Midol Maximum Strength Cramp Formula Side Effects

Generic name: ibuprofen

Note: This document contains side effect information about ibuprofen. Some of the dosage forms listed on this page may not apply to the brand name Midol Maximum Strength Cramp Formula.

Some side effects of Midol Maximum Strength Cramp Formula may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

For the Consumer

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

Get emergency medical help if you have any of these signs of an allergic reaction while taking ibuprofen (the active ingredient contained in Midol Maximum Strength Cramp Formula) hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking ibuprofen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;

• black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• swelling or rapid weight gain;

• urinating less than usual or not at all;

• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;

• bruising, severe tingling, numbness, pain, muscle weakness; or

• severe headache, neck stiffness, chills, increased sensitivity to light, and/or seizure (convulsions).

Less serious side effects of ibuprofen may include:

• upset stomach, mild heartburn, diarrhea, constipation;

• bloating, gas;

• dizziness, headache, nervousness;

• skin itching or rash;

• blurred vision; or

• ringing in your ears.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

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 Maximum Strength Cramp Formula) 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 Maximum Strength Cramp Formula) 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 Maximum Strength Cramp Formula) 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

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.

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.

Nervous system

Nervous system side effects have been reported rarely. These have included headache, drowsiness, and dizziness. Aseptic meningitis associated with ibuprofen (the active ingredient contained in Midol Maximum Strength Cramp Formula) has been described in several case reports. In addition, paresthesias and pseudotumor cerebri have been reported, although causality is unknown.

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 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.

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 Maximum Strength Cramp Formula) 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 Maximum Strength Cramp Formula) 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 Maximum Strength Cramp Formula) 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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