Drug information for PENLAC

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION; TOPICAL 8% Prescription AT (Reference Drug) CICLOPIROX ciclopirox SANOFI AVENTIS US 21022
2004-12-08 Letter
2004-12-08 Label
2003-12-29 Label
2003-12-24 Letter
2003-06-22 Letter
2003-06-22 Label
1999-12-17 Review
1999-12-17 Patient Package Insert
1999-12-17 Letter
1999-12-17 Label

Drug Adverse Effects information for PENLAC

Role code Indications Reaction # Reports
C ACNE CHOLECYSTITIS 5
C ACNE CHOLELITHIASIS 5
C ACNE INJURY 5
C ACNE PAIN 5
C CONSTIPATION ABDOMINAL DISTENSION 2
C CONSTIPATION AMAUROSIS FUGAX 2
C CONSTIPATION ANXIETY 2
C CONSTIPATION ARTHRALGIA 2
C CONSTIPATION ASCITES 2
C CONSTIPATION ASPIRATION 2
C CONSTIPATION ASTHENIA 2
C CONSTIPATION ATROPHIC VULVOVAGINITIS 2
C CONSTIPATION BACK DISORDER 2
C CONSTIPATION BACK PAIN 2
C CONSTIPATION BENIGN NEOPLASM OF ADRENAL GLAND 2
C CONSTIPATION BLINDNESS 2
C CONSTIPATION BONE DISORDER 2
C CONSTIPATION BONE PAIN 2
C CONSTIPATION BRONCHITIS 2
C CONSTIPATION BRUXISM 2
C CONSTIPATION CATARACT 2
C CONSTIPATION CENTRAL NERVOUS SYSTEM LESION 2
C CONSTIPATION CHOLELITHIASIS 2
C CONSTIPATION CHROMATURIA 2
C CONSTIPATION CONFUSIONAL STATE 2
C CONSTIPATION CONSTIPATION 2
C CONSTIPATION COUGH 2
C CONSTIPATION DEATH 2
C CONSTIPATION DECREASED INTEREST 2
C CONSTIPATION DELUSION 2
C CONSTIPATION DEVICE RELATED INFECTION 2
C CONSTIPATION DIPLOPIA 2
C CONSTIPATION DIZZINESS 2
C CONSTIPATION DRY EYE 2
C CONSTIPATION DRY MOUTH 2
C CONSTIPATION DYSPHAGIA 2
C CONSTIPATION DYSPNOEA 2
C CONSTIPATION DYSURIA 2
C CONSTIPATION EXCORIATION 2
C CONSTIPATION EYE IRRITATION 2
C CONSTIPATION FACE OEDEMA 2
C CONSTIPATION FACIAL PAIN 2
C CONSTIPATION FALL 2
C CONSTIPATION FATIGUE 2
C CONSTIPATION GASTRITIS 2
C CONSTIPATION GENERAL PHYSICAL HEALTH DETERIORATION 2
C CONSTIPATION GLOSSITIS 2
C CONSTIPATION HALLUCINATION 2
C CONSTIPATION HEADACHE 2
C CONSTIPATION HEPATIC LESION 2
C CONSTIPATION HEPATIC STEATOSIS 2
C CONSTIPATION HIP FRACTURE 2
C CONSTIPATION HYPERHIDROSIS 2
C CONSTIPATION HYPERTHERMIA 2
C CONSTIPATION HYPOAESTHESIA ORAL 2
C CONSTIPATION HYPOTENSION 2
C CONSTIPATION INFLUENZA LIKE ILLNESS 2
C CONSTIPATION INTRAOCULAR PRESSURE INCREASED 2
C CONSTIPATION IRIS ADHESIONS 2
C CONSTIPATION LOSS OF CONSCIOUSNESS 2
C CONSTIPATION LYMPHADENOPATHY 2
C CONSTIPATION MACULAR CYST 2
C CONSTIPATION MACULAR DEGENERATION 2
C CONSTIPATION MACULAR HOLE 2
C CONSTIPATION METASTASES TO BONE 2
C CONSTIPATION METASTASES TO LIVER 2
C CONSTIPATION MOUTH ULCERATION 2
C CONSTIPATION MYALGIA 2
C CONSTIPATION NASAL CONGESTION 2
C CONSTIPATION NAUSEA 2
C CONSTIPATION NOCTURIA 2
C CONSTIPATION OSTEONECROSIS OF JAW 2
C CONSTIPATION OSTEOPENIA 2
C CONSTIPATION PAIN 2
C CONSTIPATION PAIN IN EXTREMITY 2
C CONSTIPATION PAIN IN JAW 2
C CONSTIPATION PALPITATIONS 2
C CONSTIPATION PATHOLOGICAL FRACTURE 2
C CONSTIPATION PHYSICAL DISABILITY 2
C CONSTIPATION POLLAKIURIA 2
C CONSTIPATION RASH 2
C CONSTIPATION SINUSITIS 2
C CONSTIPATION SWOLLEN TONGUE 2
C CONSTIPATION SYNCOPE 2
C CONSTIPATION TONGUE ULCERATION 2
C CONSTIPATION TOOTHACHE 2
C CONSTIPATION VERTIGO 2
C CONSTIPATION VISUAL IMPAIRMENT 2
C DEPRESSION CHOLECYSTITIS 3
C DEPRESSION CHOLELITHIASIS 3
C DEPRESSION INJURY 3
C DEPRESSION PAIN 3
C MENSTRUATION IRREGULAR CHOLELITHIASIS 4
C MENSTRUATION IRREGULAR EMOTIONAL DISTRESS 4
C MENSTRUATION IRREGULAR GALLBLADDER DISORDER 4
C MENSTRUATION IRREGULAR GENERAL PHYSICAL HEALTH DETERIORATION 4
C MENSTRUATION IRREGULAR PAIN 4
C MYELODYSPLASTIC SYNDROME ABDOMINAL DISCOMFORT 3
C MYELODYSPLASTIC SYNDROME ARTERIAL DISORDER 3
C MYELODYSPLASTIC SYNDROME CHEST PAIN 3
C MYELODYSPLASTIC SYNDROME EYE DISORDER 3
C MYELODYSPLASTIC SYNDROME HAEMORRHAGE 3
C MYELODYSPLASTIC SYNDROME HYPERSENSITIVITY 3
C MYELODYSPLASTIC SYNDROME LACRIMATION INCREASED 3
C MYELODYSPLASTIC SYNDROME MALAISE 3
C MYELODYSPLASTIC SYNDROME PHARYNGITIS 3
C MYELODYSPLASTIC SYNDROME PRURITUS 3
C MYELODYSPLASTIC SYNDROME RASH GENERALISED 3
C MYELODYSPLASTIC SYNDROME RHINORRHOEA 3
C MYELODYSPLASTIC SYNDROME SEPSIS 2
C MYELODYSPLASTIC SYNDROME TOOTH INFECTION 3
C MYELODYSPLASTIC SYNDROME VOMITING 3
C NAUSEA ABDOMINAL DISTENSION 1
C NAUSEA AMAUROSIS FUGAX 1
C NAUSEA ANXIETY 1
C NAUSEA ARTHRALGIA 1
C NAUSEA ASCITES 1
C NAUSEA ASPIRATION 1
C NAUSEA ASTHENIA 1
C NAUSEA ATROPHIC VULVOVAGINITIS 1
C NAUSEA BACK DISORDER 1
C NAUSEA BACK PAIN 1
C NAUSEA BENIGN NEOPLASM OF ADRENAL GLAND 1
C NAUSEA BLINDNESS 1
C NAUSEA BONE DISORDER 1
C NAUSEA BONE PAIN 1
C NAUSEA BRONCHITIS 1
C NAUSEA BRUXISM 1
C NAUSEA CATARACT 1
C NAUSEA CENTRAL NERVOUS SYSTEM LESION 1
C NAUSEA CHOLELITHIASIS 1
C NAUSEA CHROMATURIA 1
C NAUSEA CONFUSIONAL STATE 1
C NAUSEA CONSTIPATION 1
C NAUSEA COUGH 1
C NAUSEA DEATH 1
C NAUSEA DECREASED INTEREST 1
C NAUSEA DELUSION 1
C NAUSEA DEVICE RELATED INFECTION 1
C NAUSEA DIPLOPIA 1
C NAUSEA DIZZINESS 1
C NAUSEA DRY EYE 1
C NAUSEA DRY MOUTH 1
C NAUSEA DYSPHAGIA 1
C NAUSEA DYSPNOEA 1
C NAUSEA DYSURIA 1
C NAUSEA EXCORIATION 1
C NAUSEA EYE IRRITATION 1
C NAUSEA FACE OEDEMA 1
C NAUSEA FACIAL PAIN 1
C NAUSEA FALL 1
C NAUSEA FATIGUE 1
C NAUSEA GASTRITIS 1
C NAUSEA GENERAL PHYSICAL HEALTH DETERIORATION 1
C NAUSEA GLOSSITIS 1
C NAUSEA HALLUCINATION 1
C NAUSEA HEADACHE 1
C NAUSEA HEPATIC LESION 1
C NAUSEA HEPATIC STEATOSIS 1
C NAUSEA HIP FRACTURE 1
C NAUSEA HYPERHIDROSIS 1
C NAUSEA HYPERTHERMIA 1
C NAUSEA HYPOAESTHESIA ORAL 1
C NAUSEA HYPOTENSION 1
C NAUSEA INFLUENZA LIKE ILLNESS 1
C NAUSEA INTRAOCULAR PRESSURE INCREASED 1
C NAUSEA IRIS ADHESIONS 1
C NAUSEA LOSS OF CONSCIOUSNESS 1
C NAUSEA LYMPHADENOPATHY 1
C NAUSEA MACULAR CYST 1
C NAUSEA MACULAR DEGENERATION 1
C NAUSEA MACULAR HOLE 1
C NAUSEA METASTASES TO BONE 1
C NAUSEA METASTASES TO LIVER 1
C NAUSEA MOUTH ULCERATION 1
C NAUSEA MYALGIA 1
C NAUSEA NASAL CONGESTION 1
C NAUSEA NAUSEA 1
C NAUSEA NOCTURIA 1
C NAUSEA OSTEONECROSIS OF JAW 1
C NAUSEA OSTEOPENIA 1
C NAUSEA PAIN 1
C NAUSEA PAIN IN EXTREMITY 1
C NAUSEA PAIN IN JAW 1
C NAUSEA PALPITATIONS 1
C NAUSEA PATHOLOGICAL FRACTURE 1
C NAUSEA PHYSICAL DISABILITY 1
C NAUSEA POLLAKIURIA 1
C NAUSEA RASH 1
C NAUSEA SINUSITIS 1
C NAUSEA SWOLLEN TONGUE 1
C NAUSEA SYNCOPE 1
C NAUSEA TONGUE ULCERATION 1
C NAUSEA TOOTHACHE 1
C NAUSEA VERTIGO 1
C NAUSEA VISUAL IMPAIRMENT 1
C PAIN ABDOMINAL DISTENSION 4
C PAIN AMAUROSIS FUGAX 4
C PAIN ANXIETY 4
C PAIN ARTHRALGIA 4
C PAIN ASCITES 4
C PAIN ASPIRATION 4
C PAIN ASTHENIA 4
C PAIN ATROPHIC VULVOVAGINITIS 4
C PAIN BACK DISORDER 4
C PAIN BACK PAIN 4
C PAIN BENIGN NEOPLASM OF ADRENAL GLAND 4
C PAIN BLINDNESS 4
C PAIN BONE DISORDER 4
C PAIN BONE PAIN 4
C PAIN BRONCHITIS 4
C PAIN BRUXISM 4
C PAIN CATARACT 4
C PAIN CENTRAL NERVOUS SYSTEM LESION 4
C PAIN CHOLELITHIASIS 4
C PAIN CHROMATURIA 4
C PAIN CONFUSIONAL STATE 4
C PAIN CONSTIPATION 4
C PAIN COUGH 4
C PAIN DEATH 4
C PAIN DECREASED INTEREST 4
C PAIN DELUSION 4
C PAIN DEVICE RELATED INFECTION 4
C PAIN DIPLOPIA 4
C PAIN DIZZINESS 4
C PAIN DRY EYE 4
C PAIN DRY MOUTH 4
C PAIN DYSPHAGIA 4
C PAIN DYSPNOEA 4
C PAIN DYSURIA 4
C PAIN EXCORIATION 4
C PAIN EYE IRRITATION 4
C PAIN FACE OEDEMA 4
C PAIN FACIAL PAIN 4
C PAIN FALL 4
C PAIN FATIGUE 4
C PAIN GASTRITIS 4
C PAIN GENERAL PHYSICAL HEALTH DETERIORATION 4
C PAIN GLOSSITIS 4
C PAIN HALLUCINATION 4
C PAIN HEADACHE 4
C PAIN HEPATIC LESION 4
C PAIN HEPATIC STEATOSIS 4
C PAIN HIP FRACTURE 4
C PAIN HYPERHIDROSIS 4
C PAIN HYPERTHERMIA 4
C PAIN HYPOAESTHESIA ORAL 4
C PAIN HYPOTENSION 4
C PAIN INFLUENZA LIKE ILLNESS 4
C PAIN INTRAOCULAR PRESSURE INCREASED 4
C PAIN IRIS ADHESIONS 4
C PAIN LOSS OF CONSCIOUSNESS 4
C PAIN LYMPHADENOPATHY 4
C PAIN MACULAR CYST 4
C PAIN MACULAR DEGENERATION 4
C PAIN MACULAR HOLE 4
C PAIN METASTASES TO BONE 4
C PAIN METASTASES TO LIVER 4
C PAIN MOUTH ULCERATION 4
C PAIN MYALGIA 4
C PAIN NASAL CONGESTION 4
C PAIN NAUSEA 4
C PAIN NOCTURIA 4
C PAIN OSTEONECROSIS OF JAW 4
C PAIN OSTEOPENIA 4
C PAIN PAIN 4
C PAIN PAIN IN EXTREMITY 4
C PAIN PAIN IN JAW 4
C PAIN PALPITATIONS 4
C PAIN PATHOLOGICAL FRACTURE 4
C PAIN PHYSICAL DISABILITY 4
C PAIN POLLAKIURIA 4
C PAIN RASH 4
C PAIN SINUSITIS 4
C PAIN SWOLLEN TONGUE 4
C PAIN SYNCOPE 4
C PAIN TONGUE ULCERATION 4
C PAIN TOOTHACHE 4
C PAIN VERTIGO 4
C PAIN VISUAL IMPAIRMENT 4
C PSORIASIS ABDOMINAL DISCOMFORT 3
C PSORIASIS ARTERIAL DISORDER 3
C PSORIASIS CHEST PAIN 3
C PSORIASIS EYE DISORDER 3
C PSORIASIS HAEMORRHAGE 3
C PSORIASIS HYPERSENSITIVITY 3
C PSORIASIS LACRIMATION INCREASED 3
C PSORIASIS MALAISE 3
C PSORIASIS PHARYNGITIS 3
C PSORIASIS PRURITUS 3
C PSORIASIS RASH GENERALISED 3
C PSORIASIS RHINORRHOEA 3
C PSORIASIS SEPSIS 2
C PSORIASIS TOOTH INFECTION 3
C PSORIASIS VOMITING 3
C PYREXIA CHOLELITHIASIS 2
C PYREXIA EMOTIONAL DISTRESS 2
C PYREXIA GALLBLADDER DISORDER 2
C PYREXIA GENERAL PHYSICAL HEALTH DETERIORATION 2
C PYREXIA PAIN 2
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