such therapy
as well as there is some evidence for the possible adverse effects like increased ROP and
BPD rates, especially if treated prophylactically. The aim of this study is to investigate
the effect of oral ibuprofen prophylaxis administrated on the first 24 hours of life and the
following two days on hemodynamically significant patent ductus arterioses and its long term
effects such as ROP and BPD.
Reports of Suspected Motrin (Ibuprofen) Side Effects
Drug Ineffective (27),
Drug Hypersensitivity (18),
Toxic Epidermal Necrolysis (16),
Blood Glucose Increased (15),
Pain (13), more >>
PATIENT REVIEWS / RATINGS / COMMENTS
Based on a total of 15 ratings/reviews, Motrin has an overall score of 7.80. The effectiveness score is 8 and the side effect score is 8.53. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
Motrin review by 21 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Highly Effective|
|Side effects:|| || No Side Effects|
|Condition / reason:|| || menstrual cramps|
|Dosage & duration:|| || 2 tablets a day- morning and night taken twice a day. in the morning and night for the period of 34 days every month|
|Other conditions:|| || Ihave sinus but the pill does not have any side effects so it is advisable to take it to control men|
|Other drugs taken:|| || nothing else|
|Benefits:|| || I was relieved of menstrual cramps within 15 minutes of taking the pill and during nighttime i was able to sleep peacefully without any pain.I was able to carry out my routine work|
|Side effects:|| || There are absolutely no side effects|
|Comments:|| || it is advisable to take the tablet after breakfast and after dinner so that makes it twice a day but only for 4 days|
Motrin review by 58 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Mild Side Effects|
|Condition / reason:|| || arthritis pain, neck injury|
|Dosage & duration:|| || 800mg taken three times a day for the period of daily|
|Other conditions:|| || hypertension|
|Other drugs taken:|| || baclofen|
|Benefits:|| || decreased pain and inflamation, need no other pain medication for arthritis pain, have bee taking motrin for eight years with good results and little side effects other than mild nausea when taken without food.|
|Side effects:|| || motrin has caused mild nausea when taken without food and or milk. when taken after meals it did not cause any nausea, i have not noticed any other side effect.|
|Comments:|| || take motrin 800mg, 1 three times a day as needed for arthritis pain|
Motrin review by 38 year old female patient
|Overall rating:|| || |
|Effectiveness:|| || Considerably Effective|
|Side effects:|| || Extremely Severe Side Effects|
|Condition / reason:|| || flu|
|Dosage & duration:|| || max daily dose on packet (dosage frequency: each day) for the period of 3 days|
|Other conditions:|| || none|
|Other drugs taken:|| || none|
|Benefits:|| || significant reduction of pain due to the flu virus. this is a typical prescription for the flu, pain killers with lots of fluids. I was drawn to this tablets because they look appealing, the red capsules are easy to take and the caplets are coated in sugar. Normally I'd take paracetamol, which are dry and hard to swallow, I choose these to be kind to myself !!! I had no idea they could cause this reaction. they were good pain killers. |
|Side effects:|| || asthmatic condition. Heavy chest, dry cough, weakness, cumulative effect over days. Still prone to shortness of breath and tightness and heavy chest feelings, very sensitive to sulphides in wine and vinegars etc, was not before this. I only became aware of this connection when I took some I had left for a period pain, once again within seconds I was really ill.|
|Comments:|| || Not sure what this section requires ? It's a straight forward case of pain relief in response to the flu virus. the symptoms and the side effects became inter-twined, so it was not apparent that this drug was causing a reaction and worse than that I continued taking it as I became more and more ill. This is an over the counter drug, I would have appreciated more information from my pharmacist. I have tried to tell as many people as possible about what happened. After I have stopped taking the treatment I am left with a susceptibility to asthmatic type symptoms, it was also scary as I instinctively knew I was getting worse and became concerned something very serious was going on. I have never experience that type of "illness" before, normally I take time out and get well... this was an eye-opener.|
Page last updated: 2011-12-09