Midol IB Side Effects

Generic Name: ibuprofen

Note: This page contains information about the side effects of ibuprofen. Some of the dosage forms included on this document may not apply to the brand name Midol IB.

Not all side effects for Midol IB may be reported. You should always consult a doctor or healthcare professional for medical advice. Side effects can be reported to the FDA here.

For the Consumer

Applies to ibuprofen: oral capsule, oral capsule liquid filled, oral suspension, oral tablet, oral tablet chewable

Other dosage forms:

In addition to its needed effects, some unwanted effects may be caused by ibuprofen (the active ingredient contained in Midol IB). In the event that any of these side effects do occur, they may require medical attention.

You should check with your doctor immediately if any of these side effects occur when taking ibuprofen:

More common
  • Abdominal pain
  • acid or sour stomach
  • belching
  • bloating
  • cloudy urine
  • decrease in amount of urine
  • decrease in urine output or decrease in urine-concentrating ability
  • diarrhea
  • difficulty having a bowel movement (stool)
  • excess air or gas in stomach or intestines
  • full feeling
  • heartburn
  • indigestion
  • itching skin
  • pain or discomfort in chest, upper stomach, or throat
  • pale skin
  • passing gas
  • nausea
  • noisy, rattling breathing
  • rash with flat lesions or small raised lesions on the skin
  • shortness of breath
  • swelling of face, fingers, hands, feet, lower legs, or ankles
  • troubled breathing at rest
  • troubled breathing with exertion
  • unusual bleeding or bruising
  • unusual tiredness or weakness
  • vomiting
  • weight gain
Less common
  • Abdominal cramps
  • stomach soreness or discomfort
Rare
  • Agitation
  • back, leg, or stomach pains
  • bleeding gums
  • blistering, peeling, loosening of skin
  • blood in urine or stools
  • bloody, black, or tarry stools
  • blurred vision
  • burning feeling in chest or stomach
  • change in vision
  • chest pain
  • chills
  • clay-colored stools
  • coma
  • confusion
  • constipation
  • cough or hoarseness
  • dark urine
  • decreased urine output
  • depression
  • difficulty breathing
  • difficulty swallowing
  • dilated neck veins
  • dizziness
  • dry mouth
  • extreme fatigue
  • fast, irregular, pounding, or racing heartbeat or pulse
  • fever with or without chills
  • frequent urination
  • general body swelling
  • general feeling of tiredness or weakness
  • hair loss, thinning of hair
  • headache
  • hives or welts
  • hostility
  • impaired vision
  • increased blood pressure
  • increased volume of pale, dilute urine
  • irregular breathing
  • irritability
  • itching
  • joint or muscle pain
  • lab results that show problems with liver
  • lethargy
  • light-colored stools
  • loss of appetite
  • lower back or side pain
  • muscle twitching
  • nosebleeds
  • painful or difficult urination
  • pains in stomach, side, or abdomen, possibly radiating to the back
  • pinpoint red spots on skin
  • puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
  • rash
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of skin
  • seizures
  • severe abdominal pain, cramping, burning
  • severe and continuing nausea
  • sore throat
  • sores, ulcers, or white spots in mouth or on lips
  • stiff neck or back
  • stomach upset
  • stupor
  • swollen or painful glands
  • tenderness in stomach area
  • thirst
  • tightness in chest
  • unpleasant breath odor
  • upper right abdominal pain
  • vomiting of blood
  • vomiting of material that looks like coffee grounds
  • wheezing
  • yellow eyes and skin
Symptoms of overdose
  • Bluish lips or skin
  • difficulty sleeping
  • disorientation
  • dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly
  • drowsiness to profound coma
  • hallucination
  • lightheadedness or fainting
  • mood or other mental changes
  • muscle tremors
  • not breathing
  • rapid, deep breathing
  • restlessness
  • slow or irregular heartbeat
  • stomach cramps
  • sudden fainting
  • sweating

Some of the side effects that can occur with ibuprofen may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common
  • Continuing ringing or buzzing or other unexplained noise in ears
  • hearing loss
  • nervousness
Rare
  • Crying
  • depersonalization
  • discouragement
  • dry eyes
  • dysphoria
  • euphoria
  • feeling sad or empty
  • lack of appetite
  • loss of interest or pleasure
  • mental depression
  • paranoia
  • quick to react or overreact
  • rapidly changing moods
  • runny nose
  • sleepiness or unusual drowsiness
  • sleeplessness
  • sneezing
  • stuffy nose
  • trouble concentrating
  • trouble sleeping
  • unable to sleep

For Healthcare Professionals

Applies to ibuprofen: compounding powder, intravenous solution, oral capsule, oral suspension, oral tablet, oral tablet chewable

Gastrointestinal

The incidence of gastrointestinal blood loss with ibuprofen (the active ingredient contained in Midol IB) is dose-related, occurring in up to 17% of patients receiving 1,600 mg per day and in 23% of patients receiving 2,400 mg per day.

Patients with a history of serious gastrointestinal events or alcohol abuse are at increased risk for severe gastrointestinal side effects. Ibuprofen should be used with caution in these patients.

Gastrointestinal (GI) side effects have been reported most frequently (up to 25% of patients). They have usually been mild and transient. They have included dyspepsia, nausea, vomiting, diarrhea, abdominal pain, and flatulence. More serious GI effects have been uncommonly reported and have included occult blood loss, ulcer, GI hemorrhage with or without perforation, and pancreatitis. In addition, small bowel enteropathies and ibuprofen-associated colitis have been reported. Bloody vomiting has occurred in overdose. Colonic and pyloric channel strictures have also been reported.

Hepatic

Elevations in liver function tests three times normal values have occurred in less than 1% of patients. Ibuprofen-induced hepatitis has been associated with fatal outcomes in some cases.

Vanishing bile duct syndrome has been associated with ibuprofen (the active ingredient contained in Midol IB) use. A 29-year-old male patient presented with right upper quadrant pain, jaundice, pruritus and dark urine. He had been taking ibuprofen 600 mg/day for body aches and tension related headaches three weeks prior to the onset of symptoms. The patient remained jaundiced, with xanthomatosis, and complained of fatigue and pruritus 12 months following ibuprofen ingestion. He was eventually referred to an institution for liver transplantation evaluation. The patient was diagnosed with vanishing bile duct syndrome attributed to ibuprofen use.

In patients with liver disease, frequent monitoring of liver function tests during ibuprofen therapy is recommended.

Hepatic side effects have included elevations in liver function tests in up to 15% of patients. Rarely, jaundice, cholestasis, hepatitis, and hepatic failure have been reported. Ibuprofen has also been implicated in the so-called acute vanishing bile duct syndrome in children and in cases of acute hepatitis in patients with established stable, chronic hepatitis C infection.

Renal

Ibuprofen (the active ingredient contained in Midol IB) may impair the ability of the kidney to cope with low renal blood flow states due to inhibition of prostaglandin-dependent afferent arteriolar vasodilation. Renal function may be further compromised in patients with heart failure, hypovolemia, cirrhosis, nephrotic syndrome, or hypoalbuminemia. Additional risk factors for ibuprofen-induced renal insufficiency are advanced age and concomitant use of diuretics.

A case-controlled study suggested that patients who consumed 5000 or more pills containing NSAIDs during their lifetime may be at increased risk of end-stage renal disease.

Patients with reduced renal function may be at increased risk for renal side effects.

Renal side effects have included mild renal insufficiency, urinary retention, nephrotic syndrome with or without renal failure, acute renal failure due to tubulointerstitial nephritis, papillary necrosis, and acute tubular necrosis.

Metabolic

Metabolic side effects have included hyponatremia and syndrome of inappropriate antidiuretic hormone (SIADH). In addition, gynecomastia, hypoglycemia, and acidosis have been reported, although causality is unknown. Hyperkalemia has occurred in overdose.

Cardiovascular

Cardiovascular side effects have included peripheral edema (1% to 3%) and elevated blood pressure (less than 1%). This may be important in some patients with preexisting hypertension or congestive heart failure.

A rare case of painful, persistent peripheral cyanosis and swelling of the fingers and toes which progressed to desquamation and digital pitting infarctions has been associated with ibuprofen (the active ingredient contained in Midol IB)

Nonsteroidal anti-inflammatory drugs (NSAIDs) may elevate blood pressure and increase the risk for the initiation of antihypertensive therapy. Furthermore, NSAIDs may antagonize the blood pressure lowering effect of antihypertensive medications in patients already being treated with antihypertensive drugs.

Nervous system

The incidence of aseptic meningitis is higher in patients with systemic lupus erythematosus and other connective tissue diseases although it has been reported in patients without such underlying disease states.

A recurrent episode of aseptic meningitis is reported in a 51-year-old male within the first seven days of self-administration of ibuprofen (the active ingredient contained in Midol IB) for coryza symptoms. His headache resolved within 24 hours after discontinuation of ibuprofen. The development of aseptic meningitis appears to be independent of ibuprofen dose.

Nervous system side effects have been reported rarely. These have included headache, drowsiness, and dizziness. Aseptic meningitis associated with ibuprofen has been described in several case reports. In addition, paresthesias and pseudotumor cerebri have been reported, although causality is unknown.

Hypersensitivity

Hypersensitivity side effects have included erythematous or urticarial rashes, pruritus, angioedema, bronchospasm, and anaphylactoid reactions, particularly in patients with the syndrome of asthma, nasal polyps, and angioedema and/or bronchospastic reactivity to aspirin. Rare cases of systemic reactions, including interstitial nephritis, diffuse pulmonary infiltrates, and Stevens-Johnson syndrome have been reported. Toxic epidermal necrolysis has also been reported, although causality is unknown. At least one case of an acute anaphylactic reaction has also been reported.

A 12-year-old male with significant history of urticaria and angioedema experienced an acute anaphylactic reaction coincident with ibuprofen therapy. He presented to the hospital with fever and cough of 1 day duration after receiving 150 mg dose of ibuprofen (5 mg/kg). He developed a generalized rash, facial angioedema, and shortness of breath 1 hour after ingestion. An acute anaphylactic reaction to ibuprofen was diagnosed. Resuscitation was initiated immediately, and his vital signs stabilized after treatment. His subsequent progress was uneventful, with no further progression or recurrence of symptoms.

Hematologic

Reductions in serum hemoglobin concentrations are uncommon, and are usually associated with occult gastrointestinal blood loss. Ibuprofen induces an antiplatelet effect for at least 6 hours while preserving normal antiplatelet mechanisms.

A 44-year-old female with an unremarkable medical history, except for an appendectomy at the age of 18, experienced hemolytic uremic syndrome (HUS) coincident with ibuprofen (the active ingredient contained in Midol IB) therapy. She was admitted to the hospital for thrombocytopenia and anemia after taking 8 tablets orally of 400 mg ibuprofen. She was diagnosis with HUS. She recovered completely after therapy with fresh-frozen plasma and seven plasma exchanges.

Hematologic side effects have included platelet dysfunction, neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia, thrombocytopenia, eosinophilia, and decreases in hemoglobin and hematocrit. At least one case of hemolytic uremic syndrome has also been reported.

Respiratory

Acute noncardiogenic pulmonary edema developed on two occasions in an HIV-positive patient. Infectious as well as cardiac etiologies were excluded. A close temporal relationship with the administration of ibuprofen (the active ingredient contained in Midol IB) and onset of symptoms was noted.

Respiratory side effects have included noncardiogenic pulmonary edema.

Dermatologic

Dermatologic side effects have been reported rarely. These have included maculopapular rash, pruritus, vesiculobullous eruptions, erythema multiforme, vasculitis, Stevens-Johnson syndrome, and alopecia. Photosensitivity reactions have been reported, although causality is unknown. At least one case of acute generalized exanthematous pustulosis has also been reported.

Acute generalized exanthematous pustulosis has been reported in an 80-year-old female, with a history of chronic plaque psoriasis, a week after taking ibuprofen 400 mg three times daily for hip pain. There was marked improvement of symptoms within one week of discontinuation of the drug.

Acute generalized exanthematous pustulosis is characterized by a rapid onset of numerous nonfollicular pustules on a widespread erythema associated with a pyrexia of greater than 38 degrees Celsius and a neutrophilia of greater than 7 x 10^9/L. The histopathological features include papillary edema, a mixed upper dermal perivascular infiltrate and a spongiform subcorneal pustule.

Ocular

Ocular side effects have included blurred vision (less than 1%), scotomata, and diplopia. In addition, at least one case of corneal verticillata has also been reported during ibuprofen (the active ingredient contained in Midol IB) use.

Other

Other side effects have included tinnitus (1% to 3%) and vertigo.

Psychiatric

Psychiatric side effects have included case reports of pseudodementia and psychotic exacerbation.

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